Clinical trial NCT01964950: Alogliptin Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Sulfonylurea
Official title: Nesina Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Sulfonylurea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surveillance
Keywords: drug therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2013-10-17
Enrollment: 1101
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with type 2 diabetes mellitus who have been examined at a medical institution

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Participants who did not adequately respond to the following treatment • Treatment with sulfonylurea in addition to diet therapy and exercise therapy

Exclusion Criteria:

1. 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).
2. 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).
3. Participants with a history of hypersensitivity to any ingredient of Nesina.

Primary outcomes:
measure: Number of Participants Reporting One or More Adverse Drug Reactions
timeFrame: Baseline up to 12 months
measure: Number of Participants Reporting One or More Serious Adverse Drug Reaction
timeFrame: Baseline up to 12 months
Secondary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c)
timeFrame: Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)
measure: Percentage of Participants Achieving Objective Glycemic Control
timeFrame: Baseline and final assessment (up to Month 12)
measure: Change From Baseline in Fasting Blood Glucose
timeFrame: Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)
measure: Change From Baseline in Fasting Insulin Level
timeFrame: Months 1, 3, 6, 12, and final assessment (up to Month 12)
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Takeda
name: Postmarketing Group Manager
role: STUDY_CHAIR
References: