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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)

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

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


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: sitagliptin Drug: liraglutide Drug: glimepiride Drug: metformin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 653 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 11, 2011
Actual Primary Completion Date : February 29, 2012
Actual Study Completion Date : February 29, 2012

Arm Intervention/treatment
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.
Drug: sitagliptin
100 mg tablet, orally, once daily.
Other Name: MK-0431, Januvia®, Tesavel®, Xelevia®, Ristaben®

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®

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.
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: metformin
metformin tablets at a dose of ≥1500 mg per day
Other Name: Fortamet®, Glucophage®, Glucophage® XR, Glumetza®, Riomet®, Metgluco®, Glycoran®

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. Percentage of Participants Reaching A1C Goal of <7.0% [ Time Frame: Week 26 ]
  3. Percentage of Participants Reaching A1C Goal of <6.5% [ Time Frame: Week 26 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01296412    
Other Study ID Numbers: 0431-403
First Posted: February 15, 2011    Key Record Dates
Results First Posted: March 15, 2013
Last Update Posted: June 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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