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

NCT01758380 | Completed Phase 4

• 2 other identifiers: CLAF237A24112011-005499-41
• Study Type: interventional
• Target: 557
• Locations: 15 countries
• Sites: 61

Brief Summary

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

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus; Ramadan; Vildagliptin; Hypoglycemia

Outcome Measures

Primary Outcomes (1)

• Percentage of patients experiencing at least one Hypoglycaemic Event (HE) during the Ramadan fasting period to test superiority

  1 month

Secondary Outcomes (10)

• 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)

  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)

  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

  72 hours

Study Arms (2)

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.

Drug: Vildagliptin; Drug: Metformin; Drug: Placebo to Gliclazide

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.

Drug: Gliclazide; Drug: Metformin; Drug: Placebo to Vildagliptin

Interventions

Vildagliptin DRUG

Patients will be instructed to take Vildagliptin tablets at a fixed dose of 50 mg twice daily (double blind therapy)

Also known as: Galvus

Vildagliptin + placebo to Gliclazide

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)

Gliclazide + placebo to Vildagliptin

Metformin DRUG

Patients in both arms will take Metformin at a dose between 1500mg-2500mg per day, in an open label fashion

Gliclazide + placebo to Vildagliptin; Vildagliptin + placebo to Gliclazide

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)

Vildagliptin + placebo to Gliclazide

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).

Gliclazide + placebo to Vildagliptin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (68)

Novartis Investigative Site

Frederiksberg, 1819, Denmark

Location

Novartis Investigative Site

Alexandria, 21131, Egypt

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Novartis Investigative Site

Cairo, 11566, Egypt

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Novartis Investigative Site

Augsburg, 86150, Germany

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Novartis Investigative Site

Augsburg, 86159, Germany

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Novartis Investigative Site

Bad Oeynhausen, 32549, Germany

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Novartis Investigative Site

Berlin, 10997, Germany

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Novartis Investigative Site

Dortmund, 44137, Germany

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Novartis Investigative Site

Einbeck, 37574, Germany

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Novartis Investigative Site

Löhne, 32584, Germany

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Novartis Investigative Site

Meine, 38527, Germany

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Novartis Investigative Site

München, 80339, Germany

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Novartis Investigative Site

Saarlouis, 66740, Germany

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Novartis Investigative Site

Malang, East Java, 65111, Indonesia

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Novartis Investigative Site

Surabaya, East Java, 60286, Indonesia

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Novartis Investigative Site

Jakarta, Jakarta Special Capital Region, 10220, Indonesia

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Novartis Investigative Site

Jakarta, Jakarta Special Capital Region, 10430, Indonesia

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Novartis Investigative Site

Padang, West Sumatra, 25127, Indonesia

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Novartis Investigative Site

Amman, Amman Governorate, 11196, Jordan

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Novartis Investigative Site

Kuwait City, Kuwait, 1180, Kuwait

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Novartis Investigative Site

Beirut, 1107 2020, Lebanon

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Novartis Investigative Site

Beirut, Lebanon

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Novartis Investigative Site

Hazmiyeh, 470, Lebanon

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Novartis Investigative Site

Saida, Lebanon

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Novartis Investigative Site

Kota Bharu, Kelantan, 16150, Malaysia

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Novartis Investigative Site

Kuala Lumpur, 59100, Malaysia

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Novartis Investigative Site

Krasnodar, 350063, Russia

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Novartis Investigative Site

Penza, 440026, Russia

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Novartis Investigative Site

Rostov-on-Don, 344000, Russia

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Novartis Investigative Site

Rostov-on-Don, 344718, Russia

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Novartis Investigative Site

Saint Petersburg, 191015, Russia

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Novartis Investigative Site

Saint Petersburg, 199034, Russia

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Novartis Investigative Site

Saratov, 410012, Russia

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Novartis Investigative Site

Ufa, 450000, Russia

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Novartis Investigative Site

Dammam, Dammam, 40145, Saudi Arabia

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Novartis Investigative Site

Riyadh, 11426, Saudi Arabia

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Novartis Investigative Site

Singapore, Singapore, 440080, Singapore

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Novartis Investigative Site

Singapore, Singapore, 545025, Singapore

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Novartis Investigative Site

Singapore, Singapore, 659164, Singapore

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Novartis Investigative Site

Málaga, Andalusia, 29010, Spain

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Novartis Investigative Site

Barcelona, Catalonia, 08001, Spain

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Novartis Investigative Site

Girona, Catalonia, 17007, Spain

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Novartis Investigative Site

Salt, Catalonia, 17190, Spain

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Novartis Investigative Site

Santa Coloma de Gramanet, Catalonia, 08923, Spain

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Novartis Investigative Site

Vic, Catalonia, 08500, Spain

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Novartis Investigative Site

Ceuta, Ceuta, 51002, Spain

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Novartis Investigative Site

Melilla, Melilla, 52005, Spain

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Novartis Investigative Site

Monastir, Tunisia, 5000, Tunisia

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Novartis Investigative Site

Le Belvedere - Tunis, Tunisie, 1002, Tunisia

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Novartis Investigative Site

Sfax, Tunisie, 3029, Tunisia

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Novartis Investigative Site

Tunis, Tunisie, 1007, Tunisia

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Novartis Investigative Site

Sousse, 4000, Tunisia

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Novartis Investigative Site

Tunis, 1007, Tunisia

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Novartis Investigative Site

Tunis, Tunisia

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Novartis Investigative Site

Diskapi / Ankara, Turkey, 06770, Turkey (Türkiye)

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Novartis Investigative Site

Istanbul, Turkey, 34304, Turkey (Türkiye)

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Novartis Investigative Site

Istanbul, 34093, Turkey (Türkiye)

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Novartis Investigative Site

Izmir, 35380, Turkey (Türkiye)

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Novartis Investigative Site

Kahramanmaraş, 46050, Turkey (Türkiye)

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Novartis Investigative Site

Dubai, United Arab Emirates

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Novartis Investigative Site

Leicester, Leicestershire, LE5 4PW, United Kingdom

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Novartis Investigative Site

London, London, W6 7HY, United Kingdom

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Novartis Investigative Site

Birmingham, B15 2TT, United Kingdom

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Novartis Investigative Site

Birmingham, B8 3Sw, United Kingdom

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Novartis Investigative Site

Birmingham, B9 5SS, United Kingdom

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Novartis Investigative Site

Bolton, BL4 0JR, United Kingdom

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Novartis Investigative Site

Derby, DE22 3NE, United Kingdom

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Novartis Investigative Site

Manchester, M13 9WL, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 37435938 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.

  PMID: 24920915 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypoglycemia

Interventions

Vildagliptin; Gliclazide; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzenesulfonamides; Sulfonamides; Amides; Sulfonylurea Compounds; Urea; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Biguanides; Guanidines; Amidines

Study Officials

• Novartis Pharma AG

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2012
• First Posted: January 1, 2013
• Study Start: January 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: October 17, 2013

Record last verified: 2013-10

Locations

SA (2); JO (1); DK (1); DE (10); TU (5); GB (8); MY (2); KU (1); EG (2); ES (8); SG (3); RU (8); ID (5); LE (4); AE (1)