Study of Sitagliptin Treatment in Patients With Type 2 Diabetes During Ramadan (0431-263)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus (T2DM)
Intervention: Sitagliptin phosphate (Drug); Comparator: Sulfonylurea (Drug); Metformin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Proportion of Participants With at Least One Symptomatic Hypoglycemic Event
Secondary outcome: Proportion of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: June 2010
Last updated: February 23, 2015
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