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Completed

NCT Number: NCT02756832

An Observational Study of Alogliptin Benzoate in Participants With Diabetes Mellitus Type 2

The purpose of this study is to evaluate the effect of alogliptin benzoate (VIPIDIA®) on glycosylated hemoglobin (HbA1c) level dynamics in participants with diabetes mellitus type 2 (T2DM) at Month 6.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

First City Clinical Hospital named after E.E. Vlosevich, Arkhangelsk, Russia

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About this study

The drug being studied in this study is called alogliptin benzoate. Alogliptin benzoate is being researched to treat people who have T2DM. This study will look at the HbA1c level dynamics in participants with T2DM.

The study enrolled 1409 patients. Alogliptin benzoate will be prescribed by their physician in accordance with the Russian summary of product characteristics (SmPC).

This multi-center study will be conducted in the Russian Federation. The overall duration of study for observation will be approximately 6 months. Participants will make multiple visits to the clinic as assigned by each physician according to their routine practice, in every 3 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male and female participants ≥ 18 years of age;
  • Has a diagnosis of type 2 diabetes mellitus (T2DM)
  • Participants with:
  • newly diagnosed diabetes mellitus (DM) type 2 (drug naïve) or
  • inadequate glycemic control on previously prescribed any oral antidiabetic drug.
  • VIPIDIA® is prescribed according to the approved label for the Russian Federation.
  • The participant's physician decides to prescribe VIPIDIA®:
  • as monotherapy or
  • as a part of combination therapy.
  • The participant (or, when applicable, the participant's legally acceptable representative) signs and dates a written, informed consent form prior to the start of data collection. Participant is capable of understanding the written informed consent, provides signed and written informed consent, and agrees to comply with protocol requirements. In case the participant is blind or unable to read, informed consent will also be witnessed.

Exclusion criteria

  • Contraindications of respective approved Russian summary of product characteristics (SmPC);
  • In the opinion of the physician, the participant has any reasons of medical and non-medical character, which in the opinion of the physician can prevent participant participation in the study;
  • Had used Dipeptidyl peptidase-4 inhibitors (DPP-IV inhibitors) or Glucagon like peptide-1 agonists (aGLP-1) within the 3 months prior to the start of VIPIDIA® treatment.
  • Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.

Treatment and study plan

Alogliptin Benzoate

Drug

Alogliptin benzoate tablets

Other names: VIPIDIA®

Primary outcomes

  1. Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6

    Time frame: Baseline and Month 6

    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 Month 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. A negative change from Baseline indicates improvement.

Secondary outcomes

  1. Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics

    Time frame: Baseline and Month 6

    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 Month 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. Subgroups included participants with different baseline clinical characteristics with predictors such as prior therapy of diabetes mellitus, sex, age group, cardiovascular risk group, therapy type (monotherapy or combined therapy), baseline body mass index (BMI) and initial glycemic control and T2DM duration. A negative change from Baseline indicates improvement.

  2. Percentage of Participants With a Decrease in HbA1c Level by <7.0% at Month 6

    Time frame: Baseline and Month 6

    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 Month 6 relative to baseline. Percentage of participants with a decrease of <7.0% from baseline in HbA1c were reported.

  3. Change From Baseline in HbA1c Level Over Time

    Time frame: Baseline, Months 3 and 6

    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 Months 3 and 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. A negative change from Baseline indicates improvement.

  4. Percentage of Participants With Marked Hyperglycemia at Month 3

    Time frame: Month 3

    Marked hyperglycemia is defined as fasting plasma glucose (FPG) higher than or equal to 11 mmol/L.

  5. Change From Baseline in Fasting Plasma Glucose (FPG) Levels Over Time

    Time frame: Baseline, Months 3 and 6

    The change in the value of fasting plasma glucose value collected at Months 3 and 6 relative to baseline. Target FPG depended on the defined individual targets of glycemic control by HbA1c level ≤6.5 to 8.0 mmol/l. A negative change from Baseline indicates improvement.

  6. Change From Baseline in Weight Over Time

    Time frame: Baseline, Months 3 and 6

    Change in the participant's weight was collected at Months 3 and 6 relative to baseline.

  7. Change From Baseline in Postprandial Glycemia Over Time

    Time frame: Baseline, Months 3 and 6

    The change between the baseline (pre-prandial (before meal)) and postprandial (after meal) glucose values were collected at Months 3 and 6 relative to baseline.

  8. Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time

    Time frame: Baseline, Months 3 and 6

    The change between the total cholesterol triglycerides, low density lipoproteins and high density lipoproteins values were collected at Months 3 and 6 relative to baseline.

  9. Percentage of Participants With a Decrease in HbA1c Level by ≥0.3% at Month 6

    Time frame: Baseline and Month 6

    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 Month 6 relative to baseline. Percentage of participants with a decrease of ≥0.3% from baseline in HbA1c were reported.

  10. Percentage of Participants Who Used Healthcare Resources

    Time frame: Baseline up to Month 6

    Healthcare resources included rate of hospitalization, emergency, emergency room visits, physician office visits, and other type of usage.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

Local, Multicentre, Observational, Non-Interventional Prospective Study of Alogliptin Benzoate in Patients With Diabetes Mellitus Type 2

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 29, 2016
Registry last updated
Jul 10, 2019

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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