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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01131182
First received: May 25, 2010
Last updated: August 21, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus (T2DM)
Drug: Sitagliptin phosphate
Drug: Comparator: Sulfonylurea
Drug: Metformin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 1147
Study Start Date: June 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sitagliptin
Sitagliptin 100 mg administered orally daily as monotherapy or in combination with metformin over the Ramadan period.
Drug: Sitagliptin phosphate
Sitagliptin 100 mg tablet administered orally once daily over the Ramadan period.
Other Name: Januvia
Drug: Metformin
Participants could continue pre-study metformin as concomitant therapy during the study.
Other Name: Glucophage
Active Comparator: Sulfonylurea
Sulfonylurea administered orally daily as monotherapy or in combination with metformin over the Ramadan period.
Drug: Comparator: Sulfonylurea
Sulfonylurea (glibenclamide, glimepiride, or gliclazide) administered orally daily over the Ramadan period as per physician's prescription
Drug: Metformin
Participants could continue pre-study metformin as concomitant therapy during the study.
Other Name: Glucophage

Detailed Description:

This study and NCT01340768 (MK-0431-262) have the same design but are conducted under separate protocols, in different countries, according to local guidelines.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01131182

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01131182     History of Changes
Other Study ID Numbers: 0431-263, 2010_538
Study First Received: May 25, 2010
Results First Received: December 15, 2011
Last Updated: August 21, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014