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

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ClinicalTrials.gov Identifier: NCT01758380
Recruitment Status : Completed
First Posted : January 1, 2013
Last Update Posted : October 17, 2013
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Vildagliptin Drug: Gliclazide Drug: Metformin Drug: Placebo to Gliclazide Drug: Placebo to Vildagliptin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 557 participants
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
Study Start Date : January 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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).


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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

  3. 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

  4. Proportion of patients experiencing severe hypoglycemic events during the Ramadan fasting period [ Time Frame: 1 month ]
  5. mean amplitude of glycemic excursions (MAGE) to measure glucose fluctuations during the day [ Time Frame: 72 hours ]
    assessed in a selected subgroup of patients

  6. Treatment adherence during the Ramadan fasting period [ Time Frame: 1 month ]
  7. 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

  8. 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) ]
  9. Number of days fasted during the Ramadan fasting period [ Time Frame: 1 month ]
  10. 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) ]

Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharma AG Novartis Pharmaceuticals
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted: January 1, 2013    Key Record Dates
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