Alogliptin/Pioglitazone (Liovel) Combination Tablets Survey on Long-term Use in Patients With Type 2 Diabetes Mellitus

NCT01990300 | Completed Results

• 2 other identifiers: 136-011JapicCTI-132302
• Study Type: observational
• Target: 3,281
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this survey is to examine the safety and efficacy of long-term use of alogliptin/pioglitazone(Liovel) combination tablets in patients with type 2 diabetes mellitus determined as warranting combination therapy with alogliptin benzoate and pioglitazone hydrochloride

Conditions

Type 2 Diabetes Mellitus

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Experience at Least One Adverse Events

  Up to 12 Months

• Changes From Baseline in Glycosylated Hemoglobin (HbA1c)

  Reported data are changes in HbA1c from baseline at Month 1, 3, 6, 12 and final assessment (up to 12 months).

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

Secondary Outcomes (1)

• Changes From Baseline in Fasting Blood Glucose (FBG)

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

Study Arms (1)

Alogliptin/Pioglitazone combination tablets

Alogliptin/Pioglitazone combination tablets, taken orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.

Drug: Alogliptin/Pioglitazone

Interventions

Alogliptin/Pioglitazone DRUG

Alogliptin/Pioglitazone combination tablets

Also known as: Liovel、SYR-322-4833

Alogliptin/Pioglitazone combination tablets

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

You may not qualify if:

• Patients meeting any of the following criteria will be excluded:
• Patients with current cardiac failure or a past history of cardiac failure
• Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus
• Patients with serious hepatic dysfunction
• Patients with serious renal dysfunction
• Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury
• Patients with a history of hypersensitivity to any ingredients of Alogliptin/Pioglitazone
• Pregnant or possibly pregnant women

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Someplace, Japan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

alogliptin; Pioglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Takeda (Note: This product was divested to Teijin Pharma Limited in 2023)

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: November 15, 2013
• First Posted: November 21, 2013
• Study Start: November 28, 2011
• Primary Completion: March 31, 2015
• Study Completion: March 31, 2015
• Last Updated: September 18, 2023
• Results First Posted: January 18, 2019

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)