A Study to Assess the Effect on Glucose Control and Safety and Tolerability of LY2148568 In Japanese Patients With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
exenatide (LY2148568)
exenatide (LY2148568)
exenatide (LY2148568)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring diabetes, exenatide, LY2148568, Lilly, Amylin, Japan
Eligibility 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.
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Exenatide 5 mcg/exenatide 10 mcg
Exenatide 5 mcg/exenatide 5 mcg
Exenatide 2.5 mcg/exenatide 2.5 mcg
Placebo/placebo
Arm Description
Outcomes
Primary Outcome Measures
Change in HbA1c (glycosylated hemoglobin) from Baseline to 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 Outcome Measures
Proportion of subjects achieving HbA1c <7% at Week 12
Total number of subjects achieving HbA1c <7% at Week 12
Changes in fasting blood glucose from Visits 3 to 7
Changes in fasting blood glucose from Baseline (Visit 3) to Week 12 (Visit 7)
Change in Serum lipids from Baseline to 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
Changes in body weight, waist size and waist/hip ratio from Baseline (Visit 3) to Week 12 (Visit 7)
Full Information
NCT ID
NCT00382239
First Posted
September 26, 2006
Last Updated
February 20, 2015
Sponsor
AstraZeneca
Collaborators
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00382239
Brief Title
A Study to Assess the Effect on Glucose Control and Safety and Tolerability of LY2148568 In Japanese Patients With Type 2 Diabetes
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
diabetes, exenatide, LY2148568, Lilly, Amylin, Japan
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exenatide 5 mcg/exenatide 10 mcg
Arm Type
Experimental
Arm Title
Exenatide 5 mcg/exenatide 5 mcg
Arm Type
Experimental
Arm Title
Exenatide 2.5 mcg/exenatide 2.5 mcg
Arm Type
Experimental
Arm Title
Placebo/placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
exenatide (LY2148568)
Other Intervention Name(s)
Byetta
Intervention Description
subcutaneous injection twice daily, 5 mcg for 4 weeks, then 10 mcg for 8 weeks
Intervention Type
Drug
Intervention Name(s)
exenatide (LY2148568)
Other Intervention Name(s)
Byetta
Intervention Description
subcutaneous injection twice daily, 5 mcg for 4 weeks, then 5 mcg for 8 weeks
Intervention Type
Drug
Intervention Name(s)
exenatide (LY2148568)
Other Intervention Name(s)
Byetta
Intervention Description
subcutaneous injection twice daily, 2.5 mcg for 4 weeks, then 2.5 mcg for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
subcutaneous injection twice daily, 0.02 mL to 0.04 mL
Primary Outcome Measure Information:
Title
Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 12
Description
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
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Proportion of subjects achieving HbA1c <7% at Week 12
Description
Total number of subjects achieving HbA1c <7% at Week 12
Time Frame
12 weeks
Title
Changes in fasting blood glucose from Visits 3 to 7
Description
Changes in fasting blood glucose from Baseline (Visit 3) to Week 12 (Visit 7)
Time Frame
Baseline, Week 12
Title
Change in Serum lipids from Baseline to Week 12
Description
Changes in serum lipids (total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides) from Baseline (Visit 3) to Week 12 (Visit 7)
Time Frame
Baseline, Week 12
Title
Changes in body weight, waist size and waist/hip ratio from Baseline to Week 12
Description
Changes in body weight, waist size and waist/hip ratio from Baseline (Visit 3) to Week 12 (Visit 7)
Time Frame
Baseline, Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Malone, MD
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Fukuoka
Country
Japan
Facility Name
Research Site
City
Fukushima
Country
Japan
Facility Name
Research Site
City
Gunma
Country
Japan
Facility Name
Research Site
City
Hiroshima
Country
Japan
Facility Name
Research Site
City
Hyogo
Country
Japan
Facility Name
Research Site
City
Ibaraki
Country
Japan
Facility Name
Research Site
City
Kanagawa
Country
Japan
Facility Name
Research Site
City
Kumamoto
Country
Japan
Facility Name
Research Site
City
Kyoto
Country
Japan
Facility Name
Research Site
City
Nagano
Country
Japan
Facility Name
Research Site
City
Oita
Country
Japan
Facility Name
Research Site
City
Okayama
Country
Japan
Facility Name
Research Site
City
Osaka
Country
Japan
Facility Name
Research Site
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
19194050
Citation
Kadowaki T, Namba M, Yamamura A, Sowa H, Wolka AM, Brodows RG. Exenatide exhibits dose-dependent effects on glycemic control over 12 weeks in Japanese patients with suboptimally controlled type 2 diabetes. Endocr J. 2009;56(3):415-24. doi: 10.1507/endocrj.k08e-296. Epub 2009 Feb 4.
Results Reference
result
PubMed Identifier
22236356
Citation
Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10.
Results Reference
derived
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A Study to Assess the Effect on Glucose Control and Safety and Tolerability of LY2148568 In Japanese Patients With Type 2 Diabetes
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