Safety and Efficacy of Sitagliptin Compared With Glimepiride in Elderly Participants With Type 2 Diabetes Mellitus (MK-0431-251)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: sitagliptin phosphate; Glimepiride; Placebo to Sitagliptin; Placebo to Glimepiride
Intervention description: Sitagliptin tablets, orally, at a dose of 100 mg or 50 mg QD for 30 weeks. The dose level to be administered will depend on the participant's estimated glomerular filtration rate (eGFR), calculated at Visit 3 and may be adjusted as medically indicated during the study.; Glimepiride tablets, orally, starting at a dose of 1 mg QD, which may be gradually increased, as needed, to maximum dose of 6 mg QD for 30 weeks. The dose may also be decreased as medically indicated during the study.; Matching placebo tablets to sitagliptin to allow for blinding.; Matching placebo tablets to glimepiride to allow for blinding.
Intervention MeSH terms: Sitagliptin Phosphate; Glimepiride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 480.0
Sex: All
Minimum age: 65 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes Mellitus, Hemoglobin A1C, glucagon-like peptide 1 (GLP-1), gastric inhibitory polypeptide (GIP), dipeptidyl peptidase 4 inhibitor (DPP-4)

Summary:

      The primary objectives of this study are to determine if sitagliptin treatment is not
      inferior to that of glimepiride as measured by the change in baseline hemoglobin A1C (HbA1C)
      after 30 weeks of treatment, and if sitagliptin treatment results in a lower incidence of
      symptomatic hypoglycemia compared to that of glimepiride. The study will also evaluate if
      sitagliptin treatment, compared to glimepiride results in improvements in fasting plasma
      glucose (FPG) levels, and plasma lipid levels after 30 weeks of treatment. Participants will
      be randomized to either sitagliptin or glimepiride treatment after eligibility for study
      participation is determined during screening and washout study phases. Participants and study
      staff will not know to which treatment group they have been randomized (double-blind design).
      The duration of study participation will be up to 40 weeks (with 9 clinic visits). This will
      include a screening phase (Visit 1 to Visit 2) of 2 weeks maximum; a 6-week (Visits 2 to 3)
      oral antihyperglycemic agent (AHA) wash-out phase (for those who have been taking a AHA prior
      to the study); a placebo run-in phase (Visits 3 to 4), followed by up to 30 weeks of
      treatment with study medication.
    

Eligibility criteria:

        Inclusion Criteria

          -  Diagnosis of type 2 diabetes mellitus

        Exclusion Criteria

          -  History of type 1 diabetes mellitus

          -  Has undergone a surgical procedure within the prior 4 weeks.

          -  Current participation in, or has participated, in another study with an
             investigational device or compound, with the prior 12 weeks, and/or is not willing to
             refrain from participating in any other study while participating in this study

          -  Hypersensitivity or contraindication to any sulfonylurea (e.g., glimepiride)
             medication

          -  Has been on an investigational or approved dipeptidyl peptidase-4 (DPP-4) inhibitor
             agent (e.g., sitagliptin, saxagliptin)

          -  Presence of human immunodeficiency virus (HIV)

          -  Current participation in a weight loss program or is receiving weight loss medication

          -  History of blood disorder, certain cancers, heart, liver or kidney disease

          -  Current or past use of recreational or illicit drugs, or a history of drug abuse or
             dependence, or increased alcohol consumption