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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01758380
First received: December 24, 2012
Last updated: October 16, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Vildagliptin
Drug: Gliclazide
Drug: Metformin
Drug: Placebo to Gliclazide
Drug: Placebo to Vildagliptin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Percentage of patients experiencing at least one Hypoglycaemic Event (HE) during the Ramadan fasting period to test superiority [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percentage of patients without an increase in HbA1c (≤ 0.3%) and with no Hypoglycaemic Events (HEs) [ 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 ] [ Designated as safety issue: No ]
  • Change from baseline to endpoint in glycosylated hemoglobin (HbA1c) [ Time Frame: baseline to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 12.5 weeks to maximum 30 weeks) ] [ 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

  • Change from visit 3 (pre-Ramadan visit) to endpoint in glycosylated hemoglobin (HbA1c) [ 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) ] [ 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

  • Proportion of patients experiencing severe hypoglycemic events during the Ramadan fasting period [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • mean amplitude of glycemic excursions (MAGE) to measure glucose fluctuations during the day [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    assessed in a selected subgroup of patients

  • Treatment adherence during the Ramadan fasting period [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Change from visit 3 (pre-Ramadan visit) to endpoint in body weight [ Time Frame: 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) ] [ 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

  • Number of unscheduled visit to health care professional [ Time Frame: 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) ] [ Designated as safety issue: No ]
  • Number of days fasted during the Ramadan fasting period [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Baseline to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 12.5 weeks to maximum 30 weeks) ] [ Designated as safety issue: Yes ]

Enrollment: 557
Study Start Date: January 2013
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vildagliptin + placebo to Gliclazide
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
Patients will be instructed to take Vildagliptin tablets at a fixed dose of 50 mg twice daily (double blind therapy)
Other Name: Galvus
Drug: Metformin
Patients in both arms will take Metformin at a dose between 1500mg-2500mg per day, in an open label fashion
Drug: Placebo to Gliclazide
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)
Active Comparator: Gliclazide + placebo to Vildagliptin
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
Patients will be instructed to take Gliclazide capsules at an equivalent dose to previous sulfonylurea in multiples of 80mg only (double blind therapy)
Drug: Metformin
Patients in both arms will take Metformin at a dose between 1500mg-2500mg per day, in an open label fashion
Drug: Placebo to Vildagliptin
Patients will be instructed to take Vildagliptin matching placebo tablets at a fixed dose of 50 mg twice daily (double blind therapy).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 ≤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"

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01758380

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Locations
Denmark
Novartis Investigative Site
Frederiksberg, Denmark, 1819
Egypt
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Alexandria, Egypt, 21131
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Cairo, Egypt, 11566
Germany
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Augsburg, Germany, 86150
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Augsburg, Germany, 86159
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Bad Oeynhausen, Germany, 32549
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Berlin, Germany, 10997
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Dortmund, Germany, 44137
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Einbeck, Germany, 37574
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Loehne, Germany, 32584
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Meine, Germany, 38527
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München, Germany, 80339
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Saarlouis, Germany, 66740
Indonesia
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Malang, East Java, Indonesia, 65111
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Surabaya, East Java, Indonesia, 60286
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Padang, Sumatera Barat, Indonesia, 25127
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Jakarta, Indonesia, 10430
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Jakarta, Indonesia, 10220
Jordan
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Amman, Jordan, 11196
Kuwait
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Kuwait, Kuwait, 1180
Lebanon
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Beirut, Lebanon
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Beirut, Lebanon, 1107 2020
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Hazmieh, Lebanon, 470
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Saida, Lebanon
Malaysia
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Kota Bahru, Kelantan, Malaysia, 16150
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Kuala Lumpur, Malaysia, 59100
Russian Federation
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Krasnodar, Russian Federation, 350063
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Penza, Russian Federation, 440026
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Rostov on Don, Russian Federation, 344000
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Rostov-on-Don, Russian Federation, 344718
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Saratov, Russian Federation, 410012
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St. Petersburg, Russian Federation, 191015
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St.- Petersburg, Russian Federation, 199034
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Ufa, Russian Federation, 450000
Saudi Arabia
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Dammam, Saudi Arabia, 40145
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Riyadh, Saudi Arabia, 11426
Singapore
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Singapore, Singapore, 545025
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Singapore, Singapore, 440080
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Singapore, Singapore, 659164
Spain
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Málaga, Andalucia, Spain, 29010
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Barcelona, Cataluña, Spain, 08001
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Girona, Cataluña, Spain, 17007
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Salt, Cataluña, Spain, 17190
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Santa Coloma de Gramanet, Cataluña, Spain, 08923
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Vic, Cataluña, Spain, 08500
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Ceuta, Spain, 51002
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Melilla, Spain, 52005
Tunisia
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Le Belvedere - Tunis, Tunisie, Tunisia, 1002
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Sfax, Tunisie, Tunisia, 3029
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Tunis, Tunisie, Tunisia, 1007
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Monastir, Tunisia, 5000
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Sousse, Tunisia, 4000
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Tunis, Tunisia
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Tunis, Tunisia, 1007
Turkey
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Diskapi / Ankara, Turkey, 06770
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Istanbul, Turkey, 34093
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Istanbul, Turkey, 34304
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Izmir, Turkey, 35380
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Kahramanmaras, Turkey, 46050
United Arab Emirates
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Dubai, United Arab Emirates
United Kingdom
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Leicester, Leicestershire, United Kingdom, LE5 4PW
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Birmingham, United Kingdom, B15 2TT
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Birmingham, United Kingdom, B8 3Sw
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Birmingham, United Kingdom, B9 5SS
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Bolton, United Kingdom, BL4 0JR
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Derby, United Kingdom, DE22 3NE
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London, United Kingdom, W6 7HY
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Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharma AG Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01758380     History of Changes
Other Study ID Numbers: CLAF237A2411, 2011-005499-41
Study First Received: December 24, 2012
Last Updated: October 16, 2013
Health Authority: Denmark: Danish Health and Medicines Authority
Egypt: Egyptian Drug Authority
Germany: BfArm
India: Ministry of Health and Family Welfare
Indonesia: Ministry of Health (MoH)
Jordan: Ministry of Health (MoH)
Kuwait: Ministry of Health (MoH)
Lebanon: Ministry of Public Health
Malaysia: Ministry of Health (MoH)
Russia: Ministry of Health (MoH)
Saudi Arabia: Ministry of Health (MoH)
Singapore: HSA
Spain: Spanish Agency for Medicines and Health Products
Tunisia: Ministry of Public Health
Turkey: Ministry of Health (MoH)
UAE: Ministry of Health (MoH)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:
Type 2 Diabetes Mellitus
Ramadan
Vildagliptin
Hypoglycemia

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vildagliptin
Metformin
Gliclazide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014