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.
Sponsor:
Amylin Pharmaceuticals, LLC.
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT00382239
First received: September 26, 2006
Last updated: February 6, 2013
Last verified: February 2013
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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) Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 Who Are Treated With Oral Antidiabetic(s) But Not Well Controlled |
Resource links provided by NLM:
Further study details as provided by Amylin Pharmaceuticals, LLC.:
Primary Outcome Measures:
- Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]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 Outcome Measures:
- Proportion of subjects achieving HbA1c <7% at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Total number of subjects achieving HbA1c <7% at Week 12
- Changes in fasting blood glucose from Visits 3 to 7 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]Changes in fasting blood glucose from Baseline (Visit 3) to Week 12 (Visit 7)
- Change in Serum lipids from Baseline to Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]Changes in body weight, waist size and waist/hip ratio from Baseline (Visit 3) to Week 12 (Visit 7)
| Enrollment: | 153 |
| Study Start Date: | September 2006 |
| Study Completion Date: | May 2007 |
| Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Exenatide 5 mcg/exenatide 10 mcg |
Drug: exenatide (LY2148568)
subcutaneous injection twice daily, 5 mcg for 4 weeks, then 10 mcg for 8 weeks
Other Name: Byetta
|
| Experimental: Exenatide 5 mcg/exenatide 5 mcg |
Drug: exenatide (LY2148568)
subcutaneous injection twice daily, 5 mcg for 4 weeks, then 5 mcg for 8 weeks
Other Name: Byetta
|
| Experimental: Exenatide 2.5 mcg/exenatide 2.5 mcg |
Drug: exenatide (LY2148568)
subcutaneous injection twice daily, 2.5 mcg for 4 weeks, then 2.5 mcg for 8 weeks
Other Name: Byetta
|
| Placebo Comparator: Placebo/placebo |
Drug: Placebo
subcutaneous injection twice daily, 0.02 mL to 0.04 mL
|
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 | |
| Fukuoka, Japan | |
| Research Site | |
| Fukushima, Japan | |
| Research Site | |
| Gunma, Japan | |
| Research Site | |
| Hiroshima, Japan | |
| Research Site | |
| Hyogo, Japan | |
| Research Site | |
| Ibaraki, Japan | |
| Research Site | |
| Kanagawa, Japan | |
| Research Site | |
| Kumamoto, Japan | |
| Research Site | |
| Kyoto, Japan | |
| Research Site | |
| Nagano, Japan | |
| Research Site | |
| Oita, Japan | |
| Research Site | |
| Okayama, Japan | |
| Research Site | |
| Osaka, Japan | |
| Research Site | |
| Tokyo, Japan | |
Sponsors and Collaborators
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Investigators
| Study Director: | James Malone, MD | Eli Lilly and Company |
More Information
No publications provided by Amylin Pharmaceuticals, LLC.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Amylin Pharmaceuticals, LLC. |
| ClinicalTrials.gov Identifier: | NCT00382239 History of Changes |
| Other Study ID Numbers: | H8O-JE-GWAV |
| Study First Received: | September 26, 2006 |
| Last Updated: | February 6, 2013 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Amylin Pharmaceuticals, LLC.:
|
diabetes exenatide LY2148568 |
Lilly Amylin Japan |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Exenatide Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013