NCT04801199

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

Prospective, Randomized, Double Blind, Parallel Group, Two Arm, Comparative, Multicenter, Clinical Study to Compare Efficacy and Safety of Oral CPL-2009-0031 140 mg of Cadila Pharmaceutical Limited, India Against Innovator Sitagliptin 100 mg in Patients With Uncontrolled Type-2 Diabetes Mellitus (T2DM)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 355 (actual)
• Sponsor: Cadila Pharnmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Detailed description

In this phase-III trial, after due consent and completing initial 2-weeks of placebo run-in period with diet, exercise and counseling, eligible patients with uncontrolled T2DM will be randomized in balance to receive either once daily oral CPL-2009-0031 140 mg or Sitagliptin 100 mg. After completing 12 weeks of study post-randomization for regulatory submission, patients will be instructed for continuation of extension phase of treatment and follow up upto 36 weeks. HbA1c will be measured at screening, baseline, 12 weeks, 24 weeks and 36 weeks of treatment. While, Fasting Blood Sugar (FBS) and Postprandial Blood Sugar (PPBS) measurement will be performed every 2 weeks. The enrolled patients will be monitored for safety (AE and SAE) throughout the study period.

Conditions

• Uncontrolled Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-01-26
• Primary completion: 2021-01-13
• Completion: 2021-02-11
• First posted: 2021-03-16
• Last updated: 2021-08-17

Locations

12 sites across 1 country: India