Sitagliptin in Combination With Metformin and Sulfonylurea

Charles Drew University of Medicine and Science

Status and phase

Completed

Phase 4

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Sitagliptin

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00686634

07-06-002

U54RR014616 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study will compare the effect of a new oral agent for type 2 diabetes, sitagliptin, in comparison to thiazolidinediones as the third-line oral agent, in patients with type 2 diabetes mellitus.

Full description

The aim of this protocol is to determine the non-inferiority of the effectiveness of sitagliptin compared to a control group of patients treated with thiazolidinediones as add-on therapy, in low-income ethnic minority type 2 diabetic patients who are failing to maintain adequate control with maximal doses of metformin and a sulfonylurea agent.

Enrollment

108 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female, age 18-75
Type 2 diabetes
At least 3 months of treatment with maximum tolerated doses of metformin and a sulfonylurea agent, and inadequate glycemic control (Hemoglobin A1c (HbA1c) >7.0%)
Able to comply with all scheduled visits and requirements of the protocol

Exclusion criteria

Any contraindications to the use of metformin or a sulfonylurea agent
Extreme hyperglycemia or symptoms of polyuria or polydipsia
Current or previous chronic use of insulin (other than for treatment of gestational diabetes)
History of confirmed (or clinical suspicion of) type 1 diabetes mellitus
Episodes of symptomatic hypoglycemia averaging greater than once per day
Estimated glomerular filtration rate (eGFR) < 60 mL/min
Subjects with active hemolytic anemias or hemoglobin variants that render the measurement of HbA1c unreliable
History of any clinically significant hepatic, cardiovascular (including the use of digoxin), or other major systemic disease that may make the use of sitagliptin unsafe, or otherwise make the interpretation of the data difficult.
Female subjects of childbearing potential who are sexually active and not using a reliable form of contraception
Current pregnancy or lactation.
Subjects who will likely require or initiate therapy with drugs that may interfere with glucose metabolism during the course of the study.
Subjects who are in another investigational study or have received another investigational medication within 30 days of study entry
Subjects who are unable or unwilling to give informed consent, comply with all components of the study protocol, attend all scheduled follow-up visits, or present other barriers that would make the implementation of the protocol unusually difficult.