Conditions: Type 2 Diabetes
Keywords: diabetes continuous glucose monitoring exenatide insulin glargine
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 60
Healthy volunteers: no

Brief summary:
The primary purpose of this study is to compare the effect on 24-hour blood glucose patterns, HbA1c, and weight management when adding insulin glargine, or exenatide, or a combination of insulin glargine and exenatide to metformin.

Detailed description:
The primary objective of this study was to characterize the diurnal glucose patterns produced by insulin glargine alone, exenatide (GLP-1 agonist) alone and the combination of insulin glargine and exenatide in subjects taking stable dose of metformin and to evaluate their efficacy in terms of improvement in glucose exposure, variability, stability, incidence of hypoglycemia and weight management.

An ancillary study was approved as part of this study. The purpose of the ancillary study was to use CGM to characterize the glycemic response to a fixed breakfast meal consumed by study participants receiving different medications.

Arms:
arm 1: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study arm 2: .1 unit per kg to start, titrated based on Continuous Glucose Monitoring results arm 3: Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study

\+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results

Interventions: intervention 1: Exenatide intervention 2: Insulin Glargine
Intervention descriptions: intervention 1: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study intervention 2: .1 unit per kg to start, titrated based on Continuous Glucose Monitoring results

Protocol document: