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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00518115
Other study ID # GLP110125
Secondary ID
Status Completed
Phase Phase 2
First received August 17, 2007
Last updated June 19, 2014
Start date April 2007
Est. completion date May 2008

Study information

Verified date May 2014
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Description:

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 Albiglutide (GSK716155) with Byetta as an open-label active reference, in subjects with Type 2 Diabetes Mellitus.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Albiglutide (GSK716155) or exenatide
Albiglutide weekly subcutaneous injection or exenatide twice daily injection

Locations

Country Name City State
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

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Chile,  Dominican Republic, 

References & Publications (1)

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

Outcome

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
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