Health Condition 1: null- Type 2 Diabetes Mellitus Health Condition 2: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Sugaheal: Sugaheal Tablet (350 mg, one
tablet, Oral, twice a day) for 24 weeks
Intervention2: Sugaheal: Sugaheal Tablet (500 mg, one
tablet, Oral, twice a day) for 24 weeks
Control Int
Sponsors
Indus Biotech Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Treatment naïve patients of type 2 diabetes mellitus (defined as never receiving medical treatment for diabetes [insulin and/or oral antihyperglycemic medication] for > 6 months since original diagnosis, and no oral antihyperglycemic medication for more than 3 consecutive days or 7 nonconsecutive days during the 8 weeks prior to screening) 2. Fasting Plasma glucose (FPG) between 126 mg/dl and 250 mg/dl 3. Male or Female between 30 years to 65 years of age 4. Body Mass Index (BMI) between 18 kg/m2 to 30 kg/m2 5. HbA1c between 7% to 10% both inclusive 6. If on anti-hypertensive, lipid-lowering, or thyroid medications or hormone therapy, has been on constant dosage for at least 3 months prior to screening visit. 7. Patients those have voluntarily given written informed consent 8. Women with childbearing potential, willing to use effective contraceptive measures (other than oral contraceptive pills) such mechanical or barrier contraceptives, post- menopausal will be included. 9. In the opinion of the investigator, able to comply with the requirements of the protocol 10. Patients who received counseling on diet and exercise consistent with ADA recommendations
Exclusion criteria
Exclusion criteria: • Patients on hyperglycemic agent at screening visit • Type 1 diabetes patients • Females who are pregnant, lactating or planning to become pregnant • Known allergy to study medication • Patients with underline chronic disease of heart, liver, kidney, endocrine or neurological disease. • History of diabetic ketoacidosis or hyperosmolar nonketotic coma • Has a contagious, infectious disease • Currently taking herbals, dietary supplements, or medications, during the past 12 weeks that could profoundly affect blood glucose • Active malignancy. • AST / ALT more than or equal to 2.5 times the upper limit of normal laboratory value ( i.e. AST more than or equal to 100 and ALT more than or equal to 25 ) • Serum creatinine more than or equal to1.5 mg/dl, • Any other conditions not eligible for the trial as per investigator or clinically significant abnormal laboratory values at screening visit. • Clinically significant abnormal red cell turnover, such as recent blood loss or transfusion or anemia [hemoglobin levels: less than 10 mg% (Male) and less than 9 mg% (Female)] • Patient of heart disease of Class III (marked limitation of any activity, the patient is comfortable only at rest) and Class IV (any physical activity brings discomfort and symptom occur at rest) as per New York Heart Association functional classification of heart diseases • Patients who smokes10 cigarettes per day • Alcohol intake more than 2 drinks/day • Subject participating simultaneously or 3 months prior to screening in any other clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycated hemoglobin (HbA1c) values (%)Timepoint: Screening, Week-12, Week-24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 3 h - Oral glucose tolerance test (OGTT)Timepoint: Randomization, Week-12, Week-24;Adverse Event (AE) Monitoring â?? Number and percent of subjects a) experiencing adverse events (AEs), (SAEs) b) discontinuation due to AE and c) with abnormal laboratory parameters (narratives with drug, disease, concomitantTimepoint: Randomization, Week-4, Week-8, Week-12, Week-18, Week-24;Anthropometric parameters: Body weight (kgs), Waist circumference (cm), Hip Circumference (cm)Timepoint: Screening, Randomization, Week-4, Week-8, Week-12, Week-18, Week-24;Cumulative and average daily dose of Metformin and/or other rescue medication per patient per armTimepoint: To be calculated at Week-24 (end of study);Efficacy (measurements): Fasting plasma glucose (FPG) in mg/dl.Timepoint: Screening, Randomization, Week-4, Week-8, Week-12, Week-18, Week-24;Fasting (12 h) Serum insulin levelTimepoint: Randomization, Week-12, Week-24;Fasting (12 h) Serum lipid profile [triglyceride, cholesterol, cholesterol-HDL (HDL) and cholesterol-LDL (LDL) cholesterol VLDL calculated]Timepoint: Screening and Week-24;HOMA-IR, Insulin sensitivity index, Fat content (%), Matsuda Index, Oral glucose insulin sensitivity (OGIS),BMI, Waist to Hip ratio (WHR)Timepoint: To be calculated at Week-24 (end of study);Number and Proportion of subjects achieving a) HbA1c targets less than or equal to 6.5% (IDF criteria), b) HbA1c targets less than or equal to 7 % (ADA criteria), c) 20%, 50% and 70% reduction in FPG d) requiring Metformin and /or other rescue medication additionTimepoint: To be calculated at Week-24 (end of study);Quality of Life measurementTimepoint: Randomization, Week-12, Week-24;Safety parameters: Biochemical safety parameters - Liver function (ALT, AST, Total Protein, Albumin, Alkaline phosphate, Total direct indirect), Kidney Function (BUN, and creatinine).Timepoint: Screening, Week-24;Safety parameters: Vital Signs â?? Heart rate , Blood pressure, Pulse rate, ECGTimepoint: Screening, Randomizat | — |
Countries
India
Contacts
Public ContactDr Prasad Thakurdesai
Indus Biotech Private Limited, Pune
Outcome results
None listed