Overview

Adding Sitagliptin or Pioglitazone to Type 2 Diabetes Mellitus Insufficiently Controlled With Metformin and Sulfonylurea

Status:
Completed
Trial end date:
2012-04-01
Target enrollment:
0
Participant gender:
All
Summary
This 24-weeks study will to compare the glycemic efficacy and safety of sitagliptin with pioglitazone in patients with type 2 diabetes who had inadequate glycemic control despite dual therapy with metformin and a sulfonylurea.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sung-Chen Liu
Collaborator:
Mackay Memorial Hospital
Treatments:
Metformin
Pioglitazone
Sitagliptin Phosphate
Criteria
Inclusion Criteria:

- Type 2 diabetes patients who were treated with stable doses of sulfonylurea and
metformin to their half maximally dose (sulfonylureas > half maximal dose, and
metformin > 1500 mg/d) for > 10 weeks

- > 20 years old

- A1C: > 7.0 % and < 11%

Exclusion Criteria:

- Insulin use within 12 weeks of the screening visit

- Any contraindications for use of sitagliptin or pioglitazone, impaired renal function
(serum creatinine > 1.4 mg/dl), alanine aminotransferase or aspartate aminotransferase
levels > 2.5 times the upper limit of normal

- Current or prepare to pregnancy and lactation