A Study to Assess the Effect on Glucose Control and Safety and Tolerability of LY2148568 In Japanese Patients With Type 2 Diabetes

Phase 2

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Placebo; Drug: exenatide (LY2148568)

• Registration Number: NCT00382239
• Lead Sponsor: AstraZeneca

Brief Summary

This study will examine the response of several doses of LY2148568 (exenatide) and assess the effect on glucose control and safety and tolerability in Japanese patients with type 2 diabetes.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-26
• Study First Submitted QC: 2006-09-26
• Study First Posted: 2006-09-28
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Status Verified: 2015-01
• Last Update Submitted: 2015-02-20
• Last Update Posted: 2015-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

Inclusion Criteria

• Diagnosed with type 2 diabetes.
• Have a body weight of >=50 kg.

Read More

Exclusion Criteria

• 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.
• Have participated in this study previously, or any other study using exenatide or other GLP-1 analogs.
• Are treated with any exogenous insulin within 3 months of screening.
• Are continuously treated with any of the following excluded medications within 3 months of screening (more than 7 days per 1 month): *drugs that directly affect gastrointestinal motility, including Nauzelin® (domperidone), Primperan®/Terperan® (metoclopramide), Ganaton® (itopride), Acenalin® (cisapride), Gasmotin® (mosapride), or Cerekinon® (trimebutine).
• Have characteristics contraindicating for concomitant medication, according to product-specific label.
• Have severe allergy or hypersensitivity to any drug.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo/placebo	Placebo	-
Exenatide 5 mcg/exenatide 10 mcg	exenatide (LY2148568)	-
Exenatide 2.5 mcg/exenatide 2.5 mcg	exenatide (LY2148568)	-
Exenatide 5 mcg/exenatide 5 mcg	exenatide (LY2148568)	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 12	Baseline, Week 12	Assess dose response effect on glucose control as measured by HbA1c among four doses (2.5 μg, 5 μg, 10 μg, and placebo) of subcutaneous injection of exenatide, twice daily before meals in the morning and evening, for 12 weeks

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects achieving HbA1c <7% at Week 12	12 weeks	Total number of subjects achieving HbA1c \<7% at Week 12
Changes in fasting blood glucose from Visits 3 to 7	Baseline, Week 12	Changes in fasting blood glucose from Baseline (Visit 3) to Week 12 (Visit 7)
Change in Serum lipids from Baseline to Week 12	Baseline, Week 12	Changes in serum lipids (total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides) from Baseline (Visit 3) to Week 12 (Visit 7)
Changes in body weight, waist size and waist/hip ratio from Baseline to Week 12	Baseline, Week 12	Changes in body weight, waist size and waist/hip ratio from Baseline (Visit 3) to Week 12 (Visit 7)

Trial Locations

Locations (1)

Research Site; 🇯🇵 Tokyo, Japan