Study to Compare Sitagliptin Versus Sulfonylurea Treatment During Ramadan Fasting in Patients With Type 2 Diabetes (MK-0431-262)

Merck Sharp & Dohme LLC870 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

870

Conditions

Type 2 Diabetes Mellitus

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Muslim, with type 2 diabetes mellitus * Intends to fast during the month of Ramadan * Hemoglobin A1c (HbA1c) ≤10% at screening * On a stable dose of a SU drug (glibenclamide, glimepiride, or gliclazide), for at least three months, with or without metformin therapy at a stable dose Exclusion Criteria: * Type 1 diabetes mellitus * Pregnant or breast feeding or with gestational diabetes * Hypersensitivity or contraindication to dipeptidyl peptidase-4 (DPP-4) treatment * Serum creatinine ≥1.5 mg/dL (males), ≥1.4 mg/dL (females) * History of severe hypoglycemia (defined as a hypoglycemic event requiring the assistance of another individual, and/or resulting in a emergency department admission, physician office visit and/or hospitalization) * Any use of insulin (prior to or during Ramadan) * Use of any class of oral antidiabetic therapy other than an SU or metformin * Current participation in another interventional study

Outcomes

Primary Outcomes

Percentage of Participants With at Least One Symptomatic Hypoglycemic Event

Symptomatic hypoglycemic events were based on the participants own self-reported symptoms (for example, but not limited to the following: faintness, headache, confusion, anxiety, sweating, tremor, palpitations, nausea, pallor, dizziness, hunger, sudden behavioral change).

Time frame: Up to 30 days (Day 1 through last day of Ramadan)

Secondary Outcomes

Percentage of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event

Symptomatic hypoglycemic events were based on the participants own self-reported symptoms (for example but not limited to the following: faintness, headache, confusion, anxiety, sweating, tremor, palpitations, nausea, pallor, dizziness, hunger, sudden behavioral change). Asymptomatic hypoglycemic events were based on self-monitored finger-stick blood glucose level.

Time frame: Up to 30 days (Day 1 through last day of Ramadan)