Risk of Nocturnal Hypoglycemia and Arrhythmias With Sitagliptin Versus Glimepiride in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Hypoglycemia; Diabetes Mellitus, Type 2
Intervention: Sitagliptin; Glimepiride; Sitagliptin-Placebo; Glimepiride-Placebo
Intervention description: Sitagliptin will be given in a daily dosage of 100 mg; Glimepiride will be given in a starting daily dosage of 1 mg which will be adapted up to 6 mg; Sitagliptin-Placebo will be given additional to Glimepiride (blinded). It will be given in a daily dosage of 100 mg; Glimepiride-Placebo will be given additional to Sitagliptin (blinded). It will be given in a starting daily dosage of 1 mg which will be adapted up to 6 mg
Intervention MeSH terms: Sitagliptin Phosphate; Glimepiride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 4.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Diabetes mellitus type 2; nocturnal hypoglycemia; metformin monotherapy

Summary:

      This exploratory double blind randomized active controlled study is designed to assess the
      effects of a treatment with therapeutical dosage of sitagliptin versus therapeutical dosage
      of glimepiride as add on therapy in patients with diabetes mellitus type 2 (T2DM) patients
      inadequately controlled on metformin monotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  type 2 diabetes

          -  age 40-80 years

          -  stable dose of ≥ 1500 mg metformin or maximal tolerated dose of metformin for > 6
             weeks

          -  HbA1c ≥ 7 % - ≤ 9.0% for age < 65 years and ≥ 7.5 % - ≤ 9.0% for age ≥ 65 years

          -  able and trained to perform SMBG

          -  the informed consent form must be signed before any study specific tests or procedures
             are done

          -  ability to understand and follow study-related instructions

        Exclusion Criteria:

          -  Type 1 diabetes

          -  previous treatment with insulin, GLP1 analogues and SU in < 6 month

          -  HbA1c > 9 % or FPG > 15 mmol/l at randomization

          -  renal impairment with eGFR < 60 ml/min

          -  medical history of severe hypoglycemia defined as necessity of medical assistance in <
             1 year

          -  major cardiovascular event (MACE) in medical history < 6 months

          -  preexisting atrial fibrillation, , AV block ≥II degree, pace-maker, implanted
             defibrillator

          -  major cardiovascular event in medical history < 6 months

          -  heart failure NYHA ≥ III

          -  contraindications to glimepiride and sitagliptin or to any excipients according to
             product information

          -  severe cognitive deficits

          -  Patients who are disable to read and understand informative aspects of the trial

          -  Subject currently is enrolled in or has not yet completed at least 30 days since
             ending other investigational device or drug study(s)

          -  Inability to comply with study procedures

          -  Pregnant or breast-feeding woman and woman without adequate method of contraception