A Prospective, Multi-center, Open-label, Phase IV Study to Evaluate the Safety and Efficacy of Alogliptin as Monotherapy or Add on Therapy in Indian Patients With Type 2 Diabetes Mellitus

Takeda Pharmaceuticals India Pvt Ltd0 个研究点目标入组 300 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. In the opinion of the Investigator, the subject is capable of understanding and complying with protocol requirements.
•2. Male and female patients, >=18 years, who in Investigatorâ??s opinion are eligible to receive
•alogliptin as per locally approved prescribing information along with standard care for
•management of T2DM;
•3. Patients with T2DM who are DPP-4 inhibitor- naÃ¯ve; including alogliptin.
•4. Patients willing to give written informed consent to participate in the study and also
•willing to give consent for audio-video recording of the entire informed consent process.
•5. A female subject of childbearing potential who is sexually active with a nonsterilized
•male partner agrees to use routinely adequate contraception from signing of informed
•consent throughout the duration of the study.

•1. Contraindication or limitation for administration of alogliptin tablets according to the approved label/Prescribing Information;
•2. Patients treated with alogliptin tablets outside the approved label/ prescribing information.
•3. The subject with end-stage renal disease (ESRD) (Creatinine Clearance (CrCl) <15
•mL/min or requiring hemodialysis).
•4. The subject has received any investigational compound within 30 days prior to the first
•dose of study medication.
•5. The subject is an immediate family member or is in a dependant relationship with a study
•site employee who is involved in conduct of this study (e.g., spouse, parent, child, sibling) or may consent under duress.
•6. If female, the subject is pregnant or lactating or intending to become pregnant before, during, or within 30 days after last dose of study medication; or intending to donate ova during such time period.

发起方

Takeda Pharmaceuticals India Pvt Ltd