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Completed

NCT Number: NCT03555591

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Takeda Selected Site

Tokyo, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 diabetes mellitus patients

Exclusion criteria

  • Have severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus
  • Have severe infection, perioperative status, or serious trauma
  • Have severe renal impairment or on dialysis due to end-stage renal disease
  • Have a history of hypersensitivity to any ingredients of this drug

Treatment and study plan

Trelagliptin

Drug

Trelagliptin tablets

Other names: Zafatek tablets

Primary outcomes

  1. Number of Participants Who Had One or More Adverse Events

    Time frame: 36 months

    An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

  2. Number of Participants Who Had One or More Adverse Drug Reactions

    Time frame: 36 months

    An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.

Secondary outcomes

  1. Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c)

    Time frame: Baseline, up to final assessment point (up to Month 36)

    The reported data was the change in the mean value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected between baseline and timepoints (up to final assessment point: Month 36). A negative change from baseline indicates improvement.

  2. Change From Baseline in Fasting Blood Glucose

    Time frame: Baseline, up to final assessment point (up to Month 36)

    The reported data was the change in the mean value of fasting blood glucose collected between baseline and timepoints (up to final assessment point: Month 36). A negative change from baseline indicates improvement.

  3. Change From Baseline in Fasting Insulin Level

    Time frame: Baseline, up to final assessment point (up to Month 36)

    The reported data was the change in the mean value of fasting insulin level collected between baseline and timepoints (up to final assessment point: Month 36).

  4. Change From Baseline in Homeostasis Model Assessment of Beat-cell Function (HOMA-beta)

    Time frame: Baseline, up to final assessment point (up to Month 36)

    The reported data was the change in the mean value of HOMA-beta. HOMA-beta measures as following; HOMA-beta = fasting insulin (microU/mL) ×360/ [fasting glucose (mg/dL) - 63].

  5. Change From Baseline in Fasting Glucagon

    Time frame: Baseline, up to final assessment point (up to Month 36)

    The reported data was the change in the mean value of fasting glucagon collected between baseline and timepoints (up to final assessment point: Month 36).

  6. Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 8.0 Percent)

    Time frame: Baseline, up to final assessment point (up to Month 36)

    The reported data was percentage of participants who achieved good glycemic control (defined as reduction in HbA1c values < 8.0 Percent) at baseline and timepoints (up to final assessment point: Month 36).

  7. Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 7.0 Percent)

    Time frame: Baseline, up to final assessment point (up to Month 36)

    The reported data was percentage of participants who achieved good glycemic control (defined as reduction in HbA1c values < 7.0 Percent) at baseline and timepoints (up to final assessment point: Month 36).

  8. Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.0 Percent)

    Time frame: Baseline, up to final assessment point (up to Month 36)

    The reported data was percentage of participants who achieved good glycemic control (defined as reduction in HbA1c values < 6.0 Percent) at baseline and timepoints (up to final assessment point: Month 36).

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Jun 13, 2018
Registry last updated
Dec 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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