An Open Label, Prospective, Non-Randomised, Non-Comparative Observational Clinical Study of Tenefit 20 Teneligliptin 20mg Tablets of Systopic Laboratories Pvt. Ltd. in Adults with Diabetes Mellitus Type II, Inadequately Controlled with only OHA as a Real World Clinical Practice - NIL

Systopic Laboratories Private Limited,0 个研究点目标入组 550 人开始时间: 2026年7月30日最近更新: 2026年8月3日

试验速览

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•Subjects aged between 30 to 65 years, all genders with known history of diabetes mellitus type II, Inadequately controlled by OHA.
•i. HbA1C Levels greater than or equal to 7 percentage
•ii. Fasting Blood Glucose greater than or equal to 126 mg per dL or Post Prandial Glucose greater than or equal to 200 mg per dL
•Subjects who are routinely being treated with Tenefit 20 Teneligliptin 20 mg Tablets of Systopic Laboratories Pvt. Ltd. with and without the combination of other Oral Hypoglycemic agents only.
•Subjects with inadequate control of blood glucose levels despite lifestyle changes not limited to diet and exercise modifications.
•Subjects who are willing to abstain from the use of herbal, allopathic or other nutritional supplements that are indicated at reducing blood sugar levels.
•Subjects who have no other complications associated with diabetes mellitus type II.
•Subjects who are willing to give informed consent for observation in real world setting, able to comprehend and understand the responsibilities during screening and treatment period.
•Subjects who consent to use of their routine laboratory tests not limited to HbA1C, FBG, PPG etc for scientific analysis and reporting.
•Subjects who are willing not to participate in any other clinical trial during participation in the current trial.

•Subjects who are on insulin therapy for management of diabetes mellitus type II.
•Subjects with known hypersensitivity to the ingredients of the investigational product.
•Subjects who are on herbal, AYUSH or home remedies for the management of diabetes mellitus not limited to nutraceutical supplements.
•Subjects on remission from cancer of any type less than 5 years at the time of screening.
•Subjects who are planning a pregnancy and or or currently breastfeeding.
•Subjects who have participated in a clinical study less than 1 month before screening.
•Any significant medical condition e.g., significant psychiatric or neurological disorders, active alcohol or drug abuse, etc., any medical condition that is unstable or poorly controlled or other factor e.g., planned relocation that the Investigator felt would interfere with study evaluations and study participation.
•Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
•Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study.

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