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An Observational Study to Evaluate Tolerability of Canagliflozin and Sulphonylurea in Type 2 Diabetes Patients During Ramadan (CRATOS)

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ClinicalTrials.gov Identifier: NCT02737657
Recruitment Status : Completed
First Posted : April 14, 2016
Last Update Posted : November 15, 2016
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag International NV

Tracking Information
First Submitted Date March 23, 2016
First Posted Date April 14, 2016
Last Update Posted Date November 15, 2016
Study Start Date April 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 8, 2016)
Percentage of Participants With at Least one Episode of Hypoglycaemia [ Time Frame: during the Ramadan period (up to 1 month) ]
Hypoglycaemia events are defined by symptoms (e.g., dizziness, visual blurring, palpitations, nausea, sweating, confusion, tremor or intense hunger) reported by the patient in the patient diary, with confirmation by a physician where applicable; Episode may be documented via a self-monitored blood glucose measurement <70 milligram/deciliter (mg/dl).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 8, 2016)
  • Number of Participants With Volume Depletion Events [ Time Frame: during the Ramadan period (up to 1 month) ]
  • Treatment Adherence Based on the Percentage of Prescribed Doses of Canagliflozin or Sulphonylurea Taken by Participants [ Time Frame: during the Ramadan period (up to 1 month) ]
  • Time to the First Hypoglycaemia Event [ Time Frame: during the Ramadan period (up to 1 month) ]
  • Relationship of Hypoglycaemia Events With Clinical Parameters [ Time Frame: during the Ramadan period (up to 1 month) ]
    Precipitating factors, symptoms and blood glucose concentration during hypoglycaemia episode will be described.
  • Relationship of Hypoglycaemia Events With Used Treatment [ Time Frame: during the Ramadan period (up to 1 month) ]
    Causal relationship of hypoglycaemia event to treatment will be evaluated.
  • Relationship of Hypoglycaemia Events With Treatment Adherence [ Time Frame: during the Ramadan period (up to 1 month) ]
    Treatment adherence will be based on the percentage of prescribed doses of canagliflozin or sulphonylurea that are missed during the Ramadan period, as reported in the patient diary. Any changes in study medication (i.e. missed or delayed dosing) due to hypoglycaemia events will be captured.
  • Relationship of Hypoglycaemia Events With Number of Fasting Days [ Time Frame: during the Ramadan period (up to 1 month) ]
    Number of days when fasting was broken due to hypoglycaemia or hypoglycaemia prevention will be captured.
  • Relationship of Volume Depletion Events With Clinical Parameters [ Time Frame: during the Ramadan period (up to 1 month) ]
    Precipitating factors, symptoms and blood glucose concentration during volume depletion related adverse events will be described.
  • Relationship of Volume Depletion Events With Used Treatment [ Time Frame: during the Ramadan period (up to 1 month) ]
    Causal relationship of volume depletion related adverse event to treatment will be evaluated.
  • Relationship of Volume Depletion Events With Treatment Adherence [ Time Frame: during the Ramadan period (up to 1 month) ]
    Treatment adherence will be based on the percentage of prescribed doses of canagliflozin or sulphonylurea that are missed during the Ramadan period, as reported in the patient diary. Any changes in study medication (i.e. missed or delayed dosing) due to Volume depletion related adverse events will be captured.
  • Relationship of Volume Depletion Events With Number of Fasting Days [ Time Frame: during the Ramadan period (up to 1 month) ]
    Number of days when fasting was broken due to the volume depletion related adverse event will be reported.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Observational Study to Evaluate Tolerability of Canagliflozin and Sulphonylurea in Type 2 Diabetes Patients During Ramadan
Official Title Observational, Prospective, Parallel Cohort Study to Evaluate Tolerability of Canagliflozin and Sulphonylurea on a Background Therapy of Metformin With or Without a DPP-4 Inhibitor During Ramadan Fasting in Patients With Type 2 Diabetes
Brief Summary The primary purpose of this study is to describe the tolerability of canagliflozin and any sulphonylurea (each administered with metformin with or without a DPP-4 inhibitor), in terms of the percentage of patients with at least one episode of hypoglycaemia, in patients with T2DM who fast during Ramadan.
Detailed Description This is non-randomized, parallel-cohort, prospective, multicenter (when more than one hospital works on a medical research study), observational study to describe the treatment of T2DM with canagliflozin during the Holy Month of Ramadan. Observed participants will be participants with T2DM (at the time of enrollment) who are being treated with either canagliflozin or any sulphonylurea, each administered on a background therapy of metformin with or without a DPP-4 inhibitor within clinical practice, and who intend to fast during the Ramadan period. On enrollment, patients will enter one of two parallel treatment cohorts based on their ongoing T2DM therapy: canagliflozin and metformin with or without a DPP-4 inhibitor will be the treatment of interest, while any sulphonylurea and metformin with or without a DPP-4 inhibitor will serve as the reference standard treatment. Safety will be monitored throughout the study.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants with a confirmed diagnosis of type 2 diabetes and has been treated with canagliflozin or any sulphonylurea, each on a background therapy of metformin with or without a DPP-4 inhibitor, will be enrolled in this study.
Condition Diabetes Mellitus, Type 2
Intervention Not Provided
Study Groups/Cohorts
  • Cohort 1
    Participants who are already receiving Canagliflozin and Metformin with or without a DPP-4 inhibitor daily during Ramadan period will be observed as the part of study.
  • Cohort 2
    Participants who are already receiving any sulphonylurea and Metformin with or without a DPP-4 inhibitor daily during Ramadan period will be observed as a part of study.
Publications * Hassanein M, Echtay A, Hassoun A, Alarouj M, Afandi B, Poladian R, Bennakhi A, Nazar M, Bergmans P, Keim S, Hamilton G, Azar ST. Tolerability of canagliflozin in patients with type 2 diabetes mellitus fasting during Ramadan: Results of the Canagliflozin in Ramadan Tolerance Observational Study (CRATOS). Int J Clin Pract. 2017 Oct;71(10). doi: 10.1111/ijcp.12991. Epub 2017 Aug 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 14, 2016)
379
Original Estimated Enrollment
 (submitted: April 8, 2016)
300
Actual Study Completion Date September 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Participants who has a confirmed diagnosis of type 2 diabetes for more than 12 months before enrollment
  • Participants who has been treated with canagliflozin or any sulphonylurea, each on a background therapy of metformin with or without a dipeptidyl peptidase 4 (DPP-4) inhibitor, for >12 weeks before enrollment
  • Participants Intends to fast during Ramadan in 2016
  • Participants Will be able to continue on the products under study (i.e., canagliflozin or any sulphonylurea, each with metformin with or without a DPP-4 inhibitor) through the Ramadan period, as judged by the participating physician
  • Participants who has a glycated hemoglobin (HbA1c) measurement less than and equal to (<=) 8.5% within 8 weeks before the start of Ramadan.

