Phase 4
Completed N=1,066
Study of Sitagliptin Treatment in Patients With Type 2 Diabetes During Ramadan (0431-263)
Type 2 Diabetes Mellitus (T2DM)
Source: ClinicalTrials.gov NCT01131182 ↗
Enrolled (actual)
1,066
Serious AEs
0.3%
Results posted
Jan 2012
Primary outcomePrimary: Proportion of Participants With at Least One Symptomatic Hypoglycemic Event — 0.07; 0.13 proportion of participants — p=0.0005
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.
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 | — |
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. Informational only — not medical advice.