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

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00085969
First received: June 18, 2004
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Placebo 0.04 mL twice daily
Drug: Placebo 0.04 mL once daily
Drug: Placebo 0.08 mL once daily
Drug: B - Exenatide 10 mcg twice daily
Drug: C - Exenatide 10 mcg once daily
Drug: Exenatide 20 mcg once daily
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28 [ Time Frame: Baseline, Day 28 ] [ Designated as safety issue: No ]
    Change in HbA1c from Baseline Visit 3 (Day 1) to study termination (Day 28)


Secondary Outcome Measures:
  • Change in serum fructosamine concentration from Baseline to Day 14 and to Day 28 [ Time Frame: Baseline, Day 14, Day 28 ] [ Designated as safety issue: No ]
    Change in serum fructosamine concentration from Baseline Visit 3 (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)

  • Change in body weight from Baseline to Day 14 and to Day 28 [ Time Frame: Baseline, Day 14, Day28 ] [ Designated as safety issue: No ]
    Change in body weight from Baseline Visit 3 (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)

  • Change in fasting plasma glucose concentration from Baseline to Day 14 and to Day 28 [ Time Frame: Baseline, Day 14, Day 28 ] [ Designated as safety issue: No ]
    Change in fasting plasma glucose concentration from Baseline Visit 3 (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)

  • Change in postprandial blood glucose concentrations from Baseline to Day 28 [ Time Frame: Baseline, Week 28 ] [ Designated as safety issue: No ]
    Change in postprandial blood glucose concentrations from Baseline Visit 3 (Day 1) to study termination (Day 28)


Enrollment: 99
Study Start Date: September 2003
Study Completion Date: January 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A1 - Placebo 0.04 mL twice daily Drug: Placebo 0.04 mL twice daily
Subcutaneously injected, 0.04 mL, twice daily
Placebo Comparator: A2 - Placebo 0.04 mL once daily Drug: Placebo 0.04 mL once daily
Subcutaneously injected, 0.04 mL, once daily
Placebo Comparator: A3 - Placebo 0.08 mL once daily Drug: Placebo 0.08 mL once daily
Subcutaneously injected, 0.08 mL, once daily
Experimental: B - Exenatide 10 mcg twice daily Drug: B - Exenatide 10 mcg twice daily
Subcutaneously injected, 10 mcg (0.04 mL), twice daily
Other Names:
  • ACC2993
  • synthetic exendin-4
Experimental: C - Exenatide 10 mcg once daily Drug: C - Exenatide 10 mcg once daily
Subcutaneously injected, 10 mcg (0.04 mL), once daily
Other Names:
  • ACC2993
  • synthetic exendin-4
Experimental: D - Exenatide 20 mcg once daily Drug: Exenatide 20 mcg once daily
Subcutaneously injected, 20 mcg (0.08 mL), once daily
Other Names:
  • ACC2993
  • synthetic exendin-4

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00085969

  Hide Study Locations
Locations
United States, California
The Whittier Institute for Diabetes
La Jolla, California, United States, 92037
VA Medical Center
San Diego, California, United States, 92161
United States, District of Columbia
MedStar Research Institute
Washington, District of Columbia, United States, 20003
United States, Florida
Internal Medicine Associates, Department of Research
Fort Myers, Florida, United States, 33901
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
Innovative Research of West Florida
Largo, Florida, United States, 33770
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
Grand Rapids Associated Internists
Grand Rapids, Michigan, United States, 49506
United States, Missouri
Radiant Research, Inc.
St. Louis, Missouri, United States, 63141
United States, Montana
Internal Medicine Associates
Bozeman, Montana, United States, 59715
Mercury Street Medical Group
Butte, Montana, United States, 59701
United States, Nevada
Lovelace Scientific Resources
Las Vegas, Nevada, United States, 89128
United States, New York
Rochester Clinical Research, Inc.
Rochester, New York, United States, 14609
United States, North Carolina
Metrolina Medical Research
Charlotte, North Carolina, United States, 28209
Piedmont Medical Research Associates
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Radiant Research
Columbus, Ohio, United States, 43212
Smith Clinic Research
Marion, Ohio, United States, 43302
United States, Oregon
Radiant Research
Portland, Oregon, United States, 97239
United States, Pennsylvania
Philadelphia Health Associates - Adult Medicine
Philadelphia, Pennsylvania, United States, 19146
United States, Texas
Diabetes and Glandular Disease Research Associates
San Antonio, Texas, United States, 78229-4801
S.A.M. Clinical Research Center
San Antonio, Texas, United States, 78229
United States, Virginia
McGuire VA Medical Center
Richmond, Virginia, United States, 23249
United States, Washington
Rockwood Clinic
Spokane, Washington, United States, 99202
Sponsors and Collaborators
AstraZeneca
Eli Lilly and Company
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00085969     History of Changes
Other Study ID Numbers: 2993-120
Study First Received: June 18, 2004
Last Updated: June 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
diabetes
exenatide
Amylin
Lilly

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 30, 2014