Status:

COMPLETED

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

Lead Sponsor:

AstraZeneca

Collaborating Sponsors:

Eli Lilly and Company

Conditions:

Type 2 Diabetes Mellitus

Eligibility:

All Genders

20-75 years

Phase:

PHASE2

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.

Eligibility Criteria

Inclusion

  • Diagnosed with type 2 diabetes.
  • Have a body weight of \>=50 kg.

Exclusion

  • 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.

Key Trial Info

Start Date :

September 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2007

Estimated Enrollment :

153 Patients enrolled

Trial Details

Trial ID

NCT00382239

Start Date

September 1 2006

End Date

May 1 2007

Last Update

February 23 2015

Active Locations (14)

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Page 1 of 4 (14 locations)

1

Research Site

Fukuoka, Japan

2

Research Site

Fukushima, Japan

3

Research Site

Gunma, Japan

4

Research Site

Hiroshima, Japan