Trials Sponsors Conditions Drugs Pricing

Conditions

Diabetes Mellitus, Type 2

Keywords

DiabetesInsulin glarginecomparatorAmylinLilly

Outcome Measures

Primary Outcomes (1)

Change in Glycosylated Hemoglobin (HbA1c)
Change in HbA1c from baseline to week 26
Baseline, week 26

Secondary Outcomes (6)

Percentage of Patients Achieving HbA1c <=7%
26 weeks
Change in Body Weight
Baseline, week 26
Change in Fasting Serum Glucose
Baseline, week 26
Change in 7-point Self-monitored Blood Glucose (SMBG) Profile
Baseline, week 26
Percentage of Patients With Hypoglycemic Events
26 weeks
+1 more secondary outcomes

Study Arms (2)

Exenatide Arm

EXPERIMENTAL

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

Drug: Exenatide (AC2993)

Insulin Glargine Arm

ACTIVE COMPARATOR

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

Drug: Insulin glargine

Interventions

Exenatide (AC2993)Drug

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

Also known as: Byetta

Exenatide Arm

Insulin glargineDrug

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

Also known as:

Eligibility Criteria

Age30 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Eli Lilly and Company
Industrycollaborator
AstraZeneca
Industrylead

Study Sites (91)

Radiant Research-San Diego

San Diego, California, 92108, United States

Dorothy L. and James E. Frank Diabetes Research Institute

San Mateo, California, 94401, United States

Internal Medicine Associates Department of Research

Fort Myers, Florida, 33901, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Baptist Diabetes Associates

Miami, Florida, 33176, United States

Metabolic Research Institute, Inc.

West Palm Beach, Florida, 33401, United States

Springfield Diabetes & Endocrine Center

Related Publications (3)

Heine RJ, Van Gaal LF, Johns D, Mihm MJ, Widel MH, Brodows RG; GWAA Study Group. Exenatide versus insulin glargine in patients with suboptimally controlled type 2 diabetes: a randomized trial. Ann Intern Med. 2005 Oct 18;143(8):559-69. doi: 10.7326/0003-4819-143-8-200510180-00006.
PMID: 16230722RESULT
Pencek R, Blickensderfer A, Li Y, Brunell SC, Anderson PW. Exenatide twice daily: analysis of effectiveness and safety data stratified by age, sex, race, duration of diabetes, and body mass index. Postgrad Med. 2012 Jul;124(4):21-32. doi: 10.3810/pgm.2012.07.2567.
PMID: 22913891DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

ExenatideInsulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsVenomsComplex Mixtures

Results Point of Contact

Title: Peter Ohman, Medical Science Director
Organization: AstraZeneca

Study Officials

Chief Medical Officer, MD
Eli Lilly and Company
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Enrollment

551 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 6, 2004

First Posted

May 11, 2004

Study Start

June 2003

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

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.
+1 more criteria

Effect of AC2993 Compared With Insulin Glargine in Patients With Type 2 Diabetes Also Using Combination Therapy With Sulfonylurea and Metformin

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

Exenatide Arm

Insulin Glargine Arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (91)

Related Publications (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

Exenatide Arm

Insulin Glargine Arm

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (91)

Related Publications (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations