Study to evaluate Efficacy and Safety of PreCrea® on subjects with higher than normal blood sugar levels.
- Conditions
- Health Condition 1: null- patients wih higher than normal blood sugar level
- Registration Number
- CTRI/2014/09/005016
- Lead Sponsor
- Preemptive Meds Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 210
•Age >= 18 years to <= 65 years
•Newly diagnosed Male or Female participants with higher than normal blood sugar levels i.e. Fasting Plasma Glucose of >100 mg/dl as defined by ADA expert committee on the diagnosis and classification of Pre-Diabetes and Diabetes Mellitus during screening and not on any treatment
•Participants who are on Metformin 500 mg twice a day (1000 mg per day) treatment with lifestyle modification programme for atleast 03 months and have HbA1c >7.5 %
•Ability to understand and willingness to sign and date a written Informed Consent Document at the screening visit before any protocol- specific procedures are performed and willing to adhere to the protocol and entire trial procedures
Subjects with Type 1 Diabetes Mellitus
•Participants on insulin therapy and other oral anti-diabetic agents or having uncontrolled diabetes.
•Stroke, myocardial infarction, coronary artery bypass graft (CABG) percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris within the last 12 months.
•Cardiac status New York Heart Association class III-IV
•Uncontrolled blood pressure 150 mmhg systolic and 100 mmhg diastolic
•Impaired renal function as shown by but not limited to serum creatinine >= 1.5 mg/dl for males and >= 1.4 mg/dl for female
•Clinically significant peripheral edema
•Clinical evidence of active liver disease or serum alenine aminotransferase (ALT) or aspartate amino transferase (AST) 2.5 times the upper limit of the normal range (2.5 X ULN)
•Participants on steroid
•Pregnancy or lactating women
•Known hypersensitivity to any of the study drugs
•Any malignancy within the last 5 years, with exception of adequately treated basal or squamous cell carcinoma of the skin or adequately treated carcinoma insitu.
•Current addiction or current alcohol abuse or history of substance or alcohol abuse within the last 2 years
•Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
•Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study. Subject unlikely to comply with protocol e.g. uncooperative attitude, inability to return for follow up visits and unlikelihood completing of the study.
•Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with the completion of the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the Efficacy and Safety of PreCrea® by <br/ ><br>�Measuring reduction % changes of HbA1c from baseline to the end of supplementation after 03 months and, <br/ ><br>�Evaluating safety and tolerability by measuring changes in baseline renal function and liver function tests <br/ ><br>Timepoint: 03 months
- Secondary Outcome Measures
Name Time Method â?¢Percentage of Subjects achieving HbA1c 7.0 % <br/ ><br> <br/ ><br>â?¢To assess reduction % changes of fasting plasma glucose (FPG) from baseline to at the end of supplementation after 03 months. <br/ ><br> <br/ ><br>â?¢To assess % changes in Serum Triglyceride (TG) from baseline to at the end of supplementation after 03 months <br/ ><br>Timepoint: 03 months