Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-021)

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of MK0431 Monotherapy in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00087516
• Other study ID #: 0431-021
• Secondary ID: Formally-C0604MT
• Status: Completed
• Phase: Phase 3
• First received: July 9, 2004
• Last updated: June 8, 2015
• Start date: June 2004
• Est. completion date: February 2007

Study information

• Verified date: June 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

The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 741
• Est. completion date: February 2007
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with type 2 diabetes mellitus

• Patient is not pregnant or breastfeeding

• Male or female patient unlikely to conceive

• Patient not on an antihyperglycemic drug

Exclusion Criteria:

• Patient has history of type 1 diabetes mellitus

• Patient has history of ketoacidosis

• Patient requires insulin within 8 weeks prior to start of study

• Patient on weight loss program and is not in maintenance phase

• Patient taking weight loss medication within 8 weeks prior to start of study

• Patient on or likely to require = 14 days or repeated courses of corticosteroids

• Patient taking immunosuppressive/immunomodulating medication

• Patient taking digoxin or other cardiac medication

• Patient has undergone surgical general anesthesia within 30 days prior to start of study

• Patient taking investigational drug within 8 weeks prior to start of study

• Patient is diagnosed with liver disease

• Patient has chronic myopathy, progressive neurological/neuromuscular disorder

• Patient has with severe cardiac conditions within the last 6 months

• Patient is Human immunodeficiency virus (HIV) positive

• Patient has hematological disorder

• Patient has history of malignancy

• Patient has history of alcohol or drug abuse within the past 3 years

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

Intervention

Drug:
• Sitagliptin (MK0431)
Phase A: Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.
• Sitagliptin
Phase A: Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks.
• Placebo
Phase A: Placebo matching Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.
• Placebo
Phase A: Placebo matching Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks.
• Metformin - Rescue
Phase A: Patients not meeting specific glycemic goals will receive open-label metformin as 500 mg, 850 mg, and 1000 mg oral tablets titrated at the discretion of the investigator. Phase B: These patients will not initiate Phase B double-blind medication.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Aschner P, Kipnes MS, Lunceford JK, Sanchez M, Mickel C, Williams-Herman DE; Sitagliptin Study 021 Group. Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycemic control in patients with type 2 diabetes. Diabetes Care. 2006 Dec;29(12):2632-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in A1C at Week 24	A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.	Weeks 0-24	No
Secondary	Change From Baseline in FPG at Week 24	Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG.	Weeks 0-24	No
Secondary	Change From Baseline in 2-hour Post-meal Glucose (2-hr PMG) at Week 24	Change from baseline at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG.	Weeks 0-24	No
Secondary	Change From Baseline in A1C at Week 104	A1C is measured as a percent. Thus, this change from baseline reflects the Week 104 A1C percent minus the Week 0 A1C percent.	Weeks 0-104	No
Secondary	Change From Baseline in FPG at Week 104	Change from baseline at Week 104 is defined as Week 104 FPG minus Week 0 FPG.	Weeks 0-104	No
Secondary	Change From Baseline in 2-hr PMG at Week 104	Change from baseline at Week 104 is defined as Week 104 2-hr PMG minus Week 0 2-hr PMG.	Weeks 0-104	No