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

AstraZeneca181 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

181

Conditions

Type 2 Diabetes

Interventions

exenatideDRUG

subcutaneous injection, 5mcg, twice a day

exenatideDRUG

subcutaneous injection, 10mcg, twice a day

placeboDRUG

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (12)

Research Site

Chiba, Japan

Research Site

Fukuoka, Japan

Research Site

Fukushima, Japan

Research Site

Hyōgo, Japan

Outcomes

Primary Outcomes

Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24

Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)

Time frame: baseline, 24 weeks

Secondary Outcomes

Percentage of Patients Achieving HbA1c < 7.0%

Percentage of subjects whose HbA1c was \>=7.0% at baseline who achieved an HbA1c \< 7.0% at endpoint (i.e., number of eligible subjects who achieved HbA1c \< 7.0% divided by total number of eligible subjects times 100)

Time frame: 24 weeks

Percentage of Patients Achieving HbA1c < 6.5%

Percentage of subjects whose HbA1c was \>=6.5% at baseline who achieved an HbA1c \< 6.5% at endpoint (i.e., number of eligible subjects who achieved HbA1c \< 6.5% divided by total number of eligible subjects times 100)

Time frame: 24 weeks

Change in Fasting Blood Glucose

Change in fasting blood glucose from baseline to endpoint (i.e., fasting blood glucose at week 24 minus fasting blood glucose at week 0)

Time frame: baseline, week 24

Change in Body Weight

Change in body weight form baseline to endpoint (i.e., body weight at week 24 minus body weight at week 0)

Time frame: baseline, week 24

Change in Total Cholesterol

Change in total cholesterol from baseline to endpoint (i.e., total cholesterol at week 24 minus total cholesterol at week 0)

Time frame: baseline, week 24

Change in Low Density Lipoprotein Cholesterol (LDL-C)

Data from ClinicalTrials.gov

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