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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.

First Received on March 17, 2008.   Last Updated on June 17, 2011   History of Changes
Sponsor: Amylin Pharmaceuticals, Inc.
Collaborator: Eli Lilly and Company
Information provided by: Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00641056
  Purpose

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 (HbA1c, fasting and postprandial glucose), body weight, lipids, safety and tolerability (including hypoglycemia and anti-exenatide antibodies), and patient reported outcomes.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Exenatide Once Weekly
Drug: Insulin Glargine
Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 Amylin Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Estimate the difference in change in HbA1c from baseline to treatment endpoint between 2.0 mg exenatide once weekly and insulin glargine QD in patients with type 2 diabetes and inadequate glycemic control using Met alone or in combination with SU. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare exenatide once weekly and insulin glargine with respect to the proportion of patients achieving HbA1c ≤7% and ≤6.5%; fasting serum glucose; change in body weight; 1,5-anhydroglucitol; 8-point self-monitored blood glucose profile; serum lipids [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Compare exenatide once weekly and insulin glargine with respect to frequency and rate of hypoglycemic events; patient-reported health outcomes; long-term maintenance of glycemic control, safety, and tolerability. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 456
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00641056

  Show 75 Study Locations
Sponsors and Collaborators
Amylin Pharmaceuticals, Inc.
Eli Lilly and Company
Investigators
Study Director: Chief Medical Officer, MD Eli Lilly and Company
  More Information

No publications provided by Amylin Pharmaceuticals, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, MD Study Director, Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00641056     History of Changes
Other Study ID Numbers: H8O-MC-GWBR (DURATION - 3)
Study First Received: March 17, 2008
Last Updated: June 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Amylin Pharmaceuticals, Inc.:
diabetes
exenatide
exenatide once weekly
metformin
sulfonylurea
insulin glargine
Amylin
Lilly

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Glargine
Insulin
Metformin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012