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

NCT03254446 | Unknown Phase 3 DMC

• 1 other identifier: CT/P015/CMR/16/03_01
• Study Type: interventional
• Target: 1,250
• Locations: 3 countries
• Sites: 21

Brief Summary

The phase III trial is designed with an aim of determining the efficacy of Investigational Product TRC150094 in concurrently reducing non-traditional risk factors for CV risk i.e., HbA1c, MAP and non-HDL cholesterol. This study will be a randomized, double blind, parallel group, placebo controlled, multi-centre, multinational study in 1250 subjects. All the study subjects will receive once daily dose of TRC150094 45 mg or placebo tablets in addition to their standard of care, for 24 weeks followed by roll over to a safety extension phase of 26 weeks.

Conditions

Diabetes; Dyslipidemias; Hypertension

Keywords

Diabetes; Hypertension; Dyslipidemia; Cardiovascular Risk

Outcome Measures

Primary Outcomes (2)

• Change in mean arterial pressure (MAP), non-HDL cholesterol and HbA1c

  Mean change in weighted average composite score of change in mean arterial pressure (MAP), non-HDL cholesterol and HbA1c from baseline to 24 weeks of treatment between arms

  24 Weeks

• Change in Joint British Society recommendations on the prevention of cardiovascular disease 3rd iteration (JBS3) risk score

  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

  24 Weeks

Secondary Outcomes (3)

• Change in MAP

  24 Weeks

• Change in non-HDL cholesterol

  24 Weeks

• Change in HbA1c

  24 Weeks

Other Outcomes (2)

• Change in weight

  24 Weeks

• Safety profile of TRC150094

  50 Weeks

Study Arms (2)

TRC150094 45 mg

EXPERIMENTAL

TRC150094 45 mg Tablet to be administered orally once a day for 50 weeks

Drug: TRC150094

Placebo

PLACEBO COMPARATOR

Matching Placebo Tablet to be administered orally once a day for 50 weeks

Drug: Placebo

Interventions

TRC150094 DRUG

TRC150094 Tablet 45 mg

TRC150094 45 mg

Placebo DRUG

Matching Placebo Tablet

Placebo

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects in the age range 30-70 years (both inclusive)
• BMI in the range 23-39 (inclusive) kg/m2
• HbA1C ≥7.5 %
• 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.
• Non HDL-cholesterol ≥ 160 mg/dL.
• Mean Arterial Pressure (MAP) ≥100 mm Hg based on average of 24 hours' ambulatory blood pressure monitoring (ABPM) with or without antihypertensive 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.
• Willing to give written informed consent
• Ability to adhere to the study restrictions and assessments schedule

You may not qualify if:

• Uncontrolled hypertension: SBP of ≥ 180 mm Hg and DBP ≥ 110 mmHg based on average of 24 hours' ambulatory blood pressure monitoring.
• HbA1C \> 10 % at screening.
• Serum triglycerides \>400 mg/dL.
• LDL-cholesterol \>300 mg/dL or medical history/clinical evidence of familial hyperlipidemic disorder.
• Subjects on Insulin or Sodium Glucose Co-Transporter 2 (SGLT2) inhibitors.
• Acute coronary syndrome (ACS) or stroke or any revascularization within last 6 months.
• Subjects having untreated thyroid dysfunction (TSH \<0.3 or \>5.5 µIU/mL) or hormone related obesity disorder.
• Subjects with liver enzymes (SGOT, SGPT) more than 3X of upper limit of normal value.
• eGFR \<30 mL/min as evaluated by Modification of Diet in Renal Disease (MDRD) method.
• Seropositive for HIV, Hepatitis B or Hepatitis C.
• History of alcohol or drug abuse, psychiatric disorder, any bleeding disorder, malignancy in last 3 years.
• Pregnant or lactating women.
• Female of childbearing potential, who are neither surgically sterilized nor willing to use reliable contraceptive methods (double barrier methods or intrauterine device).
• Male subjects with partners of childbearing potential not willing to use reliable contraception methods.
• 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.

Sponsors & Collaborators

• Torrent Pharmaceuticals Limited: lead
• Iqvia Pty Ltd: collaborator

Study Sites (21)

Comitê de ética em Pesquisa do Hospital Pró Cardíaco

Rio de Janeiro, Botafogo, 22270-005, Brazil

RECRUITING

Avenida Angélica

São Paulo, CEP, 01228-200, Brazil

RECRUITING

Rua Silva Jardim

São Bernardo do Campo, São Paulo, 09715-090 -, Brazil

RECRUITING

Av. Farroupilha, 8001 Prédio 21, Recepção C, Bairro São José - Canoas/RS

Canoas, Brazil

RECRUITING

Rua Coronel Aureliano de Camargo,905, Centro,

Tatuí, Brazil

RECRUITING

BAPS Pramukh Swami Hospital,

Surat, Gujarat, 395009, India

RECRUITING

Bangalore Diabetes Centre, No. 426, 4th Cross, 2nd block, kalyan nagar,

Bangalore, Karnataka, 560043, India

RECRUITING

Government Medical College, Government Medical College Campus,

Calicut, Kerala, 673008, India

RECRUITING

Lisie Hospital

Kochi, Kerala, 682017, India

RECRUITING

Indian Institute of Diabetes

Thiruvananthapuram, Kerala, 695031, India

RECRUITING

Supe Heart and Diabetes Hospital and Research Centre,

Nashik, Maharashtra, 422002, India

RECRUITING

Medipoint Hospitals Pvt. Ltd

Pune, Maharashtra, 411007,, India

RECRUITING

Ashirwad Hospital & Research Centre

Ulhasnagar, Maharashtra, 421004, India

RECRUITING

Dayanand Medical College & Hospital

Ludhiana, Punjab, 141001, India

RECRUITING

S.R Kalla Memorial Gastro and General Hospital

Jaipur, Rajasthan, 302001, India

RECRUITING

Diabetes ,Thyroid and Endocrine Centre

Jaipur, Rajasthan, 302006, India

RECRUITING

Apollo Hospitals, PR No. 3-5-836 to 838, Near Old MLA Quarters,

Hyderabad, Telangana, 500029, India

RECRUITING

De La Salle Heath Sciences Institute

Dasmariñas, Cavite, 4114, Philippines

RECRUITING

Angeles University Foundation Medical Center

Angeles City, Pampanga, 2009, Philippines

RECRUITING

St. Paul's Hospital

General Luna, Saint Iloilo City, 5000, Philippines

RECRUITING

Davao Doctors Hospital

Davao City, 8000, Philippines

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Dyslipidemias; Hypertension

Interventions

TRC150094

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nikhil Tandon, M.D., PhD

  All India Institute of Medical Sciences

  STUDY CHAIR

Central Study Contacts

Shohini Ghosh, PhD

CONTACT

+91-79-23969100; shohinighosh@torrentpharma.com

Girish Deshmukh, PhD

CONTACT

+91-79-23969100; girishdeshmukh@torrentpharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double Blind, Parallel Group, Placebo Controlled, Multi-centre, Multinational Study

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 18, 2017
• Study Start: March 12, 2018
• Primary Completion: April 1, 2022
• Study Completion: August 1, 2022
• Last Updated: July 17, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

PH (4); IN (12); BR (5)