SurveillanceNCT01964950
Alogliptin Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Sulfonylurea
An observational study of Surveillance, run by Takeda at 1 site in Japan.
Trial summary
The purpose of this study is to examine the safety and efficacy of long-term combination therapy with alogliptin (Nesina) and sulfonylurea in participants with type 2 diabetes mellitus who responded inadequately to treatment with sulfonylurea in addition to diet therapy and exercise therapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Surveillance
- Type of treatment
- Pill or oral medicine
- How many people
- 1,101 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2011to Dec 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants with type 2 diabetes mellitus who have been examined at a medical institution
Who may be able to join
- Participants who did not adequately respond to the following treatment • Treatment with sulfonylurea in addition to diet therapy and exercise therapy
Who cannot join
- Participants with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus (these participants require prompt adjustment of hyperglycemia by fluid infusion and insulin, and hence use of Nesina is not appropriate).
- Participants with severe infection, pre- or post-operative participants, or participants with serious traumatic injury (blood glucose control by insulin injection is desirable for these participants, and hence use of Nesina is not appropriate).
- Participants with a history of hypersensitivity to any ingredient of Nesina.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nesina Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Sulfonylurea
The purpose of this study is to examine the safety and efficacy of long-term combination therapy with alogliptin (Nesina) and sulfonylurea in participants with type 2 diabetes mellitus who responded inadequately to treatment with sulfonylurea in addition to diet therapy and exercise therapy.
Read the detailed description
This is a special drug use surveillance on long-term use of alogliptin with a 1-year (12-month) observational period, designed to investigate the safety and efficacy of long-term combination therapy with alogliptin and sulfonylurea in participants with type 2 diabetes mellitus in a routine clinical setting.
Participants with type 2 diabetes mellitus who responded inadequately to treatment with sulfonylurea in addition to diet therapy and exercise therapy will be enrolled in this study. The planned sample size is 1,000.
The usual adult dosage for oral use is 1 alogliptin tablet (25 mg) once daily.
- Conditions
- Surveillance
- Keywords
- drug therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Alogliptin | All participants who received alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months along with Sulfonylurea (SU) or without SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting One or More Adverse Drug Reactions
Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. The safety analysis was planned to be assessed in alogliptin + SU and alogliptin + other arm separately.
Measured: Baseline up to 12 months
Number of Participants Reporting One or More Serious Adverse Drug Reaction
Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. SAE was 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; congenital anomaly. The safety analysis was planned to be assessed in alogliptin + SU and alogliptin + other arm separately.
Measured: Baseline up to 12 months
Secondary outcomes (4)
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
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 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of SU treatment.
Measured: Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)
Percentage of Participants Achieving Objective Glycemic Control
The rate of achieving objective glycemic control in HbA1c level was calculated at baseline and final visit (last visit for a participant in the study, up to Month 12). Glycemic control was measured as <8.0%, <7.0%, and <6.0% of glycosylated hemoglobin. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of SU treatment.
Measured: Baseline and final assessment (up to Month 12)
Change From Baseline in Fasting Blood Glucose
The change between the fasting blood glucose value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of the SU treatment.
Measured: Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)
Change From Baseline in Fasting Insulin Level
The change between the fasting insulin value collected at 1 month, 3 months, 6 months, 12 months or final visit (last visit for a participant in the study, up to Month 12) relative to baseline. The efficacy analysis was planned to be assessed in the total alogliptin arm irrespective of SU treatment.
Measured: Months 1, 3, 6, 12, and final assessment (up to Month 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2013 (estimated)
- Study startJul 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SurveillanceStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Postmarketing Group Manager, Study chair, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01964950
- Sponsor's protocol ID
- 121-013
- Other IDs
- JapicCTI-132266, JapicCTI-R160882
- Status last verified
- Feb 2017
- First submitted
- 15 Oct 2013
- Last updated
- 13 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nesina Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Sulfonylurea
- ClinicalTrials.gov ID
- NCT01964950
- Acronym / sponsor ID
- 121-013
- Conditions
- Surveillance
- Keywords
- drug therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,101 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 17 Oct 2013 (estimated)
- Results
- Posted 13 Apr 2017
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 examine the safety and efficacy of long-term combination therapy with alogliptin (Nesina) and sulfonylurea in participants with type 2 diabetes mellitus who responded inadequately to treatment with sulfonylurea in addition to diet therapy and exercise therapy.
Detailed description
This is a special drug use surveillance on long-term use of alogliptin with a 1-year (12-month) observational period, designed to investigate the safety and efficacy of long-term combination therapy with alogliptin and sulfonylurea in participants with type 2 diabetes mellitus in a routine clinical setting.
Participants with type 2 diabetes mellitus who responded inadequately to treatment with sulfonylurea in addition to diet therapy and exercise therapy will be enrolled in this study. The planned sample size is 1,000.
The usual adult dosage for oral use is 1 alogliptin tablet (25 mg) once daily.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alogliptin | – | –All participants who received alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months along with Sulfonylurea (SU) or without SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with type 2 diabetes mellitus who have been examined at a medical institution
Key inclusion criteria (1 listed)
- Participants who did not adequately respond to the following treatment • Treatment with sulfonylurea in addition to diet therapy and exercise therapy
Key exclusion criteria (3 listed)
- Participants with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus (these participants require prompt adjustment of hyperglycemia by fluid infusion and insulin, and hence use of Nesina is not appropriate).
- Participants with severe infection, pre- or post-operative participants, or participants with serious traumatic injury (blood glucose control by insulin injection is desirable for these participants, and hence use of Nesina is not appropriate).
- Participants with a history of hypersensitivity to any ingredient of Nesina.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants Reporting One or More Adverse Drug Reactions
Time frame: Baseline up to 12 months
Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. The safety analysis was planned to be assessed in alogliptin + SU and alogliptin + other arm separately.
Number of Participants Reporting One or More Serious Adverse Drug Reaction
Time frame: Baseline up to 12 months
Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. SAE was 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; congenital anomaly. The safety analysis was planned to be assessed in alogliptin + SU and alogliptin + other arm separately.
4 secondary outcomes
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Time frame: Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)
Percentage of Participants Achieving Objective Glycemic Control
Time frame: Baseline and final assessment (up to Month 12)
Change From Baseline in Fasting Blood Glucose
Time frame: Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)
Change From Baseline in Fasting Insulin Level
Time frame: Months 1, 3, 6, 12, and final assessment (up to Month 12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Postmarketing Group Manager study chair
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surveillance, run by Takeda at 1 site in Japan.
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: finished, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Reporting One or More Adverse Drug Reactions (time frame: Baseline up to 12 months). The study lists 2 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 13 Apr 2017; AzTrials last refreshed its copy on 7 Nov 2026.