Remission Evaluation of a Metabolic Intervention in Type 2 Diabetes With Sitagliptin (REMIT-Sita)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin glargine; sitagliptin/metformin; lifestyle therapy
Intervention description: Dose is titrated to achieve fasting normoglycemia; Dose is titrated to 50/1000 mg bid or maximal tolerated dose; Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving
Intervention MeSH terms: Metformin; Insulin Glargine; Sitagliptin Phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: All
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Diabetes; Insulin; Glargine; Metformin; Sitagliptin; Diet; Excercise; Lifestyle

Summary:

      The purpose of the study is to determine whether in patients with early type 2 diabetes,a
      short-term intensive metabolic intervention comprising of sitagliptin, metformin, basal
      insulin glargine and lifestyle approaches will be superior to standard diabetes therapy in
      achieving sustained diabetes remission.
    

Eligibility criteria:

        Inclusion Criteria:

          1. men and women 30-80 years of age inclusive;

          2. type 2 diabetes mellitus diagnosed by a physician within 5 years prior to patient
             enrollment;

          3. anti-diabetic drug regimen (either drug or dose of drug) unchanged during 8 weeks
             prior to screening and randomization;

          4. HbA1C ≤ 9.5% on no oral hypoglycemic agents or HbA1C ≤ 8.0% on 1 oral agent or on
             half-maximal doses of 2 agents;

          5. body mass index ≥ 23 kg/m2;

          6. a negative pregnancy test and an agreement to use a reliable method of birth control
             for the duration of the trial in all females with childbearing potential;

          7. ability and willingness to perform self-monitoring of capillary blood glucose (SMBG);
             ability and willingness to self-inject insulin;

          8. provision of informed consent.

        Exclusion Criteria:

          1. current use of insulin;

          2. history of hypoglycemia unawareness; history of severe hypoglycemia requiring
             assistance within the last 5 years;

          3. renal dysfunction as evidenced by serum creatinine (Cr) ≥ 124 μmol/l;

          4. history of lactic acidosis or diabetic ketoacidosis;

          5. active liver disease or elevated alanine transferase (ALT) levels ≥ 2.5 times upper
             limit of normal at the time of enrollment;

          6. history of pancreatitis;

          7. cardiovascular disease including any of: a) systolic blood pressure > 180 mmHg or
             diastolic blood pressure > 105 mmHg; b) peripheral vascular disease; c) left bundle
             branch block or second or third degree AV block; d) tachyarrhythmias or
             bradyarrhythmias with uncontrolled ventricular rate; e) stenotic valvular heart
             disease; f) cardiomyopathy; g) history of heart failure; h) history of aortic
             dissection; i) documented history of angina or coronary artery disease; j) history of
             stroke or transient ischemic attack;

          8. history of any disease requiring continuous systemic glucocorticoid treatment;

          9. history of any major illness with a life expectancy of < 3 years;

         10. history of injury or any other condition that significantly limits participant's
             ability to achieve moderate levels of physical activity;

         11. excessive alcohol consumption (>14 alcoholic drinks per week in men and >7 alcoholic
             drinks per week in women);

         12. known hypersensitivity to insulin glargine, metformin, or any DPP-4 inhibitor.