A Study to Examine Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Exenatide Once Weekly in Japanese Patients With Type 2 Diabetes - Full Text View

Sponsors and Collaborators:	Amylin Pharmaceuticals, Inc. Eli Lilly and Company
Information provided by:	Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00612794

Purpose

Exenatide twice daily has been studied in Japanese type 2 diabetes patients. A once-weekly version of exenatide is currently being evaluated. Study GWBW is the first study of exenatide once weekly in Japanese patients. This study is designed to evaluate safety and tolerability of exenatide once weekly in Japanese patients and determine whether the dose selected for US and European development is appropriate for Japanese patients with Type 2 diabetes.

Condition	Intervention	Phase
Type 2 Diabetes	Drug: exenatide once weekly Drug: placebo	Phase II

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, Pharmacokinetics/Dynamics Study
Official Title:	Multiple-Dose Study to Examine Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY2148568 Long-Acting Release in Japanese Patients With Type 2 Diabetes Mellitus

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

Primary Outcome Measures:

To assess the safety and tolerability of exenatide administered once weekly by subcutaneous (SC) injection in subjects with type 2 diabetes mellitus. [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To assess the pharmacokinetics of exenatide administered once weekly by SC injection in subjects with type 2 diabetes mellitus. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
To explore the pharmacodynamics of exenatide administered once weekly by SC injection in subjects with type 2 diabetes mellitus regarding the following: *fasting and postprandial glucose concentrations; *HbA1c; *Body weight. [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	September 2007
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental exenatide once weekly, 0.8mg	Drug: exenatide once weekly subcutaneous injection, once weekly
2: Experimental exenatide once weekly, 2.0mg	Drug: exenatide once weekly subcutaneous injection, once weekly
3: Placebo Comparator volume equivalent to 0.8mg of exenatide once weekly	Drug: placebo subcutaneous injection, once weekly
4: Placebo Comparator volume equivalent to 2.0mg of exenatide once weekly	Drug: placebo subcutaneous injection, once weekly

Eligibility

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

Criteria

Inclusion Criteria:

Body weight ≥50 kg.
Have suboptimal glycemic control as evidenced by an HbA1c defined by the following criteria: *6.5% to 10.0%, inclusive, at study start for patients managed with diet modification and exercise or treated with oral antidiabetics drug but not alpha glucosidase inhibitor or meglitinide derivatives; *6.5% to 9.5%, inclusive, at study start for patients treated with oral antidiabetics including alpha glucosidase inhibitor or meglitinide derivatives.
Have been treated with diet modification and exercise alone or in combination with a stable regimen of oral antidiabetic drugs (sulfonylurea, metformin and thiazolidinedione) for at least 2 months prior to study start. In the case of patients with concomitant use of sulfonylurea, the dose of sulfonylurea must not be more than maximum recommended dose. The patients with concomitant use of alpha glucosidase inhibitors (Glucobay® [acarbose], Basen® [voglibose], or Seibule® [miglitol]) or meglitinide derivatives (Glufast® [mitiglinide] or Fastic®/Starsis® [nateglinide]) can be included in this study, but these drugs must be discontinued after confirmation of eligibility at study start.

Exclusion Criteria:

Subjects who have donated more than 200 mL of blood and component blood donation within one month of study start, or those who have donated more than 400 mL of blood within three months of study start.
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 and received at least one dose of exenatide or other GLP-1 analogs 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).
Females who are breastfeeding.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00612794

Locations

Japan
Research Site
Osaka, Japan
Research Site
Tokyo, Japan
Research Site
Kanagawa, 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

No publications provided

Responsible Party:	Eli Lilly and Company ( James Malone, MD, Study Director )
Study ID Numbers:	H8O-JE-GWBW
Study First Received:	January 30, 2008
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00612794 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Amylin Pharmaceuticals, Inc.:

exenatide
Byetta
diabetes
Amylin
Lilly

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Exenatide
Amylin
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Exenatide
Physiological Effects of Drugs
Diabetes Mellitus, Type 2

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009