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)

May 21, 2015 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

467

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Wollongong, New South Wales, Australia
        • Research Site
    • Queensland
      • Herston, Queensland, Australia
        • Research Site
    • South Australia
      • Adelaide, South Australia, Australia
        • Research Site
      • Keswick, South Australia, Australia
        • Research Site
    • Victoria
      • Box Hill, Victoria, Australia
        • Research Site
      • Geelong, Victoria, Australia
        • Research Site
  • Belgium
      • Brussels, Belgium
        • Research Site
      • Edegem, Belgium
        • Research Site
  • Czech Republic
      • Melnik, Czech Republic
        • Research Site
      • Praha, Czech Republic
        • Research Site
      • Stodulky, Czech Republic
        • Research Site
  • Denmark
      • Aalborg, Denmark
        • Research Site
      • Arhus C, Denmark
        • Research Site
      • Herlev, Denmark
        • Research Site
      • Koge, Denmark
        • Research Site
  • France
      • Angers, France
        • Research Site
      • Corbeil Essoness, France
        • Research Site
      • Nancy, France
        • Research Site
      • Nanterre, France
        • Research Site
      • Toulouse, France
        • Research Site
  • Germany
      • Bad Mergentheim, Germany
        • Research Site
      • Dresden, Germany
        • Research Site
      • Essen, Germany
        • Research Site
      • Falkensee, Germany
        • Research Site
      • Fulda, Germany
        • Research Site
      • Hamburg-Othmarschen, Germany
        • Research Site
      • Munster, Germany
        • Research Site
      • Rothenburg an der fulda, Germany
        • Research Site
      • Speyer, Germany
        • Research Site
  • Greece
      • Athens, Greece
        • Research Site
      • Thessaloniki, Greece
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Eger, Hungary
        • Research Site
      • Gyula, Hungary
        • Research Site
      • Pecs, Hungary
        • Research Site
  • Korea, Republic of
      • Gyeonggi-Do, Korea, Republic of
        • Research Site
      • Seoul, Korea, Republic of
        • Research Site
  • Mexico
      • Merida, Mexico
        • Research Site
      • Mexico City, Mexico
        • Research Site
      • Tampico, Mexico
        • Research Site
      • Tijuana, Mexico
        • Research Site
  • Netherlands
      • Amsterdam, Netherlands
        • Research Site
      • Gouda, Netherlands
        • Research Site
      • Hoogeveen, Netherlands
        • Research Site
      • Rotterdam, Netherlands
        • Research Site
      • Zwijndrecht, Netherlands
        • Research Site
      • Zwolle, Netherlands
        • Research Site
  • Puerto Rico
      • Caguas, Puerto Rico
        • Research Site
      • Yabucoa, Puerto Rico
        • Research Site
  • Russian Federation
      • Moscow, Russian Federation
        • Research Site
      • Rostov-on-Don, Russian Federation
        • Research Site
      • St. Petersburg, Russian Federation
        • Research Site
  • Spain
      • Alicante, Spain
        • Research Site
      • Alzira-Valencia, Spain
        • Research Site
      • Barcelona, Spain
        • Research Site
      • Bilbao, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Malaga, Spain
        • Research Site
      • Teruel, Spain
        • Research Site
  • Taiwan
      • Chia-Yi, Taiwan
        • Research Site
      • Tainan County, Taiwan
        • Research Site
      • Taipei, Taiwan
        • Research Site
      • Taoyuan, Taiwan
        • Research Site
  • United States
    • California
      • Escondido, California, United States
        • Research Site
    • Florida
      • Jacksonville, Florida, United States
        • Research Site
      • Orlando, Florida, United States
        • Research Site
      • West Palm Beach, Florida, United States
        • Research Site
    • Hawaii
      • Honolulu, Hawaii, United States
        • Research Site
    • Idaho
      • Idaho Falls, Idaho, United States
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Research Site
    • Missouri
      • St. Louis, Missouri, United States
        • Research Site
    • Ohio
      • Dayton, Ohio, United States
        • Research Site
    • Oklahoma
      • Ada, Oklahoma, United States
        • Research Site
    • Texas
      • San Antonio, Texas, United States
        • Research Site
    • Washington
      • Spokane, Washington, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c From Baseline to Week 26
Time Frame: Baseline, Week 26
Change in HbA1c from baseline to Week 26
Baseline, Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline, Week 26
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)
Baseline, Week 26
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
Baseline, 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
Baseline, 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
Baseline, 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
Baseline, 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.
Baseline, Week 26
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
Baseline, 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.
Baseline to Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

March 17, 2008

First Submitted That Met QC Criteria

March 20, 2008

First Posted (Estimate)

March 21, 2008

Study Record Updates

Last Update Posted (Estimate)

June 15, 2015

Last Update Submitted That Met QC Criteria

May 21, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H8O-MC-GWBR (DURATION - 3)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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