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Comparison of Two Treatment Regimens (Sitagliptin Versus Liraglutide) on Participants Who Failed to Achieve Good Glucose Control on Metformin Alone (MK-0431-403)

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ClinicalTrials.gov Identifier: NCT01296412
Recruitment Status : Completed
First Posted : February 15, 2011
Results First Posted : March 15, 2013
Last Update Posted : June 9, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE February 14, 2011
First Posted Date  ICMJE February 15, 2011
Results First Submitted Date  ICMJE February 5, 2013
Results First Posted Date  ICMJE March 15, 2013
Last Update Posted Date June 9, 2017
Actual Study Start Date  ICMJE March 11, 2011
Actual Primary Completion Date February 29, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2013)
Change From Baseline in Hemoglobin A1c (A1C) [ Time Frame: Baseline and Week 26 ]
A1C is measured as percent. Thus, this change from baseline reflects the Week 26 A1C percent minus the Week 0 A1C percent.
Original Primary Outcome Measures  ICMJE
 (submitted: February 14, 2011)
Change from baseline in hemoglobin A1C [ Time Frame: Baseline and Week 26 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2013)
  • Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline and Week 26 ]
    Change from baseline at Week 26 is defined as Week 26 minus Week 0.
  • Percentage of Participants Reaching A1C Goal of <7.0% [ Time Frame: Week 26 ]
  • Percentage of Participants Reaching A1C Goal of <6.5% [ Time Frame: Week 26 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2011)
  • Change From Baseline in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline and Week 26 ]
  • Percentage of patients reaching hemoglobin A1C goals (<7.0% and <6.5%) [ Time Frame: Week 26 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Two Treatment Regimens (Sitagliptin Versus Liraglutide) on Participants Who Failed to Achieve Good Glucose Control on Metformin Alone (MK-0431-403)
Official Title  ICMJE A Phase III, Multicenter, Randomized, Open-label Clinical Trial Comparing the Efficacy and Safety of a Sitagliptin-Based Treatment Paradigm to a Liraglutide-Based Treatment Paradigm in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Monotherapy
Brief Summary

This study is being done to compare the effectiveness and safety of two treatment paradigms (oral sitagliptin with or without glimepiride versus liraglutide with or without increased dosing) for the treatment of participants with Type 2 Diabetes that is not adequately controlled with metformin alone. The primary hypothesis postulated that the mean change from baseline in hemoglobin A1c (A1C) in participants treated with a sitagliptin-based treatment is non-inferior to that of participants treated with a liraglutide-based

treatment.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: sitagliptin
    100 mg tablet, orally, once daily.
    Other Name: MK-0431, Januvia®, Tesavel®, Xelevia®, Ristaben®
  • Drug: liraglutide
    0.6 mg by subcutaneous (pen) injection, once daily, on Days 1-7; up-titrated on Day 8 to 1.2 mg daily. At Week 12, dose may be increased to 1.8 mg once daily for participants who did not meet protocol-specified glycemic goals.
    Other Name: Victoza®
  • Drug: glimepiride
    starting dose of 1 mg tablet (up-titrated as needed), once daily, as needed, after Week 12.
    Other Name: Amaryl®
  • Drug: metformin
    metformin tablets at a dose of ≥1500 mg per day
    Other Name: Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®
Study Arms  ICMJE
  • Experimental: Sitagliptin +/- glimepiride
    Sitagliptin 100 mg tablet orally once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride orally for glycemic control.
    Interventions:
    • Drug: sitagliptin
    • Drug: glimepiride
    • Drug: metformin
  • Active Comparator: Liraglutide
    Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
    Interventions:
    • Drug: liraglutide
    • Drug: metformin
Publications * Charbonnel B, Steinberg H, Eymard E, Xu L, Thakkar P, Prabhu V, Davies MJ, Engel SS. Efficacy and safety over 26 weeks of an oral treatment strategy including sitagliptin compared with an injectable treatment strategy with liraglutide in patients with type 2 diabetes mellitus inadequately controlled on metformin: a randomised clinical trial. Diabetologia. 2013 Jul;56(7):1503-11. doi: 10.1007/s00125-013-2905-1. Epub 2013 Apr 19.

*   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: March 9, 2012)
653
Original Estimated Enrollment  ICMJE
 (submitted: February 14, 2011)
600
Actual Study Completion Date  ICMJE February 29, 2012
Actual Primary Completion Date February 29, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria

  • Type 2 diabetes mellitus.
  • On stable dose of metformin monotherapy at a dose of at least 1500 mg per day for at least 12 weeks and a hemoglobin A1C ≥7.0% and ≤11.0%.
  • Capable of using a liraglutide pen device.

Exclusion criteria

  • History of Type 1 Diabetes mellitus.
  • Use of any oral antihyperglycemic agent (AHA) besides metformin, within the prior 12 weeks of screening.
  • Cardiovascular disorders within the past 3 months including acute coronary syndrome or new or worsening symptoms of coronary heart disease, coronary artery intervention, stroke, or transient ischemic neurological disorder.
  • Impaired liver function.
  • Impaired kidney function.
  • History of malignancy or clinically important hematological disorder that requires disease-specific treatment (chemotherapy, radiation therapy, surgery) or, in the opinion of the investigator, is likely to recur during the duration of the study.
  • History of leukemia, lymphoma, aplastic anemia, myeloproliferative or myelodysplastic diseases, thrombocytopenia, or malignant melanoma, regardless of the time since treatment.
  • Pregnancy or breastfeeding, or intention to become pregnant or donate eggs within the projected duration of the study.
  • Participation in another study with an investigational drug or device within 12 weeks prior to screening.
  • History of hypersensitivity or any contraindication to sitagliptin, liraglutide, glimepiride, or metformin based upon the labels of the country of the investigational site.
  • Participation in a weight loss program and not yet in maintenance phase, or starting of a weight loss medication (such as orlistat or phentermine) within the prior 8 weeks.
  • Surgery within the prior 4 weeks or major surgery planned during the study.
  • Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2).
  • User of recreational or illicit drugs or recent history (within the last year) of drug abuse or increased alcohol consumption.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (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 Canada,   Colombia,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Hong Kong,   Hungary,   Israel,   Italy,   Lithuania,   New Zealand,   Poland,   Puerto Rico,   Slovakia,   Slovenia,   Spain,   Sweden,   United Kingdom,   United States
 
Administrative Information
NCT Number  ICMJE NCT01296412
Other Study ID Numbers  ICMJE 0431-403
Has Data Monitoring Committee No
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 Not Provided
PRS Account Merck Sharp & Dohme Corp.
Verification Date May 2017

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