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NCT04801199

Effect of CPL-2009-0031 in the Treatment of Patients With Uncontrolled Type 2 Diabetes Mellitus

Completed Phase 3 Last updated 17 August 2021
What this trial tests

Phase 3 trial testing CPL-2009-0031 140 mg in Uncontrolled Type 2 Diabetes Mellitus in 355 participants. Completed in 11 February 2021.

Timeline
26 January 2020
Primary endpoint
13 January 2021
11 February 2021

Quick facts

Lead sponsorCadila Pharnmaceuticals
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment355
Start date26 January 2020
Primary completion13 January 2021
Estimated completion11 February 2021
Sites12 locations across India

Drugs / interventions tested

Conditions studied

Sponsor

Cadila Pharnmaceuticals — full company profile →

Who can join

Adults 18 to 65, any sex, with Uncontrolled Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This trial is a Phase-III, Prospective, Randomized, Double Blind, Parallel Group, Two arm, Comparative, Multicenter, controlled clinical trial to determine the efficacy, safety, and tolerability of oral CPL-2009-0031 140 mg in comparison with Sitagliptin 100 mg in patients with Uncontrolled Type-2 Diabetes Mellitus (T2DM).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other Cadila Pharnmaceuticals trials

Trials by the same sponsor.

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Data sources for this page

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