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NCT Number: NCT00382239

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Fukuoka, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

exenatide (LY2148568)

Drug

subcutaneous injection twice daily, 5 mcg for 4 weeks, then 10 mcg for 8 weeks

Other names: Byetta

Placebo

Drug

subcutaneous injection twice daily, 0.02 mL to 0.04 mL

Primary outcomes

  1. Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 12

    Time frame: Baseline, 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 outcomes

  1. Proportion of subjects achieving HbA1c <7% at Week 12

    Time frame: 12 weeks

    Total number of subjects achieving HbA1c <7% at Week 12

  2. Changes in fasting blood glucose from Visits 3 to 7

    Time frame: Baseline, Week 12

    Changes in fasting blood glucose from Baseline (Visit 3) to Week 12 (Visit 7)

  3. Change in Serum lipids from Baseline to Week 12

    Time frame: Baseline, Week 12

    Changes in serum lipids (total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides) from Baseline (Visit 3) to Week 12 (Visit 7)

  4. Changes in body weight, waist size and waist/hip ratio from Baseline to Week 12

    Time frame: Baseline, Week 12

    Changes in body weight, waist size and waist/hip ratio from Baseline (Visit 3) to Week 12 (Visit 7)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Sep 28, 2006
Registry last updated
Feb 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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