Completed

Exenatide Monotherapy for Glucose Control in Type 2 Diabetes Mellitus

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This phase 2 study aims to evaluate how well Exenatide monotherapy controls your blood sugar levels, specifically measuring changes in HbA1c from the start to the end of the 28-day treatment period.

What is being tested

Placebo 0.04 mL twice daily

+ Placebo 0.04 mL once daily

+ Placebo 0.08 mL once daily

Drug
Who is being recruted

Diabetes Mellitus+2

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 18 to 75 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: September 2003
See protocol details

Summary

Principal SponsorAstraZeneca
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2003

Actual date on which the first participant was enrolled.

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.

Official TitleA 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 
NCT00085969
Principal SponsorAstraZeneca
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

99 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesGlucose Metabolism Disorders

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

6 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo

Group II

Placebo

Group III

Placebo

Group IV

Experimental

Group 5

Experimental

Group 6

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 23 locations

Suspended

The Whittier Institute for Diabetes

La Jolla, United StatesSee the location
Suspended

VA Medical Center

San Diego, United States
Suspended

MedStar Research Institute

Washington, United States
Suspended

Internal Medicine Associates, Department of Research

Fort Myers, United States
Completed23 Study Centers