Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Monotherapy/Combination Therapy With α-GI"

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01945216
First received: September 13, 2013
Last updated: July 29, 2014
Last verified: July 2014

September 13, 2013
July 29, 2014
July 2010
July 2015   (final data collection date for primary outcome measure)
  • Frequency of Adverse event [ Time Frame: 36 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 36 ] [ 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 36 relative to baseline.
Same as current
Complete list of historical versions of study NCT01945216 on ClinicalTrials.gov Archive Site
Change from Baselin in Fasting Blood Glucose [ Time Frame: Baseline and month 36 ] [ Designated as safety issue: No ]
The change in the value of fasting blood glucose collected at month 36 relative to baseline.
Same as current
Not Provided
Not Provided
 
Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Monotherapy/Combination Therapy With α-GI"
Nesina Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Monotherapy/Combination Therapy With α-GI"

The purpose of this study is to determine the safety and efficacy of long-term treatment with alogliptin (Nesina) in patients with type 2 diabetes mellitus who responded inadequately to diet therapy and exercise therapy alone, or a combination of diet therapy, exercise therapy, and α-glucosidase inhibitor.

In addition, examining the safety and efficacy of alogliptin in patients with renal impairment, information on the appropriate dosage of alogliptin according to the severity of impaired renal function should be collected.

A special drug use surveillance is planned to examine the safety and efficacy of long-term use of alogliptin in patients with type 2 diabetes mellitus under the daily clinical use conditions.

Participants of this surveillance will be patients with type 2 diabetes mellitus who failed to respond adequately to diet therapy and exercise therapy alone or to a combination of diet therapy, exercise therapy, and α-glucosidase inhibitor. The planned sample size is 3,000 subjects.

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

Patients With Type 2 Diabetes Mellitus Who Have Been Examined at a Medical Institution
Drug: Alogliptin
Alogliptin tablets
Other Name: Nesina; SYR-322
Aloglipin 25mg, tablets, orally, once daily, up to 36 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
3317
July 2015
July 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with type 2 diabetes mellitus who have not adequately responded to any one of the following therapies:

    1. Diet therapy and exercise therapy alone
    2. In addition to diet therapy and exercise therapy, use of α-glucosidase inhibitor

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
 
NCT01945216
121-011, JapicCTI-132250
No
Takeda
Takeda
Not Provided
Study Chair: Postmarketing Group Manager Takeda
Takeda
July 2014

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