To check the Efficacy and Safety of Gymne Mag D Capsules in patients with Type 2 Diabetes Mellitus
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2024/06/068889
- Lead Sponsor
- M/s Synthite Industries Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1 Adult male and non-pregnant females aged 18 to 65 years
2 Subjects with HbA1c value =7.5 and =10 percent both inclusive
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method