Sitagliptin and the Risk for Hypoglycaemia in Type 2 Diabetes Patients

• Sitagliptin 100 mg (Drug): The treatment consists of sitagliptin tablets (100 mg/day) for up to 24 weeks.
• Placebo (Drug): The treatment consists of placebo tablets for up to 24 weeks.

Primary outcomes

• The Frequency of Hypoglycaemic Episodes With Sitagliptin vs Placebo Treatment. [during the two in-house periods (54 hs each) after treatment with sitagliptin or placebo for up to 24 weeks]: The purpose of the trial was to test the influence of DPP-4 inhibition on the risk to develop hypoglycaemia. Chemical hypoglycaemic episodes (characterised by a plasma glucose nadir ≤70 mg/dL) occurring during the in-house periods of the subjects were compared.

Sex: All, ages: 18 Years to 64 Years

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.

Participant flow

Outcome results

• The Frequency of Hypoglycaemic Episodes With Sitagliptin vs Placebo Treatment. (Primary), Mean, Hypoglycaemic episodes: Sitagliptin Arm 5.35 +/- 4.137; Placebo Arm 5.72 +/- 3.045

Adverse events

Time frame: For each participant from baseline to end of trial, with a range from 7-53 weeks per participant, on average 11 weeks

Serious adverse events by term

Other adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2018-01-22)

• Christoph Kapitza, MD, Principal investigator, Profil GmbH