Safety and Efficacy Study of TRC150094 to Improve the CV Risk in Subjects With Diabetes, Dyslipidemia and Hypertension
NCT ID: NCT03254446
Last Updated: 2020-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
1250 participants
INTERVENTIONAL
2018-03-12
2022-08-31
Brief Summary
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Detailed Description
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The phase III trial is designed with an aim of determining the efficacy of 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.
Primary Objective of the study is, To evaluate the efficacy of TRC150094 in improving cardiovascular (CV) risk in subjects with diabetes, dyslipidemia and hypertension Secondary Objectives of the study are,
1. To evaluate safety of TRC150094 in subjects with diabetes, dyslipidemia and hypertension
2. To evaluate extended safety profile of TRC150094 beyond 24 weeks of treatment in subjects with diabetes, dyslipidemia and hypertension
In this study there will be five visits at week 4, 12, 24, 36 and 50 after enrolment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TRC150094 45 mg
TRC150094 45 mg Tablet to be administered orally once a day for 50 weeks
TRC150094
TRC150094 Tablet 45 mg
Placebo
Matching Placebo Tablet to be administered orally once a day for 50 weeks
Placebo
Matching Placebo Tablet
Interventions
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TRC150094
TRC150094 Tablet 45 mg
Placebo
Matching Placebo Tablet
Eligibility Criteria
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Inclusion Criteria
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 (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.
7. Willing to give written informed consent
8. Ability to adhere to the study restrictions and assessments schedule
Exclusion Criteria
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 Sodium Glucose Co-Transporter 2 (SGLT2) inhibitors.
6. Acute coronary syndrome (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 Modification of Diet in Renal Disease (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.
30 Years
70 Years
ALL
No
Sponsors
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Iqvia Pty Ltd
INDUSTRY
Torrent Pharmaceuticals Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Nikhil Tandon, M.D., PhD
Role: STUDY_CHAIR
All India Institute of Medical Sciences
Locations
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Comitê de ética em Pesquisa do Hospital Pró Cardíaco
Rio de Janeiro, Botafogo, Brazil
Avenida Angélica
São Paulo, CEP, Brazil
Rua Silva Jardim
São Bernardo do Campo, São Paulo, Brazil
Av. Farroupilha, 8001 Prédio 21, Recepção C, Bairro São José - Canoas/RS
Canoas, , Brazil
Rua Coronel Aureliano de Camargo,905, Centro,
Tatuí, , Brazil
BAPS Pramukh Swami Hospital,
Surat, Gujarat, India
Bangalore Diabetes Centre, No. 426, 4th Cross, 2nd block, kalyan nagar,
Bangalore, Karnataka, India
Government Medical College, Government Medical College Campus,
Calicut, Kerala, India
Lisie Hospital
Kochi, Kerala, India
Indian Institute of Diabetes
Thiruvananthapuram, Kerala, India
Supe Heart and Diabetes Hospital and Research Centre,
Nashik, Maharashtra, India
Medipoint Hospitals Pvt. Ltd
Pune, Maharashtra, India
Ashirwad Hospital & Research Centre
Ulhasnagar, Maharashtra, India
Dayanand Medical College & Hospital
Ludhiana, Punjab, India
S.R Kalla Memorial Gastro and General Hospital
Jaipur, Rajasthan, India
Diabetes ,Thyroid and Endocrine Centre
Jaipur, Rajasthan, India
Apollo Hospitals, PR No. 3-5-836 to 838, Near Old MLA Quarters,
Hyderabad, Telangana, India
De La Salle Heath Sciences Institute
Dasmariñas, Cavite, Philippines
Angeles University Foundation Medical Center
Angeles City, Pampanga, Philippines
St. Paul's Hospital
General Luna, Saint Iloilo City, Philippines
Davao Doctors Hospital
Davao City, , Philippines
Countries
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Central Contacts
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Facility Contacts
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Luis Augusto Russo, MD PhD, MBA
Role: primary
Joselita S Bodart, MD, Physian
Role: backup
Claudia M de Brito, MD, Physian
Role: primary
Andrea S Audi, MD, Physian
Role: backup
Dr.Chyandni R., MBBS,MD,PHD
Role: backup
Shailaja G Bhatia, MBBS,MD
Role: backup
damandeep P Kaur
Role: backup
Ygpuara M Lallaine, Int.Med
Role: primary
Aquitania Grace, Int.Med
Role: primary
Emily R Doliente, Int.Med
Role: backup
Other Identifiers
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CT/P015/CMR/16/03_01
Identifier Type: -
Identifier Source: org_study_id
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