How Glargine Insulin, Oral Diabetes Medications and Exenatide May Improve Blood Sugar Control and Weight Gain in Type 2 Diabetics

Phase 4

Completed

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 will last 32 weeks. However, all participants completing 32 weeks will be invited to continue for another 24 weeks taking the insulin and oral medication and exenatide treatment. This extension comparing insulin and oral medication with insulin and oral medication and exenatide will look at the long term weight loss/gain and blood sugar level control effects of this new drug regimen.

There is also a sub-study in the Clinical Research Center (CRC), which requires two 38-hour inpatient stays during the main study. This study offers the opportunity to study 24-hour blood sugar and metabolic patterns quantitatively.

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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

Arm && Interventions

Group	Intervention	Description
2	placebo	Participants will receive placebo rather than exenatide as part of their diabetes treatment
1	exenatide	Participants will receive exenatide as part of their diabetes treatment

Primary Outcome Measures

Name	Time	Method
The Percentage of Intent to Treat Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment	After 24 weeks of randomized treatment

Secondary Outcome Measures

Name	Time	Method
The Percentage of Per Protocol Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment	After 24 weeks of randomized treatment	efficacy criteria, 50% of per protocol participants reached A1c target of \<6.5%

Locations (3): Oregon Health and Science University
🇺🇸
Portland, Oregon, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
Medstar Research Institute
🇺🇸
Washington DC, District of Columbia, United States