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Completed

NCT Number: NCT01758380

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Frederiksberg, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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"

Treatment and study plan

Vildagliptin

Drug

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

Other names: Galvus

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)

metformin

Drug

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

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)

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).

Primary outcomes

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

    Time frame: 1 month

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: STEADFAST

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 1, 2013
Registry last updated
Oct 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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