Trial Outcomes & Findings for Clinical Trial of Efficacy and Safety of Subetta in the Combined Treatment of Patients With Type II Diabetes Mellitus (NCT NCT01868646)

Last Updated: 2019-05-31

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

190 participants

Primary outcome timeframe

In 12, 24 and 36 weeks of the treatment as compared to the baseline

Results posted on

2019-05-31

Participant Flow

Selection procedures were carried out after participant enrollment to determine whether the patient could participate in the study in accordance with the inclusion/exclusion criteria. Of the 190 patients enrolled, 42 did not meet inclusion criteria after screening procedures, they were not randomized

Participant milestones

Participant milestones
Measure	Subetta 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). One tablet contains: affinity purified antibodies to the C-terminal fragment of the beta subunit receptor insulin - 0.006g\, affinity purified antibodies to endothelial NO synthase - 0.006g\. \*applied onto isomalt crystals as a mixture of three active aqueous-alcoholic dilutions of the drug substance - diluted 100\^12, 100\^30, 100\^200 times, respectively. Excipients: isomalt, crospovidone, magnesium stearate.	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). Placebo
Overall Study STARTED	76	72
Overall Study COMPLETED	73	67
Overall Study NOT COMPLETED	3	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Subetta 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). One tablet contains: affinity purified antibodies to the C-terminal fragment of the beta subunit receptor insulin - 0.006g\, affinity purified antibodies to endothelial NO synthase - 0.006g\. \*applied onto isomalt crystals as a mixture of three active aqueous-alcoholic dilutions of the drug substance - diluted 100\^12, 100\^30, 100\^200 times, respectively. Excipients: isomalt, crospovidone, magnesium stearate.	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). Placebo
Overall Study Do not meet inclusion criteria	3	5

Baseline Characteristics

Clinical Trial of Efficacy and Safety of Subetta in the Combined Treatment of Patients With Type II Diabetes Mellitus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subetta n=73 Participants 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). Subetta: Efficacy and Safety of Subetta in the combined treatment of patients with type II diabetes mellitus	Placebo n=67 Participants 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). Placebo	Total n=140 Participants Total of all reporting groups
Age, Continuous	57.9 years STANDARD_DEVIATION 7.1 • n=5 Participants	57.3 years STANDARD_DEVIATION 6.2 • n=7 Participants	57.6 years STANDARD_DEVIATION 6.7 • n=5 Participants
Sex: Female, Male Female	59 Participants n=5 Participants	54 Participants n=7 Participants	113 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Weight	85.7 kilogram STANDARD_DEVIATION 13.0 • n=5 Participants	89.0 kilogram STANDARD_DEVIATION 11.7 • n=7 Participants	87.1 kilogram STANDARD_DEVIATION 12.5 • n=5 Participants
Height	164.1 centimeter STANDARD_DEVIATION 7.7 • n=5 Participants	165.3 centimeter STANDARD_DEVIATION 7.3 • n=7 Participants	164.7 centimeter STANDARD_DEVIATION 7.5 • n=5 Participants
BMI	31.7 kilogram/m^2 STANDARD_DEVIATION 4.0 • n=5 Participants	32.5 kilogram/m^2 STANDARD_DEVIATION 3.6 • n=7 Participants	32.1 kilogram/m^2 STANDARD_DEVIATION 3.8 • n=5 Participants

PRIMARY outcome

Timeframe: In 12, 24 and 36 weeks of the treatment as compared to the baseline

Population: Intention-to-Treat set

Outcome measures

Outcome measures
Measure	Subetta n=73 Participants 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). Subetta: Efficacy and Safety of Subetta in the combined treatment of patients with type II diabetes mellitus	Placebo n=67 Participants 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). Placebo
Changes in the Mean Value of HbA1c 12 weeks	-0.53 percentage of HbA1c Standard Deviation 1.06	-0.01 percentage of HbA1c Standard Deviation 1.06
Changes in the Mean Value of HbA1c 24 weeks	-0.54 percentage of HbA1c Standard Deviation 1.00	-0.07 percentage of HbA1c Standard Deviation 1.19
Changes in the Mean Value of HbA1c 36 weeks	-0.54 percentage of HbA1c Standard Deviation 1.11	0.15 percentage of HbA1c Standard Deviation 1.07

SECONDARY outcome

Timeframe: In 4, 12, 24 and 36 weeks of the treatment as compared to the baseline

