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:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00382239
First received: September 26, 2006
Last updated: June 6, 2014
Last verified: June 2014
  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 AstraZeneca:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
AstraZeneca
Eli Lilly and Company
Investigators
Study Director: James Malone, MD Eli Lilly and Company
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00382239     History of Changes
Other Study ID Numbers: H8O-JE-GWAV
Study First Received: September 26, 2006
Last Updated: June 6, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AstraZeneca:
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
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on October 19, 2014