Conditions: Type 2 Diabetes Mellitus
Keywords: Glucose metabolism disorders Metabolic diseases Peptidase inhibitors
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 870
Healthy volunteers: no

Brief summary:
This is a study comparing the incidence of hypoglycemia while using sitagliptin treatment versus sulfonylurea (SU) treatment in participants with type 2 diabetes mellitus (T2DM) who regularly take an SU drug, and choose to fast during the month of Ramadan. The primary hypothesis is that during the 30 days of Ramadan fasting, treatment with sitagliptin (with or without metformin) compared to SU treatment (with or without metformin) results in a lower incidence of hypoglycemia in participants with T2DM.

Detailed description:
This study and NCT01131182 (MK-0431-263) have the same design but are conducted under separate protocols, in different countries, according to local guidelines.

Arms:
arm 1: Sitagliptin 100mg taken orally once daily with or without metformin arm 2: Usual sulfonylurea therapy with or without metformin

Interventions: intervention 1: Sitagliptin intervention 2: Sulfonylurea intervention 3: Metformin
Intervention descriptions: intervention 1: One 100 mg tablet taken orally once daily intervention 2: Participant continued pre-study sulfonylurea therapy (dose as prescribed by the physician). Pre-study sulfonylurea therapy consisted of either glibenclamide, glimepiride or gliclazide. intervention 3: Participants receiving metformin at enrollment, continued pre-study doses of metformin. If necessary, the physician could either discontinue or adjust the dose of metformin during Ramadan.

Protocol document: