CTRI/2017/04/008410
Not yet recruiting
Phase 4
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 sites300 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Type 2 Diabetes Mellitus
- Sponsor
- Takeda Pharmaceuticals India Pvt Ltd
- Enrollment
- 300
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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\- naïve; 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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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