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

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Sitagliptin; Drug: Sulfonylurea; Drug: Metformin

• Registration Number: NCT01340768
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Study Timeline

• Study Start: 2010-06-22
• Study First Submitted: 2011-03-24
• Study First Submitted QC: 2011-04-21
• Study First Posted: 2011-04-25
• Primary Completion: 2011-09-21
• Study Completion: 2011-09-21
• Results First Submitted: 2012-09-07
• Results First Submitted QC: 2012-09-07
• Results First Posted: 2012-10-08
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-04
• Last Update Posted: 2017-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 870

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sitagliptin	Sitagliptin	Sitagliptin 100mg taken orally once daily with or without metformin
Sitagliptin	Metformin	Sitagliptin 100mg taken orally once daily with or without metformin
Sulfonylurea Therapy	Sulfonylurea	Usual sulfonylurea therapy with or without metformin
Sulfonylurea Therapy	Metformin	Usual sulfonylurea therapy with or without metformin

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With at Least One Symptomatic Hypoglycemic Event	Up to 30 days (Day 1 through last day of Ramadan)	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).

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event	Up to 30 days (Day 1 through last day of Ramadan)	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.