Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Gymne- Mag D Capsules with Standard of Care(SOC): Patient will be asked to consume 1 capsule twice daily in the morning after breakfast and after dinner for total of 12 weeks along with
Sponsors
M/s Synthite Industries Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Adult male and non-pregnant females aged 18 to 65 years 2 Subjects with HbA1c value >=7.5 and 3 Able to comply with all required study procedures and schedule 4 Willing and able to give written informed consent. 5 BMI less than 35.0 kg/m2 6 Subjects with insufficiently controlled Type 2 Diabetes Mellitus (T2DM) who are inadequately controlled on Metformin Monotherapy greater than or equal to 1000 mg per day for at least 3 months and having inadequate glycemic control 7 Women of childbearing potential who comply to use an adequate method of contraception to avoid pregnancy throughout the study & who have a negative urine pregnancy test
Exclusion criteria
Exclusion criteria: 1 Patient who has Type 1 diabetes mellitus or other forms of diabetes 2 Pregnancy or lactation 3 Patient who has participated in a clinical study within the last 30 days prior to entering this study 4 Subjects with hypersensitivity to any of the ingredients of the study products 5 Subjects with a history of acute or chronic illness 6 Subjects with history of hypothyroidism and hyperthyroidism 7 Subjects with history hyperlipidemia, history of severe hepatic dysfunction or renal dysfunction, uncontrolled pulmonary dysfunction, and poorly controlled hypertension. 8 Chronic chewers of tobacco and usage of drugs which exerts intoxication 9 History of unstable or rapidly progressing renal disease 10 Macroalbuminuria defined as albumin creatinine ratio of greater than 500mg per gm 11 Subjects on diuretics will only be excluded when these drugs cannot be stopped for the duration of the study 12 Volume depleted subjects at risk for volume depletion due to coexisting conditions or concomitant medications such as loop diuretics should have careful monitoring of their volume status 13 Chronic use of non steroidal anti-inflammatory drugs (NSAIDs) will not be allowed unless used as incidental medication (1to2 tablets) for nonchronic indications (sports injury headache or back ache) 14 Current urinary tract infection confirmed by the subjects medical history and active nephritis 15 Recent (less than 6 months) history of cardiovascular disease including Acute coronary syndrome Chronic heart failure (New York Heart Association grade IIIV) Stroke or transient ischemic neurologic disorder 16 Complaints compatible with neurogenic bladder and or incomplete bladder emptying (as determined by ultrasonic bladder scan) 17 (Unstable) thyroid disease; defined as free thyroxine (fT4) outside of laboratory reference values or change in treatment within 3 months prior to screening visit 18 History of or actual malignancy (except basal cell carcinoma) Active cancer personal history of cancer within 5 years History of or actual severe mental disease (Have any other condition including drug or alcohol abuse or psychiatric disorder including dementia that precludes the participant from following and completing the protocol as per judgement of the investigator) Substance abuse (alcohol defined as greater than 4 units per day) 19 Allergy to any of the agents used in the study 20 Individuals who are investigator site personnel Impartial witness directly affiliated with the study or are immediate (spouse parent child or sibling whether biological or legally adopted) family of investigator site personnel directly affiliated with the study 21 Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period 22 History of diabetic ketoacidosis or hyperosmolar nonketotic coma confirmed by the subjects medical history 23 Severe uncontrolled hypertension defined as SBP greater than or equal to150 mmHg and or Diastolic Blood Pressure (DBP) greater than or equal to 100 mmHg 24 Subjects with known history of HIV1 HIV2 Hepatitis B or C infection or syphilis infection 25 Inability to understand the study protocol or give informed Consent confirmed by the subject during consultation with the investigator 26 If participated i
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the improvement in HbA1c levelsTimepoint: from Baseline to Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Adjusted Mean Change in Fasting Plasma Glucose (FPG) 2 Mean change in fasting plasma glucose 3 Mean change in 2-hr post prandial plasma glucose 4 Proportion of patients achieving a therapeutic glycaemic response defined as HbA1c â?¤ 7.5% 5 Quality of life subject based questionnaires will be measured by increase in score 6 Sugar Craving subject-based questionnaires will be measured by decrease in scoreTimepoint: 1 from Baseline to Week 12 2 from baseline to end of the Visit(Week 12) 3 from baseline to end of the treatment visit (12 Weeks) 4 from baseline to end of the Visit(Week 12) 5 from Baseline visit to End of study 6 from Baseline visit to End of study | — |
Countries
India
Contacts
Public ContactMr Chandu Devanpally
Ardent Clinical Research Services
Outcome results
None listed