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

AstraZeneca153 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

153

Conditions

Type 2 Diabetes Mellitus

Interventions

exenatide (LY2148568)DRUG

subcutaneous injection twice daily, 5 mcg for 4 weeks, then 10 mcg for 8 weeks

exenatide (LY2148568)DRUG

subcutaneous injection twice daily, 5 mcg for 4 weeks, then 5 mcg for 8 weeks

exenatide (LY2148568)DRUG

subcutaneous injection twice daily, 2.5 mcg for 4 weeks, then 2.5 mcg for 8 weeks

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed with type 2 diabetes. * Have a body weight of \>=50 kg. 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.

Locations (14)

Research Site

Fukuoka, Japan

Research Site

Fukushima, Japan

Research Site

Gunma, Japan

Research Site

Hiroshima, Japan

Outcomes

Primary Outcomes

Change in HbA1c (glycosylated hemoglobin) from Baseline to 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

Time frame: Baseline, Week 12

Secondary Outcomes

Proportion of subjects achieving HbA1c <7% at Week 12

Total number of subjects achieving HbA1c \<7% at Week 12

Time frame: 12 weeks

Changes in fasting blood glucose from Visits 3 to 7

Changes in fasting blood glucose from Baseline (Visit 3) to Week 12 (Visit 7)

Time frame: Baseline, Week 12

Change in Serum lipids from Baseline to Week 12

Changes in serum lipids (total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides) from Baseline (Visit 3) to Week 12 (Visit 7)

Time frame: Baseline, Week 12

Changes in body weight, waist size and waist/hip ratio from Baseline to Week 12

Changes in body weight, waist size and waist/hip ratio from Baseline (Visit 3) to Week 12 (Visit 7)

Time frame: Baseline, Week 12

Data from ClinicalTrials.gov

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