A clinical study on effects of Sugaheal® in patients with Type 2 Diabetes Mellitus
- Conditions
- Type 2 diabetes mellitus without complications,
- Registration Number
- CTRI/2013/01/003314
- Lead Sponsor
- Indus Biotech Private Limited
- Brief Summary
Diabetes mellitus (DM), is a lifestyle disorder of progressive nature. Initial anti-hyperglycemic monotherapy is often unsuccessful at getting patients with type 2 DM to glycemic goals. Therefore, initial combination therapy is recommended in newly diagnosed patients. The present study is proposed to evaluate efficacy and safety of Sugaheal® in treatment naïve patients with type 2 DM. The investigational product, Sugaheal®, standardized extract of fenugreek seeds. Efficacy in animal model of DM and safety is well established Therefore, Sugaheal is expected to improve glycemic control as well as overall management of DM.
A total of 276 patients will be randomized as per blocks (based on gender and HbA1c range) in 1:1:1 ratio to 3 arms of the study i.e. Placebo, Sugaheal-350 and Sugaheal-500 each. Randomized patients will receive assigned treatment twice daily for 24 weeks. Efficacy evaluations will be based on primary and secondary outcomes. The primary outcome measure of the study is Glycated haemoglobin (HbA1c) values. Secondary outcome measures in terms of glucose homeostasis (FPG and PPPG), anthropometric parameters, skinfold thickness measurement, HOMA-IR, and lipid profile, matsuda index, oral glucose insulin sensitivity (OGIS), BMI, Waist to Hip ratio (WHR), fasting Glucose AUC, and QOL assessments. Safety parameters include biochemical liver function parameters (ALT, AST, total protein, albumin, alkaline phosphate, bilirubin (total direct indirect), and kidney function parameters (BUN, and creatinine), and vital signs (heart rate, blood pressure, pulse rate, and ECG). The provision of rescue medication is made. AE and SAE monitoring will also be done as a part of safety evaluations.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- All
- Target Recruitment
- 276
- 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.
- •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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Glycated hemoglobin (HbA1c) values (%) Screening, Week-12, Week-24
- Secondary Outcome Measures
Name Time Method Efficacy (measurements): Fasting plasma glucose (FPG) in mg/dl. Screening, Randomization, Week-4, Week-8, Week-12, Week-18, Week-24 Fasting (12 h) Serum insulin level Randomization, Week-12, Week-24 Fasting (12 h) Serum lipid profile [triglyceride, cholesterol, cholesterol-HDL (HDL) and cholesterol-LDL (LDL) cholesterol VLDL calculated] Screening and Week-24 3 h - Oral glucose tolerance test (OGTT) Randomization, Week-12, Week-24 Anthropometric parameters: Body weight (kgs), Waist circumference (cm), Hip Circumference (cm) Screening, Randomization, Week-4, Week-8, Week-12, Week-18, Week-24 Skinfold thickness measurement (mm) – in male (chest, abdomen, thigh) and in female (iliac crest, triceps, thigh) Randomization, Week-12, Week-24 Quality of Life measurement Randomization, Week-12, Week-24 HOMA-IR, Insulin sensitivity index, Fat content (%), Matsuda Index, Oral glucose insulin sensitivity (OGIS),BMI, Waist to Hip ratio (WHR) 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), Adverse Event (AE) Monitoring – 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, concomitant 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 arm To be calculated at Week-24 (end of study) Safety parameters: Biochemical safety parameters - Liver function (ALT, AST, Total Protein, Albumin, Alkaline phosphate, Total direct indirect), Kidney Function (BUN, and creatinine). Screening, Week-24 Safety parameters: Vital Signs – Heart rate , Blood pressure, Pulse rate, ECG Screening, Randomization, Week-4, Week-8, Week-12, Week-18, Week-24
Trial Locations
- Locations (1)
Ethika Clinical Research Centre
🇮🇳Thane, MAHARASHTRA, India
Ethika Clinical Research Centre🇮🇳Thane, MAHARASHTRA, IndiaDr Aparna WalanjPrincipal investigator022-25386760aparnaw@ethika.in