How Glargine Insulin, Oral Diabetes Medications and Exenatide May Improve Blood Sugar Control and Weight Gain in Type 2 Diabetics
Information source: Oregon Health and Science University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes
Intervention: exenatide (Drug); placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Oregon Health and Science University Official(s) and/or principal investigator(s): Matthew Riddle, MD, Principal Investigator, Affiliation: Oregon Health and Science University
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.
Clinical Details
Official title: Metformin, Exenatide, and Glargine Insulin in Combination for Treatment of Patients With Type 2 Diabetes
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: 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
Secondary outcome: The Percentage of Per Protocol Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment
Eligibility
Minimum age: 30 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Medstar Research Institute, Washington DC, District of Columbia 20003, United States
Mayo Clinic, Rochester, Minnesota 55905, United States
Oregon Health and Science University, Portland, Oregon 97239, United States
Additional Information
Starting date: March 2007
Last updated: February 4, 2013
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