Continuous Glucose Monitoring Evaluation of Exenatide Twice Daily Versus Insulin Glargine
Completed · Not applicable
Conditions studied: Type 2 Diabetes
In brief
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.
Key facts
- Study ID
- NCT01089569
- Run by
- HealthPartners Institute
- People needed
- 60
- Starts
- 2010-04-01
- Expected to finish
- 2013-05-01
- Last updated by the study team
- 2017-05-23
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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%)
You may not qualify if…
- 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
Where it is running
- International Diabetes Center — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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