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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT00434954
First received: February 12, 2007
Last updated: February 11, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: exenatide twice daily (BID)
Drug: premixed insulin aspart twice daily (BID)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Amylin Pharmaceuticals, LLC.:

Primary Outcome Measures:
  • Change in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    Change in HbA1c from baseline after 26 weeks of treatment (i.e., HbA1c at week 26 minus HbA1c at week 0)

  • Incidence of Hypoglycemia (Percentage of Participants With at Least One Hypoglycemic Episode) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Risk for first hypoglycemic episode (blood glucose <=3.9 mmol/L or severe episode) to occur up to week 26


Secondary Outcome Measures:
  • Percentage of Subjects Achieving HbA1c Target of < 6.5% [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    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%].

  • Percentage of Subjects Achieving HbA1c Target of < 7.0% [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    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%].

  • 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 ] [ Designated as safety issue: No ]
    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%]

  • 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 ] [ Designated as safety issue: No ]
    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%].

  • 7 Point Self-monitored Blood Glucose (SMBG) Profiles [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    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).

  • Blood Lipid Levels [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    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)

  • Change in Body Weight [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    Change in body weight from baseline after 26 weeks of treatment (i.e., body weight at week 26 minus body weight at week 0)

  • Change in Body Mass Index (BMI) [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    Change in BMI from baseline after 26 weeks of treatment (i.e., BMI at week 26 minus BMI at week 0)

  • Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ) [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    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.

  • Patient Reported Outcomes: Quality of Life (SF-12) [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 494
Study Start Date: February 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exenatide Twice Daily (BID) Drug: exenatide twice daily (BID)
subcutaneous injection (5 mcg or 10 mcg), twice a day
Other Name: Byetta
Active Comparator: Premixed Insulin Aspart Twice Daily (BID) Drug: premixed insulin aspart twice daily (BID)
subcutaneous injection (titrated appropriately), twice a day

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00434954

Locations
Germany
Research Site
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
Sponsors and Collaborators
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Investigators
Study Director: Chief Medical Officer, MD Eli Lilly and Company
  More Information

No publications provided by Amylin Pharmaceuticals, LLC.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier: NCT00434954     History of Changes
Other Study ID Numbers: H8O-SB-GWBN
Study First Received: February 12, 2007
Results First Received: June 25, 2010
Last Updated: February 11, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Amylin Pharmaceuticals, LLC.:
diabetes
exenatide
Byetta
Amylin
Lilly

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

ClinicalTrials.gov processed this record on May 22, 2013