Efficacy Evaluation of Different Medication Combination in Type 2 Diabetes Treatment
Diabetes Type 2
About this trial
This is an interventional treatment trial for Diabetes Type 2 focused on measuring Diabetes
Eligibility Criteria
Inclusion Criteria:
- A diagnosis of Type 2 DM for over six months
- A history of inadequate glycemic control (A1c > 7.5% but < 10%) despite treatment with 2 or more oral hypoglycemic agents
- 18 years of age or older
- Stable medical status (e.g., no myocardial infarction, stroke, major surgery, or major mental illness during the previous 6 months)
- Naïve to insulin (no insulin for more than 14 days during the previous 6 months and none within 60 days of beginning the study)
- On at least ½ maximum or the greatest tolerable dose of their oral agents according to the label for at least 3 months
- BMI < 40 kg/m2
- Willing to perform at least four finger stick blood glucose measurements each day
Exclusion Criteria:
- A diagnosis of Type 2 DM for less than six months
- An A1c of < 7.5% or > 10%
- Pregnancy as determined by a serum ß HCG.
- An unstable medical status
- Taking glucocorticoids, amphetamines, anabolic, or weight-reducing agents during the course of the study
- Inability to read and write English
- Someone who is not likely to return for the follow-up because they or their sponsor is likely to have a permanent change of station or termination of service before completion of the protocol
- Unwilling to perform four finger stick blood glucose measurements each day
- Previous history of use of exenatide
Sites / Locations
- MedStar Research Institute
- Walter Reed Army Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
A Levemir
B Exenatide
C Levemir+Exenatide
Levemir once daily, force titrated to reach a fasting plasma glucose of 100 mg/dl
Exenatide twice daily, started at a dose of 5 mcg b.i.d. and increased to 10 mcg b.i.d. after 2 weeks if the fasting plasma glucose of 100 mg/dl is not reached. Exenatide will be administered immediately before breakfast and dinner meals. No further increase in the dose of exenatide will take place. For those who are unable to tolerate exenatide at a 10 mcg b.i.d. dose, it will be reduced to 5 mcg b.i.d. and continued until week 12.
Patients from either Group A or Group B who have not reached the goal A1C of 6.5% will be assigned to this Group. They will receive the drug assigned to the other group in addition to the one they were originally assigned.