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

NCT01945242 | Completed Results

• 3 other identifiers: 121-012JapicCTI-132265JapicCTI-R150770
• Study Type: observational
• Target: 1,374
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine the safety and efficacy of long-term combination therapy with alogliptin (Nesina) and thiazolidinediones in patients with type 2 diabetes mellitus who failed to respond adequately to treatment with thiazolidinediones in addition to diet therapy and exercise therapy.

Conditions

Type 2 Diabetes Melitus

Keywords

Drug Therapy

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 + thiazolidinedione 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 + thiazolidinedione 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 12 months)

• Percentage of Participants of Achieving Objective Glycemic Control

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

• Change From Baseline in Fasting Blood Glucose

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

• Change From Baseline in Fasting Insulin

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

Study Arms (1)

Alogilptin 25mg, tablets, orally, once daily, up to 12 months

Drug: Alogliptin

Interventions

Alogliptin DRUG

Alogliptin tablets

Also known as: Nesina; SYR-322

Alogilptin 25mg, tablets, orally, once daily, up to 12 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 who did not adequately respond to the following treatment • Treatment with thiazolidinediones in addition to diet therapy and exercise therapy

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

MeSH Terms

Interventions

alogliptin

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: September 13, 2013
• First Posted: September 18, 2013
• Study Start: March 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 27, 2016
• Results First Posted: September 16, 2016

Record last verified: 2016-09