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Trial record 1 of 1 for:    136-011
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Alogliptin/Pioglitazone (Liovel) Liovel Combination Tablets Survey on Long-term Use in Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01990300
First Posted: November 21, 2013
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Takeda
  Purpose
The purpose of this study 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

Condition Intervention
Type 2 Diabetes Mellitus Drug: Alogliptin/pioglitazone

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Use of Alogliptin/Pioglitazone Combination Tablets in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Frequency of Adverse events [ Time Frame: 12 months ]
    The frequency of adverse events by type, seriousness, type 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 Baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline and month 12 ]
    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 12 months ]
    The change in the value of fasting blood glucose collected at month 12 relative to baseline.


Enrollment: 3281
Actual Study Start Date: November 28, 2011
Study Completion Date: March 31, 2015
Primary Completion Date: March 31, 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Alogliptin/pioglitazone (Liovel) combination tablets
Alogliptin/pioglitazone (Liovel) combination tablets, taken orally, once daily for up to 12 months
Drug: Alogliptin/pioglitazone
Alogliptin/pioglitazone combination tablets
Other Name: Liovel、SYR-322-4833

Detailed Description:

This is a special drug use surveillance on long-term use of alogliptin/pioglitazone combination tablets. This study is designed to investigate the safety and efficacy of long-term use of alogliptin/pioglitazone combination tablet in patients with type 2 diabetes mellitus in the routine clinical setting.

Participants will be patients with type 2 diabetes mellitus. The planned sample size is 3000.

The usual adult dosage is 1 tablet (containing alogliptin/pioglitazone at either 25 mg/15 mg or 25 mg/30 mg) taken orally once daily before or after breakfast.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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 with type 2 diabetes mellitus

Exclusion Criteria:

  • Patients meeting any of the following criteria will be excluded:

    1. Patients with current cardiac failure or a past history of cardiac failure
    2. Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus
    3. Patients with serious hepatic dysfunction
    4. Patients with serious renal dysfunction
    5. Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury
    6. Patients with a history of hypersensitivity to any ingredients of Liovel
    7. Pregnant or possibly pregnant women
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01990300


Sponsors and Collaborators
Takeda
Investigators
Study Director: Study Director Takeda
  More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01990300     History of Changes
Other Study ID Numbers: 136-011
JapicCTI-132302 ( Registry Identifier: JapicCTI )
First Submitted: November 15, 2013
First Posted: November 21, 2013
Last Update Posted: November 8, 2017
Last Verified: July 2017

Keywords provided by Takeda:
Drug Therapy

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