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Sitagliptin in Combination With Metformin and Sulfonylurea

This study has been completed.
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Charles Drew University of Medicine and Science Identifier:
First received: May 27, 2008
Last updated: November 25, 2014
Last verified: November 2014
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 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sitagliptin in Combination Oral Agent Therapy for Type 2 Diabetes

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Hemoglobin A1c (HbA1c) Change From Baseline [ Time Frame: Baseline, 4 months ]

Secondary Outcome Measures:
  • Number of Subjects With Hemoglobin A1c 7.5% or Less at 4 Months [ Time Frame: 4 months ]
  • Number of Subjects Maintaining Hemoglobin A1c 7.5% or Less by 1 Year [ Time Frame: 1 year ]
  • Number of Adverse Events [ Time Frame: 1 year ]

Enrollment: 108
Study Start Date: January 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Sitagliptin 100 mg once daily
Drug: Sitagliptin
Sitagliptin 100 mg by mouth once daily
Other Name: Trade name: Januvia

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.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00686634

United States, California
Charles Drew University of Medicine and Science
Los Angeles, California, United States, 90059
Sponsors and Collaborators
Charles Drew University of Medicine and Science
National Center for Research Resources (NCRR)
Principal Investigator: Stanley Hsia, MD Charles Drew University of Medicine and Science
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Charles Drew University of Medicine and Science Identifier: NCT00686634     History of Changes
Other Study ID Numbers: 07-06-002
U54RR014616 ( U.S. NIH Grant/Contract )
Study First Received: May 27, 2008
Results First Received: February 24, 2012
Last Updated: November 25, 2014

Keywords provided by Charles Drew University of Medicine and Science:
type 2 diabetes
combination therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017