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Safety and efficacy of Dapagliflozin and sitagliptin in elderly uncontrolled type 2 diabetes mellitus patients

Efficacy & safety of Dapagliflozin vs Sitagliptin as add on therapy for type 2 diabetes mellitus in geriatric population A Randomized Control Trial

Status
Recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/053833
Enrollment
120
Registered
2023-06-13
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Health Condition 1: E112- Type 2 diabetes mellitus with kidney complications

Interventions

Intervention1: Dapagliflozin: Dapagliflozin will be given once daily 10mg for 12 weeks as add on therapy in elderly uncontrolled type 2 diabetes mellitus patients Control Intervention1: Sitagliptin: S

Sponsors

Dr Mukku Venkata Pratap Reddy
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Patients with type 2 diabetes who are taking Metformin in combination with Sulfonylurea and target levels not achieved according to ADA Guidelines 2)Patients age greater than or equal to 60 years of either sex and who are willing to participate in study

Exclusion criteria

Exclusion criteria: e GFR less than 20 ml/min/1.73 m2, CKD patient on maintenance hemodialysis. 2)Type 2 Diabetes Patients PLHA. 3)Patients with hemoglobinopathies, Severe Anemia Hb 4)Patients already taking DPP4 inhibitors, SGLT2 inhibitors.

Design outcomes

Primary

MeasureTime frame
To evaluate and compare the change in HbA1c values from baseline at 12 weeks in both the groupsTimepoint: 3months

Secondary

MeasureTime frame
To compare the incidence of all major adverse events during 12 weeks of therapy To compare effect on renal outcome in both groups after 12 weeks of therapy To compare effect on lipid profile in both the groups after 12 weeks of therapy Timepoint: 3months

Countries

India

Contacts

Public ContactDr Mukku Venkata Pratap Reddy

All India Institute of Medical Sciences Bhubaneswar

genmed_rashmi@aiimsbhubaneswar.edu.in9437539784

Outcome results

None listed

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