Efficacy and Safety of Exenatide in Japanese Patients With Type 2 Diabetes Who Are Treated With Oral Antidiabetic(s)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

181 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-11-30

Brief Summary

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This long term, placebo-controlled trial is intended to assess the efficacy and safety of exenatide, dosed twice a day, in Japanese patients with Type 2 Diabetes who are treated with oral antidiabetic(s) but not well controlled.

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Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

exenatide

Intervention Type DRUG

subcutaneous injection, 5mcg, twice a day

2

Group Type EXPERIMENTAL

exenatide

Intervention Type DRUG

subcutaneous injection, 10mcg, twice a day

3

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

subcutaneous injection, volume equivalent to 5mcg or 10mcg exenatide, twice a day

Interventions

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exenatide

subcutaneous injection, 5mcg, twice a day

Intervention Type DRUG

exenatide

subcutaneous injection, 10mcg, twice a day

Intervention Type DRUG

placebo

subcutaneous injection, volume equivalent to 5mcg or 10mcg exenatide, twice a day

Intervention Type DRUG

Other Intervention Names

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LY2148568 Byetta LY2148568 Byetta

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with type 2 diabetes.
* Has been treated by sulfonylurea (SU) alone, SU and biguanide, or SU and thiazolidinedione for at least 90 days prior to study start. In a patient receiving SU alone, the dose must be within the dose range from maximum maintenance dose to maximum approved dose. The patients with concomitant use of alpha glucosidase inhibitors (acarbose, voglibose or miglitol) or meglitinide derivatives (mitiglinide or nateglinide) can be included in this study, but these drugs must be discontinued at study start.
* Have HbA1c 7.0% to 10% at study start.
* Have a body weight \>=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 glucagon-like peptide-1 (GLP-1) analogs within the last 90 days.
* Have been treated with any exogenous insulin within 90 days before study start.
* Have been continuously treated with any drug that directly affects gastrointestinal motility for more than a total of 21 days in the 90 days prior to study start.
* The combination therapy of sulfonylurea, biguanide and thiazolidinedione is not allowed.

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No