Clinical trial NCT00686634: Sitagliptin in Combination With Metformin and Sulfonylurea
Official title: Sitagliptin in Combination Oral Agent Therapy for Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Keywords: sitagliptin
type 2 diabetes
combination therapy
Lead sponsor: Charles Drew University of Medicine and Science
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2008-05-30
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hemoglobin A1c (HbA1c) Change From Baseline
timeFrame: Baseline, 4 months
Secondary outcomes:
measure: Number of Subjects With Hemoglobin A1c 7.5% or Less at 4 Months
timeFrame: 4 months
measure: Number of Subjects Maintaining Hemoglobin A1c 7.5% or Less by 1 Year
timeFrame: 1 year
measure: Number of Adverse Events
timeFrame: 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Charles Drew University of Medicine and Science
state: California
Study officials:
affiliation: Charles Drew University of Medicine and Science
name: Stanley Hsia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hsia SH, Navar MD, Duran P, Shaheen M, Davidson MB. Sitagliptin compared with thiazolidinediones as a third-line oral antihyperglycemic agent in type 2 diabetes mellitus. Endocr Pract. 2011 Sep-Oct;17(5):691-8. doi: 10.4158/EP10405.OR.