Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus

AstraZeneca99 enrolled

Overview

The purpose of this study is to evaluate the safety and efficacy of a 28-day regimen of exenatide (AC2993), given as a monotherapy to subjects with type 2 diabetes mellitus.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

Placebo 0.04 mL twice dailyDRUG

Subcutaneously injected, 0.04 mL, twice daily

Placebo 0.04 mL once dailyDRUG

Subcutaneously injected, 0.04 mL, once daily

Placebo 0.08 mL once dailyDRUG

Subcutaneously injected, 0.08 mL, once daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject has type 2 diabetes mellitus treated with diet and exercise modification alone or in combination with one oral antidiabetic agent for no longer than 4 years. Exclusion Criteria: * Subject has a clinically significant history or presence of any of the following conditions: (a) Hepatic disease, (b) Renal disease, (c) Central nervous system disease, (d) Gastrointestinal disease (e) Pulmonary disease (f) Hematologic disease. * Subject is currently treated with any of the following excluded medications: (a) Metformin/sulfonylurea combination therapy (b) Thiazolidinediones (c) Insulin as outpatient therapy (d) Regular use of drugs that directly affect gastrointestinal motility (e) Regular use of systemic corticosteroids by oral, intravenous (IV), or intramuscular (IM) route, or potent, inhaled, intrapulmonary, or intranasal steroids known to have a high rate of systemic absorption (f) Regular use of medications with addictive potential such as opiates, narcotics and tranquilizers (g) Antineoplastic agents (h) Transplantation medications (i) Prescription weight-loss medications.

Locations (23)

The Whittier Institute for Diabetes

La Jolla, California, United States

Outcomes

Primary Outcomes

Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28

Change in HbA1c from Baseline Visit 3 (Day 1) to study termination (Day 28)

Time frame: Baseline, Day 28

Secondary Outcomes

Change in serum fructosamine concentration from Baseline to Day 14 and to Day 28

Change in serum fructosamine concentration from Baseline Visit 3 (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)

Time frame: Baseline, Day 14, Day 28

Change in body weight from Baseline to Day 14 and to Day 28

Change in body weight from Baseline Visit 3 (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)

Time frame: Baseline, Day 14, Day28

Change in fasting plasma glucose concentration from Baseline to Day 14 and to Day 28

Change in fasting plasma glucose concentration from Baseline Visit 3 (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)

Time frame: Baseline, Day 14, Day 28

Change in postprandial blood glucose concentrations from Baseline to Day 28

Change in postprandial blood glucose concentrations from Baseline Visit 3 (Day 1) to study termination (Day 28)

Time frame: Baseline, Week 28

Data from ClinicalTrials.gov

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