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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:
ClinicalTrials.gov Identifier:
NCT01758380
First Posted: January 1, 2013
Last Update Posted: October 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ( Novartis Pharmaceuticals ):

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 ]

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 ]
  • 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) ]
    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) ]
    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 ]
  • mean amplitude of glycemic excursions (MAGE) to measure glucose fluctuations during the day [ Time Frame: 72 hours ]
    assessed in a selected subgroup of patients

  • Treatment adherence during the Ramadan fasting period [ Time Frame: 1 month ]
  • 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) ]
    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) ]
  • Number of days fasted during the Ramadan fasting period [ Time Frame: 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 [ Time Frame: Baseline to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 12.5 weeks to maximum 30 weeks) ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01758380


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01758380     History of Changes
Other Study ID Numbers: CLAF237A2411
2011-005499-41 ( EudraCT Number )
First Submitted: December 24, 2012
First Posted: January 1, 2013
Last Update Posted: October 17, 2013
Last Verified: October 2013

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

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