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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03604224
• Other study ID #: CR108507
• Secondary ID: 28431754DIA4030
• Status: Completed
• Start date: September 5, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: August 2020
• Source: Johnson & Johnson Private Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
India	Diacon Hospital	Bangalore
India	Dr. A. Ramachandran's Diabetes Hospitals	Chennai
India	Apollo Hospitals	Kolkata

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Private Limited

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Mean Hemoglobin A1c (HbA1c)	Change in mean HbA1c from baseline to 12 weeks will be determined. HbA1c refers to glycated haemoglobin (A1c), which identifies average plasma glucose concentration.	Baseline up to 12 weeks
Primary	Change From Baseline in Mean Weight	Change in mean body weight from baseline to 12 weeks will be determined.	Baseline up to 12 weeks