Safety and Efficacy of Alogliptin in Indian Participants With Type 2 Diabetes Mellitus

October 18, 2017 updated by: Takeda

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 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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alogliptin
Alogliptin 25 mg, tablets, orally, once, daily for 26 weeks in addition to standard care for the management of Type 2 Diabetes Mellitus (T2DM). Dose will be adjusted as per creatinine clearance [CrCl].
Drug: Alogliptin
Alogliptin tablets
Other Names:
  • SYR-322
  • Nesina

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline up to 30 days after the last dose of study drug (up to 30 weeks)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.
Baseline up to 30 days after the last dose of study drug (up to 30 weeks)
Percentage of Participants with Adverse Drug Reactions (ADRs) and Unexpected ADRs
Time Frame: Baseline up to 30 days after the last dose of study drug (up to 30 weeks)
An ADR is any response to a medicinal product which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of diseases or for the restoration, correction or modification of physiological function. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility.
Baseline up to 30 days after the last dose of study drug (up to 30 weeks)
Change from Baseline in Glycosylated Haemoglobin (HbA1c) at Weeks 13 and 26
Time Frame: Baseline and Weeks 13 and 26
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at weeks 13 and 26 relative to Baseline.
Baseline and Weeks 13 and 26
Percentage of Participants with Glycosylated Hemoglobin < 7.0%
Time Frame: Weeks 13 and 26
Clinical response at Weeks 13 and 26 will be assessed by the percentage of participants with HbA1c less than 7%.
Weeks 13 and 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 30, 2017

Primary Completion (Anticipated)

January 15, 2018

Study Completion (Anticipated)

January 15, 2018

Study Registration Dates

First Submitted

February 1, 2017

First Submitted That Met QC Criteria

February 1, 2017

First Posted (Estimate)

February 3, 2017

Study Record Updates

Last Update Posted (Actual)

October 20, 2017

Last Update Submitted That Met QC Criteria

October 18, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYR-322-4001
  • U1111-1174-1852 (Registry Identifier: WHO)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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