Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A 16-Week, Parallel-Group, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of Multiple Doses and Multiple Treatment Regimens of GSK716155, With Byetta as an Open Label Active Reference, in Subjects With Type 2 Diabetes Mellitus
Verified date | May 2014 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus who are either taking no diabetes medication or who are taking metformin only. This study will investigate the safety, tolerability, and efficacy of Albiglutide (GSK716155) and will measure the levels of Albiglutide (GSK716155) in the bloodstream when it is given for 16 weeks. As a comparison, some subjects will receive exenatide instead of Albiglutide (GSK716155). The study will involve weekly visits for 17 weeks,and less frequent follow-up visits for an additional 10 weeks. Assessments include repeat blood sampling and monitoring of any side effects.
Status | Completed |
Enrollment | 361 |
Est. completion date | May 2008 |
Est. primary completion date | May 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Has type 2 diabetes mellitus as defined by the criteria of the American Diabetes Association and recognized by World Health Organization Expert Committee on the Diagnosis and Classification of Diabetes Mellitus [American Diabetes Association, 2004a] at least three months preceding screening - Has concurrent type 2 diabetes mellitus therapy: Must be diet and exercise treated; must not have taken antidiabetic medication for at least three months prior to prescreening or Monotherapy with metformin, with a history of a stable dose for at least three months before prescreening (not taking more than one oral antidiabetic agent) - Has HbA1c level at screening =7 and =10% - Is male or female 18 to 75 years of age, inclusive, at screening - Has body mass index =20 and =40 kg/m² - If subject is a smoker, must be able to abstain while in clinic at each visit - If female, is eligible to enter and participate throughout the study, including the follow-up period: 1) If of nonchildbearing potential (i.e. physiologically incapable of becoming pregnant {tubal ligation}, including any female who is postmenopausal [>1 year without menstrual period]); or, 2) If of childbearing potential, has negative pregnancy tests at screening (serum) and at baseline (urine) and: 3) Has a male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject, or 4) Uses double-barrier methods of contraception; condoms (with spermicide) and intrauterine devices are acceptable, or 5) Uses hormonal contraceptives (oral, depots, patches, etc) with double-barrier methods of contraception as outlined above, or, 6) Abstains from sexual intercourse, or 7) Is with a same-sex partner and does not participate in bisexual activities where there is any risk of pregnancy - Signs and dates informed consent before any study-related procedures are performed Exclusion Criteria: - Has metabolic disease including but not limited to: 1) Diagnosis of type 1 diabetes mellitus, 2) Uncorrected thyroid dysfunction (NOTE: subjects with hypothyroidism on a stable dose of thyroid replacement therapy for at least three months prior to screening, and who have a screening thyroid-stimulating hormone within the limits of normal may participate) - Has qualitative changes in lifestyle that, in the opinion of the investigator, would affect the subject's weight or disease status - Had previous use of insulin within one month prior to screening, or more than seven total days of insulin treatment within three months prior to screening - Has clinically significant cardiovascular and/or cerebrovascular disease including, but not limited to: 1) Previous history of stroke or transient ischemic attack, 2) Active, unstable coronary heart disease within the past six months, 3) Documented myocardial infarction within a year prior to screening 4) Any cardiac surgery including percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery within a year prior to screening 5) Unstable angina 6) Clinically significant arrhythmia or valvular heart disease within the past year 7) Congestive heart failure with New York Heart Association Class II to Class IV symptoms. Class I is acceptable. 8) Untreated hypertension, with systolic pressure greater than 160mm Hg and/or diastolic pressure greater than 95mm Hg. 9) ECG exclusion criteria: Heart rate is <40 and >110 beats per minute, PR Interval is <120 and >210msec, QRS duration is <70 and >120msec, QTc interval (Bazett) is >450msec or >480msec with bundle branch block - Has fasting serum triglycerides =800mg/dL or 9mmol/L at screening (Visit 2). Subjects receiving lipid-lowering therapy must have been on the same dose of therapy for the past three months. Fasting is defined as no food/drink for at least eight hours prior to sampling - If female, is currently lactating, pregnant, or actively trying to become pregnant - Has significant renal disease as manifested by one or more of the following: 1) Creatinine clearance <60mL/min. (estimated from serum creatinine and demographic data using the modification of diet in renal disease calculation; refer to the SPM/ISFM), 2) Urine albumin excretion =500 µg/mL on