Clinical Trial of Efficiency and Safety of Subetta in the Combined Treatment of Patients With Type I Diabetes Mellitus
|ClinicalTrials.gov Identifier: NCT01868594|
Recruitment Status : Completed
First Posted : June 4, 2013
Last Update Posted : December 29, 2016
The purpose of this study is:
- to assess clinical efficiency of Subetta in the combined treatment of type I diabetes mellitus;
- to assess safety of Subetta in the combined treatment of type I diabetes mellitus.
|Condition or disease||Intervention/treatment||Phase|
|Type I Diabetes Mellitus||Drug: Subetta Drug: Placebo||Phase 4|
Patients with type I diabetes mellitus are included in the trial. It is concerned those patients, who by the time of the trial receive functional (basal bolus) insulin therapy of type I diabetes mellitus according to acceptable standard therapy, including basal insulin (using intermediate and long acting medications) and alimentary or prandial insulin (short and ultra short acting medications), and with lack of optimal glycemic control (HbA1c>7.0%). For patients, which will be included in the trial (mainly middle aged patients without severe complications of diabetes), HbA1c>7.0% is the marker showing that optimal individual goal of glycemic control is not achieved.
If a patient meets inclusion criteria and does not show non-inclusion criteria he/she is randomized in one of 2 groups: Group 1 - the group receiving standard type I diabetes mellitus therapy + Subetta at a dose of 1 tablet 4 times a day; Group 2 - the group receiving standard type I diabetes mellitus therapy + Placebo under the regimen used for Subetta. The invented names of the drugs containing basal and alimentary insulin should be unchanged for each patient during the whole trial.
All patients will receive glucometers and the appropriate glucose test strips, so they could self monitor blood glucose and register this data in their diaries.
The trial duration is 38 weeks; the main stages of the trial are conducted during screening, then in 4 weeks (Visit 2), in 12 weeks (Visit 3), in 24 weeks (Visit 4) and in 36 weeks (Visit 5). In 1 week after randomization and the onset of the trial therapy and between the visits to the study site (on weeks 8±1, 18±1 and 30±1) an investigator collects data on patient's health and complaints (phone visits) to decide whether it is necessary to arrange unplanned visit to the site.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Multicentre Double-blind Placebo-controlled Parallel-group Randomized Clinical Trial of Efficiency and Safety of Subetta in the Combined Treatment of Patients With Type I Diabetes Mellitus|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||December 2016|
Experimental: Subetta (1 tablet 4 times a day)
Oral administration. Per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).
Efficiency and Safety of Subetta in the combined treatment of patients with type I diabetes mellitus
Placebo Comparator: Placebo (1 tablet 4 times a day)
Placebo under Subetta regimen.
- Changes in the mean value of HbA1c [ Time Frame: In 12, 24 and 36 weeks of the treatment as compared to the baseline ]
- Fasting plasma glucose (based on the data of biochemical analysis) [ Time Frame: In 4, 12, 24 and 36 weeks of the treatment as compared to the baseline ]
- Records of the 7-point patient self-monitoring of blood glucose (SMBG) and average daily blood glucose [ Time Frame: During the whole study period (on weeks 4, 8, 12, 18, 24, 30 and 36 of the treatment) as compared to the baseline ]
Records of the 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.
- Mean value of C-peptide [ Time Frame: In 12, 24 and 36 weeks of the treatment as compared to the baseline ]
- Concentrations of plasma total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides [ Time Frame: In 12, 24 and 36 weeks of the treatment as compared to the baseline ]Blood samples (for measurement of fasting plasma glucose, concentrations of plasma C-peptide, total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides) are taken under standard conditions: after night break in food taking (at least 8 hours) and prior to administering of insulin morning dose (basal, if patient receives intermediate insulin twice-daily, and prandial), prior to any morning medicines intake (including the study drug and permitted concomitant therapy).
- Changes in dosage of insulin (basal, prandial and total daily dose insulin measured in IU and IU/kg of body weight) [ Time Frame: In 36 weeks of the treatment as compared to the baseline ]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.
- Changes in the satisfaction of diabetes treatment [ Time Frame: In 36 weeks of the treatment as compared to the baseline ]Based on DTSQ questionnaire data
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01868594
|Municipal budgetary authority "Khimki Central Clinical Hospital"|
|Moscow region, Russian Federation, 141400|
|State Healthcare Institution of Moscow "Central research institute of gastroenterology" of Department of health care of Moscow|
|Moscow, Russian Federation, 111123|
|State Educational Institution of Higher Professional Education "Moscow State Medical Academy named after I.M. Sechenov"|
|Moscow, Russian Federation, 119991|
|Nonstate Health Care Institution "Central Clinical Hospital №2 named after N.A. Semashko of Public Limited Company "Russian Railways"|
|Moscow, Russian Federation, 129128|
|The State Budgetary Institution of Health Care of the Nizhny Novgorod Region "City clinical hospital No. 10 "|
|Nizhny Novgorod, Russian Federation, 603011|
|Nizhny Novgorod regional State Budgetary Health Institution " Nizhny Novgorod regional Clinical Hospital named after N.A. Semashko "|
|Nizhny Novgorod, Russian Federation, 603126|
|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, Russian Federation, 344022|
|Co.Ltd " Diabet Center"|
|Samara, Russian Federation, 443067|
|Private company "Polyclinic Complex"|
|St. Petersburg, Russian Federation, 190013|
|St. Petersburg State Budgetary Health Care Institution "City Polyclinic №6"|
|St. Petersburg, Russian Federation, 191482|
|St. Petersburg State Budgetary Health Care Institution "Saint Venerable Martyr Elizaveta Municipal Hospital"|
|St. Petersburg, Russian Federation, 195257|
|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, Russian Federation, 197022|
|St. Petersburg Sate Budgetary Institution "Consultative-Diagnostic Polyclinic №1 of Coastal Area"|
|St. Petersburg, Russian Federation, 197183|
|Independent Health Care Institution of Voronezh Region "Voronezh Regional Clinical Consultative-Diagnostic Center"|
|Voronezh, Russian Federation, 394018|
|State Budgetary Health Care Institution of Yaroslavl Region "Regional Сlinical Hospital"|
|Yaroslavl, Russian Federation, 150062|