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)

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).

Study Overview

• Status: Completed
• Conditions: Uncontrolled Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: CPL-2009-0031 140 mg; Drug: Sitagliptin 100mg

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.

• Study Type: Interventional
• Enrollment (Actual): 355
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Gandhinagar, India, 382428
    • Apollo Hospital International Ltd
  • Andhra Pradesh
    • Nellore, Andhra Pradesh, India, 524004
      • A C Subba Reddy Government Medical College and Hospital
  • Assam
    • Guwahati, Assam, India, 781006
      • Downtown Hospital
  • Gujarat
    • Vadodara, Gujarat, India, 390001
      • SSG Hospital
  • Karnataka
    • Bangalore, Karnataka, India, 560043
      • Bangalore Diabetes Centre
  • Maharashtra
    • Nashik, Maharashtra, India, 422002
      • Dhadiwal Hospital
    • Ulhasnagar, Maharashtra, India, 421004
      • Ashirwad Hospital & Research Centre
  • Rajasthan
    • Bīkaner, Rajasthan, India, 334001
      • S.P. Medical College and A.G. Hospital
    • Jaipur, Rajasthan, India, 302015
      • Bhandari Clinic & Research Centre
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India, 226010,
      • Sanjivini Lung Centre
  • West Bengal
    • Kolkata, West Bengal, India, 700014
      • Nilratan Sircar Medical College & Hospital
    • Kolkata, West Bengal, India, 70001
      • Life Line Diagnostic Centre Cum Nursing Home

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.
• Participation in another clinical trial in the past 3 months.
• Patients with history of smoking or currently having smoking habit will not be included in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CPL-2009-0031 140 mg; Single dose, Oral tablet containing 140 mg of CPL-2009-0031, Once daily for 36-weeks	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.
ACTIVE_COMPARATOR: Sitagliptin 100 mg; Single dose, Oral tablet containing 100 mg of Sitagliptin, Once daily for 36-weeks	Drug: Sitagliptin 100mg; Patients will receive OD Sitagliptin 100 mg for 36 weeks with or without breakfast with a glass of water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cadila Pharnmaceuticals
• Collaborators: New Millennium Indian Technology Leadership Initiative (NMITLI) program of Council of Scientific and Industrial Research, India
• Investigators: Study Director: Anil Avhad, MBBS, Cadila Pharmaceutical Limited

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 26, 2020
• Primary Completion (ACTUAL): January 13, 2021
• Study Completion (ACTUAL): February 11, 2021

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 13, 2021
• First Posted (ACTUAL): March 16, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 17, 2021
• Last Update Submitted That Met QC Criteria: August 14, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Sitagliptin Phosphate
• Other Study ID Numbers: CRSC18005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No