Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00395343
Recruitment Status : Completed
First Posted : November 2, 2006
Results First Posted : October 23, 2009
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: sitagliptin phosphate Drug: Comparator : placebo (unspecified) Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 641 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 11, 2006
Actual Primary Completion Date : October 13, 2008
Actual Study Completion Date : October 13, 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
sitagliptin
Drug: sitagliptin phosphate
sitagliptin 100 mg tablet qd for a 24-wk treatment period.
Other Names:
  • MK0431
  • Januvia™

Placebo Comparator: 2
Placebo
Drug: Comparator : placebo (unspecified)
sitagliptin 100 mg Pbo tablet qd for a 24-wk treatment period.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00395343


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Layout table for investigator information
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00395343     History of Changes
Other Study ID Numbers: 0431-051
MK0431-051
2006_532
First Posted: November 2, 2006    Key Record Dates
Results First Posted: October 23, 2009
Last Update Posted: May 12, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action