Status:
COMPLETED
How Glargine Insulin, Oral Diabetes Medications and Exenatide May Improve Blood Sugar Control and Weight Gain in Type 2 Diabetics
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
Amylin Pharmaceuticals, LLC.
Eli Lilly and Company
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
30-70 years
Phase:
PHASE4
Brief Summary
This study is designed to look at how using glargine insulin with oral diabetes medications and exenatide may improve control of blood sugar levels and weight gain in type 2 diabetics. The main study...
Eligibility Criteria
Inclusion
- Male or female patients with type 2 diabetes
- Taking metformin at least 1000 mg daily plus a secretagogue, an alpha glucosidase inhibitor, a thiazolidinedione, or a single injection of any kind of insulin up to 0.4 units/kg daily for \> 3 months
- Age range 30 to 70 years
- Body mass index 25-45 kg/m2
- HbA1c 7.0 to 10.0% (or 7.0 to 8.5% if the second antihyperglycemic agent is insulin)
- Less than 50% of randomized participants will have used insulin previously
Exclusion
- Use of more than two antihyperglycemic agents within the last 3 months
- Use of more than one daily injection of any kind of insulin in the last 3 months
- Positive anti-GAD antibody (test required in screening)
- Fasting C-peptide \<0.5 ng/mL (test required in screening)
- Pregnancy (test required in screening if able to conceive) or lactation
- Excessive use of alcohol or evidence of other form of drug dependency
- Unwillingness or inability to grant informed consent
- Unwillingness or inability to perform self-monitoring of blood glucose
- Unwillingness or inability to inject insulin and/or inject exenatide
- Serum creatinine \>1.3 mg/dL in women or 1.4 in men
- Retinopathy which has required photocoagulation for treatment
- Major active systemic illness (e.g. neoplastic disorder, symptomatic ischemic heart disease, congestive heart failure) that might interfere with performing the study protocol
- Clinically significant gastrointestinal disorder including prior gastric or intestinal surgery for weight-control
- Ongoing use of any drug (e.g. narcotic analgesic, tricyclic antidepressant) that might alter gastric emptying
- Use prednisone or other systemic glucocorticoid drug in the last 3 months
- Use of any drug for weight-control (e.g. sibutramine, phentermine, orlistat) in the last 3 months
- Use of any unproven investigational drug within the last 3 months
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00667732
Start Date
March 1 2007
End Date
April 1 2010
Last Update
February 6 2013
Active Locations (3)
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1
Medstar Research Institute
Washington D.C., District of Columbia, United States, 20003
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
Oregon Health and Science University
Portland, Oregon, United States, 97239