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
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 300
- Locations
- 18
- Primary Endpoint
- Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Study Overview
Brief Summary
This is a 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
The drug being tested in this study is called alogliptin. Alogliptin is being tested to treat people who have Type 2 Diabetes Mellitus (T2DM). This study will look at side effects and glycemic control in people who take alogliptin in addition to standard care.
The study will enroll approximately 300 patients. All participants will receive alogliptin tablets at a dose determined based on the creatinine clearance. The recommended dose of alogliptin is 25 mg once daily with normal or mildly impaired renal function (creatinine clearance [CrCl] ≥60 mL/min), dose of 12.5 mg for participants with moderate renal impairment (CrCl ≥30 to <60 mL/min),
and 6.25 mg for participants severe renal impairment (CrCl ≥15 to <30 mL/ min). Participants with end-stage renal disease (ESRD) (CrCl <15 mL/min or requiring hemodialysis) will be excluded, in addition to standard care for the management of T2DM.
All participants will be asked to take one tablet every morning each day throughout the study.
This multi-center trial will be conducted in India. The overall time to participate in this study is up to 33 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone 30 days after last dose of study drug for a follow-up assessment.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •In the opinion of the Investigator, the subject is capable of understanding and complying with protocol requirements.
- •Male and female patients, ≥18 years, who in Investigator’s opinion are eligible to receive alogliptin as per locally approved prescribing information along with standard care for management of T2DM;
- •Patients with T2DM who are DPP-4 inhibitor- naïve; including alogliptin.
- •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.
- •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
- •Contraindication or limitation for administration of alogliptin tablets according to the approved label/Prescribing Information;
- •Patients treated with alogliptin tablets outside the approved label/ prescribing information.
- •The subject with end-stage renal disease (ESRD) (Creatinine Clearance (CrCl) <15 mL/min or requiring hemodialysis).
- •The subject has received any investigational compound within 30 days prior to the first dose of study medication.
- •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.
- •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
Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: week 0 | week 13 | week 26 | week 30
Percentage of Participants with Adverse Drug Reactions (ADRs) and Unexpected ADRs
Time Frame: week 0 | week 13 | week 26 | week 30
Change from Baseline in Glycosylated Haemoglobin (HbA1c)
Time Frame: week 0 | week 13 | week 26 | week 30
Percentage of Participants with Glycosylated Hemoglobin 7.0%
Time Frame: week 0 | week 13 | week 26 | week 30
Secondary Outcomes
- NA(NA)