A study to evaluate the efficacy and safety of Magnesium and Vitamin D supplement as an additional therapy to anti diabetic drugs in Type 2 Diabetic Patients.

Phase 2/3

Not yet recruiting

Conditions: Type 2 diabetes mellitus without complications,

Registration Number: CTRI/2023/03/050877

Lead Sponsor: Pharmed Limited

Brief Summary: A total of 100 evaluable subjects are plannedto enrol in this study, i.e., 50 subjects each treatment group. Recruitment andtreatment of subjects is expected to be performed in 2 study centers. Each patient will receive 90 days of treatment. The treatment assignment will be as follows: **Placebo Group (Arm 1, n = 50)****:** Placebo intervention (1510-1560 mg) + Standard antidiabetic drug(s), **Study Group****(Arm 2, n = 50):** Mg (250 mg) + Vit-D (600IU) supplement (1510-1560 mg) + Standard antidiabetic drug(s)

Change in the dose ofOHA(s) over a period of three months [from baseline (Visit 2, day 3) to the endof the study (Visit 4, day 90)]. The mean change from baseline in the dose ofOHA(s) at the end of the study will be estimated. FBS and PPBS levels will be estimatedto assess the effect of Mg + Vit-D supplement~~s~~ on the serum glucoselevels of the participants over the study periods. Themean percent change in glycosylated haemoglobin (HbA1c) over a period of threemonths [from baseline (Visit 2, day 3) to the end of the study (Visit 4, day90)]. The mean change from baseline in HbA1c% at the end of the study will beestimated. Themean change in serum insulin levels over a period of three months [frombaseline (Visit 2, day 3) to the end of the study (Visit 4, day 90)]. Themean change in Homeostasis Model Assessment-insulin Resistance (HOMA-IR) frombaseline to the end of the study (day 90). Changein the SF-36 (RAND) Health Survey scores, which measure eight multi-itemdimensions of health from baseline to the end of the study (day 90). Changein the Diabetes Symptoms Checklist (DSC) score from baseline to the end of thestudy (day 90). Changefrom baseline to the end of the study in waist circumference, body weight, andBody Mass Index (BMI). An estimated mean change from baseline to the end of thestudy in waist circumference, body weight, and BMI will be evaluated. Changein serum levels of Mg and Vit-D from baseline to the end of the study. Assessmentof the number of treatment-emergent adverse events (AEs) during theon-treatment observation period (from baseline to the end of the study). Mg+ Vit-D or matching placebo tablets will be administered orally once dailyafter breakfast for 90 days (3 months).

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

Participants of either sex aged between 18 to 70 years.
Participants diagnosed with type 2 diabetes having HbA1c>6.5% who are on any antidiabetic drugs (mono or poly OHA) 3.
Willing to participate and able to provide signed informed consent.
Having BMI between 23 to 40 kg/m2.

Exclusion Criteria

Type 1 diabetes or T2DM subject on insulin treatment/and any other supplement for glucose control.
2.Subjects those who in addition to OHA (single or poly, take any herbal/Ayurvedic or home remedies as add on to their OHA.
Subjects suffering from complications of diabetes such as diabetic neuropathy, nephropathy, retinopathy, etc.
that require urgent treatment.
Subjects with uncontrolled hypertension (with or without medication >140/90 mmHg after 5 min of rest).
Subjects with an established diagnosis of coronary artery disease (CAD) requiring any medical procedure in the next 6 months, such as angioplasty or bypass surgery; or subjects with New York Heart Association (NYHA) classification III and IV, cardiac insufficiency, or any other clinically significant cardiovascular disease.
Subjects with concurrent hepatic dysfunction (defined as AST and/or ALT > 2 times the upper limit of normal) or renal dysfunction (defined as S.
creatinine > greater than the upper limit of normal), uncontrolled pulmonary dysfunction (asthmatics and COPD patients).
Pregnant/lactating women and women of childbearing potential who do not agree to remain abstinent or use appropriate contraception during the treatment period and for 4 weeks after the end of study treatment.
Subjects already taking Mg or Vit-D supplements since preceding one month.
Subjects who have a recent or currently known history of alcohol or drug abuse.
Subjects with a current or past history of malignancy (any history of malignancy in the past five years).
Subjects suffering from major systemic diseases requiring long-term pharmacological treatment (e.g., rheumatoid arthritis, psychological, neurological, endocrine disorders, etc.).
Subjects who have completed their participation in any other clinical trial within the last three months.
Any other condition that the investigator believes may jeopardize the results of the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
a. Change in the dose of OHA(s) over a period of three months. Mean change from baseline in the dose of OHA(s) at the end of the study will be estimated.	Day 3 to Day 90
b. Mean percent change from baseline in Fasting and Postprandial plasma glucose levels at the end of the study. Fasting and Postprandial plasma glucose levels will be estimated to assess the effect of Mg + Vit-D supplements on the serum glucose levels of the participants over study periods.	Day 3 to Day 90

Secondary Outcome Measures

Name	Time	Method
a. Mean percent change in Glycosylated Hemoglobin (HbA1c) over a period of three months. Mean change from baseline in HbA1c % at the end of the study will be estimated.	b. Mean change in serum insulin levels over a period of three months.

Trial Locations

Locations (2): Care Multispeciality Hospital
🇮🇳
Pune, MAHARASHTRA, India
Pranav Diabetes Center
🇮🇳
Bangalore, KARNATAKA, India
Care Multispeciality Hospital
🇮🇳Pune, MAHARASHTRA, India
Dr Dilip Kadam
Principal investigator
7066115411
dr.dilipkadam12@gmail.com