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Evaluation of the effectiveness and safety of daily versus alternate day dapagliflozin therapy among patients with type 2 diabetes mellitus

Evaluation of efficacy and safety of daily versus alternate day dapagliflozin therapy among patients with type 2 diabetes mellitus: An open label randomized controlled study - DAPA-ADT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/12/038868
Enrollment
66
Registered
2021-12-23
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications Health Condition 2: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Tablet Dapagliflozin 10 mg: Subjects in group 1 will receive tablet dapagliflozin 10 mg daily for a period of 6 months Control Intervention1: Tablet Dapagliflozin 10 mg (to be given on

Sponsors

Department of Science Technology Renewable Energy Chandigarh Administration Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female patients with T2DM visiting the General Medicine/Endocrinology OPD/Ward who are taking stable dose of metformin more than or equal to 1500 mg per day therapy for a duration 3 months or more. 2. Age 18-59 years 3. Glycosylated hemoglobin (HbA1c) values between 7-9%

Exclusion criteria

Exclusion criteria: - Subjects with type 1 DM - Patients who have taken metformin treatment for a duration of less than 3 months - Patients taking add on anti-diabetic drugs over and above metformin - Patients having allergy to any of the study drugs - Pregnant and lactating women - Patients with kidney dysfunction (serum creatinine level more than 1.5 times more than the upper limit of normal range) - Patients with hepatic dysfunction (alanine aminotransferase and/or aspartate aminotransferase levels 3-fold more than the upper limit of normal range) - Patients having acute infections, recent trauma or surgery for which the treatment is ongoing and patients have not yet recovered - Patients with history of recent diabetic ketoacidosis - Patients with history of active cancer or past history of cancer - Patients with past history of family history of urinary bladder cancer - Patients presenting with hematuria or symptoms and signs suggestive of bladder cancer - Patients who are not able or willing to give a written informed consent.

Design outcomes

Primary

MeasureTime frame
Change in HbA1c levelTimepoint: at 3 months and 6 months (from baseline)—

Secondary

MeasureTime frame
1. Change in FBS level 2. Difference in occurrence of adverse drug events among 2 Groups Timepoint: 1. at 3 months and 6 months (from baseline) 2. at 6 months—

Countries

India

Contacts

Public ContactHarmanjit Singh

Government Medical College and Hospital, Chandigarh

harman_gmcp@yahoo.com919968118472

Outcome results

None listed

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