- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03604224
A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
August 18, 2020 updated by: Johnson & Johnson Private Limited
Retrospective Observational Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Patients With BMI>25 kg/m^2, in Real World Clinical Setting
The purpose of this study is to observe clinical effectiveness of canagliflozin by mean haemoglobin A1c (HbA1C) and body weight changes from baseline to 12 weeks in Indian type 2 diabetes participants.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
178
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bangalore, India, 560010
- Diacon Hospital
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Chennai, India, 600032
- Dr. A. Ramachandran's Diabetes Hospitals
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Kolkata, India, 700054
- Apollo Hospitals
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The study will include Indian type 2 diabetes mellitus (T2DM) participants with body mass index (BMI) greater than (>)25 kilogram per meter square (kg/m^2), initiated canagliflozin 300 milligram (mg) as part of their treatment regimens, in real world clinical setting.
Description
Inclusion Criteria:
- T2DM participants on a stable anti-hyperglycemic regimen containing one or more anti-diabetic drug for at least 30 days and had HbA1c of more than 7 percent (%) at the time of, or within 2 weeks before canagliflozin 300 mg initiation
- T2DM participants as confirmed from hospital records
- T2DM participant having BMI>25kg/m^2 at the time of canagliflozin 300 mg initiation
- Participants having clinical assessment data (at least glycated haemoglobin A1c [HbA1c] and body weight) for at least two visits, that is (i.e.) visit at which treatment with canagliflozin 300 mg was initiated or 2 weeks before initiation and follow-up visit at 12 weeks (+-4 weeks) from initiation, in accordance with the usual clinical practice
Exclusion Criteria:
- Participants with history of autoimmune diabetes (type 1 diabetes mellitus [T1DM] or latent autoimmune diabetes in adults [LADA]), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy or gestational diabetes or any off-label use or patient data refusal based on physician discretion
- Participants with a history of use of other Sodium Glucose co-Transporter 2 (SGLT2) inhibitor within 12 weeks (empagliflozin or dapagliflozin)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Canagliflozin Containing Treatment Regimens
No intervention will be administered as a part of this study.
Participants with type 2 diabetes mellitus (T2DM) who were initiated on canagliflozin 300 milligram (mg) treatment 12 weeks back and meeting the inclusion criteria will be observed.
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Participants who are initiated on canagliflozin 300 mg will be observed.
No study treatment will be administered as a part of this study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Mean Hemoglobin A1c (HbA1c)
Time Frame: Baseline up to 12 weeks
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Change in mean HbA1c from baseline to 12 weeks will be determined.
HbA1c refers to glycated haemoglobin (A1c), which identifies average plasma glucose concentration.
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Baseline up to 12 weeks
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Change From Baseline in Mean Weight
Time Frame: Baseline up to 12 weeks
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Change in mean body weight from baseline to 12 weeks will be determined.
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Baseline up to 12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 5, 2018
Primary Completion (ACTUAL)
July 1, 2019
Study Completion (ACTUAL)
July 1, 2019
Study Registration Dates
First Submitted
July 19, 2018
First Submitted That Met QC Criteria
July 19, 2018
First Posted (ACTUAL)
July 27, 2018
Study Record Updates
Last Update Posted (ACTUAL)
August 19, 2020
Last Update Submitted That Met QC Criteria
August 18, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR108507
- 28431754DIA4030 (OTHER: Johnson & Johnson Private Limited)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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