a urine spot check, 3) Known loss of a kidney either by surgical ablation, injury, or disease - Has history of significant comorbid diseases active within the last six months (e.g., gastrointestinal disease) - Has history of pancreatitis within five years prior to randomization - Has a documented history of chronic or advanced hepatobiliary disease including a history of, or positive laboratory results for, hepatitis at screening (Visit 2), and/or clinically significant hepatic enzyme elevation including: 1) Any two of the following enzymes greater than 1.5 times the upper limit of normal (ULN) value: - alanine aminotransferase (ALT), - aspartate aminotransferase (AST), - alkaline phosphatase (ALP), 2) Any one of the above enzymes two times greater than the ULN value AND total or direct bilirubin >1.5 times the ULN - Has a history of alcohol or substance abuse within the past year, as determined by the investigator or a positive urine drug screen at screening (Visit 2) or during treatment: 1) Unwilling to refrain from the use of excessive alcohol or illicit drugs and adhere to other protocol-stated restrictions while participating in the study, 2) History of alcohol abuse defined as an average weekly intake of greater than 21 units or an average daily intake of greater than three units (males) or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than two units (females). One unit is equivalent to a half-pint of beer or one measure of spirits or one glass of wine, 2) The investigator should exercise their medical judgment to determine if a urine drug screen is indicated - Is currently taking prohibited concomitant medications listed in Section 6.6.2 - Has clinically significant anemia (i.e., hemoglobin <12.0g/dL or <120.0g/L for males and <11.0g/dL or <110.0g/L for females) or any other abnormal hematological profile that is considered by the investigator to be clinically significant - Has known allergy to any formulation excipients, or history of drug or other allergy, which, in the opinion of the responsible study physician, contradicts participation - Received treatment with an investigational drug or participated in any other clinical trial during the previous 30 days - Has prior use of investigational agents with long half-lives of greater than seven days within the three months prior to screening - Has any prior use of a GLP-1 analog, including GSK716155 - In the opinion of the investigator, has a risk of noncompliance with study procedures, or cannot read, understand, or complete study-related materials, particularly the informed consent - Has any concurrent condition or any clinically significant abnormality identified on the screening physical examination, laboratory tests, ECG, including pulmonary, neurological, or inflammatory diseases, which, in the opinion of the investigator, may affect the interpretation of efficacy and safety data, or which otherwise, contraindicates participation in a clinical trial with a new chemical entity |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
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Chile | GSK Investigational Site | Buin | Región Metro De Santiago |
Chile | GSK Investigational Site | Concepcion | Región Del Biobio |
Chile | GSK Investigational Site | Santiago | Región Metro De Santiago |
Chile | GSK Investigational Site | Santiago | Región Metro De Santiago |
Dominican Republic | GSK Investigational Site | Santo Domingo | |
United States | GSK Investigational Site | Ames | Iowa |
United States | GSK Investigational Site | Anderson | Indiana |
United States | GSK Investigational Site | Anniston | Alabama |
United States | GSK Investigational Site | Asheville | North Carolina |
United States | GSK Investigational Site | Athens | Georgia |
United States | GSK Investigational Site | Atlanta | Georgia |
United States | GSK Investigational Site | Atlanta | Georgia |
United States | GSK Investigational Site | Atlanta | Georgia |
United States | GSK Investigational Site | Augusta | Georgia |
United States | GSK Investigational Site | Aurora | Illinois |
United States | GSK Investigational Site | Bend | Oregon |
United States | GSK Investigational Site | Bensalem | Pennsylvania |
United States | GSK Investigational Site | Billings | Montana |
United States | GSK Investigational Site | Birmingham | Alabama |
United States | GSK Investigational Site | Bismarck | North Dakota |
United States | GSK Investigational Site | Bismarck | North Dakota |
United States | GSK Investigational Site | Bradenton | Florida |
United States | GSK Investigational Site | Bristol | Tennessee |
United States | GSK Investigational Site | Buffalo | New York |
United States | GSK Investigational Site | Bull Shoals | Arizona |
United States | GSK Investigational Site | Caro | Michigan |
United States | GSK Investigational Site | Castro Valley | California |
United States | GSK Investigational Site | Chadbourn | North Carolina |
United States | GSK Investigational Site | Charlotte | North Carolina |
United States | GSK Investigational Site | Charlotte | North Carolina |
United States | GSK Investigational Site | Chester | Virginia |
United States | GSK Investigational Site | Clarksville | Tennessee |
United States | GSK Investigational Site | Clearwater | Florida |
United States | GSK Investigational Site | Cleburne | Texas |
United States | GSK Investigational Site | Cleveland | Ohio |
United States | GSK Investigational Site | Columbus | Ohio |
United States | GSK Investigational Site | Columbus | Georgia |
United States | GSK Investigational Site | Covington | Louisiana |
United States | GSK Investigational Site | Culver City | California |
United States | GSK Investigational Site | Dallas | Texas |
United States | GSK Investigational Site | Dearborn | Michigan |
United States | GSK Investigational Site | Decatur | Georgia |
United States | GSK Investigational Site | Denver | Colorado |
United States | GSK Investigational Site | Dubuque | Iowa |
United States | GSK Investigational Site | Euless | Texas |
United States | GSK Investigational Site | Evergreen Park | Illinois |
United States | GSK Investigational Site | Fargo | North Dakota |
United States | GSK Investigational Site | Fargo | North Dakota |
United States | GSK Investigational Site | Ft. Lauderdale | Florida |
United States | GSK Investigational Site | Fullerton | California |
United States | GSK Investigational Site | Gainesville | Florida |
United States | GSK Investigational Site | Garden Grove | California |
United States | GSK Investigational Site | Glendale | Arizona |
United States | GSK Investigational Site | Glens Falls | New York |
United States | GSK Investigational Site | Grand Forks | North Dakota |
United States | GSK Investigational Site | Greensboro | North Carolina |
United States | GSK Investigational Site | Harrisburg | Pennsylvania |
United States | GSK Investigational Site | Harrisburg | Arkansas |
United States | GSK Investigational Site | Haverhill | Massachusetts |
United States | GSK Investigational Site | Honolulu | Hawaii |
United States | GSK Investigational Site | Houston | Texas |
United States | GSK Investigational Site | Houston | Texas |
United States | GSK Investigational Site | Houston | Texas |
United States | GSK Investigational Site | Houston | Texas |
United States | GSK Investigational Site | Houston | Texas |
United States | GSK Investigational Site | Huntington Beach | California |
United States | GSK Investigational Site | Huntington Beach | California |
United States | GSK Investigational Site | Huntington Park | California |
United States | GSK Investigational Site | Indianapolis | Indiana |
United States | GSK Investigational Site | Jacksonville | Florida |
United States | GSK Investigational Site | Jefferson City | Missouri |
United States | GSK Investigational Site | Johnson City | Tennessee |
United States | GSK Investigational Site | Jonesboro | Arkansas |
United States | GSK Investigational Site | Jonesboro | Arizona |
United States | GSK Investigational Site | Kalamazoo | Michigan |
United States | GSK Investigational Site | Kansas City | Kansas |
United States | GSK Investigational Site | Knoxville | Tennessee |
United States | GSK Investigational Site | La Grange | Illinois |
United States | GSK Investigational Site | Lacombe | Louisiana |
United States | GSK Investigational Site | Lake Forest | California |
United States | GSK Investigational Site | LaPorte | Texas |
United States | GSK Investigational Site | Las Vegas | Nevada |
United States | GSK Investigational Site | Las Vegas | Nevada |
United States | GSK Investigational Site | Lewisville | Texas |
United States | GSK Investigational Site | Lexington | Kentucky |
United States | GSK Investigational Site | Libertyville | Illinois |
United States | GSK Investigational Site | Lincoln | Nebraska |
United States | GSK Investigational Site | Little Rock | Arkansas |
United States | GSK Investigational Site | Little Rock | Arkansas |
United States | GSK Investigational Site | Loma Linda | California |
United States | GSK Investigational Site | Longview | Texas |
United States | GSK Investigational Site | Los Angeles | California |
United States | GSK Investigational Site | Madison | Washington |
United States | GSK Investigational Site | Manassas | Virginia |
United States | GSK Investigational Site | Marianna | Florida |
United States | GSK Investigational Site | Memphis | Tennessee |
United States | GSK Investigational Site | Meridian | Idaho |
United States | GSK Investigational Site | Metairie | Louisiana |
United States | GSK Investigational Site | Miami | Florida |
United States | GSK Investigational Site | Midland | Texas |
United States | GSK Investigational Site | Milan | Tennessee |
United States | GSK Investigational Site | Mint Hill | North Carolina |
United States | GSK Investigational Site | Missouri City | Texas |
United States | GSK Investigational Site | Mobile | Alabama |
United States | GSK Investigational Site | Morrisville | Pennsylvania |
United States | GSK Investigational Site | Nashville | Tennessee |
United States | GSK Investigational Site | North Platte | Nebraska |
United States | GSK Investigational Site | Oak Brook | Illinois |
United States | GSK Investigational Site | Oklahoma City | Oklahoma |
United States | GSK Investigational Site | Omaha | Nebraska |
United States | GSK Investigational Site | Orange | California |
