Diabetes Mellitus, Type 2Phase 4NCT03042325
Safety and Efficacy of Alogliptin in Indian Participants With Type 2 Diabetes Mellitus
A Phase 4 study testing Alogliptin in people with Diabetes Mellitus, Type 2, run by Takeda.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Alogliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2017to 15 Jan 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Participants with T2DM who are dipeptidyl peptidase-4 (DPP-4) inhibitor-naive; including alogliptin.
Who cannot join
- Has contraindication or limitation for administration of alogliptin tablets according to the approved label/Prescribing Information.
- Participants treated with alogliptin tablets outside the approved label/ prescribing information.
- Has end-stage renal disease (ESRD) (Creatinine Clearance (CrCl) <15 mL/min or requiring hemodialysis).
About this study
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
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).
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Alogliptin
- Keywords
- Drug therapy
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlogliptinDrug
Also called SYR-322, Nesina
Alogliptin tablets
| Study group | Role | What they receive |
|---|---|---|
| Alogliptin | Experimental | 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]. Receives: Drug: Alogliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline and Weeks 13 and 26
Percentage of Participants with Glycosylated Hemoglobin < 7.0%
Clinical response at Weeks 13 and 26 will be assessed by the percentage of participants with HbA1c less than 7%.
Measured: Weeks 13 and 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start30 Jul 2017 (estimated)
- Primary completion15 Jan 2018 (estimated)
- Study completion15 Jan 2018 (estimated)
Why it stopped: Business decision, no safety or efficacy concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042325
- Sponsor's protocol ID
- SYR-322-4001
- Other IDs
- U1111-1174-1852
- Status last verified
- Oct 2017
- First submitted
- 1 Feb 2017
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03042325
- Acronym / sponsor ID
- SYR-322-4001
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Drug therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision, no safety or efficacy concerns
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2017 (estimated)
- Primary completion
- 15 Jan 2018 (estimated)
- Study completion
- 15 Jan 2018 (estimated)
- First posted
- 3 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alogliptin | Experimental | Drug: AlogliptinAlogliptin 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]. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Participants with T2DM who are dipeptidyl peptidase-4 (DPP-4) inhibitor-naive; including alogliptin.
Key exclusion criteria (3 listed)
- Has contraindication or limitation for administration of alogliptin tablets according to the approved label/Prescribing Information.
- Participants treated with alogliptin tablets outside the approved label/ prescribing information.
- Has end-stage renal disease (ESRD) (Creatinine Clearance (CrCl) <15 mL/min or requiring hemodialysis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlogliptinAlso: SYR-322, NesinaAlogliptin tablets | Drug | Alogliptin |
Primary outcome
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.
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.
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.
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%.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director Clinical Science study director
Takeda
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alogliptin in people with Diabetes Mellitus, Type 2, run by Takeda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2017.