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Clinical Trial Details

Trial ID: L5519
Source ID: NCT04801199
Associated Drug: Cpl-2009-0031 140 Mg
Title: Effect of CPL-2009-0031 in the Treatment of Patients With Uncontrolled Type 2 Diabetes Mellitus
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Uncontrolled Type 2 Diabetes Mellitus
Interventions: DRUG: CPL-2009-0031 140 mg|DRUG: Sitagliptin 100mg
Outcome Measures: Primary: Change in HbA1c level, To evaluate HbA1c levels between oral CPL-2009-0031 140 mg and oral Sitagliptin 100 mg, Baseline, 12 weeks, 24 weeks and 36 weeks from onset of therapy | Secondary: Fasting Blood Sugar (FBS) level, To compare Fasting Blood Sugar between oral CPL-2009-0031 140 mg and oral Sitagliptin 100 mg, Every 2 week till 12 weeks and every 4 weeks between 12 weeks to 36 weeks from onset of therapy|Postprandial Blood Sugar (PPBS) level, To compare Fasting Blood Sugar between oral CPL-2009-0031 140 mg and oral Sitagliptin 100 mg, Every 2 week till 12 weeks and every 4 weeks between 12 weeks to 36 weeks from onset of therapy|Frequency of Serious Adverse Events, Determination of safety and tolerability of CPL-2009-0031 140 mg versus Sitagliptin 100 mg based on Frequency of serious adverse events, From randomization to end of 12 week, 24 week and 36-weeks therapy|Number of hypoglycemic events, Determine number and severity of hypoglycemic events of CPL-2009-0031 140 mg versus Sitagliptin 100 mg, From randomization to end of 12 week, 24 week and 36-weeks therapy|Frequency of adverse events, Determine frequency and severity of adverse events of CPL-2009-0031 140 mg versus Sitagliptin 100 mg, From randomization to end of 12 week, 24 week and 36-weeks therapy
Sponsor/Collaborators: Sponsor: Cadila Pharnmaceuticals | Collaborators: New Millennium Indian Technology Leadership Initiative (NMITLI) program of Council of Scientific and Industrial Research, India
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 355
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2020-01-26
Completion Date: 2021-02-11
Results First Posted:
Last Update Posted: 2021-08-17
Locations: A C Subba Reddy Government Medical College and Hospital, Nellore, Andhra Pradesh, 524004, India|Downtown Hospital, Guwahati, Assam, 781006, India|SSG Hospital, Vadodara, Gujarat, 390001, India|Bangalore Diabetes Centre, Bangalore, Karnataka, 560043, India|Dhadiwal Hospital, Nashik, Maharashtra, 422002, India|Ashirwad Hospital & Research Centre, Ulhasnagar, Maharashtra, 421004, India|S.P. Medical College and A.G. Hospital, Bīkaner, Rajasthan, 334001, India|Bhandari Clinic & Research Centre, Jaipur, Rajasthan, 302015, India|Sanjivini Lung Centre, Lucknow, Uttar Pradesh, 226010,, India|Nilratan Sircar Medical College & Hospital, Kolkata, West Bengal, 700014, India|Life Line Diagnostic Centre cum Nursing Home, Kolkata, West Bengal, 70001, India|Apollo Hospital International Ltd, Gandhinagar, 382428, India
URL: https://clinicaltrials.gov/show/NCT04801199

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