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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00085969

Enrollment

Registered

2004-06-22

Start date

2003-09-30

Completion date

2004-01-31

Last updated

2015-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

diabetes, exenatide, Amylin, Lilly

Brief summary

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.

Interventions

DRUGPlacebo 0.04 mL twice daily

Subcutaneously injected, 0.04 mL, twice daily

DRUGPlacebo 0.04 mL once daily

Subcutaneously injected, 0.04 mL, once daily

DRUGPlacebo 0.08 mL once daily

Subcutaneously injected, 0.08 mL, once daily

DRUGB - Exenatide 10 mcg twice daily

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

DRUGC - Exenatide 10 mcg once daily

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

DRUGExenatide 20 mcg once daily

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28	Baseline, Day 28	Change in HbA1c from Baseline Visit 3 (Day 1) to study termination (Day 28)

Secondary

Measure	Time frame	Description
Change in serum fructosamine concentration from Baseline to Day 14 and to Day 28	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)
Change in body weight from Baseline to Day 14 and to Day 28	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)
Change in fasting plasma glucose concentration from Baseline to Day 14 and to Day 28	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)
Change in postprandial blood glucose concentrations from Baseline to Day 28	Baseline, Week 28	Change in postprandial blood glucose concentrations from Baseline Visit 3 (Day 1) to study termination (Day 28)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026