Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: DIABAC DS tablet: One tablet twice a daily with water orally after breakfast and dinner as per the discretion of investigator for 90 days.
Intervention2: DIABAC DS tablet + Oral hypogly
Sponsors
BACFO Pharmaceuticals (India) Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female participants between age 30-65 years (both inclusive) 2. Participants with a BMI of more than 28 and less than 35 kg per meter square 3. Participants with or without deranged lipid profile 4. Participants receiving oral hypoglycemic agents (OHA) biguanides and sulfonylureas (only combination) 5. Newly diagnosed participants who are eligible for inclusion may begin the trial with investigational product monotherapy. In the event of poor glycemic control, or safety concerns, the investigator may initiate standard of care treatment for type 2 diabetes mellitus 6. Glycated haemoglobin (HbA1c) more than 6.5% and less than 8% (both inclusive) 7. Fasting Plasma Glucose (FPG) more than 130 mg per dL and less than 250 mg per dL (both inclusive) 8. Participants willing to comply with the study procedure and sign written informed consent.
Exclusion criteria
Exclusion criteria: 1. Type 1 diabetes 2. Receiving antidiabetic drugs except for those specified in the inclusion criteria including insulin treatment 3. Participants with concurrent serious hepatic dysfunction (defined as AST and or ALT more than 3 times of the upper normal limit) or renal dysfunction (defined as S. creatinine more than 1.4 mg per dl), uncontrolled pulmonary dysfunction (asthmatic and COPD patients) or other concurrent severe disease 4. Participants suffering from major systemic illness necessitating long term drug treatment including but not limited to hematologic conditions (e.g., hemolytic anemias, sickle cell anemia), acute myocardial infarction, unstable angina, uncontrolled hypertension, congestive heart failure (class III or class IV NYHA), or cerebrovascular accident, psychiatric or neurological disorder, autoimmune condition, received chronic (more than 14 days) therapy with systemic glucocorticoids (excluding topical, intraocular, intranasal, intra articular, or inhaled preparations) within six months prior to enrollment 5. Smokers, alcoholics and or drug abusers 6. Participants with evidence or history of malignancy 7. Involvement in any other clinical trial requiring drug therapy 8. Pregnant or lactating women or women of fertile age not using effective contraception 9. Any condition that could, in the opinion of the investigator, preclude the participants ability to complete the study or that may confound study outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Changes in glycemic profile by assessing a) Fasting, and post-meal plasma glucose levels b) HbA1c levels 2. Changes in insulin resistance by assessing fasting insulin, HOMA-IR scoreTimepoint: 1.a) From Screening to end of the study b) At screening and end of the study 2.At screening and end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in lipid metabolism by assessing total cholesterol, LDL, HDL, triglycerides. 2. Changes in Metabolic Syndrome Severity Z Score (MetZ score). 3. Changes in anthropometric parameters like body weight, BMI, and waist circumference. 4. Changes in diabetes related quality of life score measured by modified DQOL questionnaire to assess quality of life.Timepoint: 1.At screening and end of the study. 2.At screening and end of the study. 3.From screening to end of study. 4.At screening and end of the study. | — |
Countries
India
Contacts
Public ContactDr Gayatri Ganu
BACFO Pharmaceuticals (India) Ltd
Outcome results
None listed