Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosed subjects of T2DM with age group between 18 to 70 years Diabetic subjects with insufficient blood glycaemic control for a period of 90 days before screening while on stable treatment with metformin more than or equal to 1000mg Glycosylated hemoglobin HbA1c between 7 to 10.5 percent Subject who submit a written informed consent
Exclusion criteria
Exclusion criteria: Subjects with uncontrolled hypertension with BP more than or equal to systolic 140 and Diastolic 90 mmHg Subjects with established diagnosis of CAD or any other clinically significant cardiovascular disease Subjects with established cases of cerebrovascular accidents such as stroke etc. Subjects with diabetic neuropathy, diabetic retinopathy Diabetic nephropathy diabetic wounds or ulcers Pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in HbA1c level from baselineTimepoint: Changes in HbA1c level from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in fasting insulin HOMA IR FBS PPBS Lipid Profile BMI Waist circumference and Quality of life from baselineTimepoint: 90 days | — |
Countries
India
Contacts
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka