Clinical trial NCT01964976: Alogliptin Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Biguanides
Official title: Nesina Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Biguanides
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surveillance
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2013-10-17
Enrollment: 1096
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: To examine the safety and efficacy of long-term combination therapy with alogliptin (Nesina) and biguanides in participants with type 2 diabetes mellitus who responded inadequately to treatment with biguanides 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 biguanides in participants with type 2 diabetes mellitus in the routine clinical setting.

Participants diagnosed with type 2 diabetes mellitus who responded inadequately to treatment with biguanides in addition to diet therapy and exercise therapy will be enrolled. 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 biguanides in addition to diet therapy and exercise therapy

Exclusion Criteria:

* Participants contraindicated for Nesina

  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 patients, or patients 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 Reactions
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 of 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: Baseline, 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: