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Completed

NCT Number: NCT00085969

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Whittier Institute for Diabetes, La Jolla, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo 0.04 mL twice daily

Drug

Subcutaneously injected, 0.04 mL, twice daily

Placebo 0.04 mL once daily

Drug

Subcutaneously injected, 0.04 mL, once daily

Placebo 0.08 mL once daily

Drug

Subcutaneously injected, 0.08 mL, once daily

B - Exenatide 10 mcg twice daily

Drug

Subcutaneously injected, 10 mcg (0.04 mL), twice daily

Other names: ACC2993, synthetic exendin-4

C - Exenatide 10 mcg once daily

Drug

Subcutaneously injected, 10 mcg (0.04 mL), once daily

Other names: ACC2993, synthetic exendin-4

Exenatide 20 mcg once daily

Drug

Subcutaneously injected, 20 mcg (0.08 mL), once daily

Other names: ACC2993, synthetic exendin-4

Primary outcomes

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

    Time frame: Baseline, Day 28

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

Secondary outcomes

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

    Time frame: Baseline, Day 14, Day 28

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

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

    Time frame: Baseline, Day 14, Day28

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

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

    Time frame: Baseline, Day 14, 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)

  4. Change in postprandial blood glucose concentrations from Baseline to Day 28

    Time frame: Baseline, Week 28

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

A Phase 2, Randomized, Triple-Blind, Placebo-Controlled, Multicenter Study to Examine the Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Jun 22, 2004
Registry last updated
Feb 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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