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Sitagliptin in Combination With Metformin and Sulfonylurea

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier:
NCT00686634
First received: May 27, 2008
Last updated: September 15, 2010
Last verified: September 2010
  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 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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 ]

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 po 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
Investigators
Principal Investigator: Stanley Hsia, MD Charles Drew University of Medicine and Science
  More Information

No publications provided by Charles Drew University of Medicine and Science

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stanley Hsia, MD, Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier: NCT00686634     History of Changes
Other Study ID Numbers: 07-06-002, U54RR014616
Study First Received: May 27, 2008
Last Updated: September 15, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014