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.

Tracking Information
First Submitted Date  ICMJE November 1, 2006
First Posted Date  ICMJE November 2, 2006
Results First Submitted Date  ICMJE September 18, 2009
Results First Posted Date  ICMJE October 23, 2009
Last Update Posted Date May 12, 2017
Actual Study Start Date  ICMJE December 11, 2006
Actual Primary Completion Date October 13, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2010)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 1, 2006)
  • HbA1c level after 24 weeks of treatment
  • Safety and tolerability
Change History Complete list of historical versions of study NCT00395343 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2010)
  • 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.
  • 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.
  • 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.)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2006)
  • FPG
  • 2-hour PPG
  • beta-cell glucose-sensitivity parameter
  • proportion of patients with an HbA1c <7.0%
Current Other Pre-specified Outcome Measures
 (submitted: May 27, 2014)
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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sitagliptin Added-on to Insulin Study (0431-051)
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: sitagliptin phosphate
    sitagliptin 100 mg tablet qd for a 24-wk treatment period.
    Other Names:
    • MK0431
    • Januvia™
  • Drug: Comparator : placebo (unspecified)
    sitagliptin 100 mg Pbo tablet qd for a 24-wk treatment period.
Study Arms  ICMJE
  • Experimental: 1
    sitagliptin
    Intervention: Drug: sitagliptin phosphate
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Comparator : placebo (unspecified)
Publications * Vilsbøll T, Rosenstock J, Yki-Järvinen 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 18, 2009)
641
Original Enrollment  ICMJE
 (submitted: November 1, 2006)
600
Actual Study Completion Date  ICMJE October 13, 2008
Actual Primary Completion Date October 13, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Australia,   Austria,   Belgium,   Bulgaria,   Canada,   Colombia,   Croatia,   Denmark,   Finland,   Former Serbia and Montenegro,   France,   Hungary,   India,   Ireland,   Israel,   Italy,   Malaysia,   New Zealand,   Portugal,   Russian Federation,   South Africa,   Spain,   Taiwan,   Thailand,   United States
 
Administrative Information
NCT Number  ICMJE NCT00395343
Other Study ID Numbers  ICMJE 0431-051
MK0431-051
2006_532
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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

Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP