A clinical trial to compare the effects of Canagliflozin and Sitagliptin in Patients with Type 2 Diabetes mellitus on a background metformin therapy.

Efficacy And Safety Of Canagliflozin Compared With Sitagliptin In Patients With Type 2 Diabetes On Metformin Therapy: A Randomized Controlled Trial - CSRCT

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2019/02/017435

Enrollment

Registered

2019-02-05

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: E00-E89- Endocrine, nutritional and metabolic diseases

Interventions

Intervention1: Canagliflozin 100mg & Sitagliptin 100mg: Canagliflozin 100mg OD for 3 months & Sitagliptin 50 mg BD or 100mg OD for 3 months Control Intervention1: Canagliflozin 100mg & Sitagliptin 10

Eligibility

Inclusion criteria

Inclusion criteria: 1. Type 2 Diabetes mellitus 2. Age: >18 yrs 3. Gender: Both 4. HbA1c: more than 8.0 % 5. eGFR: more than 60 ml/min 6. BMI: more than 22 kg/m2

Exclusion criteria

Exclusion criteria: 1. H/O Diabetic Ketoacidosis or Type 1 Diabetes mellitus. 2. H/O Chronic Kidney disease (from stage III) 3. Hypotension 4. Pregnancy 5. Any acute infections 6. Patient who are already taking Insulin and other comparative drugs

Design outcomes

Primary

Measure	Time frame
The primary outcome is to compare the effect of Canagliflozin & Sitagliptin in combination with Metformin on glycaemic control & on insulin resistance.Timepoint: The primary outcome is to compare the effect of Canagliflozin & Sitagliptin in combination with Metformin on glycaemic control & on insulin resistance at the 1st week and 12th week of the study	—

Secondary

Measure	Time frame
The secondary outcome will be to compare the reduction of epicardial fat thickness on administration of Canagliflozin & Sitagliptin in combination with Metformin in patients with type 2 diabetes.Timepoint: The secondary outcome will be to compare the reduction of epicardial fat thickness on administration of Canagliflozin & Sitagliptin in combination with Metformin in patients with type 2 diabetes at the 1st week and 12th week of the study.	—

Measure

Time frame

The secondary outcome will be to compare the reduction of epicardial fat thickness on administration of Canagliflozin & Sitagliptin in combination with Metformin in patients with type 2 diabetes.Timepoint: The secondary outcome will be to compare the reduction of epicardial fat thickness on administration of Canagliflozin & Sitagliptin in combination with Metformin in patients with type 2 diabetes at the 1st week and 12th week of the study.

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Countries

India

Contacts

Public ContactDr R KAMARAJ

SRM Institute of Science and Technology

karthickeyank@hotmail.com9841910057

Outcome results

None listed

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