Clinical trial NCT03042325: Safety and Efficacy of Alogliptin in Indian Participants With Type 2 Diabetes Mellitus
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: Drug therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2017-02-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of alogliptin tablets when given as monotherapy or add on therapy in participants who are on standard care for management of Type 2 Diabetes Mellitus (T2DM).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Participants with T2DM who are dipeptidyl peptidase-4 (DPP-4) inhibitor-naive; including alogliptin.

Exclusion Criteria:

1. Has contraindication or limitation for administration of alogliptin tablets according to the approved label/Prescribing Information.
2. Participants treated with alogliptin tablets outside the approved label/ prescribing information.
3. Has end-stage renal disease (ESRD) (Creatinine Clearance (CrCl) \<15 mL/min or requiring hemodialysis).

Primary outcomes:
measure: Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 30 days after the last dose of study drug (up to 30 weeks)
measure: Percentage of Participants with Adverse Drug Reactions (ADRs) and Unexpected ADRs
timeFrame: Baseline up to 30 days after the last dose of study drug (up to 30 weeks)
measure: Change from Baseline in Glycosylated Haemoglobin (HbA1c) at Weeks 13 and 26
timeFrame: Baseline and Weeks 13 and 26
measure: Percentage of Participants with Glycosylated Hemoglobin < 7.0%
timeFrame: Weeks 13 and 26
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Medical Director Clinical Science
role: STUDY_DIRECTOR
References: