An Observational Study of Alogliptin Benzoate in Participants With Diabetes Mellitus Type 2
- Registration Number
- NCT02756832
- Lead Sponsor
- Takeda
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1409
-
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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Alogliptin Benzoate 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.
- Primary Outcome Measures
Name Time Method Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 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 Outcome Measures
Name Time Method Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics 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.
Percentage of Participants With Marked Hyperglycemia at Month 3 Month 3 Marked hyperglycemia is defined as fasting plasma glucose (FPG) higher than or equal to 11 mmol/L.
Percentage of Participants With a Decrease in HbA1c Level by <7.0% at Month 6 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.
Change From Baseline in HbA1c Level Over Time 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.
Change From Baseline in Fasting Plasma Glucose (FPG) Levels Over Time 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.
Change From Baseline in Weight Over Time Baseline, Months 3 and 6 Change in the participant's weight was collected at Months 3 and 6 relative to baseline.
Change From Baseline in Postprandial Glycemia Over Time 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.
Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time 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.
Percentage of Participants With a Decrease in HbA1c Level by ≥0.3% at Month 6 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.
Percentage of Participants Who Used Healthcare Resources Baseline up to Month 6 Healthcare resources included rate of hospitalization, emergency, emergency room visits, physician office visits, and other type of usage.
Trial Locations
- Locations (50)
City policlinic #3
🇷🇺Tomsk, Russian Federation
Chita State Medical Academy
🇷🇺Chita, Russian Federation
City polyclinic #166
🇷🇺Moscow, Russian Federation
Clinical Diagnostical Center
🇷🇺Nizhniy Novgorod, Russian Federation
LLC Zdorovye, Diabetes Center
🇷🇺Vologda, Russian Federation
Endocrinology Research Center
🇷🇺Moscow, Russian Federation
Ciry polyclinic #10
🇷🇺Kazan, Russian Federation
First City Clinical Hospital named after E.E. Vlosevich
🇷🇺Arkhangelsk, Russian Federation
LLC Medical center Lotos
🇷🇺Chelyabinsk, Russian Federation
Regional clinical hospital #3
🇷🇺Chelyabinsk, Russian Federation
Istochnik clinic
🇷🇺Chelyabinsk, Russian Federation
Medical Center Clinic of Hormonal Health
🇷🇺Khabarovsk, Russian Federation
Road Clinical Hospital at Khabarovsk Station - 1
🇷🇺Khabarovsk, Russian Federation
Northern Clinical Emergency Hospital
🇷🇺Kirov, Russian Federation
Kirov Clinical Hospital #7 named after V.I. Yurlova
🇷🇺Kirov, Russian Federation
CJSC Medsi
🇷🇺Moscow, Russian Federation
Lobnya Central City Hospital
🇷🇺Lobnya, Russian Federation
Kostroma City hospital
🇷🇺Kostroma, Russian Federation
City polyclinic #22
🇷🇺Saratov, Russian Federation
City polyclinic #52
🇷🇺Moscow, Russian Federation
The Scientific Center of Cardiovascular Surgery named after A.N. Bakulev
🇷🇺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
Diagnostical Center #5
🇷🇺Moscow, Russian Federation
Medical Center Healthy family LLC
🇷🇺Novosibirsk, Russian Federation
City polyclinic #3
🇷🇺Nizhniy Novgorod, 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 #86
🇷🇺Saint-Petersburg, Russian Federation
Samara Regional Clinical Diagnostical polyclinic #14
🇷🇺Samara, Russian Federation
City policlinic #9
🇷🇺Samara, Russian Federation
Tomsk Regional Clinical Hospital
🇷🇺Tomsk, Russian Federation
LLC Center Diabet
🇷🇺Samara, Russian Federation
LLC Medical center Ideale
🇷🇺Tomsk, Russian Federation
City polyclinic #43
🇷🇺Ufa, Russian Federation
Regional Clinical Hospital #1
🇷🇺Volgograd, Russian Federation
Regional Clinical Hospital
🇷🇺Vladimir, Russian Federation
Volgograd State Medical University
🇷🇺Volgograd, Russian Federation
Voronezh Regional Clinical Diagnostical center
🇷🇺Voronezh, Russian Federation
Kemerovo Regional Clinical Hospital named after S.V. Belyaev
🇷🇺Kemerovo, Russian Federation
Consultative and diagnostic polyclinic 1 of Primorsky district
🇷🇺Saint-Petersburg, Russian Federation
Medical center Health Academy
🇷🇺Chita, Russian Federation
Ural State Medical Academy
🇷🇺Ekaterinburg, Russian Federation
City policlinic #117
🇷🇺Saint-Petersburg, Russian Federation
City polyclinic #11
🇷🇺Kazan, Russian Federation
Belgorod Regional Clinical hospital named after Saint I Belgorod Regional Clinical Hospital of St. Joasaph
🇷🇺Belgorod, Russian Federation
Kursk Regional Clinical Hospital
🇷🇺Kursk, Russian Federation
City polyclinic #109
🇷🇺Saint-Petersburg, Russian Federation
Regional Clinical hospital named after S.I. Sergeev
🇷🇺Khabarovsk, Russian Federation
Saint-Petersburg Territorial Diabetological Center
🇷🇺Saint-Petersburg, Russian Federation