United States | GSK Investigational Site | Oviedo | Florida |
United States | GSK Investigational Site | Palm Harbor | Florida |
United States | GSK Investigational Site | Pasadena | Texas |
United States | GSK Investigational Site | Pearland | Texas |
United States | GSK Investigational Site | Perry | Georgia |
United States | GSK Investigational Site | Pharr | Texas |
United States | GSK Investigational Site | Phoenix | Arizona |
United States | GSK Investigational Site | Picayune | Mississippi |
United States | GSK Investigational Site | Plantation | Florida |
United States | GSK Investigational Site | Raleigh | North Carolina |
United States | GSK Investigational Site | Redwood City | California |
United States | GSK Investigational Site | Reedley | California |
United States | GSK Investigational Site | Riverside | California |
United States | GSK Investigational Site | Rochester | New York |
United States | GSK Investigational Site | Rolling Fork | Mississippi |
United States | GSK Investigational Site | Round Rock | Texas |
United States | GSK Investigational Site | Sacramento | California |
United States | GSK Investigational Site | Salem | Virginia |
United States | GSK Investigational Site | Salt Lake City | Utah |
United States | GSK Investigational Site | San Antonio | Texas |
United States | GSK Investigational Site | San Marcos | Texas |
United States | GSK Investigational Site | Searcy | Arkansas |
United States | GSK Investigational Site | South Bend | Indiana |
United States | GSK Investigational Site | South Bend | Indiana |
United States | GSK Investigational Site | South Burlington | Vermont |
United States | GSK Investigational Site | Spokane | Washington |
United States | GSK Investigational Site | Spring | Texas |
United States | GSK Investigational Site | Springfield | Missouri |
United States | GSK Investigational Site | St. Peters | Missouri |
United States | GSK Investigational Site | Sugar Land | Texas |
United States | GSK Investigational Site | Suwanee | Georgia |
United States | GSK Investigational Site | Syracuse | New York |
United States | GSK Investigational Site | Tallahassee | Florida |
United States | GSK Investigational Site | Tampa | Florida |
United States | GSK Investigational Site | The Woodlands | Texas |
United States | GSK Investigational Site | Toledo | Ohio |
United States | GSK Investigational Site | Tomball | Texas |
United States | GSK Investigational Site | Topeka | Kansas |
United States | GSK Investigational Site | Torrance | California |
United States | GSK Investigational Site | Trumbull | Connecticut |
United States | GSK Investigational Site | Tucker | Georgia |
United States | GSK Investigational Site | Uniontown | Pennsylvania |
United States | GSK Investigational Site | Van Buys | California |
United States | GSK Investigational Site | Ventura | California |
United States | GSK Investigational Site | Victorville | California |
United States | GSK Investigational Site | Watertown | South Dakota |
United States | GSK Investigational Site | Watseka | Illinois |
United States | GSK Investigational Site | Williamsville | New York |
United States | GSK Investigational Site | Wilmington | North Carolina |
United States | GSK Investigational Site | Winston-Salem | North Carolina |
United States | GSK Investigational Site | Winter Haven | Florida |
United States | GSK Investigational Site | Winter Park | Florida |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
United States, Chile, Dominican Republic,
Rosenstock J, Reusch J, Bush M, Yang F, Stewart M; Albiglutide Study Group. Potential of albiglutide, a long-acting GLP-1 receptor agonist, in type 2 diabetes: a randomized controlled trial exploring weekly, biweekly, and monthly dosing. Diabetes Care. 2009 Oct;32(10):1880-6. doi: 10.2337/dc09-0366. Epub 2009 Jul 10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 16 | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the value at Week 16 minus the value at Baseline. Based on ANCOVA: Change = treatment + Baseline HbA1c + prior therapy + gender + region. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. | Baseline and Week 16 | No |
Secondary | Change From Baseline in HbA1c at Weeks 4, 5, 7, 8, 9, 12, 15, and 16 | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline in HbA1c was calculated as the post-Baseline value minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. | Baseline and Weeks 4, 5, 7, 8, 9, 12, 15, and 16 | No |
Secondary | Number of Participants Who Achieved Target Values for HbA1c <6.5% and >=6.5% to <7% at Weeks 4, 5, 7, 8, 9, 12, 15, and 16 | The number of participants who achieved target values for HbA1c (i.e., HbA1c <6.5% and >=6.5% to <7%) were assessed. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. | Weeks (W) 4, 5, 7, 8, 9, 12, 15, and 16 | No |
Secondary | Change From Baseline in Waist Circumference at Week 16 | The Baseline value is the last non-missing value before the start of treatment. Change from Baseline in waist circumference was calculated as the value at Week 16 minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. | Baseline and Week 16 | No |
