A Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly to Those of Sitagliptin and Pioglitazone,in Subjects With Type 2 Diabetes Treated With Metformin (DURATION - 2)
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|ClinicalTrials.gov Identifier: NCT00637273|
Recruitment Status : Completed
First Posted : March 17, 2008
Results First Posted : June 19, 2012
Last Update Posted : April 7, 2015
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|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: exenatide once weekly Drug: sitagliptin Drug: pioglitazone Drug: placebo tablet Drug: placebo once weekly||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||514 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-Blind, Parallel-Group, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Long-Acting Release(Once Weekly) to Those of Sitagliptin and a Thiazolidinedione in Subjects With Type 2 Diabetes Mellitus Treated With Metformin|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||July 2009|
Drug: exenatide once weekly
subcutaneous injection, 2.0mg, once a week
Drug: placebo tablet
oral tablet, once a day
|Active Comparator: 2||
oral tablet, 100mg, once a day
Other Name: Januvia
Drug: placebo once weekly
subcutaneous injection, once a week
|Active Comparator: 3||
oral tablet, 45mg, once a day
Drug: placebo once weekly
subcutaneous injection, once a week
- Change in HbA1c From Baseline to Week 26 [ Time Frame: Day 1, Week 26 ]Absolute change in HbA1c from baseline (Day 1) to Week 26 [Week 26 - Baseline].
- Percentage of Subjects Achieving HbA1c Target of <7% at Week 26 [ Time Frame: Week 26 ]Percentages of subjects achieving HbA1c target values of <7% at Week 26.
- Percentage of Subjects Achieving HbA1c Target of <=6.5% at Week 26 [ Time Frame: Week 26 ]Percentages of subjects achieving HbA1c target values of <=6.5% at Week 26.
- Percentage of Subjects Achieving HbA1c Target of <=6.0% at Week 26 [ Time Frame: Week 26 ]Percentages of subjects achieving HbA1c target values of <=6.0% at Week 26.
- Change in Body Weight From Baseline to Week 26 [ Time Frame: Day 1, Week 26 ]Change in body weight from baseline (Day 1) to Week 26.
- Change in Fasting Plasma Glucose From Baseline to Week 26 [ Time Frame: Day 1, Week 26 ]Change in fasting plasma glucose from baseline (Day 1) to Week 26.
- Change in Systolic Blood Pressure From Baseline to Week 26 [ Time Frame: Day 1, Week 26 ]Change in systolic blood pressure from baseline (Day 1) to Week 26.
- Change in Diastolic Blood Pressure From Baseline to Week 26 [ Time Frame: Day 1, Week 26 ]Change in diastolic blood pressure from baseline (Day 1) to Week 26.
- Change in Fasting Total Cholesterol From Baseline to Week 26 [ Time Frame: Day 1, Week 26 ]Change in fasting total cholesterol from baseline (Day 1) to Week 26.
- Change in Fasting High-density Lipoprotein (HDL) From Baseline to Week 26 [ Time Frame: Day 1, Week 26 ]Change in fasting HDL from baseline (Day 1) to Week 26.
- Ratio of Fasting Triglycerides at Week 26 to Baseline [ Time Frame: Day 1, Week 26 ]Ratio of triglycerides (measured in mg/dL) at Week 26 to baseline (Day 1). Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.
- Assessment on Event Rate of Treatment-emergent Hypoglycemic Events [ Time Frame: Day 1 to Week 26 ]Major hypoglycemia: events that, in the judgment of the investigator or physician, resulted in loss of consciousness, seizure, coma, or other change in mental status consistent with neuroglycopenia, in which symptoms resolved after administration of intramuscular glucagon or intravenous glucose, required third-party assistance, and was accompanied by a blood glucose concentration < 54 mg/dL prior to treatment. Minor hypoglycemia: symptoms consistent with hypoglycemia and blood glucose concentration < 54 mg/dL prior to treatment and not classified as major hypoglycemia.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Has been diagnosed with type 2 diabetes mellitus
- Has a hemoglobin-specific A1c fraction (HbA1c) of 7.1% to 11.0%, inclusive, at study start
- Has a body mass index (BMI)of 25 kg/m2 to 45 kg/m2, inclusive, at study start
- Has been on a stable treatment regimen of metformin for a minimum of 2 months prior to study start
Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start:
- Hormone replacement therapy (female subjects)
- Oral contraceptives (female subjects)
- Antihypertensive agents
- Lipid-lowering agents
- Thyroid replacement therapy
- Antidepressant agents
- Drugs known to affect body weight, including prescription medications (e.g. orlistat [XENICAL®], sibutramine [MERIDIA®], topiramate [TOPAMAX®]) and over-the-counter antiobesity agents
- Has been previously exposed to exenatide once weekly
- Has donated blood within 60 days of study start or is planning to donate blood during the study
Currently being treated, or is expected to require or undergo treatment with any of the following treatment-excluded medications:
- Exenatide (BYETTA®) or any Dipeptidyl peptidase-4 DPP-4)inhibitor, sulfonylurea (SU), thiazolidinedione (TZD), or glucagon-like peptide (GLP)-1 analog within 3 months prior to study start
- Alpha-glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days of study start
- Insulin within 2 weeks of study start or for more than 1 week within 3 months of study start
- Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption
- Drugs interacting with the CYP2C8 enzyme system, including gemfibrozil (LOPID®) and rifampin
- Has received any investigational drug within 1 month (or five half-lives of investigational drug, whichever is greater) of study start
- Has previously experienced a clinically significant adverse event (e.g., significant edema) related to TZD or DPP-4 inhibitor use
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00637273
|Study Director:||Lisa Porter, MD||Amylin Pharmaceuticals, LLC.|
|Other Study ID Numbers:||
BCB106 (DURATION - 2)
|First Posted:||March 17, 2008 Key Record Dates|
|Results First Posted:||June 19, 2012|
|Last Update Posted:||April 7, 2015|
|Last Verified:||March 2015|
exenatide once weekly
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Molecular Mechanisms of Pharmacological Action