Effect of Exenatide on 24-Hour Blood Glucose Profile Compared With Placebo in Patients With Type 2 Diabetes

AstraZeneca30 enrolled

Overview

The purpose of this study is to test the hypothesis that in patients with type 2 diabetes, the addition of exenatide will result in lower time-averaged serum glucose during a 24-hour period, compared with placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

exenatideDRUG

subcutaneous injection, 5mcg twice a day for one week; then 10 mcg twice a day for one week

PlaceboDRUG

subcutaneous injection, equivalent volume to 5 mcg exenatide twice a day for one week; then equivalent volume to 10 mcg exenatide twice a day for one week

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject has an HbA1c between 7.0% and 10.0%, inclusive. * Subject has a body mass index (BMI) \>25 kg/m\^2 and \<50 kg/m\^2. * Subject is on a stable dose of metformin or metformin plus a thiazolidinedione. Exclusion Criteria: * Subject has been treated with any of the following medications: \*exogenous insulin for more than 1 week within 3 months of screening, \*sulfonylureas or meglitinides within 2 months of screening, \*alpha-glucosidase inhibitors within 2 months of screening, \*pramlintide acetate injection within 2 months of screening. * Subject has received exenatide, GLP-1 analogs, DPP-IV inhibitors, or has participated in this study previously.

Locations (2)

Research Site

Washington D.C., District of Columbia, United States

Research Site

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Time-averaged serum glucose during a 24-hour period

Time frame: Every half-hour to hour for 24 hours

Secondary Outcomes

To compare the effects of exenatide and placebo on serum glucose

To compare the effects of exenatide and placebo on serum glucose measured as averaged daytime glucose, averaged nighttime glucose, time-averaged postprandial glucose 2 hours after each meal, time-averaged postprandial glucose 4 hours after each meal, 2-hour postprandial glucose averaged across morning and evening meals, and averaged across the three meals, and fluctuation evaluations

Time frame: Each half-hour to 2 hours for 24 hours

Data from ClinicalTrials.gov

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