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

A Dose Response Study to Assess the Effect on Glucose Control and Safety and Tolerability of LY2148568 in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s) But Not Well Controlled

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00382239

Enrollment

153

Registered

2006-09-28

Start date

2006-09-30

Completion date

2007-05-31

Last updated

2015-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetes, exenatide, LY2148568, Lilly, Amylin, Japan

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.

Interventions

DRUGexenatide (LY2148568)

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

DRUGPlacebo

subcutaneous injection twice daily, 0.02 mL to 0.04 mL

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026