NCT01089569

Continuous Glucose Monitoring Evaluation of Exenatide Twice Daily Versus Insulin Glargine

Evaluation of Insulin Glargine and Exenatide: A Randomized Clinical Trial With Continuous Glucose Monitoring and Ambulatory Glucose Profile Analysis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: HealthPartners Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Exenatide	5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
DRUG	Insulin Glargine	.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results

Timeline

• Start date: 2010-04-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2010-03-18
• Last updated: 2017-05-23
• Results posted: 2017-05-23

Locations

1 site across 1 country: United States