Population: Intention-to-Threat set

Based on the data of biochemical analysis

Outcome measures

Outcome measures
Measure	Subetta n=73 Participants 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). Subetta: Efficacy and Safety of Subetta in the combined treatment of patients with type II diabetes mellitus	Placebo n=67 Participants 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). Placebo
Change in Fasting Plasma Glucose 4 weeks	-0.5 mmol / l Standard Deviation 2.6	-0.1 mmol / l Standard Deviation 3.2
Change in Fasting Plasma Glucose 12 weeks	0.0 mmol / l Standard Deviation 2.5	0.9 mmol / l Standard Deviation 3.3
Change in Fasting Plasma Glucose 24 weeks	0.0 mmol / l Standard Deviation 2.9	0.9 mmol / l Standard Deviation 4.1
Change in Fasting Plasma Glucose 36 weeks	0.0 mmol / l Standard Deviation 3.1	1.0 mmol / l Standard Deviation 3.7

SECONDARY outcome

Timeframe: During the whole study period (on weeks 4, 8, 12, 18, 24, 30 and 36 of the treatment) as compared to the baseline

Population: Intention-to-Treat set. The SMBG in 3 patients (2 in the Subetta and 1 in the Placebo) was excluded from the analysis due to mistakes in diaries.

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.

Outcome measures

Outcome measures
Measure	Subetta n=71 Participants 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). Subetta: Efficacy and Safety of Subetta in the combined treatment of patients with type II diabetes mellitus	Placebo n=66 Participants 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). Placebo
Change in Average Daily Blood Glucose From a 7-point Patient Self-monitoring of Blood Glucose (SMBG) 30 weeks	-0.3 mmol / l Standard Deviation 1.7	-0.5 mmol / l Standard Deviation 1.5
Change in Average Daily Blood Glucose From a 7-point Patient Self-monitoring of Blood Glucose (SMBG) 36 weeks	-0.5 mmol / l Standard Deviation 1.9	-0.6 mmol / l Standard Deviation 1.7
Change in Average Daily Blood Glucose From a 7-point Patient Self-monitoring of Blood Glucose (SMBG) 4 weeks	-0.3 mmol / l Standard Deviation 1.5	-0.5 mmol / l Standard Deviation 1.8
Change in Average Daily Blood Glucose From a 7-point Patient Self-monitoring of Blood Glucose (SMBG) 8 weeks	-0.3 mmol / l Standard Deviation 1.6	-0.5 mmol / l Standard Deviation 1.7
Change in Average Daily Blood Glucose From a 7-point Patient Self-monitoring of Blood Glucose (SMBG) 12 weeks	-0.4 mmol / l Standard Deviation 1.7	-0.4 mmol / l Standard Deviation 2.1
Change in Average Daily Blood Glucose From a 7-point Patient Self-monitoring of Blood Glucose (SMBG) 18 weeks	-0.2 mmol / l Standard Deviation 1.6	-0.4 mmol / l Standard Deviation 1.6
Change in Average Daily Blood Glucose From a 7-point Patient Self-monitoring of Blood Glucose (SMBG) 24 weeks	-0.5 mmol / l Standard Deviation 1.6	-0.5 mmol / l Standard Deviation 1.7

SECONDARY outcome

Timeframe: In 12, 24 and 36 weeks of the treatment as compared to the baseline

Population: Intention-to-Treat set.

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).

Outcome measures

Outcome measures
Measure	Subetta n=73 Participants 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). Subetta: Efficacy and Safety of Subetta in the combined treatment of patients with type II diabetes mellitus	Placebo n=67 Participants 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). Placebo
Mean Value of C-peptide 0 week	615.3 pmol / l Standard Deviation 418.9	607.6 pmol / l Standard Deviation 425.4
Mean Value of C-peptide 12 weeks	628.3 pmol / l Standard Deviation 400.8	607.7 pmol / l Standard Deviation 405.6
Mean Value of C-peptide 24 weeks	643.3 pmol / l Standard Deviation 419.2	641.6 pmol / l Standard Deviation 426.3
Mean Value of C-peptide 36 weeks	589.6 pmol / l Standard Deviation 343.5	540.0 pmol / l Standard Deviation 328.3

SECONDARY outcome

Timeframe: In 12, 24 and 36 weeks of the treatment as compared to the baseline

Population: Intention-to-Treat set.

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).

