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Completed

NCT Number: NCT00395343

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sitagliptin phosphate

Drug

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

Other names: MK0431, Januvia™

Comparator : placebo (unspecified)

Drug

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

Primary outcomes

  1. Change From Baseline in A1C at Week 24

    Time frame: Baseline and 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.

Secondary outcomes

  1. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

    Time frame: Baseline and Week 24

    Change from baseline at Week 24 is defined as Week 24 minus Week 0.

  2. Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24

    Time frame: Baseline and Week 24

    Change from baseline at Week 24 is defined as Week 24 minus Week 0.

  3. Percent Change From Baseline in Index of Static Beta-Cell Sensitivity to Glucose at Week 24

    Time frame: Baseline and 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.)

  4. Percent of Patients With A1C < 7.0% at Week 24

    Time frame: 24 Weeks

  5. Percent of Patients With A1C < 6.5% at Week 24

    Time frame: Week 24

Other outcomes

  1. Change From Baseline in A1C at Week 24

    Time frame: Baseline and 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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)

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Nov 2, 2006
Registry last updated
May 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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