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

Merck Sharp & Dohme LLC641 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

641

Conditions

Type 2 Diabetes Mellitus

Interventions

sitagliptin phosphateDRUG

sitagliptin 100 mg tablet qd for a 24-wk treatment period.

Comparator : placebo (unspecified)DRUG

sitagliptin 100 mg Pbo tablet qd for a 24-wk treatment period.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Baseline and Week 24

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.)

Time frame: Baseline and Week 24

Percent of Patients With A1C < 7.0% at Week 24

Time frame: 24 Weeks

Percent of Patients With A1C < 6.5% at Week 24

Time frame: Week 24

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.