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

NCT01945216 | Completed Results

• 3 other identifiers: 121-011JapicCTI-132250JapicCTI-R171018
• Study Type: observational
• Target: 3,317
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus Who Have Been Examined at a Medical Institution

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Experience at Least One Adverse Events

  Up to Month 36

• Change From Baseline in Glycosylated Hemoglobin (HbA1c)

  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.

  Baseline, Months 1, 3, 6, 12, 18, 24, 30, 36 and final assessment (up to Month 36)

Secondary Outcomes (1)

• Change From Baseline in Fasting Blood Glucose

  Baseline, Months 1, 3, 6, 12, 18, 24, 30, 36 and final assessment (up to Month 36)

Study Arms (1)

Alogliptin 25mg, tablets, orally, once daily, up to 36 months

Drug: Alogliptin

Interventions

Alogliptin DRUG

Alogliptin tablets

Also known as: Nesina; SYR-322

Alogliptin 25mg, tablets, orally, once daily, up to 36 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients with type 2 diabetes mellitus who have not adequately responded to any one of the following therapies:
• Diet therapy and exercise therapy alone
• In addition to diet therapy and exercise therapy, use of α-glucosidase inhibitor

You may not qualify if:

• Patients contraindicated for Nesina
• 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.)
• 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.)
• Patients with a history of hypersensitivity to any ingredient of Nesina

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Osaka, Japan

Location

MeSH Terms

Interventions

alogliptin

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2013
• First Posted: September 18, 2013
• Study Start: July 8, 2010
• Primary Completion: October 31, 2015
• Study Completion: October 31, 2015
• Last Updated: November 19, 2019
• Results First Posted: November 8, 2018

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)