Vildagliptin compared to gliclazide as dual therapy with metformin in Muslim patients with type 2 diabetes fasting during Ramadan

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005499-41-DK

Enrollment

552

Registered

2012-10-11

Start date

2012-12-05

Completion date

Unknown

Last updated

2014-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus MedDRA version: 14.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Galvus Product Name: Vildagliptin Product Code: LAF237 Pharmaceutical Form: Tablet INN or Proposed INN: VILDAGLIPTIN CAS Number: 274901-16-5 Concentration unit: mg milligram(s) Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Confirmed T2DM diagnose - Plan to fast during Ramadan -Treated with a combination of a stable dose of metformin and an SU for at least 12 weeks and HbA1c = 22 AND =65 years) yes F.1.3.1 Number of subjects for this age range 55

Exclusion criteria

Exclusion criteria: -Pregnant or nursing (lactating) women -History of hypersensitivity to any of the study drugs -Patients 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-definied exclusion criteria may apply

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate in Muslim patients with T2DM who plan to fast during the Ramadan fasting period: 1. The proportion of patients with at least one HE (Hypoglycaemic event) is lower in the vildagliptin plus metformin arm compared to the gliclazide plus metformin arm during the Ramadan fasting period. 2. The efficacy of vildagliptin plus metformin by testing the hypothesis that the HbA1C reduction with vildagliptin plus metformin is not inferior to that of gliclazide plus metformin from randomisation to the last visit. The study needs to meet both co-primary objectives to declare positive.;Secondary Objective: 1. evaluate the proportion of patients with an increase in HbA1c (<=0.3%), taken at visit 3 to the last visit with no HEs during Ramadan in the vildagliptin plus metformin (A) arm versus the gliclazide plus metformin arm (B). 2. evaluate the efficacy of A by testing the hypothesis that the HbA1c reduction with A is superior to that of B from randomisation to the last visit 3. Evaluate HbA1c change, taken at Visit 3 to study end. 4. Evaluate the incidence of severe HEs during Ramadan 5. Evaluate, in a selected sub-group (approx 25 patients/arm), 72h continuous subcutaneous glucose monitoring (CGM, masked to patients) comparing glucose fluctuation during the first 10 days of Ramadan. 6. Evaluate the treatment adherence during Ramadan 7. Evaluate the body weight change taken at Visit 3 to the last visit 8. Evaluate the unscheduled visits to the HCP, at Visit 3 to the last visit 9. Evaluate the number of days fasted during Ramadan 10. Safety and tolerability;Primary end point(s): 1.Proportion of patients experiencing at least one Hypoglycaemic Evenet (HE) during the Ramadan fasting period 2. Change in glycosylated hemoglobin (HbA1c) level from "Baseline" to "endpoint" to test non-inferiority;Timepoint(s) of evaluation of this end point: 1. 1 month 2. from baseline to endpoint (average of 21 weeks)	—

Measure

Time frame

Main Objective: To evaluate in Muslim patients with T2DM who plan to fast during the Ramadan fasting period: 1. The proportion of patients with at least one HE (Hypoglycaemic event) is lower in the vildagliptin plus metformin arm compared to the gliclazide plus metformin arm during the Ramadan fasting period. 2. The efficacy of vildagliptin plus metformin by testing the hypothesis that the HbA1C reduction with vildagliptin plus metformin is not inferior to that of gliclazide plus metformin from randomisation to the last visit. The study needs to meet both co-primary objectives to declare positive.;Secondary Objective: 1. evaluate the proportion of patients with an increase in HbA1c (<=0.3%), taken at visit 3 to the last visit with no HEs during Ramadan in the vildagliptin plus metformin (A) arm versus the gliclazide plus metformin arm (B). 2. evaluate the efficacy of A by testing the hypothesis that the HbA1c reduction with A is superior to that of B from randomisation to the last visit 3. Evaluate HbA1c change, taken at Visit 3 to study end. 4. Evaluate the incidence of severe HEs during Ramadan 5. Evaluate, in a selected sub-group (approx 25 patients/arm), 72h continuous subcutaneous glucose monitoring (CGM, masked to patients) comparing glucose fluctuation during the first 10 days of Ramadan. 6. Evaluate the treatment adherence during Ramadan 7. Evaluate the body weight change taken at Visit 3 to the last visit 8. Evaluate the unscheduled visits to the HCP, at Visit 3 to the last visit 9. Evaluate the number of days fasted during Ramadan 10. Safety and tolerability;Primary end point(s): 1.Proportion of patients experiencing at least one Hypoglycaemic Evenet (HE) during the Ramadan fasting period 2. Change in glycosylated hemoglobin (HbA1c) level from "Baseline" to "endpoint" to test non-inferiority;Timepoint(s) of evaluation of this end point: 1. 1 month 2. from baseline to endpoint (average of 21 weeks)

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Secondary

Measure	Time frame
Secondary end point(s): 1. Proportion of patients without an increase in HbA1c (<=0.3%) with no HE 2. Change in HbA1c from visit 3 to endpoint 3. Number of serious HE during the Ramadan fasting period 4. Mean amplitude of glycaemic excursions (MAGE) to measure glucose fluctuations during the day 5. Change in body weight from pre-Ramadan visit (Visit 3 ) to end of study 6. Treatment adhererence during the Ramadan fasting period 7. Number of unscheduled visit to health care professional 8. Number of days fasted during the Ramadan fasting period 9. Change in HbA1c level from baseline to endpoint to test superiority;Timepoint(s) of evaluation of this end point: 1.HbA1c timeframe: From any time within (week -4) to (day-1) before the start of Ramadan fasting period to within 4 weeks post-Ramadan fasting period; HE timeframe: 1month 2. From anytime within (week -4) to (day -1) before the start of Ramadan fasting period to within 4 weeks post-Ramadan fasting period 3. 1 month 4. 10 days 5. From any time within (week-4) to (day -1) before the start of Ramadan fasting period to within 4 weeks post-Ramadan fasting period 6. 1month 7. visit 3 (anytime from week-4 to day-1 before the start of the Ramadan fasting period) to visit 4 (within 4 weeks post-Ramadan fasting period) 8. 1 month 9. from baseline to endpoint (average of 21 weeks)	—

Measure

Time frame

Secondary end point(s): 1. Proportion of patients without an increase in HbA1c (<=0.3%) with no HE 2. Change in HbA1c from visit 3 to endpoint 3. Number of serious HE during the Ramadan fasting period 4. Mean amplitude of glycaemic excursions (MAGE) to measure glucose fluctuations during the day 5. Change in body weight from pre-Ramadan visit (Visit 3 ) to end of study 6. Treatment adhererence during the Ramadan fasting period 7. Number of unscheduled visit to health care professional 8. Number of days fasted during the Ramadan fasting period 9. Change in HbA1c level from baseline to endpoint to test superiority;Timepoint(s) of evaluation of this end point: 1.HbA1c timeframe: From any time within (week -4) to (day-1) before the start of Ramadan fasting period to within 4 weeks post-Ramadan fasting period; HE timeframe: 1month 2. From anytime within (week -4) to (day -1) before the start of Ramadan fasting period to within 4 weeks post-Ramadan fasting period 3. 1 month 4. 10 days 5. From any time within (week-4) to (day -1) before the start of Ramadan fasting period to within 4 weeks post-Ramadan fasting period 6. 1month 7. visit 3 (anytime from week-4 to day-1 before the start of the Ramadan fasting period) to visit 4 (within 4 weeks post-Ramadan fasting period) 8. 1 month 9. from baseline to endpoint (average of 21 weeks)

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Countries

Denmark, Egypt, Germany, India, Indonesia, Jordan, Kuwait, Lebanon, Malaysia, Russian Federation, Saudi Arabia, Spain, Sweden, Tunisia, Turkey, United Arab Emirates, United Kingdom

Contacts

Public ContactClinical Trial Information Desk

Novartis Pharma AG

clinicaltrial.enquiries@novartis.com41613241111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026