Phase 4
N=1,066
Study of Sitagliptin Treatment in Patients With Type 2 Diabetes During Ramadan (0431-263)
Type 2 Diabetes Mellitus (T2DM)
Bottom Line
View on ClinicalTrials.gov: NCT01131182 ↗Enrolled (actual)
1,066
Serious AEs
0.3%
Results posted
Jan 2012
Primary outcome: Primary: Proportion of Participants With at Least One Symptomatic Hypoglycemic Event — 0.07; 0.13 proportion of participants — p=0.0005
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sitagliptin phosphate (Drug); Comparator: Sulfonylurea (Drug); Metformin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With at Least One Symptomatic Hypoglycemic Event |
0.07; 0.13 | 0.0005 sig |
| SECONDARY Proportion of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event |
0.08; 0.18 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01131182). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.