WHO ICTRP trial
A clinical trial to evaluate the safety and efficacy of two antidiabetic drugs…
CTRI/2022/08/044563 · Clinical Trials Registry India (CTRI) · Not Recruiting
Key facts
| Trial ID | CTRI/2022/08/044563 |
|---|---|
| Public title | A clinical trial to evaluate the safety and efficacy of two antidiabetic drugs versus one antidiabetic drug in patients with type 2 diabetes mellitus |
| Scientific title | A phase 3, multicenter, randomized, double-blind, double- dummy, parallel-group study to compare the efficacy and safety of fixed dose combination tablets of Dapagliflozin 10 mg and Linagliptin 5 mg versus Trajenta 5 mg(Linagliptin 5 mg) in patients with Type 2 Diabetes Mellitus(T2DM) inadequately… |
| Primary sponsor | Alkem Laboratories Limited |
| Secondary sponsors | Alkem Laboratories Limited |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | Phase 3 |
| Countries | India |
| Conditions | Health Condition 1: E119- Type 2 diabetes mellitus without complications |
| Interventions | Intervention1: Fixed dose combination of Dapagliflozin and Linagliptin: Fixed dose combination of Dapagliflozin 10 mg and Linagliptin 5 mg . Treatment Duration 16 weeks to be taken orally once daily after food Control Intervention1… |
| Registration date | Jan 8, 2022 |
| Target size | 232 |
| Secondary IDs | ALK27-DAL1 Version 2.0, Dated 14/Jun/2022 |
| Registry page | ctri.nic.in |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: