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

NCT01964976 | Completed Results

• 3 other identifiers: 121-014JapicCTI-132282JapicCTI-R150790
• Study Type: observational
• Target: 1,096
• Locations: 1 country
• Sites: 1

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.

Conditions

Surveillance

Outcome Measures

Primary Outcomes (2)

• Number of Participants Reporting One or More Adverse Drug Reactions

  Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. The safety analysis was planned to be assessed in alogliptin + biguanides and alogliptin + other arm separately.

  Baseline up to 12 months

• Number of Participants Reporting One or More Serious Adverse Drug Reactions

  Serious adverse drug reactions are defined as serious adverse events (SAEs) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The safety analysis was planned to be assessed in alogliptin + biguanides and alogliptin + other arm separately.

  Baseline up to 12 months

Secondary Outcomes (4)

• Change From Baseline in Glycosylated Hemoglobin (HbA1c)

  Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)

• Percentage of Participants of Achieving Objective Glycemic Control

  Baseline and final assessment (up to Month 12)

• Change From Baseline in Fasting Blood Glucose

  Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)

• Change From Baseline in Fasting Insulin Level

  Baseline, Months 1, 3, 6, 12, and final assessment (up to Month 12)

Study Arms (1)

Alogliptin + Biguanides

All participants who received alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months along with biguanide or without biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.

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

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

You may qualify if:

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

You may not qualify if:

• Participants contraindicated for Nesina
• Participants with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus \[these participants require prompt adjustment of hyperglycemia by fluid infusion and insulin, and hence use of Nesina is not appropriate\].
• Participants with severe infection, pre- or post-operative patients, or patients with serious traumatic injury \[blood glucose control by insulin injection is desirable for these participants, and hence use of Nesina is not appropriate\].
• Participants with a history of hypersensitivity to any ingredient of Nesina.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Tokyo, Japan

Location

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Postmarketing Group Manager

  Takeda

  STUDY CHAIR

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: October 15, 2013
• First Posted: October 17, 2013
• Study Start: July 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 13, 2017
• Results First Posted: April 13, 2017

Record last verified: 2017-02

Locations

JP (1)