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

Local, Multicentre, Observational, Non-Interventional Prospective Study of Alogliptin Benzoate in Patients 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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Drug: Alogliptin Benzoate

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 1409

Contacts and Locations

Study Locations

• Russian Federation
  • Arkhangelsk, Russian Federation, 163001
    • First City Clinical Hospital named after E.E. Vlosevich
  • Barnaul, Russian Federation, 656019
    • City polyclinic #11
  • Belgorod, Russian Federation, 308007
    • Belgorod Regional Clinical hospital named after Saint I Belgorod Regional Clinical Hospital of St. Joasaph
  • Chelyabinsk, Russian Federation, 454100
    • Istochnik clinic
  • Chelyabinsk, Russian Federation, 454091
    • LLC Medical center Lotos
  • Chelyabinsk, Russian Federation, 454138
    • Regional Clinical Hospital #3
  • Chita, Russian Federation, 672090
    • Chita State Medical Academy
  • Chita, Russian Federation, 672038
    • Medical center Health Academy
  • Ekaterinburg, Russian Federation, 620043
    • Ural State Medical Academy
  • Kazan, Russian Federation, 420039
    • City polyclinic #11
  • Kazan, Russian Federation, 420066
    • Ciry polyclinic #10
  • Kemerovo, Russian Federation, 650066
    • Kemerovo Regional Clinical Hospital named after S.V. Belyaev
  • Khabarovsk, Russian Federation, 680000
    • Medical Center Clinic of Hormonal Health
  • Khabarovsk, Russian Federation, 680009
    • Regional Clinical hospital named after S.I. Sergeev
  • Khabarovsk, Russian Federation, 68022
    • Road Clinical Hospital at Khabarovsk Station - 1
  • Kirov, Russian Federation, 610011
    • Northern Clinical Emergency Hospital
  • Kirov, Russian Federation, 610030
    • Kirov Clinical Hospital #7 named after V.I. Yurlova
  • Kostroma, Russian Federation, 156005
    • Kostroma City hospital
  • Kursk, Russian Federation, 305007
    • Kursk Regional Clinical Hospital
  • Lobnya, Russian Federation, 141730
    • Lobnya Central City Hospital
  • Moscow, Russian Federation, 117036
    • Endocrinology Research Center
  • Moscow, Russian Federation, 115551
    • City polyclinic #166
  • Moscow, Russian Federation, 117218
    • City polyclinic #22
  • Moscow, Russian Federation, 117546
    • City polyclinic #52
  • Moscow, Russian Federation, 121552
    • The Scientific Center of Cardiovascular Surgery named after A.N. Bakulev
  • Moscow, Russian Federation, 123056
    • CJSC Medsi
  • Moscow, Russian Federation, 127543
    • Diagnostical Center #5
  • Moscow, Russian Federation, 199435
    • Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation
  • Nizhniy Novgorod, Russian Federation, 603006
    • Clinical Diagnostical Center
  • Nizhniy Novgorod, Russian Federation, 603155
    • City polyclinic #3
  • Novosibirsk, Russian Federation, 630099
    • Medical Center Healthy Family LLC
  • Petrozavodsk, Russian Federation, 185000
    • Republican hospital named after V.A.Baranov
  • Rostov-on-Don, Russian Federation, 344022
    • Rostov State Medical University
  • Ryazan, Russian Federation, 390037
    • City Clinical Hospital #11
  • Saint-Petersburg, Russian Federation, 125167
    • City policlinic #117
  • Saint-Petersburg, Russian Federation, 192289
    • City polyclinic #109
  • Saint-Petersburg, Russian Federation, 194354
    • Saint-Petersburg Territorial Diabetological Center
  • Saint-Petersburg, Russian Federation, 195299
    • City policlinic #86
  • Saint-Petersburg, Russian Federation, 197183
    • Consultative and diagnostic polyclinic 1 of Primorsky district
  • Samara, Russian Federation, 443011
    • Samara Regional Clinical Diagnostical polyclinic #14
  • Samara, Russian Federation, 443041
    • LLC Center Diabet
  • Samara, Russian Federation, 443110
    • City policlinic #9
  • Saratov, Russian Federation, 410005
    • City polyclinic #22
  • Tomsk, Russian Federation, 634063
    • Tomsk Regional Clinical Hospital
  • Tomsk, Russian Federation, 634009
    • City policlinic #3
  • Tomsk, Russian Federation, 634009
    • LLC Medical center Ideale
  • Tomsk, Russian Federation, 634024
    • City policlinic #3
  • Ufa, Russian Federation, 450099
    • City polyclinic #43
  • Vladimir, Russian Federation, 600023
    • Regional Clinical Hospital
  • Volgograd, Russian Federation, 400131
    • Volgograd State Medical University
  • Volgograd, Russian Federation, 400081
    • Regional Clinical Hospital #1
  • Vologda, Russian Federation, 160019
    • LLC Zdorovye, Diabetes Center
  • Voronezh, Russian Federation, 394018
    • Voronezh Regional Clinical Diagnostical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult participants diagnosed with type 2 diabetes mellitus (T2DM) will be observed.

