Comparison of Two Treatment Regimens (Sitagliptin Versus Liraglutide) on Participants Who Failed to Achieve Good Glucose Control on Metformin Alone (MK-0431-403)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: sitagliptin; liraglutide; glimepiride; metformin
Intervention description: 100 mg tablet, orally, once daily.; 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.; starting dose of 1 mg tablet (up-titrated as needed), once daily, as needed, after Week 12.; metformin tablets at a dose of ≥1500 mg per day
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Liraglutide; Glimepiride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 653.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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.