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

October 16, 2013 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
557

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Frederiksberg, Denmark, 1819
        • Novartis Investigative Site
  • Egypt
      • Alexandria, Egypt, 21131
        • Novartis Investigative Site
      • Cairo, Egypt, 11566
        • Novartis Investigative Site
  • Germany
      • 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
        • Novartis Investigative Site
  • Indonesia
      • Jakarta, Indonesia, 10220
        • Novartis Investigative Site
      • Jakarta, Indonesia, 10430
        • Novartis Investigative Site
    • East Java
      • Malang, East Java, Indonesia, 65111
        • Novartis Investigative Site
      • Surabaya, East Java, Indonesia, 60286
        • Novartis Investigative Site
    • Sumatera Barat
      • Padang, Sumatera Barat, Indonesia, 25127
        • Novartis Investigative Site
  • Jordan
      • Amman, Jordan, 11196
        • Novartis Investigative Site
  • Kuwait
      • Kuwait, Kuwait, 1180
        • Novartis Investigative Site
  • Lebanon
      • Beirut, Lebanon, 1107 2020
        • Novartis Investigative Site
      • Beirut, Lebanon
        • Novartis Investigative Site
      • Hazmieh, Lebanon, 470
        • Novartis Investigative Site
      • Saida, Lebanon
        • Novartis Investigative Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Novartis Investigative Site
    • Kelantan
      • Kota Bahru, Kelantan, Malaysia, 16150
        • Novartis Investigative Site
  • Russian Federation
      • 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
        • Novartis Investigative Site
  • Saudi Arabia
      • Dammam, Saudi Arabia, 40145
        • Novartis Investigative Site
      • Riyadh, Saudi Arabia, 11426
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 440080
        • Novartis Investigative Site
      • Singapore, Singapore, 545025
        • Novartis Investigative Site
      • Singapore, Singapore, 659164
        • Novartis Investigative Site
  • Spain
      • Ceuta, Spain, 51002
        • Novartis Investigative Site
      • Melilla, Spain, 52005
        • Novartis Investigative Site
    • Andalucia
      • Málaga, Andalucia, Spain, 29010
        • Novartis Investigative Site
    • Cataluña
      • 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
  • Tunisia
      • Monastir, Tunisia, 5000
        • Novartis Investigative Site
      • Sousse, Tunisia, 4000
        • Novartis Investigative Site
      • Tunis, Tunisia
        • Novartis Investigative Site
      • Tunis, Tunisia, 1007
        • Novartis Investigative Site
    • Tunisie
      • Le Belvedere - Tunis, Tunisie, Tunisia, 1002
        • Novartis Investigative Site
      • Sfax, Tunisie, Tunisia, 3029
        • Novartis Investigative Site
      • Tunis, Tunisie, Tunisia, 1007
        • Novartis Investigative Site
  • Turkey
      • 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
        • Novartis Investigative Site
  • United Arab Emirates
      • Dubai, United Arab Emirates
        • Novartis Investigative Site
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Novartis Investigative Site
      • Birmingham, United Kingdom, B15 2TT
        • Novartis Investigative Site
      • Birmingham, United Kingdom, B8 3Sw
        • 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
        • Novartis Investigative Site
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE5 4PW
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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"

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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: Metformin
Patients in both arms will take Metformin at a dose between 1500mg-2500mg per day, in an open label fashion
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: 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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of patients experiencing at least one Hypoglycaemic Event (HE) during the Ramadan fasting period to test superiority
Time Frame: 1 month
1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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)
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
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
Time Frame: 1 month
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
72 hours
Treatment adherence during the Ramadan fasting period
Time Frame: 1 month
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
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
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)
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
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)
Baseline to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 12.5 weeks to maximum 30 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 24, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 24, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 1, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 17, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLAF237A2411
  • 2011-005499-41 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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