Phase 4
N=41
How Glargine Insulin, Oral Diabetes Medications and Exenatide May Improve Blood Sugar Control and Weight Gain in Type 2 Diabetics
Type 2 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT00667732 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcome: Primary: 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 — 47; 12 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- exenatide (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Oregon Health and Science University
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
47; 12 | — |
| SECONDARY The Percentage of Per Protocol Participants Randomized and Treated in Each Arm Who Had Lab-measured A1c <6.5% at 24 Weeks of Treatment |
50; 12 | — |
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT00667732). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.