Continuous Glucose Monitoring Evaluation of Exenatide Twice Daily Versus Insulin Glargine
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | April 2010 |
| End Date: | May 2013 |
Evaluation of Insulin Glargine and Exenatide: A Randomized Clinical Trial With Continuous Glucose Monitoring and Ambulatory Glucose Profile Analysis
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.
patterns, HbA1c, and weight management when adding insulin glargine, or exenatide, or a
combination of insulin glargine and exenatide to metformin.
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 <30 ml/min (using MDRD equation
- ALT>2xULN
- 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
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