Clinical trial NCT02756832: An Observational Study of Alogliptin Benzoate in Participants With Diabetes Mellitus Type 2
Official title: Local, Multicentre, Observational, Non-Interventional Prospective Study of Alogliptin Benzoate in Patients With Diabetes Mellitus Type 2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2016-04-29
Enrollment: 1409
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants diagnosed with type 2 diabetes mellitus (T2DM) will be observed.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6
timeFrame: Baseline and Month 6
Secondary outcomes:
measure: Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics
timeFrame: Baseline and Month 6
measure: Percentage of Participants With a Decrease in HbA1c Level by <7.0% at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in HbA1c Level Over Time
timeFrame: Baseline, Months 3 and 6
measure: Percentage of Participants With Marked Hyperglycemia at Month 3
timeFrame: Month 3
measure: Change From Baseline in Fasting Plasma Glucose (FPG) Levels Over Time
timeFrame: Baseline, Months 3 and 6
measure: Change From Baseline in Weight Over Time
timeFrame: Baseline, Months 3 and 6
measure: Change From Baseline in Postprandial Glycemia Over Time
timeFrame: Baseline, Months 3 and 6
measure: Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time
timeFrame: Baseline, Months 3 and 6
measure: Percentage of Participants With a Decrease in HbA1c Level by ≥0.3% at Month 6
timeFrame: Baseline and Month 6
measure: Percentage of Participants Who Used Healthcare Resources
timeFrame: Baseline up to Month 6
Other outcomes:
Locations:
city: Arkhangelsk
country: Russian Federation
facility: First City Clinical Hospital named after E.E. Vlosevich
city: Barnaul
country: Russian Federation
facility: City polyclinic #11
city: Belgorod
country: Russian Federation
facility: Belgorod Regional Clinical hospital named after Saint I Belgorod Regional Clinical Hospital of St. Joasaph
city: Chelyabinsk
country: Russian Federation
facility: LLC Medical center Lotos
city: Chelyabinsk
country: Russian Federation
facility: Istochnik clinic
city: Chelyabinsk
country: Russian Federation
facility: Regional clinical hospital #3
city: Chita
country: Russian Federation
facility: Medical center Health Academy
city: Chita
country: Russian Federation
facility: Chita State Medical Academy
city: Ekaterinburg
country: Russian Federation
facility: Ural State Medical Academy
city: Kazan
country: Russian Federation
facility: City polyclinic #11
city: Kazan
country: Russian Federation
facility: Ciry polyclinic #10
city: Kemerovo
country: Russian Federation
facility: Kemerovo Regional Clinical Hospital named after S.V. Belyaev
city: Khabarovsk
country: Russian Federation
facility: Medical Center Clinic of Hormonal Health
city: Khabarovsk
country: Russian Federation
facility: Regional Clinical hospital named after S.I. Sergeev
city: Khabarovsk
country: Russian Federation
facility: Road Clinical Hospital at Khabarovsk Station - 1
city: Kirov
country: Russian Federation
facility: Northern Clinical Emergency Hospital
city: Kirov
country: Russian Federation
facility: Kirov Clinical Hospital #7 named after V.I. Yurlova
city: Kostroma
country: Russian Federation
facility: Kostroma City hospital
city: Kursk
country: Russian Federation
facility: Kursk Regional Clinical Hospital
city: Lobnya
country: Russian Federation
facility: Lobnya Central City Hospital
city: Moscow
country: Russian Federation
facility: City polyclinic #166
city: Moscow
country: Russian Federation
facility: Endocrinology Research Center
city: Moscow
country: Russian Federation
facility: City polyclinic #22
city: Moscow
country: Russian Federation
facility: City polyclinic #52
city: Moscow
country: Russian Federation
facility: The Scientific Center of Cardiovascular Surgery named after A.N. Bakulev
city: Moscow
country: Russian Federation
facility: CJSC Medsi
city: Moscow
country: Russian Federation
facility: Diagnostical Center #5
city: Moscow
country: Russian Federation
facility: 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
city: Nizhniy Novgorod
country: Russian Federation
facility: Clinical Diagnostical Center
city: Nizhniy Novgorod
country: Russian Federation
facility: City polyclinic #3
city: Novosibirsk
country: Russian Federation
facility: Medical Center Healthy family LLC
city: Petrozavodsk
country: Russian Federation
facility: Republican Hospital named after V.A.Baranov
city: Rostov-on-Don
country: Russian Federation
facility: Rostov State Medical University
city: Ryazan
country: Russian Federation
facility: City Clinical hospital #11
city: Saint-Petersburg
country: Russian Federation
facility: City policlinic #117
city: Saint-Petersburg
country: Russian Federation
facility: City polyclinic #109
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg Territorial Diabetological Center
city: Saint-Petersburg
country: Russian Federation
facility: City policlinic #86
city: Saint-Petersburg
country: Russian Federation
facility: Consultative and diagnostic polyclinic 1 of Primorsky district
city: Samara
country: Russian Federation
facility: Samara Regional Clinical Diagnostical polyclinic #14
city: Samara
country: Russian Federation
facility: LLC Center Diabet
city: Samara
country: Russian Federation
facility: City policlinic #9
city: Saratov
country: Russian Federation
facility: City polyclinic #22
city: Tomsk
country: Russian Federation
facility: City policlinic #3
city: Tomsk
country: Russian Federation
facility: LLC Medical center Ideale
city: Tomsk
country: Russian Federation
facility: City policlinic #3
city: Tomsk
country: Russian Federation
facility: Tomsk Regional Clinical Hospital
city: Ufa
country: Russian Federation
facility: City polyclinic #43
city: Vladimir
country: Russian Federation
facility: Regional Clinical Hospital
city: Volgograd
country: Russian Federation
facility: Regional Clinical Hospital #1
city: Volgograd
country: Russian Federation
facility: Volgograd State Medical University
city: Vologda
country: Russian Federation
facility: LLC Zdorovye, Diabetes Center
city: Voronezh
country: Russian Federation
facility: Voronezh Regional Clinical Diagnostical center
Study officials:
affiliation: Takeda
name: Medical Director Clinical Science
role: STUDY_DIRECTOR
References: