A multi-centre study to assess tolerabilty and efficacy of the vildagliptin plus metformin versus gliclazide plus 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 - STEADFAST

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/05/005821

Enrollment

552

Registered

2015-05-26

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: E08-E13- Diabetes mellitus Health Condition 2: null- Type 2 Diabetes Mellitus

Interventions

Intervention1: Vildagliptin: Treatment Arm: 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

Eligibility

Inclusion criteria

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 •Taking a sulfonylurea treatment for less than 3 years prior to Visit 1 •Body mass index (BMI) >=22 and

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
1. Hypoglycaemic Event (HE):Proportion of patients experiencing at least one HE during the Ramadan fasting period to test superiority[Designated as safety issue: Yes]. 2.Glycosylated Hemoglobin (HbA1c):Change from baseline to endpoint in HbA1c to test non-inferiority[Designated as safety issue: No] 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. Timepoint: 1. Hypoglycaemic Event (HE): at Visit 4 2.Glycosylated Hemoglobin (HbA1c):at Visit 4. 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.	—

Measure

Time frame

1. Hypoglycaemic Event (HE):Proportion of patients experiencing at least one HE during the Ramadan fasting period to test superiority[Designated as safety issue: Yes]. 2.Glycosylated Hemoglobin (HbA1c):Change from baseline to endpoint in HbA1c to test non-inferiority[Designated as safety issue: No] 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. Timepoint: 1. Hypoglycaemic Event (HE): at Visit 4 2.Glycosylated Hemoglobin (HbA1c):at Visit 4. 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.

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Secondary

Measure	Time frame
1. Proportion of patients without an increase in HbA1c (â?¤ 0.3%) and with no Hypoglycaemic Events (HEs)[ Designated as safety issue: No ]Timepoint: 1.Time Frame: 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;10. 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 [Designated as safety issue: Yes] Timepoint: 10. Time Frame: Baseline to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 12.5 weeks to maximum 30 weeks);2.Change from baseline to endpoint in glycosylated hemoglobin (HbA1c) to test superiority (provided the 2 primary objectives are met) [Designated as safety issue: No] 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. Timepoint: 2.Time Frame: baseline to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 12.5 weeks to maximum 30 weeks);3. Change from visit 3 (pre-Ramadan visit) to endpoint in glycosylated hemoglobin (HbA1c) [Designated as safety issue: No] 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. Timepoint: 3. Time Frame: 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);4. Proportion of patients experiencing severe hypoglycemic events during the Ramadan fasting period [Designated as safety issue: Yes] Timepoint: 4. Time Frame: 1 month;5. Mean amplitude of glycemic excursions (MAGE) to measure glucose fluctuations during the day [Designated as safety issue: No] assessed in a selected s	—

Measure

Time frame

1. Proportion of patients without an increase in HbA1c (â?¤ 0.3%) and with no Hypoglycaemic Events (HEs)[ Designated as safety issue: No ]Timepoint: 1.Time Frame: 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;10. 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 [Designated as safety issue: Yes] Timepoint: 10. Time Frame: Baseline to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 12.5 weeks to maximum 30 weeks);2.Change from baseline to endpoint in glycosylated hemoglobin (HbA1c) to test superiority (provided the 2 primary objectives are met) [Designated as safety issue: No] 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. Timepoint: 2.Time Frame: baseline to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 12.5 weeks to maximum 30 weeks);3. Change from visit 3 (pre-Ramadan visit) to endpoint in glycosylated hemoglobin (HbA1c) [Designated as safety issue: No] 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. Timepoint: 3. Time Frame: 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);4. Proportion of patients experiencing severe hypoglycemic events during the Ramadan fasting period [Designated as safety issue: Yes] Timepoint: 4. Time Frame: 1 month;5. Mean amplitude of glycemic excursions (MAGE) to measure glucose fluctuations during the day [Designated as safety issue: No] assessed in a selected s

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Countries

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

Contacts

Public ContactMurugananthan K

murugananthan.k@novartis.com022-24958545

Outcome results

None listed

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