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

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)

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: sitagliptin phosphate; Drug: Comparator : placebo (unspecified)

• Study Type: Interventional
• Enrollment (Actual): 641
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; Placebo	Drug: Comparator : placebo (unspecified); sitagliptin 100 mg Pbo tablet qd for a 24-wk treatment period.
Experimental: 1; sitagliptin	Drug: sitagliptin phosphate; sitagliptin 100 mg tablet qd for a 24-wk treatment period.; Other Names: Januvia™; MK0431

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Percent of Patients With A1C < 7.0% at Week 24		24 Weeks
Percent of Patients With A1C < 6.5% at Week 24		Week 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Vilsboll T, Rosenstock J, Yki-Jarvinen 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 Metab. 2010 Feb;12(2):167-77. doi: 10.1111/j.1463-1326.2009.01173.x.

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2006
• Primary Completion (Actual): October 13, 2008
• Study Completion (Actual): October 13, 2008

Study Registration Dates

• First Submitted: November 1, 2006
• First Submitted That Met QC Criteria: November 1, 2006
• First Posted (Estimate): November 2, 2006

Study Record Updates

• Last Update Posted (Actual): May 12, 2017
• Last Update Submitted That Met QC Criteria: April 6, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Sitagliptin Phosphate
• Other Study ID Numbers: 0431-051; MK0431-051; 2006_532

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php