Completed

Exenatide vs. Biphasic Insulin Aspart for Type 2 Diabetes Glycemic Control

Study Aim

This study aims to compare the effectiveness of Exenatide and Biphasic Insulin Aspart in controlling blood sugar levels, specifically measuring changes in Glycosylated Hemoglobin (HbA1c) over a period of 52 weeks in individuals with Type 2 Diabetes.

What is being tested

exenatide

+ biphasic insulin aspart

Drug

Who is being recruted

Diabetes Mellitus+3

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 30 to 75 Years

+23 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: November 2003

See protocol details

Summary

Principal SponsorAstraZeneca

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2003

Actual date on which the first participant was enrolled.

This is a Phase 3, multicenter, open-label, comparator-controlled trial comparing the effect of exenatide twice daily to twice daily biphasic insulin aspart on glycemic control, as measured by hemoglobin A1c (HbA1c).

Official TitleEfficacy of Exenatide (AC2993, Synthetic Exendin-4, LY2148568) Compared With Twice-Daily Biphasic Insulin Aspart in Patients With Type 2 Diabetes Using Sulfonylurea and Metformin

NCT00082407

Principal SponsorAstraZeneca

Last updated: January 27, 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

505 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 30 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 DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

4 inclusion criteria required to participate

Patients have been treated with a stable dose of the following for at least 3 months prior to screening: 1. >=1500 mg/day immediate-release metformin or extended-release metformin and at least an optimally effective dose for brand of sulfonylurea, or 2. a fixed-dose sulfonylurea/metformin combination therapy with the same sulfonylurea and metformin requirements as for the individual components

HbA1c between 7.0% and 11.0%, inclusive.

Patients have a body mass index >25kg/m2 and <40 kg/m2.

Female patients are not breastfeeding, and female patients of childbearing potential test negative for pregnancy, do not intend to become pregnant during the study, and agree to continue using a reliable method of birth control

19 exclusion criteria prevent from participating

Patients are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study.

Patients are employed by Lilly or Amylin.

Patients have previously, in this or any other study, received exenatide or glucagon-like peptide-1 analogs.

Patients have participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry.

Show More Criteria

Study Plan

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

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks

Group II

Active Comparator

subcutaneous injection, twice daily; titration to target blood glucose level

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 69 locations

Suspended

Diabetes Unit, Blackburn Royal Infirmary

Blackburn, United KingdomOpen Diabetes Unit, Blackburn Royal Infirmary in Google Maps

Suspended

Colchester General Hospital

Colchester, United Kingdom

Suspended

Royal Infirmary of Edinburgh

Edinburgh, United Kingdom

Suspended

Glasgow Royal Infirmary

Glasgow, United Kingdom

Completed69 Study Centers