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: July 30, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Surveillance
Drug: Alogliptin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nesina Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Biguanides

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 1096
Study Start Date: July 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Aloglipin
Aloglipin 25 mg, tablets, orally, once daily for up to 12 months
Drug: Alogliptin
Alogliptin tablets
Other Names:
  • Nesina
  • SYR-322

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 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01964976

Locations
Japan
Tokyo, Japan
Sponsors and Collaborators
Takeda
Investigators
Study Chair: Postmarketing Group Manager Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01964976     History of Changes
Other Study ID Numbers: 121-014, JapicCTI-132282
Study First Received: October 15, 2013
Last Updated: July 30, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Alogliptin
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on October 22, 2014