About JANUVIA^® (sitagliptin)

Nauck et al, 2007

A multinational, randomised, parallel-group, non-inferiority study of type 2 diabetes patients with inadequate glycaemic control on metformin at a dose of at least 1500 mg/day. 1172 patients were randomised to sitagliptin 100 mg/day or glipizide 5 mg/day (up titrated to a maximum of 20 mg/day) for 52 weeks. The primary analysis assessed whether sitagliptin was non-inferior to glipizide regarding HbA_1c changes from baseline at week 52 using a per-protocol (PP) approach. The PP population consists of patients who completed all 52 weeks of treatment and did not have any reasons for exclusion from this population, including no baseline data, no treatment data at week 52 or major protocol violations. The study continued as a randomised, double-blind, active-controlled study for an additional year. The results over the two year treatment period have been reported and evaluated by Seck et al.

The primary efficacy analysis confirmed that sitagliptin was non-inferior to glipizide (mean dose = 10.3 mg/day) regarding HbA_1c changes from baseline at Week 52, when both were added to metformin, using a per-protocol (PP) approach.

Valensi et al, 2015

ODYSSÉE was a Real World Evidence (RWE) study; a multicentre, longitudinal, non-randomised, prospective, observational study, conducted in metropolitan France. ODYSSÉE was developed to address requests from the French Health Authority, Transparency Commission and CEPS (Health Product Economic Committee) to obtain real world data.

The primary objective of the ODYSSÉE study was to compare the duration of treatment of dual therapy with JANUVIA or a sulphonylurea in combination with metformin in patients with type 2 diabetes. The planned follow-up period for each patient was three years.

Duration of treatment was defined as the time from initiation of dual therapy until the time of withdrawal of an agent, replacement of one agent with another, or addition of a third agent. Dose changes in the initial therapy were not considered to be treatment modifications.

There were 2,607 eligible patients to examine the primary objective, including 1,874 patients receiving metformin + JANUVIA and 733 patients receiving metformin + suphonylurea.

An HbA_1c level decrease of 0.6% up to treatment modification occurred in both treatment groups.

Symptomatic self-reported hypoglycaemia occurred in 9.7% of patients in the metformin + JANUVIA group compared to 21% of patients in the metformin + suphonylurea group. The most widely prescribed sulphonylurea was gliclazide (54%).

Disclaimer: JANUVIA is indicated as a dual therapy with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control. In the ODYSSÉE study, 5.4% of patients were started on initial dual therapy of metformin + JANUVIA, with no prior anti-diabetic therapy.