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Completed

NCT Number: NCT01340768

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sitagliptin

Drug

One 100 mg tablet taken orally once daily

Other names: Sitagliptin phosphate, MK-0431, JANUVIA®

Sulfonylurea

Drug

Participant continued pre-study sulfonylurea therapy (dose as prescribed by the physician). Pre-study sulfonylurea therapy consisted of either glibenclamide, glimepiride or gliclazide.

Other names: Amaryl (glimepiride)

metformin

Drug

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.

Other names: Glucophage

Primary outcomes

  1. Percentage of Participants With at Least One Symptomatic Hypoglycemic Event

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An Open-Label, Randomized Naturalistic Study to Evaluate the Incidence of Hypoglycemia Comparing Sitagliptin With Sulfonylurea Treatment in Patients With Type 2 Diabetes During Ramadan Fasting

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 25, 2011
Registry last updated
Jun 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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