Sitagliptin in Combination With Metformin and Sulfonylurea

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Sitagliptin in Combination Oral Agent Therapy for Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00686634
• Other study ID #: 07-06-002
• Secondary ID: U54RR014616
• Status: Completed
• Phase: Phase 4
• First received: May 27, 2008
• Last updated: November 25, 2014
• Start date: January 2008
• Est. completion date: March 2010

Study information

• Verified date: November 2014
• Source: Charles Drew University of Medicine and Science
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Sitagliptin
Sitagliptin 100 mg by mouth once daily

Locations

Country	Name	City	State
United States	Charles Drew University of Medicine and Science	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Charles Drew University of Medicine and Science	National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c (HbA1c) Change From Baseline		Baseline, 4 months	No
Secondary	Number of Subjects With Hemoglobin A1c 7.5% or Less at 4 Months		4 months	No
Secondary	Number of Subjects Maintaining Hemoglobin A1c 7.5% or Less by 1 Year		1 year	No
Secondary	Number of Adverse Events		1 year	Yes