Efficacy of Once-Weekly Exenatide Versus Once or Twice Daily Insulin Detemir in Patients With Type 2 Diabetes

March 19, 2015 updated by: AstraZeneca

Efficacy of Once-Weekly Exenatide Versus Once or Twice Daily Insulin Detemir in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulphonylurea

The purpose of this study is to compare the effects of exenatide once weekly (QW) and insulin detemir with respect to glycemic control, body weight, lipids, safety, tolerability, and patient reported outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

222

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

  • Ireland
      • Dublin, Ireland
        • Research Site
  • United Kingdom
      • Leytonstone, United Kingdom
        • Research Site
      • Livingston, United Kingdom
        • Research Site
    • England
      • Addlestone, England, United Kingdom
        • Research Site
      • Bath, England, United Kingdom
        • Research Site
      • Birmingham, England, United Kingdom
        • Research Site
      • Blackburn, England, United Kingdom
        • Research Site
      • Bournemouth, England, United Kingdom
        • Research Site
      • Chippenham, England, United Kingdom
        • Research Site
      • Derby, England, United Kingdom
        • Research Site
      • Exeter, England, United Kingdom
        • Research Site
      • High Wycombe, England, United Kingdom
        • Research Site
      • Hull, England, United Kingdom
        • Research Site
      • Leicester, England, United Kingdom
        • Research Site
      • Liverpool, England, United Kingdom
        • Research Site
      • London, England, United Kingdom
        • Research Site
      • Manchester, England, United Kingdom
        • Research Site
      • Merseyside, England, United Kingdom
        • Research Site
      • Middlesborough, England, United Kingdom
        • Research Site
      • Newcastle, England, United Kingdom
        • Research Site
      • Northampton, England, United Kingdom
        • Research Site
      • Oldham, England, United Kingdom
        • Research Site
      • Plymouth, England, United Kingdom
        • Research Site
      • Portsmouth, England, United Kingdom
        • Research Site
      • Sheffield, England, United Kingdom
        • Research Site
      • Stevenage, England, United Kingdom
        • Research Site
      • Suffolk, England, United Kingdom
        • Research Site
      • Wakefield, England, United Kingdom
        • Research Site
      • Wiltshire, England, United Kingdom
        • Research Site
    • Scotland
      • Aberdeen, Scotland, United Kingdom
        • Research Site
      • Dundee, Scotland, United Kingdom
        • Research Site
    • Wales
      • Carmathen, Wales, United Kingdom
        • Research Site
      • Swansea, Wales, United Kingdom
        • Research Site
      • Wrexham, Wales, United Kingdom
        • 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:

  • Have suboptimal glycaemic control as evidenced by an HbA1c 7.1% to 10.0%, inclusive
  • Have a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive
  • Are receiving metformin at a stable dose (consistent with country specific requirements) of a minimum of 1000mg for at least 3 months prior to start start OR are receiving metformin at a minimum dose (consistent with country specific requirements) of 1000mg and sulphonylurea (as separate medications not as a fixed dose combination) at stable doses for 3 months prior to study start

Exclusion Criteria:

