Sitagliptin Comparative Study in Patients With Type 2 Diabetes (0431-049)

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of Sitagliptin Compared With Metformin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00449930
• Other study ID #: 0431-049
• Secondary ID: MK0431-0492006_5
• Status: Completed
• Phase: Phase 3
• First received: March 19, 2007
• Last updated: April 27, 2015
• Start date: March 2007
• Est. completion date: July 2008

Study information

• Verified date: April 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A study to evaluate the efficacy and safety of sitagliptin in comparison to a commonly used medication in patients with type 2 diabetes

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1050
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 78 Years

Eligibility

General Inclusion Criteria:

• Patient has type 2 diabetes mellitus (T2DM)

• Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy

General Exclusion Criteria:

• Patient has a history of type 1 diabetes mellitus or history of ketoacidosis

• Patient was on antihyperglycemic therapy (insulin or oral) within the prior 4 months

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• sitagliptin phosphate
(1) sitagliptin 100mg tablet once daily (q.d.) for a 24-wk treatment period
• Comparator: metformin hydrochloride
(4) Metformin 500mg tablets once daily (q.d.) for a 24-wk treatment period.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Aschner P, Katzeff HL, Guo H, Sunga S, Williams-Herman D, Kaufman KD, Goldstein BJ; Sitagliptin Study 049 Group. Efficacy and safety of monotherapy of sitagliptin compared with metformin in patients with type 2 diabetes. Diabetes Obes Metab. 2010 Mar;12(3 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24	HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.	Baseline and 24 weeks	No
Secondary	Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Diarrhea		Baseline to Week 24	No
Secondary	Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Nausea		Baseline to Week 24	No
Secondary	Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Abdominal Pain		Baseline to Week 24	No
Secondary	Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Vomiting		Baseline to Week 24	No

External Links

•   MedWatch - FDA maintained medical product safety Information
•   Merck: Patient & Caregiver U.S. Product Web Site