Description

Inclusion Criteria:

1. Male and female participants ≥ 18 years of age;
2. Has a diagnosis of type 2 diabetes mellitus (T2DM)

3. Participants with:

   • newly diagnosed diabetes mellitus (DM) type 2 (drug naïve) or
   • inadequate glycemic control on previously prescribed any oral antidiabetic drug.
4. VIPIDIA® is prescribed according to the approved label for the Russian Federation.

5. The participant's physician decides to prescribe VIPIDIA®:

   • as monotherapy or
   • as a part of combination therapy.
6. 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:

1. Contraindications of respective approved Russian summary of product characteristics (SmPC);
2. 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;
3. 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.
4. 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Alogliptin Benzoate; Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months.	Drug: Alogliptin Benzoate; Alogliptin benzoate tablets; Other Names: VIPIDIA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at 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.	Baseline and Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics	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.	Baseline and Month 6
Percentage of Participants With a Decrease in HbA1c Level by <7.0% at 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.	Baseline and Month 6
Change From Baseline in HbA1c Level Over Time	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.	Baseline, Months 3 and 6
Percentage of Participants With Marked Hyperglycemia at Month 3	Marked hyperglycemia is defined as fasting plasma glucose (FPG) higher than or equal to 11 mmol/L.	Month 3
Change From Baseline in Fasting Plasma Glucose (FPG) Levels Over Time	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.	Baseline, Months 3 and 6
Change From Baseline in Weight Over Time	Change in the participant's weight was collected at Months 3 and 6 relative to baseline.	Baseline, Months 3 and 6
Change From Baseline in Postprandial Glycemia Over Time	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.	Baseline, Months 3 and 6
Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time	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.	Baseline, Months 3 and 6
Percentage of Participants With a Decrease in HbA1c Level by ≥0.3% at 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.	Baseline and Month 6
Percentage of Participants Who Used Healthcare Resources	Healthcare resources included rate of hospitalization, emergency, emergency room visits, physician office visits, and other type of usage.	Baseline up to Month 6

Collaborators and Investigators

• Sponsor: Takeda

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2016
• Primary Completion (Actual): April 28, 2018
• Study Completion (Actual): April 28, 2018

Study Registration Dates

• First Submitted: April 27, 2016
• First Submitted That Met QC Criteria: April 27, 2016
• First Posted (Estimate): April 29, 2016

Study Record Updates

• Last Update Posted (Actual): July 10, 2019
• Last Update Submitted That Met QC Criteria: July 9, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Drug Therapy
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Alogliptin
• Other Study ID Numbers: Alogliptin-4018; MACS-2015-101024 (Other Identifier: Takeda)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No