Effect of Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes

March 19, 2015 updated by: AstraZeneca

Effect of Exenatide Plus Metformin vs. Premixed Human Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Inadequate Control of Type 2 Diabetes on Oral Antidiabetic Treatment

This study in Germany is designed to compare the effects of twice-daily exenatide plus metformin and twice-daily premixed human insulin aspart plus metformin with respect to glycemic control, as measured by HbA1c, combined with the percentage of patients with at least one treatment-emergent hypoglycemic episode. Patients will be treated with study therapy for approximately 26 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

494

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

  • Germany
      • Bad Mergentheim, Germany
        • Research Site
      • Berlin, Germany
        • Research Site
      • Bosenheim, Germany
        • Research Site
      • Burghausen, Germany
        • Research Site
      • Datteln, Germany
        • Research Site
      • Dresden, Germany
        • Research Site
      • Essen, Germany
        • Research Site
      • Friedrichsthal, Germany
        • Research Site
      • Hildesheim, Germany
        • Research Site
      • Hirschhorn, Germany
        • Research Site
      • Hohenmolsen, Germany
        • Research Site
      • Jena, Germany
        • Research Site
      • Lehrte, Germany
        • Research Site
      • Leipzig, Germany
        • Research Site
      • Ludwigsburg, Germany
        • Research Site
      • Mannheim, Germany
        • Research Site
      • Marburg, Germany
        • Research Site
      • Marktheidenfeld, Germany
        • Research Site
      • Meissen, Germany
        • Research Site
      • Munchen, Germany
        • Research Site
      • Offenbach, Germany
        • Research Site
      • Oschatz, Germany
        • Research Site
      • Pohlheim, Germany
        • Research Site
      • Regensburg, Germany
        • Research Site
      • Riesa, Germany
        • Research Site
      • Rodgau, Germany
        • Research Site
      • Roding, Germany
        • Research Site
      • Rosenheim, Germany
        • Research Site
      • Schluchtern, Germany
        • Research Site
      • Schwedt/Oder, Germany
        • Research Site
      • Sinsheim, Germany
        • Research Site
      • Speyer, Germany
        • Research Site
      • Unterhaching, Germany
        • Research Site
      • Volklingen, Germany
        • Research Site
      • Wallerfing, Germany
        • Research Site
      • Wangen, Germany
        • Research Site
      • Warburg, Germany
        • Research Site
      • Wiesbaden, Germany
        • Research Site
      • Wolfsburg, Germany
        • 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 to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have been treated with diet and exercise and a stable, maximally tolerated dose of immediate-release or extended-release metformin, or the combination of metformin (any dosage) with sulfonylurea/meglitinides for at least 3 months prior to study start
  • Have not received thiazolidinediones, or alpha-glucosidase inhibitors for longer than 2 weeks within 3 months prior to study start, and have not received any insulin formulation for more than 14 days (other than in emergency situations) and within 14 days prior to study start
  • Have an HbA1c between 6.5% and 10.0%, inclusive
  • Have a body mass index (BMI) between 25 kg/m^2 and 40 kg/m^2, inclusive

Exclusion Criteria:

  • Have type 1 diabetes or known latent autoimmune diabetes in adults
  • Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks prior to study start
  • Are receiving treatment for gastrointestinal disease with a drug directly affecting gastrointestinal motility (e.g., metoclopramide, cisapride, and chronic macrolide antibiotics)
  • Have used any prescription drug to promote weight loss within 3 months prior to study start
  • Have received treatment within 30 days prior to study start with a drug that has not received regulatory approval for any indication at the time of study entry
  • Have previously completed or withdrawn from this study or any other study investigating exenatide or GLP-1 analogs

