A randomized, double-blind, comparative, multicentric, clinical study to evaluate the safety and efficacy of Glucotas Capsules in patients with Prediabetic and Type 2 Diabetes Mellitus.
- Conditions
- Other specified diabetes mellituswithout complications, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,
- Registration Number
- CTRI/2023/09/057720
- Lead Sponsor
- Zoom Technologies Inc
- Brief Summary
The proposed study is a randomized, double-blind, comparative, multicentric clinical trial to evaluate the safety and efficacy of GLUCOTAS Capsule in Patients with Prediabetes and Type 2 Diabetes Mellitus. The study is proposed to be conducted at multiple sites across India to recruit 200 number of patients to meet the objective of the study. Primary outcome of this study is to evaluate percentage (%) change of mean HbA1c at the end of 90 days from baseline and secondary outcome of this study is to evaluate percentage (%) change of mean FBG and 2-hour PPBG levels from baseline to end of the treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
- All patients with duly filled in ICFs [Informed Consent Forms] 2.
- Treatment naive Type 2 Diabetes or Type 2 Diabetes on monotherapy 3.
- Hba1c level should be ≥ 5.7 and ≤ 7 4.
- BMI should be ≥ 25 kg/m2 and ≤ 45 kg/m2 5.
- Absence of any oral antidiabetic drug or any injectable antidiabetic therapy.
- WOCBP (Women of Childbearing Potential) must be willing to use double barrier contraception for the entire study duration.
- Patients full filling all inclusion criteria and none of exclusion criteria will be enrolled.
- Historyof Type-1 diabetes mellitus orhistoryof ketoacidosis.
- Patients already on Insulin therapy.
- Patients already on oral anti-diabetic drug therapy.
- History of coronary angioplasty, coronary stent placement, coronary bypass surgery, myocardial infarction, stroke or transient ischemic attack in the previous 3 months.
- Pregnancy or lactating women.
- Patients known or thought to be hypersensitivity to the investigational products.
- Any medication or indication that might point to an increased risk, associated with study participation or Investigational Product administration or may interfere with the interpretation of study results and, in the judgment of the study personnel, would make the subject inappropriate for inclusion.
- Participation in other clinical trials in the last three months and during study participation.
- Patients with severe renal impairment, including those receiving dialysis.
- Patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function.
- Patient not willing to fill Informed consent form.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •Percentage (%) change of mean HbA1c at the end of 90 days from base line. 90 days •Percentage (%) change of mean Weight at the end of 90 days from base line 90 days •Number of & Nature of adverse events arising out of treatment of patients with the medication & their causal relationship to study medication. 90 days •Subjects will also be questioned about the occurrence of anticipated side effects of both treatment arm. 90 days •Any significant changes in laboratory values of subjects compared to their baseline values. 90 days
- Secondary Outcome Measures
Name Time Method Percentage (%) change of mean FBG & 2-hour PPBG levels from baseline to the end of treatment. 90 days
Trial Locations
- Locations (4)
Aatman Hospital
🇮🇳Ahmadabad, GUJARAT, India
Hi-Tech Medical College and Hospital
🇮🇳Khordha, ORISSA, India
Jeevan Rekha Hospital
🇮🇳Belgaum, KARNATAKA, India
Kanungo Institute of Diabetes Specialities
🇮🇳Khordha, ORISSA, India
Aatman Hospital🇮🇳Ahmadabad, GUJARAT, IndiaDr Chintan PatelPrincipal investigator7381264432drchintanpatel8@gmail.com