Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus

May 21, 2015 updated by: AstraZeneca

Parallel Group Study to Evaluate the Efficacy and Safety of Exenatide Once-Weekly Injection Compared to Once-Daily Insulin in Type 2 Diabetes Mellitus Treated With Oral Antidiabetic(s)

The objectives of this clinical trial are to compare the effects of exenatide once weekly and insulin glargine on blood glucose control, body weight, lipids, safety, and tolerability.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

427

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

  • Japan
      • Aomori, Japan
        • Research Site
      • Chiba, Japan
        • Research Site
      • Ehime, Japan
        • Research Site
      • Fukuoka, Japan
        • Research Site
      • Gunma, Japan
        • Research Site
      • Hiroshima, Japan
        • Research Site
      • Hokkaido, Japan
        • Research Site
      • Hyogo, Japan
        • Research Site
      • Ibaragi, Japan
        • Research Site
      • Kagawa, Japan
        • Research Site
      • Kanagawa, Japan
        • Research Site
      • Kumamoto, Japan
        • Research Site
      • Kyoto, Japan
        • Research Site
      • Nagano, Japan
        • Research Site
      • Nagasaki, Japan
        • Research Site
      • Nara, Japan
        • Research Site
      • Oita, Japan
        • Research Site
      • Osaka, Japan
        • Research Site
      • Saitama, Japan
        • Research Site
      • Shizuoka, Japan
        • Research Site
      • Tokyo, Japan
        • Research Site
      • Toyama, Japan
        • 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

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • present with type 2 diabetes mellitus
  • HbA1c between 7.1% and 11.0% inclusive
  • body mass index (BMI) of >18kg/m2 and <35kg/m2, inclusive
  • treated with a stable dose regimen of either of biguanide (BG) alone, BG + thiazolidinedione (TZD), BG + sulfonylurea (SU), or BG + TZD + SU for 90 days prior to study start

Exclusion Criteria:

  • Have received chronic (>14 consecutive days) systemic adrenocorticosteroid therapy by oral, intravenous, or intramuscular route or intraarticular steroid injection within 4 weeks prior to study start.
  • Have been treated with drugs that promote weight loss within 90 days prior to study start.
  • Have been treated with drugs that directly affect gastrointestinal motility for > 21 consecutive days within 90 days prior to study start.
  • Have had prior exposure to exenatide BID or QW or participated in the clinical trial of exenatide BID or QW (including the case that the study drug was not administered).
  • Have been treated for >2 consecutive weeks with any of the following excluded medications within 90 days prior to study start: Insulin, Dipeptidyl peptidase-4 (DPP-4) inhibitors, GLP-1 analogs
  • Have received treatment within 30 days prior to study start drug that has not received regulatory approval for any indication.
  • Are currently enrolled in any other clinical study or participated in and completed the clinical study within 30 days prior to study start.
  • Have donated blood within 30 days prior to study start.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: exenatide once weekly
Drug: exenatide once weekly
subcutaneous injection, 2.0mg, once a week;
ACTIVE_COMPARATOR: insulin glargine
Drug: insulin glargine
subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
Other Names:
  • insulin glargine-Lantus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c From Baseline to Endpoint (Week 26)
Time Frame: Baseline, Week 26
Change in HbA1c from baseline to endpoint (Week 26).
Baseline, Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Achieving HbA1c<=7%
Time Frame: Baseline, Week 26
Percentage of subjects achieving HbA1c <=7.0% (for subjects with HbA1c >7% at baseline)
Baseline, Week 26
Percentage of Subjects Achieving HbA1c<=6.5%
Time Frame: Baseline, Week 26
Percentage of subjects achieving HbA1c <=6.5% (for subjects with HbA1c >6.5% at baseline)
Baseline, Week 26
Change in Fasting Serum Glucose (FSG) From Baseline to Endpoint (Week 26)
Time Frame: Baseline, Week 26
Change in FSG (centralized measurement) from baseline to endpoint (Week 26)
Baseline, Week 26
Change in Body Weight From Baseline to Endpoint (Week 26)
Time Frame: Baseline, Week 26
Change in Body Weight from baseline to endpoint (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 Cholesterol (HDL-C) From Baseline to Endpoint (Week 26)
Time Frame: Baseline, Week 26
Change in HDL-C from baseline to endpoint (Week 26)
Baseline, Week 26
Ratio of Fasting Triglycerides at Endpoint (Week 26) to Baseline
Time Frame: Baseline, Week 26
Ratio of Triglycerides (measured in mg/dL) at endpoint (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 Endpoint (Week 26)
Time Frame: Baseline, Week 26
Change in Blood Pressure from baseline to endpoint (Week 26)
Baseline, Week 26
Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events
Time Frame: Baseline to Week 26
Major confirmed hypoglycemia was defined as (1) any event accompanying symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure but resolved promptly in response to administration of glucagon or (2) glucose, or documented hypoglycemia (blood glucose <3.0 mmol/L [54 mg/dL]) requiring assistance because of severe impairment in consciousness or motor activity whether or not symptoms of hypoglycemia were felt by the patient. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last postbaseline visit date - baseline visit date. Mean and SE were then derived from FAS.
Baseline to Week 26
Assessment on Event Rate of Treatment-emergent Minor Hypoglycemic Events
Time Frame: Baseline to Week 26
Minor confirmed hypoglycemia was defined as any event a patient felt that he or she was experiencing a sign or symptom associated with hypoglycemia that resolved by self-treatment or on its own, and a concurrent self-monitoring fingerstick blood glucose <3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Event rate per subject year was calculated for each subject: (number of events observed from a subject/exposure from a subject)*365.25 where exposure = last postbaseline visit date - baseline visit date. Mean and SE were then derived from FAS.
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

July 1, 2009

Primary Completion (ACTUAL)

September 1, 2010

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

July 8, 2009

First Submitted That Met QC Criteria

July 8, 2009

First Posted (ESTIMATE)

July 9, 2009

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-JE-GWBX

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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