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

NCT03604224 | Completed FDA Drug

• 2 other identifiers: CR10850728431754DIA4030
• Study Type: observational
• Target: 178
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• 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

• Change From Baseline in Mean Weight

  Change in mean body weight from baseline to 12 weeks will be determined.

  Baseline up to 12 weeks

Study Arms (1)

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.

Drug: Canagliflozin 300 mg

Interventions

Canagliflozin 300 mg DRUG

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

Canagliflozin Containing Treatment Regimens

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johnson & Johnson Private Limited: lead

Study Sites (3)

Diacon Hospital

Bangalore, 560010, India

Location

Dr. A. Ramachandran's Diabetes Hospitals

Chennai, 600032, India

Location

Apollo Hospitals

Kolkata, 700054, India

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Canagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Johnson & Johnson Private Limited Clinical Trial

  Johnson & Johnson Private Limited

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: July 27, 2018
• Study Start: September 5, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: August 19, 2020

Record last verified: 2020-08

Locations

IN (3)