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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02756832
• Other study ID #: Alogliptin-4018
• Secondary ID: MACS-2015-101024
• Status: Completed
• Start date: September 20, 2016
• Est. completion date: April 28, 2018

Study information

• Verified date: July 2019
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1409
• Est. completion date: April 28, 2018
• Est. primary completion date: April 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Alogliptin Benzoate
Alogliptin benzoate tablets

Locations

Country	Name	City	State
Russian Federation	First City Clinical Hospital named after E.E. Vlosevich	Arkhangelsk
Russian Federation	City polyclinic #11	Barnaul
Russian Federation	Belgorod Regional Clinical hospital named after Saint I Belgorod Regional Clinical Hospital of St. Joasaph	Belgorod
Russian Federation	Istochnik clinic	Chelyabinsk
Russian Federation	LLC Medical center Lotos	Chelyabinsk
Russian Federation	Regional clinical hospital #3	Chelyabinsk
Russian Federation	Chita State Medical Academy	Chita
Russian Federation	Medical center Health Academy	Chita
Russian Federation	Ural State Medical Academy	Ekaterinburg
Russian Federation	Ciry polyclinic #10	Kazan
Russian Federation	City polyclinic #11	Kazan
Russian Federation	Kemerovo Regional Clinical Hospital named after S.V. Belyaev	Kemerovo
Russian Federation	Medical Center Clinic of Hormonal Health	Khabarovsk
Russian Federation	Regional Clinical hospital named after S.I. Sergeev	Khabarovsk
Russian Federation	Road Clinical Hospital at Khabarovsk Station - 1	Khabarovsk
Russian Federation	Kirov Clinical Hospital #7 named after V.I. Yurlova	Kirov
Russian Federation	Northern Clinical Emergency Hospital	Kirov
Russian Federation	Kostroma City hospital	Kostroma
Russian Federation	Kursk Regional Clinical Hospital	Kursk
Russian Federation	Lobnya Central City Hospital	Lobnya
Russian Federation	City polyclinic #166	Moscow
Russian Federation	City polyclinic #22	Moscow
Russian Federation	City polyclinic #52	Moscow
Russian Federation	CJSC Medsi	Moscow
Russian Federation	Diagnostical Center #5	Moscow
Russian Federation	Endocrinology Research Center	Moscow
Russian Federation	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
Russian Federation	The Scientific Center of Cardiovascular Surgery named after A.N. Bakulev	Moscow
Russian Federation	City polyclinic #3	Nizhniy Novgorod
Russian Federation	Clinical Diagnostical Center	Nizhniy Novgorod
Russian Federation	Medical Center Healthy family LLC	Novosibirsk
Russian Federation	Republican Hospital named after V.A.Baranov	Petrozavodsk
Russian Federation	Rostov State Medical University	Rostov-on-Don
Russian Federation	City Clinical hospital #11	Ryazan
Russian Federation	City policlinic #117	Saint-Petersburg
Russian Federation	City policlinic #86	Saint-Petersburg
Russian Federation	City polyclinic #109	Saint-Petersburg
Russian Federation	Consultative and diagnostic polyclinic 1 of Primorsky district	Saint-Petersburg
Russian Federation	Saint-Petersburg Territorial Diabetological Center	Saint-Petersburg
Russian Federation	City policlinic #9	Samara
Russian Federation	LLC Center Diabet	Samara
Russian Federation	Samara Regional Clinical Diagnostical polyclinic #14	Samara
Russian Federation	City polyclinic #22	Saratov
Russian Federation	City policlinic #3	Tomsk
Russian Federation	City policlinic #3	Tomsk
Russian Federation	LLC Medical center Ideale	Tomsk
Russian Federation	Tomsk Regional Clinical Hospital	Tomsk
Russian Federation	City polyclinic #43	Ufa
Russian Federation	Regional Clinical Hospital	Vladimir
Russian Federation	Regional Clinical Hospital #1	Volgograd
Russian Federation	Volgograd State Medical University	Volgograd
Russian Federation	LLC Zdorovye, Diabetes Center	Vologda
Russian Federation	Voronezh Regional Clinical Diagnostical center	Voronezh

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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