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

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Type 2 Diabetes

Treatments

Drug: exenatide

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00577824

H8O-JE-GWBB

Details and patient eligibility

About

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.

Enrollment

181 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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.