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

This study has been completed.

Sponsors and Collaborators:	Amylin Pharmaceuticals, Inc. Eli Lilly and Company
Information provided by:	Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00382239

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: exenatide (LY2148568)	Phase II

MedlinePlus related topics: Diabetes

Drug Information available for: Exenatide Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Dose Response Study to Assess the Effect on Glucose Control and Safety and Tolerability of LY2148568 in Japanese Patients With Type 2 Diabetes

Further study details as provided by Amylin Pharmaceuticals, Inc.:

Primary Outcome Measures:

To assess the effect on glucose control (as measured by HbA1c) of LY2148568 (exenatide). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the effect of LY2148568 (exenatide) on the following items: *proportion of patients achieving HbA1c <7%; *fasting glucose; *body weight; *treatment emergent adverse events; *various pharmacokinetic and pharmacodynamic parameters. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	140
Study Start Date:	September 2006
Study Completion Date:	May 2007
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Intervention Details:

subcutaneous injection

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00382239

Locations

Japan
Research Site
Tokyo, Japan
Research Site
Fukushima, Japan
Research Site
Ibaraki, Japan
Research Site
Kanagawa, Japan
Research Site
Kyoto, Japan
Research Site
Nagano, Japan
Research Site
Fukuoka, Japan
Research Site
Gunma, Japan
Research Site
Kumamoto, Japan
Research Site
Okayama, Japan
Research Site
Oita, Japan
Research Site
Hyogo, Japan
Research Site
Hiroshima, Japan
Research Site
Osaka, Japan

Sponsors and Collaborators

Amylin Pharmaceuticals, Inc.

Eli Lilly and Company

Investigators

Study Director:

James Malone, MD

Eli Lilly and Company

More Information

Responsible Party:	Eli Lilly and Company ( James Malone, MD, Study Director )
Study ID Numbers:	H8O-JE-GWAV
Study First Received:	September 26, 2006
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00382239
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Amylin Pharmaceuticals, Inc.:

diabetes
exenatide
LY2148568

Lilly
Amylin
Japan

Study placed in the following topic categories:

Metabolic Diseases
Exenatide
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009