Evaluation of Insulin Glargine in Combination With Sitagliptin in Type 2 Diabetes Patients: EASIE Extension Trial
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Insulin Glargine; Sitagliptin; Metformin
Intervention description: Subcutaneous injection. 100 Units/mL solution for injection in a prefilled SoloStar® pen (3 mL).; Oral administration. 100mg film-coated tablets.; Patients continued with metformin as usual oral anti-diabetic treatment.
Intervention MeSH terms: Metformin; Insulin Glargine; Sitagliptin Phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 112.0
Sex: All
Minimum age: 35 Years
Maximum age: 71 Years
Healthy volunteers: No

Summary:

      This study was the extension of the LANTU_C_02761 study named EASIE and identified as
      NCT00751114 (core study comparing insulin glargine versus sitagliptin in insulin-naïve
      patients treated with metformin and not adequately controlled).

      All patients with Glycosylated Hemoglobin A1c (HbA1c) ≥ 7% at the end of the core study had
      the possibility to enter this extension study if they met the other inclusion criteria and
      did not present with any exclusion criteria.

      The visit 14 of the core study (week 24) was the visit 1 (baseline, week 0) of the extension
      study which consisted of a 12-week treatment period.

      The objectives of this extension study were:

        -  To assess the glycemic control (HbA1c <7%) of a 3-month combination therapy with
           metformin, insulin glargine and sitagliptin in patients not adequately controlled by a
           previous treatment with metformin plus either insulin glargine or sitagliptin.

        -  To assess the effect of insulin glargine in combination with sitagliptin on HbA1c level,
           fasting plasma glucose, 7-point glucose profile, hypoglycemia occurrence, body weight
           and overall safety.
    

Eligibility criteria:

        Inclusion criteria:

          -  Patients who completed the core study LANTU_C_02761 (NCT00751114) i.e. went through
             the visit 14 investigation,

          -  HbA1c >= 7 %,

          -  Dose of metformin compliant with the inclusion criteria of the core study (i.e. at
             least 1 g/day), and maintained stable for the duration of the core study

          -  Ability and willingness to perform plasma blood glucose monitoring using the
             sponsor-provided plasma glucose meter and to complete the patient dairy,

          -  Signed informed consent obtained prior any study procedure,

          -  Willingness and ability to comply with the study protocol.

        Exclusion Criteria:

          -  Treatment with oral antidiabetic drugs other than metformin and sitagliptin in the
             core study,

          -  Treatment with insulin other than Insulin Glargine in the core study (except in case
             of an emergency, for a period of time less than 7 days),

          -  Treatment with a non-permitted drug during the core study,

          -  Pregnant or lactating women,

          -  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 in the core study),

          -  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,

          -  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),

          -  History of pancreatitis.