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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: sitagliptin phosphate
* Drug: Comparator : placebo (unspecified)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |