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A Phase III Randomized, Double Blind, Parallel Group, Placebo Controlled, Multi- centre, Multinational Study to Evaluate Efficacy and Safety of TRC150094 as an Add-On to Standard of Care in Improving Cardiovascular Risk in Subjects with Diabetes, Dyslipidemia and Hypertension -

SLCTR Registration Number

SLCTR/2018/009


Date of Registration

08 Mar 2018

The date of last modification

Jun 13, 2018


View original TRDS


Trial Status



Application Summary


Scientific Title of Trial

A Phase III Randomized, Double Blind, Parallel Group, Placebo Controlled, Multi- centre, Multinational Study to Evaluate Efficacy and Safety of TRC150094 as an Add-On to Standard of Care in Improving Cardiovascular Risk in Subjects with Diabetes, Dyslipidemia and Hypertension


Public Title of Trial

A Phase III Randomized, Double Blind, Parallel Group, Placebo Controlled, Multi- centre, Multinational Study to Evaluate Efficacy and Safety of TRC150094 as an Add-On to Standard of Care in Improving Cardiovascular Risk in Subjects with Diabetes, Dyslipidemia and Hypertension


Disease of Health Condition(s) Studied

Diabetes, Dyslipidemias, Hypertension


Scientific Acronym

None


Public Acronym

None


Brief title

Safety and Efficacy Study of TRC150094 to Improve the Cardiovascular Risk in Subjects With Diabetes, Dyslipidemia and Hypertension


Universal Trail Number

Not available


Any other number(s) assigned to the trial and issuing authority

Registered with Clinicaltrials.gov, Identifier number: NCT03254446


Trial Details


What is the research question being addressed?

Is TRC150094 safe and effective in reducing CV risk in subjects with diabetes, dyslipidemia and hypertension?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Double blinded


Control

Placebo


Assignment

Parallel


Purpose

Treatment


Intervention(s) planned

• Study Setting

National Hospital of Sri Lanka

Colombo South Teaching Hospital, Kalubowila

Colombo North Teaching Hospital, Ragama

Karapitiya Teaching Hospital, Galle

Teaching Hospital Kandy

• Method of randomization

Subjects (male or female) aged 30 to 70 years (both inclusive) with history of diabetes mellitus, dyslipidemia and hypertension will be screened for the eligibility. The screening procedure will be conducted after obtaining written informed consent from the subject or his/her legally acceptable representative as per regulatory requirements. At enrollment/randomization visit, subject will be randomly assigned to one of the treatment groups (test and placebo) in a ratio of 1:1 using an interactive system (Interactive Web Response System [IWRS] or Interactive Voice Response System [IVRS]). The sites, CRO and sponsor will be blinded till Database lock. However, for safety reason, if any site wants to unblind any subject, they can do so via Interactive Web Response System (IWRS). The unblinded team from Cenduit will send randomization allocation to Data Safety Monitoring Board biostastician directly during Data Safety Monitoring Board (DSMB) analysis of data. (Cenduit- Interactive Response Technology (IRT) systems automate patient and drug management, reducing errors and increasing efficiency.

• Blinding Procedures

Subjects and investigator (and other personnel involved in the study) will be unaware of the study drugs administered to individual subjects. The Sponsor will remain blind during the study. The placebo tablets will be identical in appearance and taste to that of TRC150094 tablets. At regular monitoring visits, a study monitor will ensure that the blind is maintained and all code-break envelopes remain intact. All study personal (study personnel involves the, data collectors, outcome adjudicators, data analysts) involved in the conduct and management of the study will remain blinded throughout the conduct of stud

• Intervention

Subjects will receive either test product- TRC150094 45 mg or matching placebo once daily for a period of 24 weeks. The subjects will be advised to take the test product-TRC150094 or placebo orally, swallowed as a whole with water preferably in the morning under fasting conditions. Subjects completing 24 weeks of main study will be rolled over to safety extension phase of 26 weeks where they will continue to receive either test product, TRC150094 45 mg, or matching placebo according to their initial randomization in the study.


Inclusion criteria

1.Male and female subjects in the age range 30-70 years (both inclusive)
2.BMI in the range 23-39 (inclusive) kg/m2
3. HbA1c > 7.5 %
4. Stable therapy of < 2 oral hypoglycemic agents for at least two months prior to screening at doses that are appropriate for the duration of the study in the judgment of the investigator.
5. Non HDL cholesterol > 160 mg/dL
6. Mean Arterial Pressure (MAP) >100 mm Hg based on average of 24 hours’ ambulatory blood pressure monitoring with or without anti-hypertensive treatment (subjects will have to be on stable dose of anti hypertensive treatment for at least two months prior to screening); Dose should be appropriate for the duration of the study in the judgment of the investigator.
7. Willing to give written informed consent
8. Ability to adhere to the study restrictions and assessments schedule


Exclusion criteria

  1. Uncontrolled hypertension: SBP of >180 mmHg and DBP >110 mmHg based on 24 hours Ambulatory Blood Pressure Monitoring
  2. HbA1C > 10% at screening
  3. Serum triglycerides >400 mg/dL
  4. LDL-cholesterol >300 mg/dL or medical history/clinical evidence of familial hyperlipidemic disorder.
  5. Subjects on insulin or SGLT2 inhibitors
  6. ACS or stroke or any revascularization within last 6 months.
  7. Subjects having untreated thyroid dysfunction (TSH <0.3 or >5.5 µIU/mL) or hormone related obesity disorder
  8. Subjects with liver enzymes (SGOT, SGPT) more than 3X of upper limit of normal value
  9. eGFR <30 mL/min as evaluated by MDRD method
  10. Seropositive for HIV, Hepatitis B or Hepatitis C
  11. History of alcohol or drug abuse, psychiatric disorder, any bleeding disorder, malignancy in last 3 years
  12. Pregnant or lactating women
  13. Female of childbearing potential, who are neither surgically sterilized nor willing to use reliable contraceptive methods (double barrier methods or intrauterine device).
  14. Male subjects with partners of childbearing potential not willing to use reliable contraception methods.
  15. Clinically significant abnormal physical findings, laboratory results, ECG findings and/or any other clinical observation or history during the screening examination, which would interfere with the objectives of the study.
  16. Intake of any investigational drug within 3 months prior to the first dose of study drug.
  17. In the opinion of the investigator, subject is unable to cooperate with any study procedures, unlikely to adhere to the study procedures, keep appointments, or plan to relocate during the study.


Primary outcome(s)

  1. Mean change in weighted average composite score (-6 to 6) of change in mean arterial pressure (MAP), non-HDL cholesterol and HbA1c from baseline to 24 weeks Ref study protocol version 1.1 dated 15/11/2017, table 5, page 86

  2. Mean change in Joint British Society recommendations on the prevention of Cardiovascular disease 3rd iteration (JBS3) risk score at the end of 24 weeks of treatment between arms Ref study protocol version 1.1 dated 15/11/2017, table 6, page 86


Primary outcome(s) - Time of assessment(s)

1.From baseline to 24 weeks of treatment between arms 2.At the end of 24 weeks of treatment between arms


Secondary outcome

  1. Mean change in MAP
  2. Mean change in non-HDL cholesterol
  3. Mean change in HbA1c

Secondary outcome(s) - Time of assessment(s)

  1. Mean change in MAP
  2. Mean change in non-HDL cholesterol
  3. Mean change in HbA1c


Target number/sample size

Approximately 60 patients from Sri Lanka. Globally- 1250


Countries of recruitment

Brazil, India, Philippines, Sri Lanka, Thailand


Anticipated start date

2018-03-08


Anticipated end date

2020-04-30


Recruitment status

Recruiting


State of ethics review approval

Approved by the Ethics Review Committee, Faculty of Medicine, and University of Kelaniya on 15 Nov 2017.


Funding source

TORRENT pharmaceuticals limited, Research Centre, Village: Bhat-382 428, Dist. Gandhinagar, (Gujarat), India



Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr. Noel Somasundaram
Consultant Endocrinologist
Diabetes and Endocrine Unit, National Hospital of Sri Lanka, Colombo 10
+9411-2691111-2800
+94 773 660 923

noelsomasundaram@gmail.com

Contact Person for Public Queries

Dr. Noel Somasundaram
Consultant Endocrinologist
Diabetes and Endocrine Unit, National Hospital of Sri Lanka, Colombo 10
+9411-2691111-2800
+94 773 660 923

noelsomasundaram@gmail.com


Primary study sponsor/organization

Dr Shohini Ghosh

TORRENT pharmaceuticals limited, Research Centre, Village: Bhat-382 428, Dist. Gandhinagar, (Gujarat), India
+91-79-23969100

shohinighosh@torrentpharma.com

Secondary study sponsor (If any)

None