  • Have any contraindication for the OAD that they have been using
  • Have a known allergy or hypersensitivity to insulin detemir, exenatide or excipients contained in these agents
  • Have been treated within 4 weeks of screening with systemic glucocorticoid therapy by oral, intravenous (IV) or intramuscular (IM) route, or are regularly treated with potent, inhaled intranasal steroids that are known to have a high rate of systemic absorption. Exceptions to this criterion include patients who are receiving glucocorticoid therapy for corticotropic hypopituitary deficiency (e.g. Addison disease)
  • Have been treated with drugs that promote weight loss, 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, alpha-glucosidase, Byetta® (exenatide BID formulation), thiazolidinediones (TZD), dipeptidyl peptidase (DPP)-4 inhibitors
  • Have previously completed or withdrawn from this study or any other study investigating exenatide QW
  • 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, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this 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, 2mg, once a week
Active Comparator: 2
Drug: insulin detemir
subcutaneous injection, with dosage titrated according to the determir label and published titration schedule, once or twice a day
Other Names:
  • Levemir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients Achieving Glycosylated Hemoglobin (HbA1c) Concentration ≤7.0% With Weight Loss (≥1.0 kg) at Endpoint (Week 26)
Time Frame: Baseline, Week 26
The primary endpoint is the percentage of patients achieving HbA1c concentration ≤7.0% with weight loss (≥1.0 kg) at endpoint. The last post-baseline measurement set of both non-missing HbA1c concentration and weight (measured at the same time point, i.e. visit) is used as endpoint value. Patients who do not have a baseline weight measurement, have a protocol violation of baseline HbA1c <=7.0%, and/or have missing post-baseline measurements for HbA1c concentration and/or weight, are included in the analysis as non-responders regarding the primary objective.
Baseline, Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients Who Have Achieved HbA1c ≤7.4% With Weight Loss (≥1.0 kg) at Endpoint (Week 26)
Time Frame: Baseline, Week 26
Percentage of patients who have achieved HbA1c ≤7.4% with weight loss (≥1.0 kg) at endpoint (Week 26)
Baseline, Week 26
Change in HbA1c From Baseline to Week 26
Time Frame: Baseline, Week 26
Change in HbA1c from baseline to week 26
Baseline, Week 26
Change in Body Weight From Baseline to Week 26
Time Frame: Baseline, Week 26
Change in body weight from baseline to week 26
Baseline, Week 26
Percentage of Patients Achieving HbA1c ≤7.4% at Endpoint
Time Frame: Week 26
Percentage of patients who have achieved HbA1c ≤.7.4% at endpoint
Week 26
Percentage of Patients Achieving ≤7.0% at Endpoint
Time Frame: Week 26
Percentage of patients achieving ≤7.0% at endpoint.
Week 26
Percentage of Patients Achieving ≤6.5% at Endpoint
Time Frame: Week 26
Percentage of patients achieving HbA1c ≤6.5% at endpoint
Week 26
Change in Fasting Serum Glucose From Baseline to Endpoint (Week 26).
Time Frame: Baseline, Week 26
Change in fasting serum glucose from baseline to endpoint (Week 26).
Baseline, Week 26
Changes in Systolic Blood Pressure From Baseline to Week 26
Time Frame: Baseline, Week 26
Change in systolic blood pressure from baseline to Week 26
Baseline, Week 26
Change in Diastolic Blood Pressure From Baseline to Week 26.
Time Frame: Baseline, Week 26
Change in diastolic blood pressure from baseline to week 26.
Baseline, Week 26
Change in Total Cholesterol From Baseline to Endpoint (Week 26).
Time Frame: Baseline, Week 26
Change in total cholesterol from baseline to endpoint (week 26).
Baseline, Week 26
Change in High-density Lipoprotein (HDL) Cholesterol From Baseline to Endpoint (Week 26).
Time Frame: Baseline, Week 26
Change in High-density lipoprotein (HDL) cholesterol from baseline to endpoint (week 26).
Baseline, Week 26
Change in Triglycerides From Baseline to Endpoint (Week 26).
Time Frame: Baseline, Week 26
Change in triglycerides from baseline to endpoint (week 26).
Baseline, Week 26
Hypoglycemia Rate Per Year
Time Frame: Baseline, Week 26
All confirmed hypoglycemia episodes defined as either minor (any time a patient feels that he or she is experiencing a sign or symptom associated with hypoglycaemia and blood glucose (BG) <3.0 mmol/L (54 mg/dL)) or major (any hypoglycaemic episode with symptoms consistent with hypoglycaemia, resulting in loss of consciousness or seizure, and shows prompt recovery in response to administration of glucagon or glucose, or BG measurement < 3.0mmol/L is available and the patient is not capable of self-treating were taken into account.
Baseline, 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

October 1, 2009

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

October 15, 2009

First Submitted That Met QC Criteria

October 27, 2009

First Posted (Estimate)

October 28, 2009

Study Record Updates

Last Update Posted (Estimate)

April 7, 2015

Last Update Submitted That Met QC Criteria

March 19, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H8O-EW-GWDL

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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