A clinical study of BGR 34, in patients with type 2 diabetes mellitus.
Phase 1
- Conditions
- Health Condition 1: null- Type 2 Diabetes Mellitus.
- Registration Number
- CTRI/2016/11/007476
- Lead Sponsor
- AIMIL PHARMACEUTICALS INDIA LIMITED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 64
Inclusion Criteria
Patients with type 2 Diabetes mellitus
Fasting blood glucose >126 mg/dL
Absence of any other significant disease or clinically significant medical history on physical examination during screening in the view of the investigator.
Subjects willing to provide written informed consent to participate in the study.
Exclusion Criteria
Patients on Insulin
Patients with acute infections or chronic debilitating diseases, tuberculosis, malignancy,
HIV infection etc.
Any life threatening serious disorder of the liver, kidneys, heart, lungs or other organs
Pregnancy and lactation
Patients diagnosed with severe end organ damage
Unwillingness to give written informed consent for participation in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment has been done on the basis of specially prepared performa for assessing blood sugar fasting and blood sugar post parandial blood sugar on days 0,30,60,90,120 and for HbA1c it is 0 and 120.Timepoint: Time point of days for blood sugar fasting and blood sugar post parandial blood sugar: 0,30,60,90,120 Time point of days for HbA1c: 0; 120 <br/ ><br>Time point of days for change in patient reported diabetes symptoms: polyuria, nocturia, polyphagia, polydispia, pain calf muscle, burning sensations of soles and palm, general fatigue, loss of weight, decreased libido, itching on genital, blurred vision delayed healing of wound and quality of life at: 0,30,60,90,120 days. <br/ ><br>
- Secondary Outcome Measures
Name Time Method Assessment was done on the basis of specially prepared performa for assessing relating parameters indicating safety and additional details.Timepoint: 120 days