CTRI/2023/09/057720
Completed
Phase 3
A randomized, double-blind, comparative, multicentric clinical study to evaluate the safety and efficacy of GLUCOTAS Capsule in patients with prediabetes and Type 2 Diabetes Mellitus. - NI
Zoom Technologies Inc0 sites217 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: E139- Other specified diabetes mellituswithout complicationsHealth Condition 2: E119- Type 2 diabetes mellitus without complications
- Sponsor
- Zoom Technologies Inc
- Enrollment
- 217
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. 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.
- •6\. WOCBP (Women of Childbearing Potential) must be willing to use double barrier contraception for the entire study duration.
- •7\. Patients full filling all inclusion criteria and none of exclusion criteria will be enrolled.
Exclusion Criteria
- •1\. Historyof Type\-1 diabetes mellitus orhistoryof ketoacidosis.
- •2\. Patients already on Insulin therapy.
- •3\. Patients already on oral anti\-diabetic drug therapy.
- •4\. NYHF (New York Heart Association) Class III–IV heart failure.
- •5\. History of coronary angioplasty, coronary stent placement, coronary bypass surgery, myocardial infarction, stroke or transient ischemic attack in the previous 3 months.
- •6\. Pregnancy or lactating women.
- •7\. Patients known or thought to be hypersensitivity to the investigational products.
- •8\. 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.
- •9\. Participation in other clinical trials in the last three months and during study participation.
- •10\. Patients with severe renal impairment, including those receiving dialysis.
Outcomes
Primary Outcomes
Not specified
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