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: Exenatide Twice Daily (BID)
Drug: exenatide twice daily (BID)
subcutaneous injection (5 mcg or 10 mcg), twice a day
Other Names:
  • Byetta
Active Comparator: Premixed Insulin Aspart Twice Daily (BID)
Drug: premixed insulin aspart twice daily (BID)
subcutaneous injection (titrated appropriately), twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Glycosylated Hemoglobin (HbA1c)
Time Frame: Baseline and 26 weeks
Change in HbA1c from baseline after 26 weeks of treatment (i.e., HbA1c at week 26 minus HbA1c at week 0)
Baseline and 26 weeks
Incidence of Hypoglycemia (Percentage of Participants With at Least One Hypoglycemic Episode)
Time Frame: 26 weeks
Risk for first hypoglycemic episode (blood glucose <=3.9 mmol/L or severe episode) to occur up to week 26
26 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects Achieving HbA1c Target of < 6.5%
Time Frame: 26 weeks
Percentage of subjects achieving HbA1c target of < 6.5% at the end of study (week 26) [i.e., number of subjects who achieved HbA1c < 6.5% divided by total number of subjects times 100%].
26 weeks
Percentage of Subjects Achieving HbA1c Target of < 7.0%
Time Frame: 26 weeks
Percentage of subjects achieving HbA1c target of < 7.0% at the end of study (week 26) [i.e., number of subjects who achieved HbA1c < 7.0% divided by total number of subjects times 100%].
26 weeks
Incidence of Hypoglycemic Episodes [Blood Glucose <= 3.0 mmol/L or Severe] (Percentage of Subjects Who Experienced at Least One Treatment-emergent Hypoglycemic Episode During the 26-week Treatment Period)
Time Frame: 26 weeks
Risk for the first hypoglycemic episode to occur up to Week 26 (percentage of subjects who experienced at least one treatment-emergent hypoglycemic episode during the 26-week treatment period)[ i.e., number of subjects experiencing at least one hypoglycemic episode divided by total number of subjects times 100%]
26 weeks
Incidence of Nocturnal Hypoglycemia (Percentage of Subjects Who Experienced at Least One Episode of Nocturnal Hypoglycemia During the 26 Week Treatment Period)
Time Frame: 26 weeks
Risk for first nocturnal (night-time) hypoglycemic episode to occur up to week 26 (percentage of subjects who experienced at least one episode of nocturnal hypoglycemia during the 26 week treatment period) [i.e., number of subjects who experienced nocturnal hypoglycemia divided by total number of subjects times 100%].
26 weeks
7 Point Self-monitored Blood Glucose (SMBG) Profiles
Time Frame: Baseline and 26 weeks
7-point self-monitored blood glucose profiles at baseline and the end of the study, measured at 7 times during the day (pre-breakfast, 2 hours post-breakfast, pre-lunch, 2 hours post-lunch, pre-dinner, 2 hours post-dinner, and 3:00am).
Baseline and 26 weeks
Blood Lipid Levels
Time Frame: Baseline and 26 weeks
Total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol (calculated), and triglyceride levels at baseline (week 0) and the end of the study (week 26)
Baseline and 26 weeks
Change in Body Weight
Time Frame: Baseline and 26 weeks
Change in body weight from baseline after 26 weeks of treatment (i.e., body weight at week 26 minus body weight at week 0)
Baseline and 26 weeks
Change in Body Mass Index (BMI)
Time Frame: Baseline and 26 weeks
Change in BMI from baseline after 26 weeks of treatment (i.e., BMI at week 26 minus BMI at week 0)
Baseline and 26 weeks
Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Time Frame: Baseline and 26 weeks
Total DTSQ treatment satisfaction score at baseline (week 0) and after 26 weeks of treatment (LOCF). Total DTSQ treatment satisfaction score is derived as sum score of the individual components 1 and 4-8 of the DTSQ questionnaire. Each component is scored on a scale of 0 (worst case) to 6 (best case). Higher values represent higher treatment satisfaction.
Baseline and 26 weeks
Patient Reported Outcomes: Quality of Life (SF-12)
Time Frame: Baseline and 26 weeks
SF-12 Physical and Mental Component Summary Scores at baseline (week 0) and after 26 weeks of treatment (LOCF). SF-12 Physical and Mental Component Summary Scores are normalized scores ranging from 0 (worst case) to 100 (best case), and are derived from responses to 12 questions. Scores > 50 indicate an above-average health status.
Baseline and 26 weeks

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

February 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

February 12, 2007

First Submitted That Met QC Criteria

February 12, 2007

First Posted (Estimate)

February 14, 2007

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-SB-GWBN

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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