This study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in older patients (55 to 80 years of age) with type 2 diabetes mellitus (T2DM) with inadequate control on their current diabetes treatment regimen.

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin Compared With Placebo in the Treatment of Older Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Glucose Lowering Therapy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/002997

Enrollment

720

Registered

2010-11-25

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Type 2 Diabetes Mellitus Patients

Interventions

Intervention1: Canagliflozin 300 mg: 300 mg capsule OD for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry. Intervention2: Canagliflozin 100 mg: 300

Eligibility

Inclusion criteria

Inclusion criteria: Adult Male or females aged between 55 to 80 years of age with diagnosis of T2DM and may be currently treated with a stable regimen of antihyperglycemic agent(s) Patients in the study must have a HbA1c between greater ot equal to 7 and less than or equal to 10 percent. Patients must have a fasting plasma glucose (FPG) less than 270 mg/dL (15 mmol/L)

Exclusion criteria

Exclusion criteria: History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy, or a severe hypoglycemic episode within 6 months before screening

Design outcomes

Primary

Measure	Time frame
To assess the effect of canagliflozin relative to placebo on hemoglobin A1c (HbA1c) in the main study.Timepoint: After 26 weeks of treatment with study drug	—

Secondary

Measure	Time frame
To assess the effect of study drug on body composition (eg total fat mass) as measured by DXATimepoint: After 26 weeks of treatment;To assess the effect of study drug on bone mineral density as measured by dual-energy X-ray absorptiometry (DXA)Timepoint: After 26, 52 and 104 weeks of treatment with study drug;To assess the effect of study drug on bone strength as measured by Quantitative Computerized Tomography (QCT) in a subgroup of patientsTimepoint: After 52 weeks of treatment;To assess the effect of study drug on markers of bone turnoverTimepoint: After 12 and 26 weeks of treatment	—

Measure

Time frame

To assess the effect of study drug on body composition (eg total fat mass) as measured by DXATimepoint: After 26 weeks of treatment;To assess the effect of study drug on bone mineral density as measured by dual-energy X-ray absorptiometry (DXA)Timepoint: After 26, 52 and 104 weeks of treatment with study drug;To assess the effect of study drug on bone strength as measured by Quantitative Computerized Tomography (QCT) in a subgroup of patientsTimepoint: After 52 weeks of treatment;To assess the effect of study drug on markers of bone turnoverTimepoint: After 12 and 26 weeks of treatment

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Countries

Australia, Brazil, Canada, Colombia, Estonia, France, Greece, India, New Zealand, Other, Poland, Romania, South Africa, Spain, Sweden, Switzerland, Ukraine, United Kingdom, United States of America

Contacts

Public ContactDr Jitendra Dixit

Johnson and Johnson Ltd

jdixit@its.jnj.com9167068006

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026