Clinical Trial of Efficacy and Safety of Subetta in the Combined Treatment of Patients With Type II Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT01868646|
Recruitment Status : Completed
First Posted : June 4, 2013
Last Update Posted : December 7, 2017
The purpose of this study is:
- to assess clinical efficacy of Subetta in the combined treatment of type II diabetes mellitus;
- to assess safety of Subetta in the combined treatment of type II diabetes mellitus.
|Condition or disease||Intervention/treatment||Phase|
|Type II Diabetes Mellitus||Drug: Subetta Drug: Placebo||Phase 4|
Patients with type II diabetes mellitus are included in the trial. It is concerned those patients, who by the time of the trial receive basal insulin with metformin or metformin and sulfonylurea derivatives 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 exclusion criteria he/she is randomized in one of 2 groups: Group 1 - the group receiving standard type II diabetes mellitus therapy + Subetta at a dose of 1 tablet 4 times a day; Group 2 - the group receiving standard type II diabetes mellitus therapy + Placebo under the regimen used for Subetta. The invented names of the drugs containing basal insulin, metformin and sulfonylurea derivatives used as standard type II diabetes mellitus therapy, 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±1and 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 :||190 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 Efficacy and Safety of Subetta in the Combined Treatment of Patients With Type II Diabetes Mellitus|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||December 2016|
Standard therapy of type II diabetes mellitus + Subetta (1 tablet 4 times a day).
Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).
Efficacy and Safety of Subetta in the combined treatment of patients with type II diabetes mellitus
Placebo Comparator: Placebo
Standard therapy of type II diabetes mellitus + Placebo (1 tablet 4 times a day).
Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).
- Changes in the mean value of HbA1c [ Time Frame: In 12, 24 and 36 weeks of the treatment as compared to the baseline ]
- Dynamics of Fasting Plasma Glucose [ Time Frame: In 4, 12, 24 and 36 weeks of the treatment as compared to the baseline ]Based on the data of biochemical analysis
- Change in Average Daily Blood Glucose From a 7-point Patient Self-monitoring of Blood Glucose (SMBG) [ 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 ]
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.
- Mean value of C-peptide [ Time Frame: In 12, 24 and 36 weeks of the treatment as compared to the baseline ]
- Proportion of patients with increased and reduced level of C-peptide [ Time Frame: In 36 weeks of the treatment as compared to the baseline ]
- Dynamics of Lipid Spectrum (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 (if patient receives intermediate insulin twice-daily), prior to any morning medicines intake (including the study drug, metformin, sulfonylurea derivatives, permitted concomitant therapy).
- Changes in dosage of insulin (basal dose insulin measured in IU and IU/ kg of body weight) [ Time Frame: In 36 weeks of the treatment as compared to the baseline ]
Changes in basal insulin dose is based on the mean value of 3 consecutive measuring of level of fasting blood glucose.
- If value of fasting blood glucose at 7:00 AM on January 21, 2012 - 4.2 mmol/L, at 7:30 AM on January 22, 2012- 5.0 mmol/L, at 7:00 AM on January 23, 2012 4.8 mmol/L, then the mean level of blood glucose =4.7 mmol/L (4.2 +5.0 +4.8 divided by 3). It is not recommended to change the dose.
- If the mean value of fasting blood glucose is lower than 4.0 mmol/L and a patient shows unreasonable signs or symptoms of hypoglycemia, then dose of basal insulin should be reduced by 2 units.
- If value of fasting blood glucose for 3 consecutive days was ≥7 mmol/L, then dose of basal insulin should be increased by 2 units and more (depending on individual values).
Based on the same values investigator can change dose of per oral blood sugar-lowering drugs.
- Proportion of patients with changed daily dose of per oral blood sugar- lowering drugs [ Time Frame: In 36 weeks of the treatment ]
- Changes in the mean absolute value of body weight (kg) and body build index (kg/m^2) [ Time Frame: In 36 weeks of the treatment as compared to the baseline ]
- Satisfaction of Diabetes Treatment [ Time Frame: In 36 weeks of the treatment ]
Based on Diabetes Treatment Satisfaction Questionnaire (DTSQ) data. The DTSQ allows to assess the degree of satisfaction with treatment for diabetes and its complications - retinopathy and nephropathy.
The DTSQ included 8 questions. DTSQ scores from +3 = much more satisfied now to -3 = much less satisfied now, with 0 (midpoint), representing no change
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01868646
|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|
|Nizhny Novgorod regional State Budgetary Health Institution " Nizhny Novgorod regional Clinical Hospital named after N.A. Semashko "|
|Nizhny Novgorod Region, 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|
|The State Budgetary Educational Institution of Higher Professional Education "Smolensk National Research Medical University" Ministry of Health of the Russian Federation|
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|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"|
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|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|
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|St. Petersburg Sate Budgetary Institution "Consultative-Diagnostic Polyclinic №1 of Coastal Area"|
|St. Petersburg, Russian Federation, 197183|
|St. Petersburg State Budgetary Health Care Institution "Consultative-Diagnostic Center № 85", Diabetes Center №2|
|St. Petersburg, Russian Federation, 198260|
|St. Petersburg State Budgetary Health Care Institution "City Polyclinic №77 of Nevsky District", The City Diabetes Center №4|
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|Vladimir region State budgetary institution of health care "Regional clinical hospital"|
|Vladimir, Russian Federation, 600023|
|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|