Health Condition 1: null- Type 2 Diabetes Mellitus
Conditions
Interventions
Intervention1: Alogliptin tablets 25 mg/12.5 mg/6.5 mg: Alogliptin tablets 25 mg/12.5 mg/6.5 mg, tablets, orally, once, daily for 26 weeks in addition to standard care for the management of Type 2 Dia
Sponsors
Takeda Pharmaceuticals India Pvt Ltd
SIRO Clinpharm Pvt Ltd
Eligibility
Inclusion 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
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) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Percentage of Participants with Adverse Drug Reactions (ADRs) and Unexpected ADRs Change from Baseline in Glycosylated Haemoglobin (HbA1c) Percentage of Participants with Glycosylated Hemoglobin 7.0%Timepoint: week 0 week 13 week 26 week 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
India
Contacts
Public ContactDr Prashant Agrawal
Takeda Pharmaceuticals India Pvt. Ltd.
Outcome results
None listed