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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

This study has been completed.
Sponsor:
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
History of Changes

September 26, 2006
February 6, 2013
September 2006
May 2007   (final data collection date for primary outcome measure)
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
To assess the effect on glucose control (as measured by HbA1c) of LY2148568 (exenatide).
Complete list of historical versions of study NCT00382239 on ClinicalTrials.gov Archive Site
  • 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)
To assess the effect of LY2148568 (exenatide) on the following items: *proportion of patients achieving HbA1c <7%; *fasting glucose; *body weight; *treatment emergent adverse events; *various pharmacokinetic and pharmacodynamic parameters.
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: exenatide (LY2148568)
    subcutaneous injection twice daily, 5 mcg for 4 weeks, then 10 mcg for 8 weeks
    Other Name: Byetta
  • Drug: exenatide (LY2148568)
    subcutaneous injection twice daily, 5 mcg for 4 weeks, then 5 mcg for 8 weeks
    Other Name: Byetta
  • Drug: exenatide (LY2148568)
    subcutaneous injection twice daily, 2.5 mcg for 4 weeks, then 2.5 mcg for 8 weeks
    Other Name: Byetta
  • Drug: Placebo
    subcutaneous injection twice daily, 0.02 mL to 0.04 mL
  • Experimental: Exenatide 5 mcg/exenatide 10 mcg
    Intervention: Drug: exenatide (LY2148568)
  • Experimental: Exenatide 5 mcg/exenatide 5 mcg
    Intervention: Drug: exenatide (LY2148568)
  • Experimental: Exenatide 2.5 mcg/exenatide 2.5 mcg
    Intervention: Drug: exenatide (LY2148568)
  • Placebo Comparator: Placebo/placebo
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
153
May 2007
May 2007   (final data collection date for primary outcome measure)

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.
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00382239
H8O-JE-GWAV
No
Amylin Pharmaceuticals, LLC.
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Study Director: James Malone, MD Eli Lilly and Company
Amylin Pharmaceuticals, LLC.
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP