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

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Exenatide (AC2993)
Drug: Insulin glargine

Registration Number: NCT00082381

Lead Sponsor: AstraZeneca

Brief Summary: 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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 551

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exenatide Arm	Exenatide (AC2993)	exenatide subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 22 weeks
Insulin Glargine Arm	Insulin glargine	subcutaneous injection, once daily; forced titration to target blood glucose level

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients Achieving HbA1c <=7%	26 weeks	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	Baseline, week 26	Change in body weight from baseline to week 26
Change in Fasting Serum Glucose	Baseline, week 26	Change in fasting serum glucose from baseline to week 26
Change in 7-point Self-monitored Blood Glucose (SMBG) Profile	Baseline, 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 With Hypoglycemic Events	26 weeks	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	Baseline, week 26	Change in rate of hypoglycemic events per 30 days per patient from baseline to week 26

Trial Locations

Locations (87): Radiant Research-San Diego
🇺🇸
San Diego, California, United States
Dorothy L. and James E. Frank Diabetes Research Institute
🇺🇸
San Mateo, California, United States
Internal Medicine Associates Department of Research
🇺🇸
Fort Myers, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸
Jacksonville, Florida, United States
Baptist Diabetes Associates
🇺🇸
Miami, Florida, United States
Metabolic Research Institute, Inc.
🇺🇸
West Palm Beach, Florida, United States
Springfield Diabetes & Endocrine Center
🇺🇸
Springfield, Illinois, United States
Frederick Primary Care Associates
🇺🇸
Frederick, Maryland, United States
Radiant Research, Inc.
🇺🇸
St. Louis, Missouri, United States
Lovelace Scientific Resources, Inc.
🇺🇸
Las Vegas, Nevada, United States
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Radiant Research-San Diego
🇺🇸San Diego, California, United States