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Specified Drug-Use Survey of Alogliptin and Metformin Hydrochloride Combination Tablets "Survey on Long-term Use in Type 2 Diabetes Mellitus Patients With Renal or Hepatic Impairment or Advanced Age"

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ClinicalTrials.gov Identifier: NCT03555565
Recruitment Status : Active, not recruiting
First Posted : June 13, 2018
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda

Brief Summary:
The purpose of this survey is to evaluate the long-term safety and efficacy of the alogliptin and metformin hydrochloride combination tablet in type 2 diabetes mellitus patients with renal impairment (mild), hepatic impairment (mild or moderate), or advanced age (65 years and more) in the routine clinical setting.

Condition or disease Intervention/treatment
Type 2 Diabetes Mellitus Drug: Alogliptin and Metformin hydrochloride

Detailed Description:

The drug being tested in this survey is called alogliptin and metformin hydrochloride combination tablet. This tablet is being tested to treat people who have type 2 diabetes mellitus with renal impairment (mild), hepatic impairment (mild or moderate), or advanced age (65 years and more).

This survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the alogliptin and metformin hydrochloride combination tablet in the routine clinical setting. The planned number of observed patients will be approximately 600.

This multi-center observational trial will be conducted in Japan.


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Study Type : Observational
Actual Enrollment : 1022 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Specified Drug-Use Survey of Alogliptin and Metformin Hydrochloride Combination Tablets "Survey on Long-term Use in Type 2 Diabetes Mellitus Patients With Renal or Hepatic Impairment or Advanced Age"
Actual Study Start Date : February 28, 2017
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Alogliptin and Metformin hydrochloride
Alogliptin 25 mg and metformin hydrochloride 500 mg, combination tablet, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.
Drug: Alogliptin and Metformin hydrochloride
Alogliptin and Metformin hydrochloride combination tablets
Other Name: Inisync combination tablets




Primary Outcome Measures :
  1. Percentage of Participants who had One or More Adverse Events [ Time Frame: Up to Month 12 ]

Secondary Outcome Measures :
  1. Change from Baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline, up to final assessment point (up to 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 final assessment point (up to Month 12) relative to baseline.

  2. Change from Baseline in Fasting Blood Glucose [ Time Frame: Baseline, up to final assessment point (up to Month 12) ]
    The change in the value of fasting blood glucose collected at final assessment point (up to Month 12) relative to baseline.

  3. Change from Baseline in Fasting Insulin Level [ Time Frame: Baseline, up to final assessment point (up to Month 12) ]
    The change in the value of fasting insulin collected at final assessment point (up to Month 12) relative to baseline.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with type 2 diabetes mellitus for whom combination therapy with alogliptin and metformin hydrochloride is appropriate in the opinion of a physician as the routine medical care.
Criteria

Inclusion Criteria:

  • Participants should meet one or more of the following:

    1. Have renal impairment (mild)
    2. Have hepatic impairment (mild or moderate)
    3. Elderly (aged 65 years or more)

Exclusion Criteria:

  • Participants with any contraindication for study drug.

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): NCT03555565


Locations
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Japan
Takeda Selected Site
Tokyo, 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: NCT03555565     History of Changes
Other Study ID Numbers: Alogliptin-Met-5003
JapicCTI-183979 ( Registry Identifier: JapicCTI )
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 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
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
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