Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Metformin or Sulfonylureas and Metformin

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00324363

Enrollment

466

Registered

2006-05-11

Start date

2006-01-31

Completion date

2007-04-30

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

Type 2 Diabetes Mellitus

Keywords

exenatide, diabetes, Amylin, Lilly, China

Brief summary

This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control.

Interventions

DRUGexenatide

subcutaneous injection, 5mcg or 10mcg, twice a day for 16 weeks

DRUGPlacebo

subcutaneous injection twice daily in volumes equal to exenatide

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Treated with a stable dose of one of the following for at least 3 months prior to screening: \* \>=1000 mg/day immediate-release metformin; or metformin \>=1000 mg/day and sulfonylurea; or sulfonylurea/metformin combination therapy. * HbA1c between 7.1% and 11.0%, inclusive. * Body Mass Index (BMI) \>21 kg/m\^2 and \<35 kg/m\^2.

Exclusion criteria

* Have participated in this study previously, or any other study using exenatide or GLP-1 analogs. * Have participated in an interventional, medical, surgical, or pharmaceutical study within 30 days of screening. * Have characteristics contraindicating metformin or sulfonylurea use. * Have been treated with exogenous insulin for more than 1 week within the 3 months prior to screening. * Have used drugs for weight loss within 1 month of screening.

Design outcomes

Primary

Measure	Time frame
To test the hypothesis that exenatide (before morning and evening meals) produces a greater decrease in HbA1c than placebo in patients with type 2 diabetes and inadequate glycemic control taking metformin alone or metformin and sulfonylureas.	16 weeks

Secondary

Measure	Time frame
To compare exenatide and placebo groups with respect to: safety and tolerability; proportion of patients achieving HbA1c<=7%; body weight; incidence and rate of hypoglycemic events; *glucose measurements	16 weeks

Countries

China, India, South Korea, Taiwan

Outcome results

None listed

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