Sitagliptin in Combination With Metformin and Sulfonylurea

This study is currently recruiting participants.

Verified by Charles Drew University of Medicine and Science, May 2008

Sponsors and Collaborators:	Charles Drew University of Medicine and Science National Institutes of Health (NIH)
Information provided by:	Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier:	NCT00686634

Purpose

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.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: Sitagliptin	Phase IV

MedlinePlus related topics: Diabetes

Drug Information available for: Metformin Metformin hydrochloride Sitagliptin phosphate Sitagliptin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Sitagliptin in Combination Oral Agent Therapy for Type 2 Diabetes

Further study details as provided by Charles Drew University of Medicine and Science:

Primary Outcome Measures:

Hemoglobin A1c change from baseline [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects with hemoglobin A1c 7.5% or less [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Proportion of subjects maintaining hemoglobin A1c 7.5% or less [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Any adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	January 2008
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Sitagliptin 100 mg once daily	Drug: Sitagliptin Sitagliptin 100 mg po once daily

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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 (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 GFR (MDRD) < 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00686634

Contacts

Contact: Maria Navar, NP

310-668-3610

m.d.navar@sbcglobal.com

Locations

United States, California
Charles Drew University of Medicine and Science	Recruiting
Los Angeles, California, United States, 90059
Principal Investigator: Stanley Hsia, MD
Sub-Investigator: Mayer Davidson, MD

Sponsors and Collaborators

Charles Drew University of Medicine and Science

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Stanley Hsia, MD

Charles Drew University of Medicine and Science

More Information

Responsible Party:	Charles Drew University of Medicine and Science ( Stanley Hsia, MD )
Study ID Numbers:	07-06-002
Study First Received:	May 27, 2008
Last Updated:	May 29, 2008
ClinicalTrials.gov Identifier:	NCT00686634
Health Authority:	United States: Institutional Review Board

Keywords provided by Charles Drew University of Medicine and Science:

sitagliptin
type 2 diabetes
combination therapy

Study placed in the following topic categories:

Metabolic Diseases
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Sitagliptin

Additional relevant MeSH terms:

Dipeptidyl-Peptidase IV Inhibitors
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009