Sitagliptin and the Risk for Hypoglycaemia in Type 2 Diabetes Patients
Condition: Pharmacological Action
MeSH terms: Hypoglycemia
Intervention: Sitagliptin 100 mg; Placebo
Intervention description: The treatment consists of sitagliptin tablets (100 mg/day) for up to 24 weeks.; The treatment consists of placebo tablets for up to 24 weeks.
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a postmarketing phase 2 trial. The trial is designed as single centre, randomised, double blind, two-way treatment, placebo controlled crossover trial in subjects with type 2 diabetes mellitus treated to fasting plasma glucose targets with insulin glargine and metformin.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: This is a double-blind randomised trial. Except for the unblinded persons involved in the preparation of the IMP (these persons are not involved in any other trial activities), everyone involved in the trial will be blinded until completion of the trial and the final data review.
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      Sitagliptin, through its effects on sensitizing alpha-cell sensitivity to glucose, can
      initiate counter-regulatory glucagon responses at higher glycemic thresholds, thus reducing
      the number of clinically apparent hypoglycemic episodes, and/or ameliorating the severity of
      hypoglycemic episodes in the case that they should occur. The endpoints have defined such
      that consequences of this hypothesis can be measured.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subject with diabetes mellitus type 2.

          -  Age between 18 and 64 years, both inclusive.

          -  HbA1c <= 8.5%.

          -  Stable treatment with insulin glargine (any dose) and metformin (>= 1500 mg/day or at
             highest tolerated dose) for at least 3 months prior to inclusion into the trial with
             or without additional oral glucose-lowering agents (except thiazolidinediones).

          -  Considered generally healthy (apart from diabetes mellitus type 2 and associated
             conditions such as hypertension, hyperlipidaemia and hyperuricaemia) upon completion
             of medical history, physical examination, vital signs, ECG and analysis of laboratory
             safety variables, as judged by the Investigator.

        Exclusion Criteria:

          -  Known or suspected hypersensitivity to sitagliptin or related products.

          -  More than one episode of severe hypoglycaemia with seizure, coma or requiring medical
             assistance of another person during the past 6 months or hypoglycaemic unawareness as
             judged by the Investigator.

          -  Current or previous treatment (less than 3 months prior to screening) with insulin
             products other than insulin glargine and/or with Glucagon-like peptide (GLP) 1
             receptor agonists and/or with thiazolidinediones.

          -  Unwillingness to wash-off any oral glucose-lowering agents other than metformin.