NCT02325960

A Comparison of Exenatide and Insulin Glargine

A Comparison of Exenatide and Insulin Glargine on Glycemic Variability in T2DM Patients Inadequately Controlled With Metformin Monotherapy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a 16-week, Single-center, Randomized, Open Label, Parallel Controlled Group Comparison of the Comprehensive Glycemic Control of Exenatide and Insulin Glargine on Type 2 Diabetes Patients Inadequately Controlled With Metformin Monotherapy.

Detailed description

Screening will be made to select eligible patients, then 44 patients receiving a stable dose of metformin (≥1500 mg daily) will be randomized (1:1) to receive exenatide or insulin glargine for 16 weeks. Exenatide will be administered twice daily by subcutaneous injection 30- 60 minutes before breakfast and dinner; the dose was 5 μg twice-daily for the first 4 weeks of treatment and 10 μg thereafter. Insulin glargine will be administered once daily at bedtime by subcutaneous injection. The dose of insulin glargine will initiate at ≥8 IU once-daily, and titrate based on a dosing algorithm targeting fasting blood glucose (FPG)\<6.1 mmol/L. Titration is only allowed in first 4 weeks. At the end of the study, data will be collected and analyzed.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	exenatide	5 μg BID for the first 4 weeks of treatment and 10 μg thereafter.
DRUG	Insulin glargine	≥8 IU QD, and titrate based on a dosing algorithm targeting FPG \<6.1 mmol/L. Titration is only allowed in first 4 weeks.

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-07-01
• Completion: 2016-10-01
• First posted: 2014-12-25
• Last updated: 2017-02-23

Locations

1 site across 1 country: China