Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005499-41 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate vildagliptin as compared to gliclazide, given in combination with metformin in Muslim patients with type 2 diabetes fasting during Ramadan.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vildagliptin + placebo to Gliclazide | Experimental | 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. |
|
| Gliclazide + placebo to Vildagliptin | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vildagliptin | Drug | Patients will be instructed to take Vildagliptin tablets at a fixed dose of 50 mg twice daily (double blind therapy) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients experiencing at least one Hypoglycaemic Event (HE) during the Ramadan fasting period to test superiority | 1 month |
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
"Other protocol-defined inclusion/exclusion criteria may apply"
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharma AG | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Frederiksberg | 1819 | Denmark | |||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37435938 | Derived | Lee SWH, Chen WS, Sellappans R, Md Sharif SB, Metzendorf MI, Lai NM. Interventions for people with type 2 diabetes mellitus fasting during Ramadan. Cochrane Database Syst Rev. 2023 Jul 12;7(7):CD013178. doi: 10.1002/14651858.CD013178.pub2. | |
| 24920915 | Derived | Hassanein M, Abdallah K, Schweizer A. A double-blind, randomized trial, including frequent patient-physician contacts and Ramadan-focused advice, assessing vildagliptin and gliclazide in patients with type 2 diabetes fasting during Ramadan: the STEADFAST study. Vasc Health Risk Manag. 2014 May 28;10:319-26. doi: 10.2147/VHRM.S64038. eCollection 2014. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Gliclazide | Drug | Patients will be instructed to take Gliclazide capsules at an equivalent dose to previous sulfonylurea in multiples of 80mg only (double blind therapy) |
|
| Metformin | Drug | Patients in both arms will take Metformin at a dose between 1500mg-2500mg per day, in an open label fashion |
|
| Placebo to Gliclazide | Drug | 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) |
|
| Placebo to Vildagliptin | Drug | Patients will be instructed to take Vildagliptin matching placebo tablets at a fixed dose of 50 mg twice daily (double blind therapy). |
|
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) |
| Alexandria |
| 21131 |
| Egypt |
| Novartis Investigative Site | Cairo | 11566 | Egypt |
| Novartis Investigative Site | Augsburg | 86150 | Germany |
| Novartis Investigative Site | Augsburg | 86159 | Germany |
| Novartis Investigative Site | Bad Oeynhausen | 32549 | Germany |
| Novartis Investigative Site | Berlin | 10997 | Germany |
| Novartis Investigative Site | Dortmund | 44137 | Germany |
| Novartis Investigative Site | Einbeck | 37574 | Germany |
| Novartis Investigative Site | Löhne | 32584 | Germany |
| Novartis Investigative Site | Meine | 38527 | Germany |
| Novartis Investigative Site | München | 80339 | Germany |
| Novartis Investigative Site | Saarlouis | 66740 | Germany |
| Novartis Investigative Site | Malang | East Java | 65111 | Indonesia |
| Novartis Investigative Site | Surabaya | East Java | 60286 | Indonesia |
| Novartis Investigative Site | Jakarta | Jakarta Special Capital Region | 10220 | Indonesia |
| Novartis Investigative Site | Jakarta | Jakarta Special Capital Region | 10430 | Indonesia |
| Novartis Investigative Site | Padang | West Sumatra | 25127 | Indonesia |
| Novartis Investigative Site | Amman | Amman Governorate | 11196 | Jordan |
| Novartis Investigative Site | Kuwait City | Kuwait | 1180 | Kuwait |
| Novartis Investigative Site | Beirut | 1107 2020 | Lebanon |
| Novartis Investigative Site | Beirut | Lebanon |
| Novartis Investigative Site | Hazmiyeh | 470 | Lebanon |
| Novartis Investigative Site | Saida | Lebanon |
| Novartis Investigative Site | Kota Bharu | Kelantan | 16150 | Malaysia |
| Novartis Investigative Site | Kuala Lumpur | 59100 | Malaysia |
| Novartis Investigative Site | Krasnodar | 350063 | Russia |
| Novartis Investigative Site | Penza | 440026 | Russia |
| Novartis Investigative Site | Rostov-on-Don | 344000 | Russia |
| Novartis Investigative Site | Rostov-on-Don | 344718 | Russia |
| Novartis Investigative Site | Saint Petersburg | 191015 | Russia |
| Novartis Investigative Site | Saint Petersburg | 199034 | Russia |
| Novartis Investigative Site | Saratov | 410012 | Russia |
| Novartis Investigative Site | Ufa | 450000 | Russia |
| Novartis Investigative Site | Dammam | Dammam | 40145 | Saudi Arabia |
| Novartis Investigative Site | Riyadh | 11426 | Saudi Arabia |
| Novartis Investigative Site | Singapore | Singapore | 440080 | Singapore |
| Novartis Investigative Site | Singapore | Singapore | 545025 | Singapore |
| Novartis Investigative Site | Singapore | Singapore | 659164 | Singapore |
| Novartis Investigative Site | Málaga | Andalusia | 29010 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08001 | Spain |
| Novartis Investigative Site | Girona | Catalonia | 17007 | Spain |
| Novartis Investigative Site | Salt | Catalonia | 17190 | Spain |
| Novartis Investigative Site | Santa Coloma de Gramanet | Catalonia | 08923 | Spain |
| Novartis Investigative Site | Vic | Catalonia | 08500 | Spain |
| Novartis Investigative Site | Ceuta | Ceuta | 51002 | Spain |
| Novartis Investigative Site | Melilla | Melilla | 52005 | Spain |
| Novartis Investigative Site | Monastir | Tunisia | 5000 | Tunisia |
| Novartis Investigative Site | Le Belvedere - Tunis | Tunisie | 1002 | Tunisia |
| Novartis Investigative Site | Sfax | Tunisie | 3029 | Tunisia |
| Novartis Investigative Site | Tunis | Tunisie | 1007 | Tunisia |
| Novartis Investigative Site | Sousse | 4000 | Tunisia |
| Novartis Investigative Site | Tunis | 1007 | Tunisia |
| Novartis Investigative Site | Tunis | Tunisia |
| Novartis Investigative Site | Diskapi / Ankara | Turkey | 06770 | Turkey (Türkiye) |
| Novartis Investigative Site | Istanbul | Turkey | 34304 | Turkey (Türkiye) |
| Novartis Investigative Site | Istanbul | 34093 | Turkey (Türkiye) |
| Novartis Investigative Site | Izmir | 35380 | Turkey (Türkiye) |
| Novartis Investigative Site | Kahramanmaraş | 46050 | Turkey (Türkiye) |
| Novartis Investigative Site | Dubai | United Arab Emirates |
| Novartis Investigative Site | Leicester | Leicestershire | LE5 4PW | United Kingdom |
| Novartis Investigative Site | London | London | W6 7HY | United Kingdom |
| Novartis Investigative Site | Birmingham | B15 2TT | United Kingdom |
| Novartis Investigative Site | Birmingham | B8 3Sw | United Kingdom |
| Novartis Investigative Site | Birmingham | B9 5SS | United Kingdom |
| Novartis Investigative Site | Bolton | BL4 0JR | United Kingdom |
| Novartis Investigative Site | Derby | DE22 3NE | United Kingdom |
| Novartis Investigative Site | Manchester | M13 9WL | United Kingdom |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077597 | Vildagliptin |
| D005907 | Gliclazide |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D013453 | Sulfonylurea Compounds |
| D014508 | Urea |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
Not provided
Not provided