Efficacy and Safety of Exenatide in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s) - Full Text View

Sponsors and Collaborators:	Amylin Pharmaceuticals, Inc. Eli Lilly and Company
Information provided by:	Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00577824

Purpose

This long term, placebo-controlled trial is intended to assess the efficacy and safety of exenatide, dosed twice a day, in Japanese patients with Type 2 Diabetes who are treated with oral antidiabetic(s) but not well controlled.

Condition	Intervention	Phase
Type 2 Diabetes	Drug: exenatide Drug: placebo	Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Exenatide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of LY2148568 in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s) But Not Well Controlled

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

Primary Outcome Measures:

To assess the hypothesis that glycemic control (mean change of HbA1c from baseline to endpoint) with exenatide is superior to placebo in Japanese patients with type 2 diabetes whose glycemic control is inadequate. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the effect of exenatide on the following measures of efficacy: *Proportion of patients achieving HbA1c <7.0% and <6.5%; *Glucose (fasting); *Body weight; *Serum lipids; *Waist size and waist/hip ratio. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
To assess the effect of exenatide on the following measures of efficacy: *Glucose measured at different times throughout the day; *Beta cell function and insulin sensitivity as assessed by homeostasis model assessment analyses and C-peptide. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
To assess the effect of exenatide on the following measures of safety: *Treatment emergent adverse events; *Laboratory tests; *Vital signs; *Electrocardiogram; *Anti-exenatide antibody; *Hypoglycemia. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
To measure the effect of exenatide on glycemic control (HbA1c) over an extended period of time. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	175
Study Start Date:	January 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: exenatide subcutaneous injection, 5mcg, twice a day
2: Experimental	Drug: exenatide subcutaneous injection, 10mcg, twice a day
3: Placebo Comparator	Drug: placebo subcutaneous injection, volume equivalent to 5mcg or 10mcg exenatide, twice a day

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.
Has been treated by sulfonylurea (SU) alone, SU and biguanide, or SU and thiazolidinedione for at least 90 days prior to study start. In a patient receiving SU alone, the dose must be within the dose range from maximum maintenance dose to maximum approved dose. The patients with concomitant use of alpha glucosidase inhibitors (acarbose, voglibose or miglitol) or meglitinide derivatives (mitiglinide or nateglinide) can be included in this study, but these drugs must be discontinued at study start.
Have HbA1c 7.0% to 10% at study start.
Have a body weight >=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 GLP-1 analogs within the last 90 days.
Have been treated with any exogenous insulin within 90 days before study start.
Have been continuously treated with any drug that directly affects gastrointestinal motility for more than a total of 21 days in the 90 days prior to study start.
The combination therapy of sulfonylurea, biguanide and thiazolidinedione is not allowed.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00577824

Locations

Japan
Research Site
Ibaragi, Japan
Research Site
Chiba, Japan
Research Site
Tokyo, Japan
Research Site
Kanagawa, Japan
Research Site
Nagano, Japan
Research Site
Osaka, Japan
Research Site
Hyogo, Japan
Research Site
Oita, Japan
Research Site
Kumamoto, Japan
Research Site
Fukushima, Japan
Research Site
Kyoto, Japan
Research Site
Fukuoka, Japan

Sponsors and Collaborators

Amylin Pharmaceuticals, Inc.

Eli Lilly and Company

Investigators

Study Director:

James Malone, MD

Eli Lilly and Company

More Information

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

Responsible Party:	Eli Lilly and Company ( James Malone, MD, Study Director )
Study ID Numbers:	H8O-JE-GWBB
Study First Received:	December 18, 2007
Last Updated:	May 9, 2008
ClinicalTrials.gov Identifier:	NCT00577824
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Amylin Pharmaceuticals, Inc.:

diabetes
exenatide
LY2148568

Byetta
Lilly
Amylin

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 16, 2009