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Trial record 3 of 948 for:    tablet | Japan

Specified Drug-Use Survey of Trelagliptin Tablets "Survey on Long-term Use in Patients With Type 2 Diabetes Mellitus"

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ClinicalTrials.gov Identifier: NCT03555591
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 trelagliptin tablets in patients with type 2 diabetes mellitus in the routine clinical setting.

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

Detailed Description:

The drug being tested in this survey is called trelagliptin tablet. This tablet is being tested to treat people who have type 2 diabetes mellitus.

This survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the trelagliptin tablet in the routine clinical setting. The planned number of observed patients will be approximately 3000.

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


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Study Type : Observational
Actual Enrollment : 3198 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Specified Drug-Use Survey of Trelagliptin Tablets "Survey on Long-term Use in Patients With Type 2 Diabetes Mellitus"
Actual Study Start Date : May 1, 2016
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Trelagliptin 100 mg
Trelagliptin 100 mg tablet, orally, once weekly for up to 36 months. Participants received interventions as part of routine medical care.
Drug: Trelagliptin
Trelagliptin tablets
Other Name: Zafatek tablets




Primary Outcome Measures :
  1. Percentage of Participants who had One or More Adverse Events [ Time Frame: Up to Month 36 ]

Secondary Outcome Measures :
  1. Change from Baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline, up to final assessment point (up to Month 36) ]
    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 36) relative to baseline.

  2. Change from Baseline in Fasting Blood Glucose [ Time Frame: Baseline, up to final assessment point (up to Month 36) ]
    The change in the value of fasting blood glucose collected at final assessment point (up to Month 36) relative to baseline.

  3. Change from Baseline in Fasting Insulin Level [ Time Frame: Baseline, up to final assessment point (up to Month 36) ]
    The change in the value of fasting insulin collected at final assessment point (up to Month 36) relative to baseline.

  4. Change from Baseline in Homeostasis Model Assessment of β-cell Function (HOMA-β) [ Time Frame: Baseline, up to final assessment point (up to Month 36) ]
    The change in the value of HOMA-β collected at final assessment point (up to Month 36) relative to baseline. HOMA-β will be calculated by (fasting insulin multiplied by a constant [360]) divided by (fasting blood glucose minus 63).



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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 in the routine clinical setting
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus patients

Exclusion Criteria:

  1. Have severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus
  2. Have severe infection, perioperative status, or serious trauma
  3. Have severe renal impairment or on dialysis due to end-stage renal disease
  4. Have a history of hypersensitivity to any ingredients of this 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): NCT03555591


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: NCT03555591     History of Changes
Other Study ID Numbers: Trelagliptin-5001
JapicCTI-183980 ( Registry Identifier: JapicCTI )
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018

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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