Exclusion Criteria:

  • Participant is being treated with insulin and/or any type 2 diabetes mellitus (T2DM) therapy other than canagliflozin, any sulphonylurea, and metformin with or without a DPP 4 inhibitor, or has changed their T2DM therapy within 12 weeks before enrollment (dose changes of canagliflozin, a sulphonylurea, metformin, and a DPP 4 inhibitor where applicable are accepted)
  • Participant is currently being treated with loop diuretics
  • Participants who has a history of severe hypoglycaemia events within the 6 months prior to enrollment (defined as a hypoglycaemia event for which the patient required assistance from another person, or which resulted in seizure or loss of consciousness).
  • Participants who has heart failure (NYHA 3-4) or advanced cardiovascular disease.
  • Participants who has an estimated glomerular filtration rate (eGFR) less than (<) 60 milliliter/minute (mL/min)/1.73 m^2.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Kuwait,   Lebanon,   United Arab Emirates
Removed Location Countries  
 
Administrative Information
NCT Number NCT02737657
Other Study ID Numbers CR108100
28431754DIA4016 ( Other Identifier: Janssen-Cilag International )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Janssen-Cilag International NV
Study Sponsor Janssen-Cilag International NV
Collaborators Not Provided
Investigators
Study Director: Janssen-Cilag International NV Clinical Trial Janssen-Cilag International NV
PRS Account Janssen-Cilag International NV
Verification Date November 2016