Diabetes, Dyslipidemias, Hypertension
Conditions
Interventions
• Study Setting
National Hospital of Sri Lanka
Colombo South Teaching Hospital, Kalubowila
Colombo North Teaching Hospital, Ragama
Karapitiya Teaching Hospital, Galle
Teaching Hospital Kand
Sponsors
Dr Shohini Ghosh
Eligibility
Inclusion criteria
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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 [From baseline to 24 weeks of treatment between arms ] 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 [At the end of 24 weeks of treatment between arms ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in MAP [From baseline to 24 weeks of treatment] Mean change in non-HDL cholesterol [From baseline to 24 weeks of treatment] Mean change in HbA1c [From baseline to 24 weeks of treatment] | — |
Countries
Brazil,India,Philippines,Sri Lanka,Thailand
Contacts
Public ContactDr. Noel Somasundaram
Consultant Endocrinologist
Outcome results
None listed