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