Secondary | Change From Baseline in Body Weight at Week 16 | The Baseline value is the last non-missing value before the start of treatment. Change from Baseline in body weight was calculated as the value at Week 16 minus the value at Baseline. The last observation carried forward (LOCF) method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. | Baseline and Week 16 | No |
Secondary | Percent Change From Baseline in Body Weight at Week 16 | The Baseline value is the last non-missing value before the start of treatment. Change from Baseline in body weight was calculated as the value at Week 16 minus the value at Baseline. Percent change from Baseline was calculated as the ([value at Week 16 minus the Baseline value] divided by the Baseline value) multiplied by 100. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. | Baseline and Week 16 | No |
Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 4, 5, 7, 8, 9, 12, 15, and 16 | The FPG test measures blood sugar levels after the participant has not eaten (fasted) for at least eight hours prior to the sampling. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline in FPG was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. | Baseline and Weeks 4, 5, 7, 8, 9, 12, 15, and 16 | No |
Secondary | Change From Baseline in Fasting Fructosamine at Weeks 5, 8, 12, and 16 | Fasting fructosamine levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline fructosamine value is the last non-missing value before the start of treatment. Change from Baseline in fructosamine was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. | Baseline and Weeks 5, 8, 12, and 16 | No |
Secondary | Change From Baseline in Fasting C-peptide at Weeks 5, 8, 12, and 16 | Fasting C-peptide levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline C-peptide value is the last non-missing value before the start of treatment. Change from Baseline in C-peptide was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. | Baseline and Weeks 5, 8, 12, and 16 | No |
Secondary | Change From Baseline in Fasting Glucagon at Weeks 5, 8, 12, and 16 | Fasting glucagon levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline glucagon value is the last non-missing value before the start of treatment. Change from Baseline in glucagon was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. | Baseline and Weeks 5, 8, 12, and 16 | No |
Secondary | Change From Baseline in Fasting Insulin at Weeks 5, 8, 12, and 16 | Fasting insulin levels were measured after the participant had not eaten (fasted) for at least eight hours prior to the sampling. The Baseline insulin value is the last non-missing value before the start of treatment. Change from Baseline in insulin was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. | Baseline and Weeks 5, 8, 12, and 16 | No |
Secondary | Change From Baseline in Triglycerides, Free Fatty Acids, Total Cholesterol, Low-density Lipoprotein Cholesterol, and High-density Lipoprotein Cholesterol at Weeks 5, 8, 12, and 16 | Serum lipid components, including triglycerides (TG), free fatty acids (FFA), total cholesterol (CL), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C), were measured at Baseline and Weeks 5, 8, 12, and 16. The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The LOCF method was used to impute missing data, in which the last valid observation recorded on treatment (scheduled or unscheduled) was used to impute the missing measurement. For participants who had missing observations before their last observation on treatment, the closest previous non-missing on-treatment observation was carried forward to missing visits. If a participant had missing observation(s) immediately after Baseline, the Baseline observation was not carried forward and was left as missing. | Baseline and Weeks 5, 8, 12, and 16 | No |
Secondary | Change From Baseline in Functional Living Index - Emesis (FLIE) Scores at Week 16 | The FLIE questionnaire is used to record the participant's feelings/opinions concerning the effects of nausea/vomiting on their quality of life during the past five days. Participants completed the questionnaire by responding to 18 questions. The first set of 9 questions refer to nausea, and the second set of 9 questions refer to vomiting. Each question is scored on a seven-point visual analog scale (1 to 7). On this scale, a score of 1 corresponds to 0 millimeters (mm), and a score of 7 correspond to 100 mm. Anything in between is marked at the appropriate point on the scale and is measured in mm. Data are reported in mm in this table. In FLIE questions (FLIEQ) 1, 2, 4, 5, 7, 8, 9, 10, 12, 13, 14, 16, and 17, a score of 1 indicates no effect on the quality of life, and a score of 7 indicates a great effect on the quality of life. In FLIEQ 3, 6, 11, 15, and 18, a score of 1 indicates a great effect on the quality of life, and a score of 7 indicates no effect on the quality of life. | Baseline and Week 16 | No |
