Sitagliptin Added-on to Insulin Study (0431-051)

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Phase III, Multicenter, Randomized, Double-Blind Clinical Trial to Study the Safety and Efficacy of the Addition of Sitagliptin (MK0431) to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Insulin Therapy (Alone or In Combination With Metformin)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00395343
• Other study ID #: 0431-051
• Secondary ID: MK0431-0512006_5
• Status: Completed
• Phase: Phase 3
• First received: November 1, 2006
• Last updated: April 24, 2015
• Start date: December 2006
• Est. completion date: October 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 clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2 Diabetes Mellitus who have inadequate glycemic control on insulin or insulin/metformin combination therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 641
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Patient has type 2 diabetes mellitus

• Patient is poorly controlled while on insulin or insulin and metformin

Exclusion Criteria:

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

• Patient is taking oral antidiabetic agents other than metformin during the past 3 months

• Patient is currently on treatment with daily use of pre-prandial short-acting or rapid-acting insulin

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
sitagliptin 100 mg tablet qd for a 24-wk treatment period.
• Comparator : placebo (unspecified)
sitagliptin 100 mg Pbo tablet qd 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)

Vilsbøll T, Rosenstock J, Yki-Järvinen H, Cefalu WT, Chen Y, Luo E, Musser B, Andryuk PJ, Ling Y, Kaufman KD, Amatruda JM, Engel SS, Katz L. Efficacy and safety of sitagliptin when added to insulin therapy in patients with type 2 diabetes. Diabetes Obes M — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline in A1C at Week 24	A1C in subset of patients on long-acting or intermediate-acting insulin.; A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.	Baseline and Week 24	No
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.	Baseline and Week 24	No
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24	Change from baseline at Week 24 is defined as Week 24 minus Week 0.	Baseline and Week 24	No
Secondary	Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24	Change from baseline at Week 24 is defined as Week 24 minus Week 0.	Baseline and Week 24	No
Secondary	Percent Change From Baseline in Index of Static Beta-Cell Sensitivity to Glucose at Week 24	Static sensitivity is a measure of the effect of glucose on beta-cell secretion and is the ratio between the insulin secretion rate and glucose concentration above the threshold level at steady state. (See Breda and Cobelli, Annals of Biomedical Engineering 29, 692-700 (2001) for more details.)	Baseline and Week 24	No
Secondary	Percent of Patients With A1C < 7.0% at Week 24		24 Weeks	No
Secondary	Percent of Patients With A1C < 6.5% at Week 24		Week 24	Yes

External Links

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