Study to Compare Sitagliptin Versus Sulfonylurea Treatment During Ramadan Fasting in Patients With Type 2 Diabetes (MK-0431-262)

Study Overview
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Brief Summary
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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.

Detailed Description
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This study and NCT01131182 (MK-0431-263) 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

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


Participation Criteria
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Eligibility Criteria
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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

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 100mg taken orally once daily with or without metformin | Drug: Sitagliptin<br>* One 100 mg tablet taken orally once daily<br>* Other names: Sitagliptin phosphate, MK-0431, JANUVIA®;Drug: Metformin<br>* Participants receiving metformin at enrollment, continued pre-study doses of metformin. If necessary, the physician could either discontinue or adjust the dose of metformin during Ramadan.<br>* Other names: Glucophage;|
| Active Comparator: Sulfonylurea Therapy<br>Usual sulfonylurea therapy with or without metformin | Drug: Sulfonylurea<br>* Participant continued pre-study sulfonylurea therapy (dose as prescribed by the physician). Pre-study sulfonylurea therapy consisted of either glibenclamide, glimepiride or gliclazide.<br>* Other names: Amaryl (glimepiride);Drug: Metformin<br>* Participants receiving metformin at enrollment, continued pre-study doses of metformin. If necessary, the physician could either discontinue or adjust the dose of metformin during Ramadan.<br>* Other names: Glucophage;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With at Least One Symptomatic Hypoglycemic Event | Symptomatic hypoglycemic events were based on the participants own self-reported symptoms (for example, but not limited to the following: faintness, headache, confusion, anxiety, sweating, tremor, palpitations, nausea, pallor, dizziness, hunger, sudden behavioral change). | Up to 30 days (Day 1 through last day of Ramadan) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With at Least One Symptomatic or Asymptomatic Hypoglycemic Event | Symptomatic hypoglycemic events were based on the participants own self-reported symptoms (for example but not limited to the following: faintness, headache, confusion, anxiety, sweating, tremor, palpitations, nausea, pallor, dizziness, hunger, sudden behavioral change). Asymptomatic hypoglycemic events were based on self-monitored finger-stick blood glucose level. | Up to 30 days (Day 1 through last day of Ramadan) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glucose metabolism disorders Metabolic diseases Peptidase inhibitors