A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Insulin With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-254)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Sitagliptin; Placebo; Insulin; Metformin
Intervention description: Sitagliptin 100 mg once daily for 24 weeks; Matching placebo once daily for 24 weeks; Participants can be on on pre-mixed (mixture of rapid- and long-acting insulin) or intermediate- or long-acting insulin at a dose of at least 12 U/day.; At randomization, participants will be stratified according to their use of metformin (on or not on). All participants receiving metformin will be required to be on a daily dose of metformin at least 1500 mg per day.
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 467.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      A study to compare safety and efficacy of sitagliptin and placebo therapy when added to
      stable insulin alone or in combination with metformin in participants with type 2 diabetes
      mellitus (T2DM). The primary hypothesis of this study is that after 24 weeks, the addition of
      sitagliptin compared with placebo provides greater reduction in hemoglobin A1C (HbA1C) in
      T2DM participants on insulin alone or in combination with metformin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  has T2DM

          -  is currently on a stable regimen of pre-mixed, intermediate-acting, or long-acting
             insulin at a dose of at least 12 U/day, either alone or in combination with metformin
             >=1500 mg/day for ≥ 10 weeks

          -  has a Visit 1/Screening HbA1C between 7.5% and 11.0%

          -  is a male, or a female who is highly unlikely to conceive during the study and for 14
             days after the last dose of study medication

        Exclusion Criteria:

          -  has been treated with any antihyperglycemic therapies other than a protocol-required
             insulin (alone or with metformin) within the prior 12 weeks or has ever

        been treated with a dipeptidyl peptidase-4 inhibitor or a glucagon-like peptide-1 mimetic
        or analogue

          -  is currently on treatment with daily use (one or more injections per day) of

        pre-prandial short-acting or rapid-acting insulin

          -  has a history of 2 or more episodes of hypoglycemia resulting in seizure,

        coma, or loss of consciousness, or has had recurrent episodes of hypoglycemia over the past
        8 weeks

          -  has a history of intolerance or hypersensitivity, or has any contraindication to
             sitagliptin, insulin, or metformin

          -  is on a weight loss program and not in the maintenance phase, or has started a weight
             loss medication or has undergone bariatric surgery within 12 months

          -  has undergone a surgical procedure within 4 weeks or has planned major surgery during
             the study

          -  has a medical history of active liver disease

          -  has had new or worsening signs or symptoms of coronary heart disease within the past 3
             months, or has acute coronary syndrome, coronary artery intervention, or stroke or
             transient ischemic neurological disorder

          -  has a diagnosis of congestive heart failure with New York Heart Association Class III
             - IV cardiac status

          -  has a systolic blood pressure ≥ 160 mmHg or a diastolic blood pressure ≥ 90 mmHg

          -  has human immunodeficiency virus (HIV)

          -  has severe peripheral vascular disease

          -  is currently being treated for hyperthyroidism or is on thyroid hormone therapy and
             has not been on a stable dose for at least 6 weeks

          -  has a history of malignancy ≤ 5 years before the study, except for adequately treated
             basal cell or squamous cell skin cancer, or in situ cervical cancer

          -  has a clinically important hematological disorder (such as aplastic anemia,

        myeloproliferative or myelodysplastic syndromes, thrombocytopenia)

          -  is pregnant or breast feeding, or is expecting to conceive or donate eggs during the
             study, including 14 days after the last dose of study medication

          -  is a user of recreational or illicit drugs or has had a recent history of drug abuse