Outcome measures

Outcome measures
Measure	Subetta n=73 Participants 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). Subetta: Efficacy and Safety of Subetta in the combined treatment of patients with type II diabetes mellitus	Placebo n=67 Participants 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). Placebo
Changes in Lipids (Concentrations of Plasma Total Cholesterol, HDL Cholesterol, LDL Cholesterol and Triglycerides) HDL cholesterol (12 weeks)	0.0 mmol / l Standard Deviation 0.2	0.0 mmol / l Standard Deviation 0.2
Changes in Lipids (Concentrations of Plasma Total Cholesterol, HDL Cholesterol, LDL Cholesterol and Triglycerides) Triglycerides (36 weeks)	0.1 mmol / l Standard Deviation 0.9	-0.1 mmol / l Standard Deviation 0.9
Changes in Lipids (Concentrations of Plasma Total Cholesterol, HDL Cholesterol, LDL Cholesterol and Triglycerides) Total cholesterol (12 weeks)	0.1 mmol / l Standard Deviation 1.1	0.1 mmol / l Standard Deviation 1.2
Changes in Lipids (Concentrations of Plasma Total Cholesterol, HDL Cholesterol, LDL Cholesterol and Triglycerides) Total cholesterol (24 weeks)	0.1 mmol / l Standard Deviation 1.2	0.1 mmol / l Standard Deviation 0.9
Changes in Lipids (Concentrations of Plasma Total Cholesterol, HDL Cholesterol, LDL Cholesterol and Triglycerides) Total cholesterol (36 weeks)	0.3 mmol / l Standard Deviation 1.1	0.0 mmol / l Standard Deviation 1.1
Changes in Lipids (Concentrations of Plasma Total Cholesterol, HDL Cholesterol, LDL Cholesterol and Triglycerides) HDL cholesterol (24 weeks)	0.0 mmol / l Standard Deviation 0.2	0.0 mmol / l Standard Deviation 0.2
Changes in Lipids (Concentrations of Plasma Total Cholesterol, HDL Cholesterol, LDL Cholesterol and Triglycerides) HDL cholesterol (36 weeks)	0.0 mmol / l Standard Deviation 0.3	0.0 mmol / l Standard Deviation 0.2
Changes in Lipids (Concentrations of Plasma Total Cholesterol, HDL Cholesterol, LDL Cholesterol and Triglycerides) LDL cholesterol (12 weeks)	0.1 mmol / l Standard Deviation 0.8	0.0 mmol / l Standard Deviation 0.9
Changes in Lipids (Concentrations of Plasma Total Cholesterol, HDL Cholesterol, LDL Cholesterol and Triglycerides) LDL cholesterol (24 weeks)	0.1 mmol / l Standard Deviation 0.9	0.1 mmol / l Standard Deviation 0.8
Changes in Lipids (Concentrations of Plasma Total Cholesterol, HDL Cholesterol, LDL Cholesterol and Triglycerides) LDL cholesterol (36 weeks)	0.2 mmol / l Standard Deviation 0.8	0.1 mmol / l Standard Deviation 0.9
Changes in Lipids (Concentrations of Plasma Total Cholesterol, HDL Cholesterol, LDL Cholesterol and Triglycerides) Triglycerides (12 weeks)	0.2 mmol / l Standard Deviation 0.8	0.2 mmol / l Standard Deviation 0.9
Changes in Lipids (Concentrations of Plasma Total Cholesterol, HDL Cholesterol, LDL Cholesterol and Triglycerides) Triglycerides (24 weeks)	0.1 mmol / l Standard Deviation 0.9	0.0 mmol / l Standard Deviation 0.8

SECONDARY outcome

Timeframe: In 36 weeks of the treatment as compared to the baseline

Population: Intention-to-Treat

Changes in basal insulin dose is based on the mean value of 3 consecutive measuring of level of fasting blood glucose. 1. 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. 2. 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. 3. 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.

Outcome measures

Outcome measures
Measure	Subetta n=73 Participants 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). Subetta: Efficacy and Safety of Subetta in the combined treatment of patients with type II diabetes mellitus	Placebo n=67 Participants 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). Placebo
Changes in Dosage of Insulin (Basal Dose Insulin Measured in IU/Day)	-0.9 IU/day Standard Deviation 2.4	3.5 IU/day Standard Deviation 9.5

SECONDARY outcome

Timeframe: In 36 weeks of the treatment as compared to the baseline

Population: Intention-to-Treat set

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.

Outcome measures

Outcome measures
Measure	Subetta n=73 Participants 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). Subetta: Efficacy and Safety of Subetta in the combined treatment of patients with type II diabetes mellitus	Placebo n=67 Participants 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). Placebo
Changes in Dosage of Insulin (Basal Dose Insulin Measured in IU/ kg of Body Weight)	-0.01 IU/kg Standard Deviation 0.03	0.04 IU/kg Standard Deviation 0.1

SECONDARY outcome

Timeframe: In 36 weeks of the treatment

Population: Intention-to-Treat set

Outcome measures

Outcome measures
Measure	Subetta n=73 Participants 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). Subetta: Efficacy and Safety of Subetta in the combined treatment of patients with type II diabetes mellitus	Placebo n=67 Participants 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). Placebo
Percentage of Patients With Changed Daily Dose of Per Oral Blood Sugar- Lowering Drugs	4.1 percentage of patients	9.0 percentage of patients

SECONDARY outcome

Timeframe: In 36 weeks of the treatment as compared to the baseline

Population: Intention-to-Treat set. Data on body weight in one patient from the placebo group were absent

Outcome measures

Outcome measures
Measure	Subetta n=73 Participants 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). Subetta: Efficacy and Safety of Subetta in the combined treatment of patients with type II diabetes mellitus	Placebo n=66 Participants 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). Placebo
Changes in the Mean Absolute Value of Body Weight (kg)	-0.1 kg Standard Deviation 2.2	0.4 kg Standard Deviation 3.4

SECONDARY outcome

Timeframe: baseline and 36 weeks of the treatment

Population: Intention-to-Treat set. Data on body weight in one patient from the placebo group were absent

Outcome measures

Outcome measures
Measure	Subetta n=73 Participants 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). Subetta: Efficacy and Safety of Subetta in the combined treatment of patients with type II diabetes mellitus	Placebo n=66 Participants 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). Placebo
Changes in the Mean Absolute Value of Body Mass Index (BMI) (kg/m^2)	-0.04 kg/m^2 Standard Deviation 0.78	0.14 kg/m^2 Standard Deviation 1.33

SECONDARY outcome

Timeframe: In 36 weeks of the treatment

Population: Intention-to-Treat set. 8 patients (6 in the Subetta group and 2 in the Placebo group) was excluded from the analysis due to lake of questionnaires.

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).

Outcome measures

Outcome measures
Measure	Subetta n=67 Participants 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). Subetta: Efficacy and Safety of Subetta in the combined treatment of patients with type II diabetes mellitus	Placebo n=65 Participants 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). Placebo
Satisfaction of Diabetes Treatment Based on Diabetes Treatment Satisfaction Questionnaire Data Satisfaction	9.8 Scores on a scale Standard Deviation 5.7	8.3 Scores on a scale Standard Deviation 6.1
Satisfaction of Diabetes Treatment Based on Diabetes Treatment Satisfaction Questionnaire Data Hyperglycemia	-1.1 Scores on a scale Standard Deviation 1.6	-0.9 Scores on a scale Standard Deviation 1.7
Satisfaction of Diabetes Treatment Based on Diabetes Treatment Satisfaction Questionnaire Data Hypoglycemia	-1.1 Scores on a scale Standard Deviation 1.5	-1.0 Scores on a scale Standard Deviation 1.6

Adverse Events

Subetta

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Subetta n=76 participants at risk 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). Subetta: Efficacy and Safety of Subetta in the combined treatment of patients with type II diabetes mellitus	Placebo n=72 participants at risk 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). Placebo
Nervous system disorders Brain stem stroke	1.3% 1/76 • Adverse/Serious adverse events were registered during 36 weeks of therapy and 30 days after the end of therapy. Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=148, Safety Population)	0.00% 0/72 • Adverse/Serious adverse events were registered during 36 weeks of therapy and 30 days after the end of therapy. Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=148, Safety Population)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain tumor NOS	0.00% 0/76 • Adverse/Serious adverse events were registered during 36 weeks of therapy and 30 days after the end of therapy. Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=148, Safety Population)	1.4% 1/72 • Adverse/Serious adverse events were registered during 36 weeks of therapy and 30 days after the end of therapy. Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=148, Safety Population)

Other adverse events

Additional Information

Michael Putilovskiy, MD, PhD, Clinical Research and Medical Information Director

Materia Medica Holding

Phone: +74952761571

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place