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

NCT04801199 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 355

Last updated 2021-08-17

No results posted yet for this study

Summary

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).

Conditions

  • Uncontrolled Type 2 Diabetes Mellitus

Interventions

DRUG

CPL-2009-0031 140 mg

Patients will receive OD CPL-2009-0031 140 mg for 36 weeks with or without breakfast with a glass of water.

DRUG

Sitagliptin 100mg

Patients will receive OD Sitagliptin 100 mg for 36 weeks with or without breakfast with a glass of water.

Sponsors & Collaborators

  • New Millennium Indian Technology Leadership Initiative (NMITLI) program of Council of Scientific and Industrial Research, India

    collaborator UNKNOWN

  • Cadila Pharnmaceuticals

    lead INDUSTRY

Principal Investigators

  • Anil Avhad, MBBS · Cadila Pharmaceutical Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-26
Primary Completion
2021-01-13
Completion
2021-02-11

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04801199 on ClinicalTrials.gov