Canagliflozin (Invokana™) vs. Standard Dual Therapy Regimen for T2DM During Ramadan

Sponsor
University of Leicester
Study ID
NCT02694263
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
25 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Canagliflozin — DRUG
    Comparison of Canagliflozin (Invokana™) vs. standard dual therapy (Repaglinide, Pioglitazone, Gliclazide or Glimepiride) for the treatment of Type 2 Diabetes.
  • Repaglinide — DRUG
    Comparison of Canagliflozin (Invokana™) vs. standard dual therapy (Repaglinide) for the treatment of Type 2 Diabetes.
  • Pioglitazone — DRUG
    Comparison of Canagliflozin (Invokana™) vs. standard dual therapy (Pioglitazone) for the treatment of Type 2 Diabetes.
  • Gliclazide — DRUG
    Comparison of Canagliflozin (Invokana™) vs. standard dual therapy (Gliclazide) for the treatment of Type 2 Diabetes.
  • Glimepiride — DRUG
    Comparison of Canagliflozin (Invokana™) vs. standard dual therapy (Glimepiride) for the treatment of Type 2 Diabetes.

Study Details

This study aims to determine if the addition of Canagliflozin (Invokana™) therapy to monotherapy of metformin is more effective at achieving the double composite endpoint of a reduction in HbA1c (≥ 0.3%) and weight loss (≥1kg) 3-4 weeks post-Ramadan. The study will also include patients currently on dual therapy, specifically metformin plus a sulphonylurea, pioglitazone or repaglinide to determine whether switching to metformin plus Canagliflozin (Invokana™) is more effective at achieving the composite endpoint compared to those remaining on previous dual therapy. There are a number of secondary outcomes including weight loss, rates of hypoglycaemia, blood pressure and a number of biochemical endpoints.

Key Dates

Start date
Jul 31, 2016
Status verified
Oct 2017
Primary completion
Sep 13, 2018
Completion
Sep 13, 2018

Study Design

Enrollment
25 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Canagliflozin + Metformin
    Canagliflozin + metformin (using the participant's current dose, or dose recommended by the study clinician). An initial dose of 100mg once daily of Canagliflozin will be prescribed, and this will be titrated up to a maximum of 300mg once daily.
  • Active Comparator: Repaglinide + Metformin
    Repaglinide + Metformin (using the participant's current dose(s), or dose recommended by the study clinician). An initial dose of 0.5mg once daily where no prior treatment has been given will be prescribed. However, where prior treatment has been in place, an initial dose of 1-2mg once daily will be started and this will be titrated up to a maximum dose of 4mg daily.
  • Active Comparator: Pioglitazone + Metformin
    Piogliazone + Metformin (using the participant's current dose(s), or dose recommended by the study clinician). For example, Pioglitazone dose will initially be 15mg or 30mg once daily. If the response is inadequate, the maximum daily dosage will be increased to 45mg once daily.
  • Active Comparator: Gliclazide + Metformin
    Gliclazide + Metformin (using the participant's current dose(s), or dose recommended by the study clinician). For example, Gliclazide dose will initially be 40-80 mg once daily, up to maximum dose of 160mg twice daily..
  • Active Comparator: Glimepiride + Metformin
    Glimepiride + Metformin (using the participant's current dose(s), or dose recommended by the study clinician). Glimepiride will initially be administered as 1mg once daily, up to a maximum dose of 4mg once daily.

Primary Outcome Measure

HbA1c + weight loss [ Time Frame: Baseline and 3-4 weeks post-Ramadan ]

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