Date

2018-06-04

Protocol

Protocol changed

Item Changed

Inclusion criteria

Previous Version

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. Systolic Blood Pressure (SBP) >140 mm Hg and Diastolic Blood Pressure (DBP) >90 mmHg based on average of 24 hours' Ambulatory Blood Pressure Monitoring (ABPM) 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

Next Version

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