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

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ClinicalTrials.gov Identifier: NCT01990300
Recruitment Status : Completed
First Posted : November 21, 2013
Results First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

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

Condition or disease Intervention/treatment
Type 2 Diabetes Mellitus Drug: Alogliptin/Pioglitazone

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.


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Study Type : Observational
Actual Enrollment : 3281 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Use of Alogliptin/Pioglitazone Combination Tablets in Patients With Type 2 Diabetes Mellitus
Actual Study Start Date : November 28, 2011
Actual Primary Completion Date : March 31, 2015
Actual Study Completion Date : March 31, 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Alogliptin/Pioglitazone combination tablets
Other Name: Liovel、SYR-322-4833




Primary Outcome Measures :
  1. Number of Participants Who Experience at Least One Adverse Events [ Time Frame: Up to 12 Months ]
  2. Changes From Baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline and Month 1, 3, 6, 12 and final assessment (up to 12 Months) ]
    Reported data are changes in HbA1c from baseline at Month 1, 3, 6, 12 and final assessment (up to 12 months).


Secondary Outcome Measures :
  1. Changes From Baseline in Fasting Blood Glucose (FBG) [ Time Frame: Baseline and Month 1, 3, 6, 12 and final assessment (up to 12 Months) ]
    Reported data are changes in fasting blood glucose level from baseline at Month 1, 3, 6, 12 and final assessment (up to 12 months).



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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 Alogliptin/Pioglitazone
    7. Pregnant or possibly pregnant women

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


Locations
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Japan
Someplace, Japan
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Study Director Takeda

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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01990300     History of Changes
Other Study ID Numbers: 136-011
JapicCTI-132302 ( Registry Identifier: JapicCTI )
First Posted: November 21, 2013    Key Record Dates
Results First Posted: January 18, 2019
Last Update Posted: January 18, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda:
Drug Therapy
Additional relevant MeSH terms:
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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