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NCT Number: NCT01131182

Study of Sitagliptin Treatment in Patients With Type 2 Diabetes During Ramadan (0431-263)

This study will examine whether the incidence of hypoglycemia in patients fasting for Ramadan is lower when treated with sitagliptin as compared to sulfonylurea treatment.

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) 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 4

About this study

This study and NCT01340768 (MK-0431-262) 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 men and women with type 2 diabetes
  • Participants who intend to fast during the month of Ramadan
  • Participants who have been on a stable dose of sulfonylurea for at least three months

Exclusion criteria

  • Participants with type 1 diabetes mellitus
  • Pregnant or breast feeding women
  • Participants with hypersensitivity or contraindication to dipeptidyl peptidase (DPP-4) treatment
  • Participants on insulin
  • Participants on any class of oral diabetic therapy other than sulfonylurea or metformin

Treatment and study plan

sitagliptin phosphate

Drug

Sitagliptin 100 mg tablet administered orally once daily over the Ramadan period.

Other names: Januvia

Comparator: Sulfonylurea

Drug

Sulfonylurea (glibenclamide, glimepiride, or gliclazide) administered orally daily over the Ramadan period as per physician's prescription

metformin

Drug

Participants could continue pre-study metformin as concomitant therapy during the study.

Other names: Glucophage

Primary outcomes

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

    Time frame: 30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10)

    Symptomatic hypoglycemic event was determined based on the participant's self-reported symptoms including faintness, headache, confusion, anxiety, sweating, tremor, palpitation, nausea, pallor, dizziness, hunger, and sudden behavioral change.

Secondary outcomes

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

    Time frame: 30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10)

    Hypoglycemic event was based on the participant's self-report and/or finger-stick blood glucose level. Symptomatic hypoglycemic symptoms included faintness, headache, confusion, anxiety, sweating, tremor, palpitation, nausea, pallor, dizziness, hunger, and sudden behavioral change.

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
2010
Study completion
2010
First posted
May 26, 2010
Registry last updated
Sep 21, 2022

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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