Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Phase IIIb, 24-week, Randomised, Placebo-controlled, Double-blinded, Efficacy and Safety Study of Linagliptin (BI 1356) in Black/African American Patients With Type 2 Diabetes With a MTT Sub-study
| Verified date | December 2013 |
| Source | Boehringer Ingelheim |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
Study of linagliptin vs. placebo in Black/African American patients with T2DM with a MTT sub-study
| Status | Completed |
| Enrollment | 234 |
| Est. completion date | October 2011 |
| Est. primary completion date | October 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion criteria: 1. Dated written informed consent that is in accordance with GCP and local legislation. 2. Male and female Black / African American patients 3. Diagnosis of type 2 diabetes at least 3 months prior to the informed consent. 4. HbA1c more than or equal to 7.5% and less than or equal to 11% at Visit 1. 5. Patients are currently treatment-naive or being treated with up to one oral antidiabetic medication. Antidiabetic medication is to be unchanged for at least 10 weeks prior to the informed consent. 6. Age more than 18 and less than 80 years at Visit 1 (Screening). 7. BMI (Body Mass Index) less than 45 kg/m2 at Visit 1. Exclusion criteria: 1. Myocardial infarction (MI), stroke or transient ischemic attack (TIA) within 3 months of informed consent. 2. Type 1 diabetes. 3. Impaired hepatic function, defined by serum levels of either alanine aminotransferase (ALT, SGPT), aspartate aminotransferase (AST, SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at Visit 1. 4. Known prior hypersensitivity or allergy to the investigational product or its excipients. 5. Treatment with insulin within 3 months prior to informed consent. 6. Treatment with anti-obesity drugs (e.g., sibutramine, orlistat, rimonabant) within three months prior to informed consent or initiating therapy during the study. 7. Any prior use of dipeptidyl peptidase-4 (DPP-4) inhibitors. 8. Glucagon-like peptide-1 (GLP-1) agonists are excluded 3 months prior to informed consent. 9. History of alcohol or drug abuse within 3 months prior to informed consent that would interfere with trial participation as assessed by the Investigator. 10. Participation in another trial with an investigational drug within 3 months prior to informed consent or during the study. 11. Pre-menopausal women (last menstruation less than 1 year prior to informed consent) who: - are nursing or pregnant - are not surgically sterile - or are of child-bearing potential and are not practicing an acceptable method of birth control or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include transdermal patch, intrauterine devices/systems (IUDs / IUSs), oral, implantable or injectable contraceptives, and vasectomised partners. No exceptions will be made. Hormonal birth control should have been in use for at least three months prior to signing informed consent and continue at least until the next menstrual period after completing the study. 12. Current treatment with chronic use of systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent. 13. History of bariatric surgery. 14. Patients who have demonstrated an inability to be compliant (80-120%) with the dosing regimen during the placebo run-in period. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | 1218.75.096 Boehringer Ingelheim Investigational Site | Akron | Ohio |
| United States | 1218.75.071 Boehringer Ingelheim Investigational Site | Anaheim | California |
| United States | 1218.75.091 Boehringer Ingelheim Investigational Site | Anderson | South Carolina |
| United States | 1218.75.038 Boehringer Ingelheim Investigational Site | Asheboro | North Carolina |
| United States | 1218.75.006 Boehringer Ingelheim Investigational Site | Atco | New Jersey |
| United States | 1218.75.049 Boehringer Ingelheim Investigational Site | Atlanta | Georgia |
| United States | 1218.75.106 Boehringer Ingelheim Investigational Site | Bartow | Florida |
| United States | 1218.75.044 Boehringer Ingelheim Investigational Site | Baton Rouge | Louisiana |
| United States | 1218.75.099 Boehringer Ingelheim Investigational Site | Biloxi | Mississippi |
| United States | 1218.75.059 Boehringer Ingelheim Investigational Site | Birmingham | Alabama |
| United States | 1218.75.098 Boehringer Ingelheim Investigational Site | Bradenton | Florida |
| United States | 1218.75.024 Boehringer Ingelheim Investigational Site | Brentwood | Tennessee |
| United States | 1218.75.086 Boehringer Ingelheim Investigational Site | Brockton | Massachusetts |
| United States | 1218.75.031 Boehringer Ingelheim Investigational Site | Brooklyn | New York |
| United States | 1218.75.095 Boehringer Ingelheim Investigational Site | Brooklyn | New York |
| United States | 1218.75.067 Boehringer Ingelheim Investigational Site | Calhoun | Georgia |
| United States | 1218.75.004 Boehringer Ingelheim Investigational Site | Camden | New Jersey |
| United States | 1218.75.009 Boehringer Ingelheim Investigational Site | Charlotte | North Carolina |
| United States | 1218.75.023 Boehringer Ingelheim Investigational Site | Charlotte | North Carolina |
