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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Johnson & Johnson Private Limited
Sponsor class: INDUSTRY
First posted: 2018-07-27
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change From Baseline in Mean Hemoglobin A1c (HbA1c)
timeFrame: Baseline up to 12 weeks
measure: Change From Baseline in Mean Weight
timeFrame: Baseline up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Diacon Hospital
city: Chennai
country: India
facility: Dr. A. Ramachandran's Diabetes Hospitals
city: Kolkata
country: India
facility: Apollo Hospitals
Study officials:
affiliation: Johnson & Johnson Private Limited
name: Johnson & Johnson Private Limited Clinical Trial
role: STUDY_DIRECTOR
References: