Vildagliptin Compared to Gliclazide as Dual Therapy With Metformin in Muslim Patients With Type 2 Diabetes Fasting During Ramadan

Study Overview
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Brief Summary
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To evaluate vildagliptin as compared to gliclazide, given in combination with metformin in Muslim patients with type 2 diabetes fasting during Ramadan.

Official Title
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A Double Blind, Double Dummy, Randomised, Multi-centre Study to Assess the Tolerability and Efficacy Profile of Vildagliptin Compared to Gliclazide as Dual Therapy With Metformin in Muslim Patients With Type 2 Diabetes Fasting During Ramadan

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Vildagliptin
* Drug: Gliclazide
* Drug: Metformin
* Drug: Placebo to Gliclazide
* Drug: Placebo to Vildagliptin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed Type 2 Diabetes diagnosis Plan to fast during Ramadan Treated with a combination of metformin and an Sulfonylurea (SU) for at least 12 weeks and HbA1c ≤8.5% at Visit 1 Taking a sulfonylurea treatment for less than 3 years prior to Visit 1 Body mass index (BMI) ≥22 and ≤45 kg/m2 at Visit 1 Exclusion Criteria: Pregnant or nursing (lactating) women History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. Patients who are taking any other anti-diabetes drug (oral or injection) other than metformin and an SU component. Inability to comply with the study procedures or medications. Other protocol-defined inclusion/exclusion criteria may apply

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vildagliptin + placebo to Gliclazide<br>Vildagliptin tablets will be given at 50mg twice daily (bid). Placebo to Gliclazide capsules will be given at an equivalent dose to previous sulfonylurea in multiples of 80mg only (80-320 mg/day). Patients will continue their open-label metformin therapy at dosage between 1500-2500 mg daily. | Drug: Vildagliptin<br>* Patients will be instructed to take Vildagliptin tablets at a fixed dose of 50 mg twice daily (double blind therapy)<br>* Other names: Galvus;Drug: Metformin<br>* Patients in both arms will take Metformin at a dose between 1500mg-2500mg per day, in an open label fashion<br>Drug: Placebo to Gliclazide<br>* Patients will be instructed to take the Gliclazide matching placebo capsules at an equivalent dose to previous sulfonylurea in multiples of 80mg only (double blind therapy)<br>|
| Active Comparator: Gliclazide + placebo to Vildagliptin<br>Gliclazide capsules will be given in multiples of 80 mg (80-320 mg/day) at a dose equivalent to previous sulfonylurea dose, unless at the investigator's discretion it could be up-titrated to the next available dose (if HbA1c is higher than 7.5%). Placebo to Vildagliptin tablets will be given at 50mg twice daily (bid). Patients will continue their open-label metformin therapy at dosage between 1500-2500 mg daily. | Drug: Gliclazide<br>* Patients will be instructed to take Gliclazide capsules at an equivalent dose to previous sulfonylurea in multiples of 80mg only (double blind therapy)<br>Drug: Metformin<br>* Patients in both arms will take Metformin at a dose between 1500mg-2500mg per day, in an open label fashion<br>Drug: Placebo to Vildagliptin<br>* Patients will be instructed to take Vildagliptin matching placebo tablets at a fixed dose of 50 mg twice daily (double blind therapy).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients experiencing at least one Hypoglycaemic Event (HE) during the Ramadan fasting period to test superiority |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients without an increase in HbA1c (≤ 0.3%) and with no Hypoglycaemic Events (HEs) |  | visit 3 (anytime from week -4 to day -1 before start of Ramadan) to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 4.5 weeks to maximum 12 weeks) for HbA1c; and during 1 month (Ramadan) for HEs | 
| Change from baseline to endpoint in glycosylated hemoglobin (HbA1c) | Endpoint is defined as the visit 4 (post-Ramadan) measurement or the last observation obtained during or after Ramadan, prior to or at initiation of rescue medication | baseline to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 12.5 weeks to maximum 30 weeks) | 
| Change from visit 3 (pre-Ramadan visit) to endpoint in glycosylated hemoglobin (HbA1c) | Endpoint is defined as the visit 4 (post-Ramadan) measurement or the last observation obtained during or after Ramadan, prior to or at initiation of rescue medication | visit 3 (anytime from week-4 to day-1 before start of Ramadan) to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 4.5 weeks to maximum 12 weeks) | 
| Proportion of patients experiencing severe hypoglycemic events during the Ramadan fasting period |  | 1 month | 
| mean amplitude of glycemic excursions (MAGE) to measure glucose fluctuations during the day | assessed in a selected subgroup of patients | 72 hours | 
| Treatment adherence during the Ramadan fasting period |  | 1 month | 
| Change from visit 3 (pre-Ramadan visit) to endpoint in body weight | Endpoint is defined as the visit 4 (post-Ramadan) measurement or the last observation obtained during or after Ramadan, prior to or at initiation of rescue medication | From visit 3 (anytime from week-4 to day-1 before start of Ramadan) to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 4.5 weeks to maximum 12 weeks) | 
| Number of unscheduled visit to health care professional |  | From visit 3 (anytime from week-4 to day-1 before start of Ramadan) to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 4.5 weeks to maximum 12 weeks) | 
| Number of days fasted during the Ramadan fasting period |  | 1 month | 
| Number of patients with treatment emergent adverse events (AEs), serious AEs, discontinuation due to AEs, deaths or laboratory abnormalities as assessment of safety and tolerability |  | Baseline to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 12.5 weeks to maximum 30 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus, Ramadan, Vildagliptin, Hypoglycemia