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Diabetes MellitusNCT02756832

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

An observational study of Diabetes Mellitus, run by Takeda at 53 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus
What is being tested?
Alogliptin Benzoate
Type of treatment
Pill or oral medicine
How many people
1,409 participants
Where
53 sitesRussia
Study dates
20 Sep 2016to 28 Apr 2018
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

53 sites in 1 country.

53 sites in 1 country

Russia53 sites

  • First City Clinical Hospital named after E.E. Vlosevich

    Arkhangelsk, 163001

  • City polyclinic #11

    Barnaul, 656019

  • Belgorod Regional Clinical hospital named after Saint I Belgorod Regional Clinical Hospital of St. Joasaph

    Belgorod, 308007

  • LLC Medical center Lotos

    Chelyabinsk, 454091

  • Istochnik clinic

    Chelyabinsk, 454100

  • Regional clinical hospital #3

    Chelyabinsk, 454138

  • Medical center Health Academy

    Chita, 672038

  • Chita State Medical Academy

    Chita, 672090

  • City polyclinic #11

    Kazan', 420039

  • Ciry polyclinic #10

    Kazan', 420066

  • Kemerovo Regional Clinical Hospital named after S.V. Belyaev

    Kemerovo, 650066

  • Medical Center Clinic of Hormonal Health

    Khabarovsk, 680000

  • Regional Clinical hospital named after S.I. Sergeev

    Khabarovsk, 680009

  • Road Clinical Hospital at Khabarovsk Station - 1

    Khabarovsk, 68022

  • Northern Clinical Emergency Hospital

    Kirov, 610011

  • Kirov Clinical Hospital #7 named after V.I. Yurlova

    Kirov, 610030

  • Kostroma City hospital

    Kostroma, 156005

  • Kursk Regional Clinical Hospital

    Kursk, 305007

  • Lobnya Central City Hospital

    Lobnya, 141730

  • City polyclinic #166

    Moscow, 115551

  • Endocrinology Research Center

    Moscow, 117036

  • City polyclinic #22

    Moscow, 117218

  • City polyclinic #52

    Moscow, 117546

  • The Scientific Center of Cardiovascular Surgery named after A.N. Bakulev

    Moscow, 121552

  • CJSC Medsi

    Moscow, 123056

  • Diagnostical Center #5

    Moscow, 127543

  • 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

    Moscow, 199435

  • Clinical Diagnostical Center

    Nizhny Novgorod, 603006

  • City polyclinic #3

    Nizhny Novgorod, 603155

  • Medical Center Healthy family LLC

    Novosibirsk, 630099

  • Republican Hospital named after V.A.Baranov

    Petrozavodsk, 185000

  • Rostov State Medical University

    Rostov-on-Don, 344022

  • City Clinical hospital #11

    Ryazan, 390037

  • City policlinic #117

    Saint Petersburg, 125167

  • City polyclinic #109

    Saint Petersburg, 192289

  • Saint-Petersburg Territorial Diabetological Center

    Saint Petersburg, 194354

  • City policlinic #86

    Saint Petersburg, 195299

  • Consultative and diagnostic polyclinic 1 of Primorsky district

    Saint Petersburg, 197183

  • Samara Regional Clinical Diagnostical polyclinic #14

    Samara, 443011

  • LLC Center Diabet

    Samara, 443041

  • City policlinic #9

    Samara, 443110

  • City polyclinic #22

    Saratov, 410005

  • City policlinic #3

    Tomsk, 634009

  • LLC Medical center Ideale

    Tomsk, 634009

  • City policlinic #3

    Tomsk, 634024

  • Tomsk Regional Clinical Hospital

    Tomsk, 634063

  • City polyclinic #43

    Ufa, 450099

  • Regional Clinical Hospital

    Vladimir, 600023

  • Regional Clinical Hospital #1

    Volgograd, 400081

  • Volgograd State Medical University

    Volgograd, 400131

  • LLC Zdorovye, Diabetes Center

    Vologda, 160019

  • Voronezh Regional Clinical Diagnostical center

    Voronezh, 394018

  • Ural State Medical Academy

    Yekaterinburg, 620043

Other trials in Russia

About this study

Official title: 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.

Read the 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.

Being tested
Alogliptin Benzoate
Keywords
Drug Therapy
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alogliptin BenzoateDrug

    Also called VIPIDIA®

    Alogliptin benzoate tablets

Study groups in NCT02756832
Study groupRoleWhat they receive
Alogliptin BenzoateParticipants 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.
Receives: Drug: Alogliptin Benzoate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and Month 6

Secondary outcomes (10)

  1. 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.

    Measured: Baseline and Month 6

  2. 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.

    Measured: Baseline and Month 6

  3. 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.

    Measured: Baseline, Months 3 and 6

  4. 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.

    Measured: Month 3

  5. 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.

    Measured: Baseline, Months 3 and 6

  6. Change From Baseline in Weight Over Time

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

    Measured: Baseline, Months 3 and 6

  7. 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.

    Measured: Baseline, Months 3 and 6

  8. 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.

    Measured: Baseline, Months 3 and 6

  9. 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.

    Measured: Baseline and Month 6

  10. 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.

    Measured: Baseline up to Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2016 (estimated)
  2. Study start20 Sep 2016
  3. Primary completion28 Apr 2018
  4. Study completion28 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,409 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02756832
Sponsor's protocol ID
Alogliptin-4018
Other IDs
MACS-2015-101024
Status last verified
Jul 2019
First submitted
27 Apr 2016
Last updated
10 Jul 2019
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, run by Takeda at 53 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 (time frame: Baseline and Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02756832.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.

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