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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

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.

Condition or disease
Diabetes Mellitus, Type 2

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.

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Study Type : Observational
Actual Enrollment : 379 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : April 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

Group/Cohort
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.



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Number of Participants With Volume Depletion Events [ Time Frame: during the Ramadan period (up to 1 month) ]
  2. 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) ]
  3. Time to the First Hypoglycaemia Event [ Time Frame: during the Ramadan period (up to 1 month) ]
  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

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): NCT02737657


Locations
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Kuwait
Kuwait City, Kuwait
Lebanon
Amioun, Lebanon
Beirut, Lebanon
Nabatieh, Lebanon
Saida, Lebanon
Taalabya, Lebanon
Tripoli, Lebanon
United Arab Emirates
Al Ain, United Arab Emirates
Dubai, United Arab Emirates
Sponsors and Collaborators
Janssen-Cilag International NV
Investigators
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Study Director: Janssen-Cilag International NV Clinical Trial Janssen-Cilag International NV

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Janssen-Cilag International NV
ClinicalTrials.gov Identifier: NCT02737657     History of Changes
Other Study ID Numbers: CR108100
28431754DIA4016 ( Other Identifier: Janssen-Cilag International )
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016
Keywords provided by Janssen-Cilag International NV:
Canagliflozin
Metformin
Diabetes Mellitus, Type 2
INVOKANA
Sulfonylurea
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Canagliflozin
Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors
Enzyme Inhibitors