Completed

AC2993 vs Insulin Glargine for Type 2 Diabetes Control on Sulfonylurea and Metformin Therapy

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Study AimThis study aims to compare the effectiveness of AC2993 versus Insulin Glargine in controlling Type 2 Diabetes in individuals who are currently on Sulfonylurea and Metformin therapy, by observing changes in Glycosylated Hemoglobin (HbA1c) levels from the start to the 26th week.
What is being tested

Exenatide (AC2993)

+ Insulin glargine
Drug
Who is being recruted

Diabetes Mellitus
+2

+ Diabetes Mellitus, Type 2
+ Endocrine System Diseases
From 30 to 75 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: June 2003
See protocol details

Summary

Principal SponsorAstraZeneca
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 2003Actual date on which the first participant was enrolled.

This is a multicenter, comparator-controlled, open-label, randomized, two-arm, parallel trial to compare the effect of exenatide twice daily and insulin glargine on glycemic control, as measured by hemoglobin A1c (HbA1c).

Official TitleEffect of AC2993 (Synthetic Exendin-4) Compared With Insulin Glargine in Patients With Type 2 Diabetes Also Using Combination Therapy With Sulfonylurea and Metformin 
NCT00082381
Principal SponsorAstraZeneca
Last updated: January 14, 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
551 patients to be enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 30 to 75 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Metabolic Diseases
Glucose Metabolism Disorders
Criteria

Inclusion Criteria: * Patients have been treated with a stable dose of one of the following for at least 3 months prior to screening: 1. 1500 to 2550 mg/day immediate-release metformin (or 1500 to 2000 mg/day extended-release metformin) and at least an optimally effective dose of a 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 10.0%, inclusive. * History of stable body weight (not varying by \>10% for at least three months prior to screening). * Female patients are not breastfeeding, and female patients of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopause) Exclusion Criteria: * 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 participated in this study previously or any other study using AC2993 or GLP-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. * Patients have had greater than three episodes of severe hypoglycemia within 6 months prior to screening. * Patients are undergoing therapy for a malignancy, other than basal cell or squamous cell skin cancer. * Patients have cardiac disease that is Class III or IV, according to the New York Heart Association criteria. * Patients have a known allergy or hypersensitivity to insulin glargine, AC2993, or excipients contained in these agents. * Patients have characteristics contraindicating metformin or sulfonylurea use, according to product-specific label, in the opinion of the investigator. * Patients have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine \>=1.5 mg/dL for males and \>=1.3 mg/dL for females. * Patients have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine aminotransferase/serum glutamicpyruvic transaminase greater than three times the upper limit of the reference range. * Patients have known hemoglobinopathy or chronic anemia. * Patients are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to screening. * Patients have used any prescription drug to promote weight loss within 3 months prior to screening. * Patients have any other condition (including known drug or alcohol abuse or psychiatric disorder) that precludes them from following and completing the protocol, in the opinion of the investigator. * Patients fail to satisfy the investigator of suitability to participate for any other reason.

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
exenatide subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 22 weeks

subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 22 weeks
Group II
Active Comparator
subcutaneous injection, once daily; forced titration to target blood glucose level

subcutaneous injection, once daily; forced titration to target blood glucose level
Study Objectives
Primary Objectives

Change in HbA1c from baseline to week 26
Secondary Objectives

Percentage of patients in each arm who had HbA1c \>7% at baseline and had HbA1c \<=7% at week 26 (percentage = \[number of subjects with HbA1c \<=7% at week 26 divided by number of subjects with HbA1c \>7% at baseline\] \* 100%).

Change in body weight from baseline to week 26

Change in fasting serum glucose from baseline to week 26

Change in 7-point (pre-breakfast, 2 hour post breakfast, pre-lunch, 2 hour post lunch, pre-dinner, 2 hour post dinner, 0300 hours) SMBG profile from baseline to week 26

Percentage of patients who experienced at least one episode of hypoglycemia at any point during the 26 week Parent Study (incidence of hypoglycemia = number of patients who experienced at least one episode of hypoglycemia at any point during the 26 week Parent Study divided by the total number of patients who participated in the 26 week Parent Study

Change in rate of hypoglycemic events per 30 days per patient from baseline to week 26

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 91 locations
Suspended
Radiant Research-San DiegoSan Diego, United StatesSee the location
Suspended
Dorothy L. and James E. Frank Diabetes Research InstituteSan Mateo, United States
Suspended
Oddzial Chorob WewnetrznychCzestochowa, Poland
Suspended
NZOZ "Diab-Endo-Met"Krakow, Poland
Completed91 Study Centers