Effects of Exenatide and Insulin Glargine in Subjects 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:
NCT00097500
First received: November 24, 2004
Last updated: October 31, 2013
Last verified: October 2013

November 24, 2004
October 31, 2013
September 2004
December 2009   (final data collection date for primary outcome measure)
Beta-cell Function After 52 Weeks of Therapy [ Time Frame: Baseline (week -2) and 52 weeks ] [ Designated as safety issue: No ]
Treatment effect on beta-cell function as measured by the ratio of Week 52 arginine-stimulated insulin secretion during a hyperglycemic clamp(specifically, the incremental AUC of insulin with respect to basal value over a 10 min period [i.e., clamp time 290 min to 300 min]) to that at baseline (i.e., the ratio is calculated as arginine-stimulated insulin secretion at week 52 divided by arginine-stimulated insulin secretion at baseline [week -2]).
Not Provided
Complete list of historical versions of study NCT00097500 on ClinicalTrials.gov Archive Site
  • Beta-cell Function 4 Weeks After Cessation of Therapy [ Time Frame: Baseline (week -2) and 56 weeks ] [ Designated as safety issue: No ]
    Treatment effect on beta-cell function as measured by the ratio of Week 56 arginine-stimulated insulin secretion during a hyperglycemic clamp(specifically, the incremental AUC of insulin with respect to basal value over a 10 min period [i.e., clamp time 290 min to 300 min]) to that at baseline (i.e., the ratio is calculated as arginine-stimulated insulin secretion at week 56 divided by arginine-stimulated insulin secretion at baseline [week -2]).
  • Change in First Phase C-peptide Release [ Time Frame: baseline (week -2), 52 weeks, and 56 weeks ] [ Designated as safety issue: No ]
    Ratio of first phase C-peptide response to glucose at 52 weeks (end of on-drug period) and 56 weeks (during off-drug period) compared to first phase C-peptide response to glucose at baseline (i.e., C-peptide response to glucose at week 52 or week 56 divided by C-peptide response to glucose at baseline [week -2]). C-peptide is measured as a surrogate marker of insulin secretion. First phase C-peptide/insulin release is measured during the first ten minutes of glucose infusion during a hyperglycemic clamp procedure.
  • Change in Second Phase C-peptide Release [ Time Frame: baseline (-2 weeks), 52 weeks, and 56 weeks ] [ Designated as safety issue: No ]
    Ratio of second phase C-peptide response to glucose at 52 weeks (end of on-drug period) and 56 weeks (during off-drug period) compared to second phase C-peptide response to glucose at baseline (i.e., C-peptide response to glucose at week 52 or week 56 divided by C-peptide response to glucose at baseline [week -2]). C-peptide is measured as a surrogate marker of insulin secretion. Second phase C-peptide/insulin release is measured from time=10 minutes to time=80 minutes of glucose infusion during a hyperglycemic clamp procedure.
  • Change in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Week 0 and week 52 ] [ Designated as safety issue: No ]
    Change in HbA1c from week 0 to week 52 (i.e., HbA1c at week 52 minus HbA1c at week 0).
  • Change in Fasting Plasma Glucose [ Time Frame: 0 weeks and 52 weeks ] [ Designated as safety issue: No ]
    Change in fasting plasma glucose from week 0 to week 52 (i.e., fasting plasma glucose at week 52 minus fasting plasma glucose at week 0).
  • Seven Point Self Monitored Blood Glucose (SMBG) Measurements [ Time Frame: 0 weeks and 52 weeks ] [ Designated as safety issue: No ]
    SMBG measured at 7 time points (before and after breakfast, before and after lunch, before and after dinner, at bedtime).
  • Change in Body Weight [ Time Frame: 0 weeks and 52 weeks ] [ Designated as safety issue: No ]
    Change in body weight from week 0 to week 52 (i.e., body weight at week 52 minus body weight at week 0).
  • M-value at Baseline, Week 52 and Week 56 [ Time Frame: baseline (week -2), 52 weeks, and 56 weeks ] [ Designated as safety issue: No ]
    M-value at baseline (week -2), week 52 (end of on-drug period), and week 56 (during off-drug period). Insulin sensitivity was assessed during the euglycemic/hyperglycemic clamp test at baseline (week -2), week 52, and week 56. Insulin-mediated glucose uptake (M-value) was calculated as the mean glucose requirement during the 90-120 minute interval of the clamp.
Not Provided
Not Provided
Not Provided
 
Effects of Exenatide and Insulin Glargine in Subjects With Type 2 Diabetes
A Phase 3, Randomized, Open Label, Comparator-Controlled, Parallel Group, Multicenter Study to Compare the Effects of Exenatide and Insulin Glargine on Beta Cell Function and Cardiovascular Risk Markers in Subjects With Type 2 Diabetes Treated With Metformin Who Have Not Achieved Target HbA1c

This Phase 3, open-label, multicenter study is designed to compare the effects of exenatide and insulin glargine (Lantus® injection) on beta-cell function in patients with type 2 diabetes mellitus using metformin.

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
    subcutaneous injection, titrated up to a maximum of 20mcg three times a day in order to meet defined blood glucose targets
    Other Name: Byetta
  • Drug: Insulin glargine
    subcutaneous injection, once a day, titrated as necessary in order to meet defined blood glucose targets
    Other Name: Lantus
  • Drug: Metformin
    Patients usual dosage
  • Experimental: Exenatide Arm
    Exenatide and Metformin
    Interventions:
    • Drug: exenatide
    • Drug: Metformin
  • Active Comparator: Insulin Glargine Arm
    Insulin Glargine and Metformin
    Interventions:
    • Drug: Insulin glargine
    • Drug: Metformin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
69
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of type 2 diabetes, but otherwise healthy
  • HbA1c between 6.6% and 9.5%, inclusive.
  • Body mass index (BMI) of 25 kg/m2 to 40 kg/m2, inclusive.
  • Treated with a stable dose of metformin for at least 2 months prior to screening.

Exclusion Criteria:

  • Patients previously in a study using exenatide.
  • Treated with oral anti-diabetic medications other than metformin within 2 months of screening (thiazolidinediones within 5 months of screening).
  • Treated with insulin within 3 months of screening.
Both
30 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland,   Netherlands,   Sweden
 
NCT00097500
2993-114
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Eli Lilly and Company
Study Director: Vice President, Research and Development, MD Amylin Pharmaceuticals, LLC.
Bristol-Myers Squibb
October 2013

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