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):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00434954
First received: February 12, 2007
Last updated: September 16, 2013
Last verified: September 2013

February 12, 2007
September 16, 2013
February 2007
June 2009   (final data collection date for primary outcome measure)
  • 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
To test the hypothesis that exenatide is non-inferior to premixed human insulin aspart in terms of glycemic control, and superior to premixed human insulin aspart in terms of hypoglycemia incidence, when given in combination with metformin.
Complete list of historical versions of study NCT00434954 on ClinicalTrials.gov Archive Site
  • 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.
  • To compare the two injectable treatment regimens with respect to:
  • >proportion of patients achieving pre-specified HbA1c targets
  • >percentage of patients with at least one treatment-emergent hypoglycemic episode
  • >nocturnal hypoglycemia
  • >blood glucose control
  • >blood lipid levels
  • >anthropometric measures
  • >patient reported outcomes
Not Provided
Not Provided
 
Effect of Exenatide Plus Metformin vs. Insulin Aspart Plus Metformin on Glycemic Control and Hypoglycemia in Patients With Type 2 Diabetes
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: exenatide twice daily (BID)
    subcutaneous injection (5 mcg or 10 mcg), twice a day
    Other Name: Byetta
  • Drug: premixed insulin aspart twice daily (BID)
    subcutaneous injection (titrated appropriately), twice a day
  • Experimental: Exenatide Twice Daily (BID)
    Intervention: Drug: exenatide twice daily (BID)
  • Active Comparator: Premixed Insulin Aspart Twice Daily (BID)
    Intervention: Drug: premixed insulin aspart twice daily (BID)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
494
June 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00434954
H8O-SB-GWBN
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Eli Lilly and Company
Study Director: Chief Medical Officer, MD Eli Lilly and Company
Bristol-Myers Squibb
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP