Study to Examine the Effect on Glucose Control and Safety/Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes

An Open Label Study to Examine the Long Term Effect on Glucose Control (HbA1c) and Safety and Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes Mellitus

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00111540

Enrollment

456

Registered

2005-05-24

Start date

2002-11-30

Completion date

2006-09-30

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

exenatide, diabetes, Amylin, exendin-4

Brief summary

This open label study is designed to assess long term glucose control, as measured by hemoglobin A1c (HbA1c) and to evaluate long term safety and tolerability in subjects with type 2 diabetes mellitus who receive subcutaneously injected exenatide administered twice a day.

Interventions

DRUGexenatide

subcutaneous injection, 5 mcg, twice a day for 4 weeks (transition period), then 10 mcg twice a day till study termination

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* The subject has an HbA1c value \<=11.0% * The subject has a body mass index (BMI) of 25 kg/m\^2 to 45 kg/m\^2, inclusive

Exclusion criteria

* Is currently treated with certain medications, including exogenous insulin

Design outcomes

Primary

Measure	Time frame	Description
Change in HbA1c (glycosylated hemoglobin) from Visit 1 to each protocol visit	Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)	Change in HbA1c from Visit 1 to each visit up to open-ended study termination
Change in body weight from Visit 1 to each protocol visit	Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)	Change in body weight (kg) from Visit 1 to each visit up to open-ended study termination
Change in fasting plasma glucose from Visit 1 to each protocol visit	Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)	Change in fasting plasma glucose from Visit 1 to each visit up to open-ended study termination
Change in lipids from Visit 1 to each protocol visit	Day 1, Weeks 2, 4, 8, 15, 22, 30, 38, 46 and every 12 weeks while on study (78 week target)	Change in lipids from Visit 1 to each visit up to open-ended study termination

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026