Effects of Exenatide and Insulin Glargine in Subjects With Type 2 Diabetes | RxWiki

Effects of Exenatide and Insulin Glargine in Subjects With Type 2 Diabetes

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Type 2 Diabetes Mellitus
Intervention	Drug: exenatide Drug: Insulin glargine Drug: Metformin
Phase	Phase 3
Sponsor	Bristol-Myers Squibb
Responsible Party	Bristol-Myers Squibb
ClinicalTrials.gov Identifier	NCT00097500
First Received	November 24, 2004
Last Updated	October 31, 2013
Last verified	October 2013

Tracking Information[ + expand ][ + ]

First Received Date	November 24, 2004
Last Updated Date	October 31, 2013
Start Date	September 2004
Estimated Primary Completion Date	December 2009
Current Primary Outcome Measures	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]).
Current Secondary Outcome Measures	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.

Descriptive Information[ + expand ][ + ]

Brief Title	Effects of Exenatide and Insulin Glargine in Subjects With Type 2 Diabetes
Official Title	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Type 2 Diabetes Mellitus
Intervention	Drug: exenatide subcutaneous injection, titrated up to a maximum of 20mcg three times a day in order to meet defined blood glucose targets Other Names: ByettaDrug: Insulin glargine subcutaneous injection, once a day, titrated as necessary in order to meet defined blood glucose targets Other Names: LantusDrug: Metformin Patients usual dosage
Study Arm (s)	Experimental: Exenatide Arm Exenatide and Metformin Active Comparator: Insulin Glargine Arm Insulin Glargine and Metformin

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	69
Estimated Completion Date	December 2009
Estimated Primary Completion Date	December 2009
Eligibility Criteria	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.
Gender	Both
Ages	30 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Finland, Netherlands, Sweden

Administrative Information[ + expand ][ + ]

NCT Number	NCT00097500
Other Study ID Numbers	2993-114
Has Data Monitoring Committee	No
Information Provided By	Bristol-Myers Squibb
Study Sponsor	Bristol-Myers Squibb
Collaborators	Eli Lilly and Company
Investigators	Study Director: Vice President, Research and Development, MD Amylin Pharmaceuticals, LLC.
Verification Date	October 2013

Locations[ + expand ][ + ]