| Trial ID: | L2154 |
| Source ID: | NCT01868594
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| Associated Drug: |
Subetta
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| Title: |
Clinical Trial of Efficacy and Safety of Subetta in the Combined Treatment of Patients With Type I Diabetes Mellitus
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT01868594/results
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| Conditions: |
Type I Diabetes Mellitus
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| Interventions: |
DRUG: Subetta|DRUG: Placebo
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| Outcome Measures: |
Primary: Changes in the Mean Value of HbA1c, The HbA1C test was performed using a method that is certified by the National Glycohemoglobin Standardization Program (NGSP) (www.ngsp.org) and standardized or traceable to the Diabetes Control and Complications Trial (DCCT) reference assay., baseline and 12, 24 and 36 weeks of the treatment | Secondary: Change in Fasting Plasma Glucose (Based on the Data of Biochemical Analysis), baseline and 4, 12, 24 and 36 weeks of the treatment|Change in Average Daily Blood Glucose From a 7-point Patient Self-monitoring of Blood Glucose (SMBG), A 7-point patient self-monitoring of blood glucose (SMBG): three measurements of blood glucose before the meal; three measurements of postprandial blood glucose (1-2 h after the start of the meal) and one measurement at 3:00 a.m., baseline and 4, 8, 12, 18, 24, 30 and 36 weeks of the treatment|Changes in Lipids (Concentrations of Plasma Total Cholesterol, HDL Cholesterol, LDL Cholesterol and Triglycerides), Blood samples (for measurement of fasting plasma glucose, concentrations of plasma total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides) are taken under standard conditions: after night break in food taking (at least 12 hours) and prior to administering of insulin morning dose (prandial), prior to any morning medicines intake (including the study drug and permitted concomitant therapy)., baseline and 12, 24 and 36 weeks of the treatment|Changes in Dosage of Insulin (Basal, Prandial and Total Daily Dose Insulin Measured in IU), Insulin dose should be corrected by a patient on a daily basis taking into consideration data on blood glucose self- monitoring during a day and amount of food carbohydrates. Physician can correct insulin dose based on the same data., baseline and 36 weeks of the treatment|Changes in Dosage of Total Insulin Measured in IU/kg of Body Weight, Insulin dose should be corrected by a patient on a daily basis taking into consideration data on blood glucose self- monitoring during a day and amount of food carbohydrates. Physician can correct insulin dose based on the same data., baseline and 36 weeks of the treatment|Satisfaction of Diabetes Treatment Based on Diabetes Treatment Satisfaction Questionnaire Data, The Diabetes Treatment Satisfaction Questionnaire allows to assess the degree of satisfaction with treatment for diabetes and its complications - retinopathy and nephropathy, how patients' satisfaction and perceived hyper- and hypoglycemia have changed compared to the initial period (before the treatment). The Diabetes Treatment Satisfaction Questionnaire contains six items scored on 7-point scales from +3 (equals "very satisfied") to -3 (equals "very dissatisfied"), with 0 (equals "no change"). These are summed to produce a total Treatment Satisfaction score. Two questions concerning "Perceived Hyperglycaemia" and "Perceived Hypoglycaemia" respectively, are calculated separately. According to these two items, low scores represent good perceived blood glucose control (+3 means "most of the time" of Hyperglycaemia or Hypoglycaemia whereas -3 means "none of the time" of Hyperglycaemia or Hypoglycaemia)., 36 weeks of the treatment
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| Sponsor/Collaborators: |
Sponsor: Materia Medica Holding
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE4
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| Enrollment: |
200
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
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| Start Date: |
2013-05-07
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| Completion Date: |
2016-07-10
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| Results First Posted: |
2019-03-04
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| Last Update Posted: |
2019-05-30
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| Locations: |
Municipal budgetary authority "Khimki Central Clinical Hospital", Moscow region, 141400, Russian Federation|State Healthcare Institution of Moscow "Central research institute of gastroenterology" of Department of health care of Moscow, Moscow, 111123, Russian Federation|State Educational Institution of Higher Professional Education "Moscow State Medical Academy named after I.M. Sechenov", Moscow, 119991, Russian Federation|Nonstate Health Care Institution "Central Clinical Hospital №2 named after N.A. Semashko of Public Limited Company "Russian Railways", Moscow, 129128, Russian Federation|The State Budgetary Institution of Health Care of the Nizhny Novgorod Region "City clinical hospital No. 10 ", Nizhny Novgorod, 603011, Russian Federation|Nizhny Novgorod regional State Budgetary Health Institution " Nizhny Novgorod regional Clinical Hospital named after N.A. Semashko ", Nizhny Novgorod, 603126, Russian Federation|State Budgetary Educational Institution of High Professional Training "Rostov State Medical University" of Ministry of Health of Russian Federation, Department of Endocrinology, Rostov-on-Don, 344022, Russian Federation|Co.Ltd " Diabet Center", Samara, 443067, Russian Federation|Private company "Polyclinic Complex", St. Petersburg, 190013, Russian Federation|St. Petersburg State Budgetary Health Care Institution "City Polyclinic №6", St. Petersburg, 191482, Russian Federation|St. Petersburg State Budgetary Health Care Institution "Saint Venerable Martyr Elizaveta Municipal Hospital", St. Petersburg, 195257, Russian Federation|State Budgetary Educational Institution of High Professional Training "St. Petersburg State Medical University named after academician I.P. Pavlov" of Ministry of Health of Russian Federation, Therapy Faculty Board, St. Petersburg, 197022, Russian Federation|St. Petersburg Sate Budgetary Institution "Consultative-Diagnostic Polyclinic №1 of Coastal Area", St. Petersburg, 197183, Russian Federation|Independent Health Care Institution of Voronezh Region "Voronezh Regional Clinical Consultative-Diagnostic Center", Voronezh, 394018, Russian Federation|State Budgetary Health Care Institution of Yaroslavl Region "Regional Сlinical Hospital", Yaroslavl, 150062, Russian Federation
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| URL: |
https://clinicaltrials.gov/show/NCT01868594
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