Continuous Glucose Monitoring Evaluation of Exenatide Twice Daily Versus Insulin Glargine

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to compare the effect on 24-hour blood glucose patterns, HbA1c, and weight management when adding insulin glargine, or exenatide, or a combination of insulin glargine and exenatide to metformin.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: HealthPartners Institute
• Collaborators: International Diabetes Center at Park Nicollet; Sanofi
• Treatments: Exenatide; Insulin; Insulin Glargine; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• Male or female subjects ≥18 and ≤75 years of age

• Clinical diagnosis of type 2 diabetes

• Diabetes duration ≥ 1 year

• HbA1c ≥7.0%

• Currently treated with metformin (HbA1c ≤9%) or metformin/sulfonylurea (SU) (HbA1c ≤8%)or SU alone (HbA1c ≤8%)

Exclusion Criteria:

• Previously treated with insulin or incretin-based therapy

• Treated with a thiazolidinedione within past 6 weeks

• Taken oral or injected prednisone or cortisone medications in the previous 30 days

• Any pancreatic disease or at high risk of pancreatitis (history of alcohol abuse, active gallbladder disease)

• Serum creatinine >1.4mg/dL (women) or >1.5 mg/dL (men)

• eGFR (Estimated Glomerular Filtration Rate) <30 ml/min (using MDRD/ Modification of Diet in Renal Disease equation)

• ALT(Alanine Transaminase) > 2x Upper Limit of Normal (ULN)

• Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise he subject's safety or successful participation in the study

• Currently pregnant or planning pregnancy during the study period

• Unable to follow the study protocol

• Unable to speak, read and write in English

• Uncontrolled hyperglycemia with HbA1c > 9% on metformin or >8% on SU or metformin/SU combination or ketonuria requiring immediate insulin therapy

• At the investigator's discretion for other medical or psychological reasons