Secondary | Number of Participants With the Indicated Response to Questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16 | The HCFQ questionnaire is used to record how often participants have felt hungry or craved food, and how full participants felt after finishing meals, on average, in the past week. Participants answered the following seven questions with the response that best described their feelings of hunger, craving, and fullness: Q1, "In the past week I was hungry"; Q2, "In the past week I thought about food"; Q3, "In the past week I wanted to eat"; Q4, "In the past week I ate more than I should have"; Q5, "In the past week, I craved specific food"; Q6, "In the past week when finished meals I felt full"; Q7, "In the past week when finished meals I felt satisfied." | Week 16 | No |
Secondary | Mean Clearance of Albiglutide | Clearance is defined as the volume of plasma cleared of albiglutide per unit time. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose pharmacokinetic (PK) sampling was performed within 6 days of drug administration. | Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27 | No |
Secondary | Mean Volume of Distribution of Albiglutide | Volume of distribution is defined as the apparent volume in which albiglutide is distributed. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose (PK sampling was performed within 6 days of drug administration. | Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27 | No |
Secondary | Mean Absorption Rate of Albiglutide | Absorption rate is defined as the rate at which albiglutide enters the blood circulation. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose (PK sampling was performed within 6 days of drug administration. | Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27 | No |
Secondary | Mean Half-maximal Effective Concentration (EC50) of Albiglutide for HbA1c and FPG | EC50 is defined as the concentration of albiglutide that give a half-maximal HbA1c and FPG response. Samples were collected prior to the administration of study medication on dosing days (Weeks 0, 4, 5, 7, 8, 9, 12, 15) and on the day of the clinic visit at Weeks 16, 17, 18, 20, 23, and 27. The Week 5, 8, and 12 post-dose (PK sampling was performed within 6 days of drug administration. EC50 estimates used PK data as well as HbA1c and FPG efficacy data. EC50 was estimated from an inhibitory Emax (maximal possible effect of albiglutide) model. | Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27 | No |
Status | Clinical Trial | Phase | |
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Active, not recruiting |
NCT05666479 -
CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
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Completed |
NCT05647083 -
The Effect of Massage on Diabetic Parameters
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N/A | |
Active, not recruiting |
NCT05661799 -
Persistence of Physical Activity in People With Type 2 Diabetes Over Time.
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N/A | |
Completed |
NCT03686722 -
Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin
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Phase 1 | |
Completed |
NCT02836704 -
Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose)
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Phase 4 | |
Completed |
NCT01819129 -
Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes
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Phase 3 | |
Completed |
NCT04562714 -
Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy
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N/A | |
Completed |
NCT02009488 -
Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM)
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Phase 1 | |
Completed |
NCT05896319 -
Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2
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N/A | |
Recruiting |
NCT05598203 -
Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes
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N/A | |
Completed |
NCT05046873 -
A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People
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Phase 1 | |
Completed |
NCT04030091 -
Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus
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Phase 4 | |
Terminated |
NCT04090242 -
Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes
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N/A | |
Completed |
NCT03604224 -
A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
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Completed |
NCT03620357 -
Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D)
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N/A | |
Completed |
NCT01696266 -
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
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Completed |
NCT03620890 -
Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy
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Phase 4 | |
Withdrawn |
NCT05473286 -
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
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Not yet recruiting |
NCT05029804 -
Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes
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N/A | |
Completed |
NCT04531631 -
Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes
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Phase 2 |