| United States | 1218.75.060 Boehringer Ingelheim Investigational Site | Charlotte | North Carolina |
| United States | 1218.75.001 Boehringer Ingelheim Investigational Site | Chicago | Illinois |
| United States | 1218.75.055 Boehringer Ingelheim Investigational Site | Chicago | Illinois |
| United States | 1218.75.036 Boehringer Ingelheim Investigational Site | Chiefland | Florida |
| United States | 1218.75.018 Boehringer Ingelheim Investigational Site | Chino | California |
| United States | 1218.75.025 Boehringer Ingelheim Investigational Site | Collierville | Tennessee |
| United States | 1218.75.040 Boehringer Ingelheim Investigational Site | Colorado Springs | Colorado |
| United States | 1218.75.072 Boehringer Ingelheim Investigational Site | Columbia | South Carolina |
| United States | 1218.75.090 Boehringer Ingelheim Investigational Site | Columbus | Ohio |
| United States | 1218.75.053 Boehringer Ingelheim Investigational Site | Dallas | Texas |
| United States | 1218.75.078 Boehringer Ingelheim Investigational Site | Dayton | Ohio |
| United States | 1218.75.047 Boehringer Ingelheim Investigational Site | Denver | Colorado |
| United States | 1218.75.051 Boehringer Ingelheim Investigational Site | Detroit | Michigan |
| United States | 1218.75.016 Boehringer Ingelheim Investigational Site | Dunwoody | Georgia |
| United States | 1218.75.108 Boehringer Ingelheim Investigational Site | Essex | Maryland |
| United States | 1218.75.088 Boehringer Ingelheim Investigational Site | Flint | Michigan |
| United States | 1218.75.105 Boehringer Ingelheim Investigational Site | Fort Lauderdale | Florida |
| United States | 1218.75.083 Boehringer Ingelheim Investigational Site | Fort Myers | Florida |
| United States | 1218.75.081 Boehringer Ingelheim Investigational Site | Garden Grove | California |
| United States | 1218.75.011 Boehringer Ingelheim Investigational Site | Germantown | Tennessee |
| United States | 1218.75.005 Boehringer Ingelheim Investigational Site | Greensboro | North Carolina |
| United States | 1218.75.068 Boehringer Ingelheim Investigational Site | Greenwood | South Carolina |
| United States | 1218.75.097 Boehringer Ingelheim Investigational Site | Greer | South Carolina |
| United States | 1218.75.002 Boehringer Ingelheim Investigational Site | Hialeah | Florida |
| United States | 1218.75.107 Boehringer Ingelheim Investigational Site | High Point | North Carolina |
| United States | 1218.75.057 Boehringer Ingelheim Investigational Site | Houston | Texas |
| United States | 1218.75.064 Boehringer Ingelheim Investigational Site | Houston | Texas |
| United States | 1218.75.104 Boehringer Ingelheim Investigational Site | Houston | Texas |
| United States | 1218.75.043 Boehringer Ingelheim Investigational Site | Houton | Texas |
| United States | 1218.75.042 Boehringer Ingelheim Investigational Site | Humboldt | Tennessee |
| United States | 1218.75.054 Boehringer Ingelheim Investigational Site | Huntsville | Alabama |
| United States | 1218.75.020 Boehringer Ingelheim Investigational Site | Jacksonville | North Carolina |
| United States | 1218.75.080 Boehringer Ingelheim Investigational Site | Jacksonville | Florida |
| United States | 1218.75.065 Boehringer Ingelheim Investigational Site | Jupiter | Florida |
| United States | 1218.75.063 Boehringer Ingelheim Investigational Site | Lawrenceville | Georgia |
| United States | 1218.75.066 Boehringer Ingelheim Investigational Site | Little Rock | Alaska |
| United States | 1218.75.109 Boehringer Ingelheim Investigational Site | Los Angeles | California |
| United States | 1218.75.056 Boehringer Ingelheim Investigational Site | Marietta | Georgia |
| United States | 1218.75.030 Boehringer Ingelheim Investigational Site | Memphis | Tennessee |
| United States | 1218.75.050 Boehringer Ingelheim Investigational Site | Memphis | Tennessee |
| United States | 1218.75.007 Boehringer Ingelheim Investigational Site | Miami | Florida |
| United States | 1218.75.029 Boehringer Ingelheim Investigational Site | Miami | Florida |
| United States | 1218.75.045 Boehringer Ingelheim Investigational Site | Miami | Florida |
| United States | 1218.75.084 Boehringer Ingelheim Investigational Site | Miami | Florida |
| United States | 1218.75.035 Boehringer Ingelheim Investigational Site | Mobile | Alabama |
| United States | 1218.75.017 Boehringer Ingelheim Investigational Site | Ocala | Florida |
| United States | 1218.75.069 Boehringer Ingelheim Investigational Site | Owensboro | Kentucky |
| United States | 1218.75.008 Boehringer Ingelheim Investigational Site | Pell City | Alaska |
| United States | 1218.75.037 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania |
| United States | 1218.75.082 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania |
| United States | 1218.75.012 Boehringer Ingelheim Investigational Site | Pinellas Park | Florida |
| United States | 1218.75.074 Boehringer Ingelheim Investigational Site | Port Orange | Florida |
| United States | 1218.75.026 Boehringer Ingelheim Investigational Site | Rosswell | Georgia |
| United States | 1218.75.022 Boehringer Ingelheim Investigational Site | San Antonio | Texas |
