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

Study Overview
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Brief Summary
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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.

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

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus (T2DM)

Intervention / Treatment
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* Drug: Sitagliptin phosphate
* Drug: Comparator: Sulfonylurea
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sitagliptin<br>Sitagliptin 100 mg administered orally daily as monotherapy or in combination with metformin over the Ramadan period. | Drug: Sitagliptin phosphate<br>* Sitagliptin 100 mg tablet administered orally once daily over the Ramadan period.<br>* Other names: Januvia;Drug: Metformin<br>* Participants could continue pre-study metformin as concomitant therapy during the study.<br>* Other names: Glucophage;|
| Active Comparator: Sulfonylurea<br>Sulfonylurea administered orally daily as monotherapy or in combination with metformin over the Ramadan period. | Drug: Comparator: Sulfonylurea<br>* Sulfonylurea (glibenclamide, glimepiride, or gliclazide) administered orally daily over the Ramadan period as per physician's prescription<br>Drug: Metformin<br>* Participants could continue pre-study metformin as concomitant therapy during the study.<br>* Other names: Glucophage;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants With at Least One Symptomatic Hypoglycemic Event | 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. | 30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event | 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. | 30 days: first day of Ramadan (August 11) to last day of Ramadan (September 10) |