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

NCT04801199 | Completed Phase 3 DMC

• 1 other identifier: CRSC18005
• Study Type: interventional
• Target: 355
• Locations: 1 country
• Sites: 12

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Fasting Blood Sugar (FBS) level

  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

  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

  From randomization to end of 12 week, 24 week and 36-weeks therapy

• Number of hypoglycemic events

  From randomization to end of 12 week, 24 week and 36-weeks therapy

• Frequency of adverse events

  From randomization to end of 12 week, 24 week and 36-weeks therapy

Study Arms (2)

CPL-2009-0031 140 mg

EXPERIMENTAL

Single dose, Oral tablet containing 140 mg of CPL-2009-0031, Once daily for 36-weeks

Drug: CPL-2009-0031 140 mg

Sitagliptin 100 mg

ACTIVE COMPARATOR

Single dose, Oral tablet containing 100 mg of Sitagliptin, Once daily for 36-weeks

Drug: Sitagliptin 100mg

Interventions

CPL-2009-0031 140 mg DRUG

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

CPL-2009-0031 140 mg

Sitagliptin 100mg DRUG

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

Sitagliptin 100 mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female adult patient of 18-65 years with uncontrolled type 2 diabetes Mellitus (T2DM).
• Patients with HbA1c ≥ 7 to 10 and those on oral hypoglycemic agents ≤ 2 other than Insulin and Gliptins.
• BMI in the range of 18.5 - 35 kg/m2.
• All patients must be willing to give informed consent and can understand \& complying protocol requirement.
• Patients who are in good health at the time of entry into the study as determined by medical, medication and hypersensitivity histories, clinical examination, vital sign measurements, chest X-ray, 12-lead ECG measurement and clinical judgment of the investigator.
• Documented negative test for human immuno virus (HIV), Hepatitis B surface antigen (HBsAg) and Hepatitis C virus (HCV).

You may not qualify if:

• Those who are on insulin and not ready for wash out of 3 months.
• Those who are on gliptin and not ready for wash out of 3 months.
• Those with a history of severe ketosis, diabetic coma or pre-coma, or type 1 diabetes.
• Those scheduled for or who had undergone surgery.
• Those with a severe infection or serious injury
• Pregnant and lactating women.
• Hypersensitivity and contraindication to DPP-IV inhibitors or excipients of investigational drug formulation.
• Hypertensive patients with blood pressure ≥160/100 mm of Hg.
• History of ischemic heart disease (as evident from ECG), stroke and/or transient ischemic attack.
• Debilitating neurological or psychiatric disorders
• History or currently consuming abusing drugs or alcohol.
• Serious hepatic or renal impairment (liver dysfunction as evidenced by SGPT/SGOT level of 2.5 X ULN and renal dysfunction as evidenced by creatinine level 2.5 X ULN).
• Patient with abnormal clinical chemistry, hematology or urinalysis results that are considered clinically significant by the investigator or the sponsor.
• Patient has any concurrent illness which, in the opinion of the investigator or coinvestigator, may interfere with treatment or evaluation of safety or completion of this study.
• In the investigator's judgment, the patient is unable to adhere to the treatment regimen, protocol procedures or study requirements.

Sponsors & Collaborators

• Cadila Pharnmaceuticals: lead
• New Millennium Indian Technology Leadership Initiative (NMITLI) program of Council of Scientific and Industrial Research, India: collaborator

Study Sites (12)

A C Subba Reddy Government Medical College and Hospital

Nellore, Andhra Pradesh, 524004, India

Location

Downtown Hospital

Guwahati, Assam, 781006, India

Location

SSG Hospital

Vadodara, Gujarat, 390001, India

Location

Bangalore Diabetes Centre

Bangalore, Karnataka, 560043, India

Location

Dhadiwal Hospital

Nashik, Maharashtra, 422002, India

Location

Ashirwad Hospital & Research Centre

Ulhasnagar, Maharashtra, 421004, India

Location

S.P. Medical College and A.G. Hospital

Bikaner, Rajasthan, 334001, India

Location

Bhandari Clinic & Research Centre

Jaipur, Rajasthan, 302015, India

Location

Sanjivini Lung Centre

Lucknow, Uttar Pradesh, 226010,, India

Location

Nilratan Sircar Medical College & Hospital

Kolkata, West Bengal, 700014, India

Location

Life Line Diagnostic Centre cum Nursing Home

Kolkata, West Bengal, 70001, India

Location

Apollo Hospital International Ltd

Gandhinagar, 382428, India

Location

Related Links

• Clinical trial database uploaded on Clinical Trial Registry of India (CTRI)

MeSH Terms

Interventions

Sitagliptin Phosphate

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Anil Avhad, MBBS

  Cadila Pharmaceutical Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator, patient, study staff, data monitors and database personnel will be blinded to the study treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, Randomized, Double Blind, Parallel Group, Two arm, Comparative, Multicenter, controlled study

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 16, 2021
• Study Start: January 26, 2020
• Primary Completion: January 13, 2021
• Study Completion: February 11, 2021
• Last Updated: August 17, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (12)