Alogliptin Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Biguanides

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01964976
First received: October 15, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted

October 15, 2013
October 15, 2013
July 2011
December 2014   (final data collection date for primary outcome measure)
  • Frequency of Adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    The frequency of adverse events by type, seriousness, time to onset, etc. Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug to the last dose of study drug.
  • Change from Baselin in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline and month 12 ] [ Designated as safety issue: No ]
    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 month 12 relative to baseline.
Same as current
No Changes Posted
Change from Baselin in Fasting blood glucose [ Time Frame: Baseline and month 12 ] [ Designated as safety issue: No ]
The change in the value of fasting blood glucose collected at month 12 relative to baseline.
Same as current
Not Provided
Not Provided
 
Alogliptin Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Biguanides
Nesina Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Biguanides

To examine the safety and efficacy of long-term combination therapy with alogliptin (Nesina) and biguanides in patients with type 2 diabetes mellitus who responded inadequately to treatment with biguanides in addition to diet therapy and exercise therapy.

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 patients with type 2 diabetes mellitus in the routine clinical setting.

Participants will be patients with type 2 diabetes mellitus who responded inadequately to treatment with biguanides in addition to diet therapy and exercise therapy. The planned sample size is 1,000.

The usual adult dosage for oral use is 1 alogliptin tablet (25 mg) once daily.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients with type 2 diabetes mellitus who have been examined at a medical institution

Surveillance
Drug: Alogliptin
Alogliptin tablets
Other Names:
  • Nesina
  • SYR-322
Aloglipin
Aloglipin 25 mg, tablets, orally, once daily for up to 12 months
Intervention: Drug: Alogliptin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1000
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who did not adequately respond to the following treatment • Treatment with biguanides in addition to diet therapy and exercise therapy

Exclusion Criteria:

  • Patients contraindicated for Nesina

    1. Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus [these patients require prompt adjustment of hyperglycemia by fluid infusion and insulin, and hence use of Nesina is not appropriate.]
    2. Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury [blood glucose control by insulin injection is desirable for these patients, and hence use of Nesina is not appropriate.]
    3. Patients with a history of hypersensitivity to any ingredient of Nesina
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01964976
121-014, JapicCTI-132282
No
Takeda
Takeda
Not Provided
Study Chair: Postmarketing Group Manager Takeda
Takeda
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP