Efficacy of Exenatide Once Weekly and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea (DURATION - 3)
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| ClinicalTrials.gov Identifier: NCT00641056 |
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Recruitment Status :
Completed
First Posted : March 21, 2008
Results First Posted : July 4, 2012
Last Update Posted : June 15, 2015
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Sponsor:
AstraZeneca
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
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Brief Summary:
The purpose of this study is to compare the effects of 2.0 mg exenatide once weekly and insulin glargine, titrated to glucose targets using the algorithm described by Yki- Järvinen et al.(2007), with respect to glycemic improvements, body weight, fasting lipids, safety, and tolerability.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Type 2 Diabetes Mellitus | Drug: Exenatide Once Weekly Drug: Insulin Glargine | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 467 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Efficacy of Once-Weekly Exenatide Long-Acting Release and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea |
| Study Start Date : | April 2008 |
| Actual Primary Completion Date : | May 2009 |
| Actual Study Completion Date : | November 2009 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Type 2 diabetes
| Arm | Intervention/treatment |
|---|---|
| Experimental: 1 |
Drug: Exenatide Once Weekly
subcutaneous injection, 2.0mcg, once weekly |
| Active Comparator: 2 |
Drug: Insulin Glargine
subcutaneous injection, variable dose, QD |
Primary Outcome Measures :
- Change in HbA1c From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ]Change in HbA1c from baseline to Week 26
Secondary Outcome Measures :
- Percentage of Patients Achieving HbA1c <=7.0% at Week 26 [ Time Frame: Baseline, Week 26 ]Percentage of patients achieving HbA1c <=7.0% at Week 26 (for patients with HbA1c >7% at baseline)
- Percentage of Patients Achieving HbA1c <=6.5% at Week 26 [ Time Frame: Baseline, Week 26 ]Percentage of patients achieving HbA1c <=6.5% at Week 26 (for patients with HbA1c >6.5% at baseline)
- Change in Fasting Serum Glucose (FSG) From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ]Change in FSG (mmol/L) from Baseline to Week 26
- Change in Body Weight (BW) From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ]Change in BW (kg) from Baseline to Week 26
- Change in Total Cholesterol From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ]Change in Total Cholesterol (mmol/L) from Baseline to Week 26
- Change in High-density Lipoprotein Cholesterol (HDL) From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ]Change in HDL (mmol/L) from Baseline to Week 26
- Ratio of Triglycerides at Week 26 to Baseline [ Time Frame: Baseline, Week 26 ]Ratio of Triglycerides (measured in mmol/L) at Week 26 to Baseline. Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.
- Change in Blood Pressure From Baseline to Week 26 [ Time Frame: Baseline, Week 26 ]Change in Systolic Blood Pressure (mmHg) and Diastolic Blood Pressure (mmHg) from Baseline to Week 26
- Assessment on Event Rate of Treatment-emergent Hypoglycemic Episodes [ Time Frame: Baseline to Week 26 ]Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose or documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) and required the assistance of another person. Minor hypoglycemia: any time a patient felt that he or she was experiencing a sign or symptom of hypoglycemia that was self-treated or resolved on its own and had a blood glucose level <3.0 mmol/L (54 mg/dL) 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 |
Criteria
Inclusion Criteria:
- Has type 2 diabetes and at least 18 years of age at screening.
- Hemoglobin A1c (HbA1c) of 7.1% to 11.0%, inclusive, at screening.
- Body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening.
- Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).
- Have been treated with metformin(Met) for at least 3 months and have been taking a stable dose for at least 8 weeks prior to screening OR
- Have been treated with metformin(Met) for at least 3 months and have been taking a stable dose for at least 8 weeks prior to screening and have been treated with SU for at least 3 months and have been taking a stable dose of at least an optimally effective dose of brand of SU for 8 weeks prior to screening.
Exclusion Criteria:
- Have had a clinically significant history of cardiac disease or presence of active cardiac disease within the year prior to inclusion in the study, including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure, coronary artery bypass surgery, or angioplasty; or is expected to require coronary artery bypass surgery or angioplasty during the course of the study.
- Have clinical signs or symptoms of liver disease, acute or chronic hepatitis.
- Have a history of renal transplantation or are currently receiving renal dialysis.
- Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
- Have had greater than three episodes of major hypoglycemia within 6 months prior to screening.
- Have any contraindication for the oral antidiabetic agent which they use.
- Have a known allergy or hypersensitivity to insulin glargine, exenatide once weekly, or excipients contained in these agents.
- Are known to have active proliferative retinopathy.
- Have been treated with drugs that promote weight loss (e.g., Xenical® [orlistat], Meridia® [sibutramine], Acomplia® [rimonabant], Acutrim® [phenylpropanolamine], or similar over-the-counter medications) within 3 months of screening.
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Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening:
- Insulin
- Thiazolidinediones (e.g., Actos® [pioglitazone] or Avandia® [rosiglitazone])
- Alpha-glucosidase inhibitors (e.g., Glyset® [miglitol] or Precose® [acarbose])
- Meglitinides (e.g., Prandin® [repaglinide] or Starlix® [nateglinide]).
- Byetta® (exenatide BID formulation)
- Dipeptidyl peptidase (DPP)-4 inhibitors (e.g., Januvia™ [sitagliptin], Galvus® [vildagliptin])
- Symlin® (pramlintide acetate).
- Have had an organ transplant.
- Have donated blood within 30 days of screening.
- Have previously completed or withdrawn from this study or any other study investigating exenatide once weekly.
- Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- Are currently enrolled in any other clinical study.
Information from the National Library of Medicine
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): NCT00641056
Locations
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Sponsors and Collaborators
AstraZeneca
Eli Lilly and Company
Investigators
| Study Director: | Chief Medical Officer, MD | Eli Lilly and Company |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00641056 |
| Other Study ID Numbers: |
H8O-MC-GWBR (DURATION - 3) |
| First Posted: | March 21, 2008 Key Record Dates |
| Results First Posted: | July 4, 2012 |
| Last Update Posted: | June 15, 2015 |
| Last Verified: | May 2015 |
Keywords provided by AstraZeneca:
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diabetes exenatide exenatide once weekly metformin |
sulfonylurea insulin glargine Amylin Lilly |
Additional relevant MeSH terms:
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Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Insulin Glargine Exenatide |
Hypoglycemic Agents Physiological Effects of Drugs Anti-Obesity Agents Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |