Phase 3
N=870
Study to Compare Sitagliptin Versus Sulfonylurea Treatment During Ramadan Fasting in Patients With Type 2 Diabetes (MK-0431-262)
Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT01340768 ↗Enrolled (actual)
870
Serious AEs
0.1%
Results posted
Oct 2012
Primary outcome: Primary: Percentage of Participants With at Least One Symptomatic Hypoglycemic Event — 3.8; 7.3 percentage of participants — p=0.028
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Sitagliptin (Drug); Sulfonylurea (Drug); Metformin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With at Least One Symptomatic Hypoglycemic Event |
3.8; 7.3 | 0.028 sig |
| SECONDARY Percentage of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event |
4.8; 9.6 | 0.006 sig |
Summary
This is a study comparing the incidence of hypoglycemia while using sitagliptin treatment versus sulfonylurea (SU) treatment in participants with type 2 diabetes mellitus (T2DM) who regularly take an SU drug, and choose to fast during the month of Ramadan. The primary hypothesis is that during the 30 days of Ramadan fasting, treatment with sitagliptin (with or without metformin) compared to SU treatment (with or without metformin) results in a lower incidence of hypoglycemia in participants with T2DM.
Eligibility Criteria
Inclusion Criteria
- Muslim, with type 2 diabetes mellitus
- Intends to fast during the month of Ramadan
- Hemoglobin A1c (HbA1c) ≤10% at screening
- On a stable dose of a SU drug (glibenclamide, glimepiride, or gliclazide), for at least three months, with or without metformin therapy at a stable dose
Exclusion Criteria
- Type 1 diabetes mellitus
- Pregnant or breast feeding or with gestational diabetes
- Hypersensitivity or contraindication to dipeptidyl peptidase-4 (DPP-4) treatment
- Serum creatinine ≥1.5 mg/dL (males), ≥1.4 mg/dL (females)
- History of severe hypoglycemia (defined as a hypoglycemic event requiring the assistance of another individual, and/or resulting in a emergency department admission, physician office visit and/or hospitalization)
- Any use of insulin (prior to or during Ramadan)
- Use of any class of oral antidiabetic therapy other than an SU or metformin
- Current participation in another interventional study
Data sourced from ClinicalTrials.gov (NCT01340768). 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.