A Study to Assess the Effect on Glucose Control and Safety and Tolerability of LY2148568 In Japanese Patients With Type 2 Diabetes

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00382239
• Other study ID #: H8O-JE-GWAV
• Status: Completed
• Phase: Phase 2
• First received: September 26, 2006
• Last updated: February 20, 2015
• Start date: September 2006
• Est. completion date: May 2007

Study information

• Verified date: January 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• exenatide (LY2148568)
subcutaneous injection twice daily, 5 mcg for 4 weeks, then 10 mcg for 8 weeks
• exenatide (LY2148568)
subcutaneous injection twice daily, 5 mcg for 4 weeks, then 5 mcg for 8 weeks
• exenatide (LY2148568)
subcutaneous injection twice daily, 2.5 mcg for 4 weeks, then 2.5 mcg for 8 weeks
• Placebo
subcutaneous injection twice daily, 0.02 mL to 0.04 mL

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

References & Publications (1)

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. Epub 2009 Feb 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Proportion of subjects achieving HbA1c <7% at Week 12	Total number of subjects achieving HbA1c <7% at Week 12	12 weeks	No
Secondary	Changes in fasting blood glucose from Visits 3 to 7	Changes in fasting blood glucose from Baseline (Visit 3) to Week 12 (Visit 7)	Baseline, Week 12	No
Secondary	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)	Baseline, Week 12	No
Secondary	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)	Baseline, Week 12	No