A two-arm, randomized, double-blinded, placebo-controlled, parallel study to evaluate the efficacy and safety of Beta Amyrin Palmitate in newly diagnosed patients of type 2 diabetes mellitus associated with dyslipidaemia. - NI

Sam Sabinsa Group Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年7月22日

试验速览

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•1.Participants should be willing to give a written informed consent.
•2.Participants should be willing to comply with the requirements of the trial/ study.
•3.Male and female participants aged between 25-65 years.
•4.Females with childbearing potential who agree to use a barrier method of contraception throughout the study period.
•5.Participants, newly diagnosed with Type 2 Diabetes (T2DM) and is drug naive with FBS between 126 to 210 mg/dL, PPBS between 200 to 300 mg/dL and HbA1c between 6.5 to 8.9 %.
•6.Lipid parameters:
•Total Cholesterol between 200 to 300 mg/dL,
•Triglyceride between 160 to 300 mg/dL and
•LDL between 120 to 200 mg/dL.
•7.Ability to swallow and retain oral medications as per the protocol.

•1. History of Smoking and Alcohol intake (within 3 months before screening)
•2. Type-1 Diabetes
•3. Presence of chronic gastrointestinal diseases, severe immune deficiencies, lactose intolerance.
•4. Use of any lipid lowering therapies in the past 3 months.
•5. Patients on antihypertensive medications.
•6. Patient with history of clinically significant thyroid disorder, gastrointestinal, cardiovascular, haematological, hepatic, renal, respiratory, active malignancies or genitourinary abnormalities or diseases.
•7. Patient who has participated in any clinical trial within the past 3 months.
•8. Pregnant and lactating women and those not willing to follow a reliable and effective contraceptive measure during the study.
•9. Any planned surgery during the study.
•10. A history of significant multiple and/or severe allergies or anaphylactic reactions.
•11. Patient with known history of hypersensitivity to the investigational product.
•12. Participant who has participated in any clinical trial within the last 3 months.
•13. Any other condition that the Principal Investigator thinks may jeopardize the study.
•14. Any other reason(s) as per principal investigator discretion.

发起方

Sam Sabinsa Group Limited