Sitagliptin Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus (T2DM) Clinical Trial

Official title:

A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00337610
• Other study ID #: 0431-053
• Secondary ID: 2006_017
• Status: Completed
• Phase: Phase 3
• First received: June 14, 2006
• Last updated: May 11, 2016
• Start date: June 2006
• Est. completion date: August 2007

Study information

• Verified date: May 2016
• 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 clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic (blood sugar) control on metformin therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: August 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 78 Years

Eligibility

Inclusion Criteria:

• Patient has type 2 diabetes mellitus

• Males

• Females who are highly unlikely to become pregnant

• Patients poorly controlled while taking one or two oral antidiabetic medications

Exclusion Criteria:

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

• Patient required insulin therapy within the prior 8 weeks

• Patient is on or has been taking Thiazolidinediones (TZDs) such as Actos® (pioglitazone) or Avandia® (rosiglitazone) or is on or has been taking Byetta® (exenatide) within the prior 12 weeks of the screening visit

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 (T2DM)

Intervention

Drug:
• sitagliptin 100 mg q.d./metformin = 1500 mg/day
Patients will receive blinded sitagliptin 100 mg q.d. and open-label metformin = 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin = 1500 mg/day will be administered as oral tablets.
• comparator: placebo to match sitagliptin 100 mg q.d./metformin = 1500 mg/day
Patients will receive placebo to match sitagliptin 100 mg q.d. and open-label metformin = 1500 mg/day for up to 30 weeks. Sitagliptin 100 mg q.d. and metformin = 1500 mg/day will be administered as oral tablets.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Raz I, Chen Y, Wu M, Hussain S, Kaufman KD, Amatruda JM, Langdon RB, Stein PP, Alba M. Efficacy and safety of sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes. Curr Med Res Opin. 2008 Feb;24(2):537-50. doi: 10.1185/030079908X260925 . — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in A1C at Week 18	A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.	Baseline and Week 18	No
Secondary	Change From Baseline in FPG at Week 18	Change from baseline at Week 18 is defined as Week 18 FPG minus Week 0 FPG.	Baseline and Week 18	No
Secondary	Change From Baseline in 2 Hr-PMG at Week 18	Change from baseline at Week 18 is defined as Week 18 minus Week 0.	Baseline and Week 18	No
Secondary	Change From Baseline in A1C at Week 30	A1C was measured as a percent. Thus, this change from baseline reflects the Week 30 A1C percent minus the Week 0 A1C percent.	Baseline and Week 30	No

External Links

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