A Study to Examine the Effects of Exenatide Once-Weekly Injection on Glucose Control and Safety in Asian Subjects

Phase 3

Completed

• Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2009/091/000608
• Lead Sponsor: Eli Lilly and Company India Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 202

Inclusion Criteria

Have been diagnosed with Type 2 Diabetes
-Have suboptimal glycemic control as evidenced by a HbA1c between 7.1% and 11.0% inclusive
-Have a body mass index (BMI) of greater than 21 kg/m2 and less than 35 kg/m2 inclusive
-Have a history of stable body weight (not varying by greater than 5% for at least 90 days prior to study start)
-Have been treated witha stable dose regimen of Met, SU, TZD, Met plus SU, Met plus TZD for at least 90 days prior to study start

Exclusion Criteria

-Have any contraindication for the OAD(s) that they use
-Have a known allergy or hypersensivity to exenatide BID, exenatide QW, or excipients contained in these agents
-Have received chronic (greater than 14 days) systemic glucocorticoid therapy by oral, intravenous (IV), or intramuscular (IM) route or intra-articular steroid injection within 4 weeks prior to study start or are regularly treated with potent, inhaled steroids that are known to have a high rate of systemic absorption
-Have been treated with drugs that promote weight loss (for example GLP-1 analogue, orlistat, sibutramine, phenylpropanolamine, or similar over-the-counter medications) within 90 days prior to study start
-Have been treated for greater than 2 weeks with any of the following excluded medications within 90 days prior to study start: insulin, dipeptidyl peptidase (DPP)-4 inhibitors like sitagliptin or vildagliptin, pramlinitude acetate, or drugs that directly affect gastrointestinal motility
-Have had prior exposure to exenatide
-Have previously completed or withdrawn from this study or any other study investigating exenatide BID or QW
-Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
-Are currently enrolled in another clinical study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To estimate the difference in change in HbA1c from baseline to endpoint between 2 mg exenatide QW and 10 μg exenatide BID in patients with type 2 diabetes and inadequate glycemic control with OAD(s) alone or in combinationTimepoint: 26 weeks