A Study to Assess the Effect on Glucose Control and Safety and Tolerability of LY2148568 In Japanese Patients With Type 2 Diabetes
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
1 other identifier
interventional
153
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 type-2-diabetes-mellitus
Started Sep 2006
Shorter than P25 for phase_2 type-2-diabetes-mellitus
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 26, 2006
CompletedFirst Posted
Study publicly available on registry
September 28, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedFebruary 23, 2015
January 1, 2015
8 months
September 26, 2006
February 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Baseline, Week 12
Secondary Outcomes (4)
Proportion of subjects achieving HbA1c <7% at Week 12
12 weeks
Changes in fasting blood glucose from Visits 3 to 7
Baseline, Week 12
Change in Serum lipids from Baseline to Week 12
Baseline, Week 12
Changes in body weight, waist size and waist/hip ratio from Baseline to Week 12
Baseline, Week 12
Study Arms (4)
Exenatide 5 mcg/exenatide 10 mcg
EXPERIMENTALExenatide 5 mcg/exenatide 5 mcg
EXPERIMENTALExenatide 2.5 mcg/exenatide 2.5 mcg
EXPERIMENTALPlacebo/placebo
PLACEBO COMPARATORInterventions
subcutaneous injection twice daily, 5 mcg for 4 weeks, then 10 mcg for 8 weeks
Eligibility Criteria
You may qualify if:
- Diagnosed with type 2 diabetes.
- Have a body weight of \>=50 kg.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Eli Lilly and Companycollaborator
Study Sites (14)
Research Site
Fukuoka, Japan
Research Site
Fukushima, Japan
Research Site
Gunma, Japan
Research Site
Hiroshima, Japan
Research Site
Hyōgo, Japan
Research Site
Ibaraki, Japan
Research Site
Kanagawa, Japan
Research Site
Kumamoto, Japan
Research Site
Kyoto, Japan
Research Site
Nagano, Japan
Research Site
Okayama, Japan
Research Site
Osaka, Japan
Research Site
Ōita, Japan
Research Site
Tokyo, Japan
Related Publications (2)
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.
PMID: 19194050RESULTFineman 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.
PMID: 22236356DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
James Malone, MD
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2006
First Posted
September 28, 2006
Study Start
September 1, 2006
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
February 23, 2015
Record last verified: 2015-01