Clinical study of Alogliptin in Patients With Type 2 Diabetes Mellitus

Phase 4

Conditions: Health Condition 1: null- Type 2 Diabetes Mellitus

Registration Number: CTRI/2017/04/008410

Lead Sponsor: Takeda Pharmaceuticals India Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 300

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- 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.

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) <br/ ><br> <br/ ><br>Percentage of Participants with Adverse Drug Reactions (ADRs) and Unexpected ADRs <br/ ><br>Change from Baseline in Glycosylated Haemoglobin (HbA1c) <br/ ><br>Percentage of Participants with Glycosylated Hemoglobin 7.0%Timepoint: week 0 <br/ ><br>week 13 <br/ ><br>week 26 <br/ ><br>week 30

Secondary Outcome Measures