| United States | 1218.75.079 Boehringer Ingelheim Investigational Site | Sandy Springs | Georgia |
| United States | 1218.75.034 Boehringer Ingelheim Investigational Site | Snellville | Georgia |
| United States | 1218.75.076 Boehringer Ingelheim Investigational Site | South Miami | Florida |
| United States | 1218.75.003 Boehringer Ingelheim Investigational Site | St. Petersburg | Florida |
| United States | 1218.75.039 Boehringer Ingelheim Investigational Site | St. Petersburg | Florida |
| United States | 1218.75.058 Boehringer Ingelheim Investigational Site | Sugar Land | Texas |
| United States | 1218.75.075 Boehringer Ingelheim Investigational Site | Tallahassee | Florida |
| United States | 1218.75.100 Boehringer Ingelheim Investigational Site | Tamarac | Florida |
| United States | 1218.75.015 Boehringer Ingelheim Investigational Site | Tampa | Florida |
| United States | 1218.75.033 Boehringer Ingelheim Investigational Site | Tomball | Texas |
| United States | 1218.75.102 Boehringer Ingelheim Investigational Site | Tomball | Texas |
| United States | 1218.75.101 Boehringer Ingelheim Investigational Site | Toney | Alabama |
| United States | 1218.75.010 Boehringer Ingelheim Investigational Site | Uniontown | Pennsylvania |
| United States | 1218.75.028 Boehringer Ingelheim Investigational Site | Uniontown | Pennsylvania |
| United States | 1218.75.019 Boehringer Ingelheim Investigational Site | Virgnia Beach | Virginia |
| United States | 1218.75.094 Boehringer Ingelheim Investigational Site | Waco | Texas |
| United States | 1218.75.087 Boehringer Ingelheim Investigational Site | Watertown | Massachusetts |
| United States | 1218.75.103 Boehringer Ingelheim Investigational Site | West Palm Beach | Florida |
| United States | 1218.75.092 Boehringer Ingelheim Investigational Site | Whitney | Texas |
| United States | 1218.75.027 Boehringer Ingelheim Investigational Site | Winston Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim | Eli Lilly and Company |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 24 Weeks | Glycosylated hemoglobin is reported as a percentage of the total hemoglobin | baseline, 24 weeks | No |
| Secondary | Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 6 Weeks | Glycosylated hemoglobin is reported as a percentage of the total hemoglobin | baseline, 6 weeks | No |
| Secondary | Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 12 Weeks | Glycosylated hemoglobin is reported as a percentage of the total hemoglobin | baseline, 12 weeks | No |
| Secondary | Change From Baseline in HbA1c (Glycosylated Hemoglobin) After 18 Weeks | Glycosylated hemoglobin is reported as a percentage of the total hemoglobin | baseline, 18 weeks | No |
| Secondary | Occurrence of Absolute Efficacy Response (HbA1c < 7%) After 24 Weeks | Glycosylated hemoglobin is reported as a percentage of the total hemoglobin | 24 weeks | No |
| Secondary | Occurrence of Absolute Efficacy Response (HbA1c < 6.5%) After 24 Weeks | Glycosylated hemoglobin is reported as a percentage of the total hemoglobin | 24 weeks | No |
| Secondary | Occurrence of Relative Efficacy Response (Reduction in HbA1c >= 0.5%) After 24 Weeks | Glycosylated hemoglobin is reported as a percentage of the total hemoglobin | 24 weeks | No |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) After 24 Weeks | baseline, 24 weeks | No | |
| Secondary | Change From Baseline in 2-hour Post-prandial Glucose (PPG) After 24 Weeks | baseline, 24 weeks | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05666479 -
CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
|
||
| Completed |
NCT05647083 -
The Effect of Massage on Diabetic Parameters
|
N/A | |
| Active, not recruiting |
NCT05661799 -
Persistence of Physical Activity in People With Type 2 Diabetes Over Time.
|
N/A | |
| Completed |
NCT03686722 -
Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin
|
Phase 1 | |
| Completed |
NCT02836704 -
Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose)
|
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
|
Phase 3 | |
| Completed |
NCT04562714 -
Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy
|
N/A | |
| Completed |
NCT02009488 -
Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM)
|
Phase 1 | |
| Completed |
NCT05896319 -
Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2
|
N/A | |
| Recruiting |
NCT05598203 -
Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes
|
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
|
Phase 1 | |
| Terminated |
NCT04090242 -
Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes
|
N/A | |
| Completed |
NCT04030091 -
Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus
|
Phase 4 | |
| Completed |
NCT03620357 -
Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D)
|
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
|
||
| Completed |
NCT01696266 -
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
|
||
| Completed |
NCT03620890 -
Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy
|
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
|
||
| Not yet recruiting |
NCT05029804 -
Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes
|
N/A | |
| Completed |
NCT04531631 -
Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes
|
Phase 2 |