Evaluation of Insulin Glargine Versus Sitagliptin in Insulin-naive Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Insulin Glargine; Sitagliptin; Metformin
Intervention description: Subcutaneous injection. 100 Units/mL solution for injection in a pre-filled SoloStar® pen (3 mL).; Oral administration. 100 mg film-coated tablets.; Patients continued with metformin as usual oral anti-diabetic treatment.
Intervention MeSH terms: Metformin; Insulin Glargine; Sitagliptin Phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 515.0
Sex: All
Minimum age: 35 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The primary objective was to demonstrate the superiority of insulin glargine over sitagliptin
      in reducing Glycosylated Hemoglobin A1c (HbA1c) from baseline to the end of the treatment
      period.

      Secondary objective was to assess the effect of insulin glargine in comparison with
      sitagliptin on:

        -  HbA1c level

        -  Fasting Plasma Glucose (FPG)

        -  7-point plasma glucose (PG) profiles

        -  Percentage of patients with HbA1c <7% and <6.5%

      Safety objectives consisted of:

        -  Hypoglycemia occurrence

        -  Body weight

        -  Overall safety
    

Eligibility criteria:

        Inclusion Criteria:

          -  With type 2 diabetes diagnosed for at least 6 months,

          -  Not previously treated with insulin,

          -  On metformin for at least 3 months and a stable minimal dose of 1 g/day for at least 2
             months

          -  HbA1c ≥ 7 and < 11 %,

          -  Body Mass Index (BMI) between 25 and 45 kg/m² inclusively,

          -  Ability and willingness to perform plasma glucose (PG) monitoring using the
             Sponsor-provided PG meter and to complete the patient diary,

          -  Signed informed consent obtained prior any study procedures,

          -  Willingness and ability to comply with the study protocol.

        Exclusion Criteria:

          -  Treatment with oral antidiabetic drugs other than metformin within the last 3 months,

          -  Previous treatment with the combination of metformin + sulfonylurea for more than 1
             year,

          -  Previous treatment with Glucagon Like Peptide-1 (GLP-1) agonists or DiPeptidyl
             Peptidase (DPP) IV inhibitors,

          -  FPG (assessed by central laboratory measurement) ≥ 280 mg/dL (15.4 mmol/L),

          -  Diabetes other than type 2 diabetes (e.g. secondary to pancreatic disorders, drug or
             chemical agents intake...),

          -  Pregnant or lactating women (women of childbearing potential must have a negative
             pregnancy test at study entry and a medically approved contraception method),

          -  In-patient care,

          -  Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy
             occurrence in the 6 months prior to visit 1, or any other unstable (rapidly
             progressing) retinopathy that may require photocoagulation or surgical treatment
             during the study (an optic fundus examination should have been performed within the 2
             years prior to study entry),

          -  Impaired renal function: serum creatinine ≥ 1.5 mg/dL (≥ 133µmol/L) or ≥ 1.4 mg/dL (≥
             124 µmol/L) in men and women, respectively,

          -  History of sensitivity to the study drugs or to drugs with a similar chemical
             structure,

          -  Impaired hepatic function: alanine aminotransferase (ALT), aspartate aminotransferase
             (AST) > 3 x upper limit of normal range,

          -  Treatment with systemic corticosteroids within the 3 months prior to study entry or
             likelihood of requiring treatment during the study that are not permitted during the
             study (exception: in case of chronic adrenal insufficiency, systemic glucosteroids are
             accepted only if the disease is stable and the treatment dose stable for at least 3
             months before study entry),

          -  Alcohol or drug abuse within the last year,

          -  Night shift worker,

          -  Presence of any condition (medical, psychological, social or geographical), current or
             anticipated that the investigator feels would compromise the patient's safety or limit
             the patient successful participation in the study,

          -  Treatment with weight loss medications (e.g. sibutramine, orlistat, rimonabant) within
             the last 3 months,

          -  Participation in another clinical trial within the month prior to visit 1,

          -  History of pancreatitis.