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

NCT ID: NCT03604224

Last Updated: 2020-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

178 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-05

Study Completion Date

2019-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Canagliflozin 300 mg

Intervention Type DRUG

Participants who are initiated on canagliflozin 300 mg will be observed. No study treatment will be administered as a part of this study.

Interventions

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Canagliflozin 300 mg

Participants who are initiated on canagliflozin 300 mg will be observed. No study treatment will be administered as a part of this study.

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson Private Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johnson & Johnson Private Limited Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Private Limited

Locations

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Diacon Hospital

Bangalore, , India

Site Status

Dr. A. Ramachandran's Diabetes Hospitals

Chennai, , India

Site Status

Apollo Hospitals

Kolkata, , India

Site Status

Countries

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India

Other Identifiers

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28431754DIA4030

Identifier Type: OTHER

Identifier Source: secondary_id

CR108507

Identifier Type: -

Identifier Source: org_study_id

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