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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

Tracking Information
First Submitted Date June 1, 2018
First Posted Date June 13, 2018
Last Update Posted Date November 7, 2018
Actual Study Start Date February 28, 2017
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 1, 2018)
Percentage of Participants who had One or More Adverse Events [ Time Frame: Up to Month 12 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03555565 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 1, 2018)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief 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"
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"
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Type 2 Diabetes Mellitus
Intervention Drug: Alogliptin and Metformin hydrochloride
Alogliptin and Metformin hydrochloride combination tablets
Other Name: Inisync combination tablets
Study Groups/Cohorts 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.
Intervention: Drug: Alogliptin and Metformin hydrochloride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: November 6, 2018)
1022
Original Estimated Enrollment
 (submitted: June 1, 2018)
600
Estimated Study Completion Date October 31, 2019
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03555565
Other Study ID Numbers Alogliptin-Met-5003
JapicCTI-183979 ( Registry Identifier: JapicCTI )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Takeda
Study Sponsor Takeda
Collaborators Not Provided
Investigators
Study Director: Study Director Takeda
PRS Account Takeda
Verification Date November 2018