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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)

This study has been completed.
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: March 17, 2008
Last updated: May 21, 2015
Last verified: May 2015
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 Intervention Phase
Type 2 Diabetes Mellitus
Drug: Exenatide Once Weekly
Drug: Insulin Glargine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

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.

Enrollment: 467
Study Start Date: April 2008
Study Completion Date: November 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Exenatide Once Weekly
subcutaneous injection, 2.0mcg, once weekly
Active Comparator: 2 Drug: Insulin Glargine
subcutaneous injection, variable dose, QD


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  • 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.
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Please refer to this study by its identifier: NCT00641056

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United States, California
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Escondido, California, United States
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Tainan County, Taiwan
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Taoyuan, Taiwan
Sponsors and Collaborators
Eli Lilly and Company
Study Director: Chief Medical Officer, MD Eli Lilly and Company
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: AstraZeneca Identifier: NCT00641056     History of Changes
Other Study ID Numbers: H8O-MC-GWBR (DURATION - 3)
Study First Received: March 17, 2008
Results First Received: February 14, 2012
Last Updated: May 21, 2015

Keywords provided by AstraZeneca:
exenatide once weekly
insulin glargine

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on May 25, 2017