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Trial record 45 of 2363 for:    "Diabetes Mellitus, Insulin-Dependent"

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

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ClinicalTrials.gov Identifier: NCT01868594
Recruitment Status : Completed
First Posted : June 4, 2013
Results First Posted : March 4, 2019
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Materia Medica Holding

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition Type I Diabetes Mellitus
Interventions Drug: Subetta
Drug: Placebo
Enrollment 200
Recruitment Details The study enrolled patients using intensive insulin regimen (Short-acting and Long-acting human insulins) with type 1 diabetes who were not meeting glycemic control (HbA1c>7.0%). Eligible patients were assessed by endocrinologists. The study was performed in 15 medical institutions in Russia from May 2013 to October 2015.
Pre-assignment Details

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 200 patients enrolled, 49 did not meet inclusion criteria after screening procedures, they were not randomized

Arm/Group Title Subetta Placebo
Hide Arm/Group Description

Short-acting and Long-acting human insulins + 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 I diabetes mellitus

Short-acting and Long-acting human insulins + 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

Period Title: Overall Study
Started 76 75
Completed 72 72
Not Completed 4 3
Reason Not Completed
Do not meet inclusion criteria             4             3
Arm/Group Title Subetta Placebo Total
Hide Arm/Group Description

Short-acting and Long-acting human insulins + 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 I diabetes mellitus

Short-acting and Long-acting human insulins + 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 of all reporting groups
Overall Number of Baseline Participants 72 72 144
Hide Baseline Analysis Population Description
Intention-to-Treat set
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 72 participants 72 participants 144 participants
37.2  (9.6) 35.0  (10.4) 36.1  (10.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 72 participants 144 participants
Female
34
  47.2%
36
  50.0%
70
  48.6%
Male
38
  52.8%
36
  50.0%
74
  51.4%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram
Number Analyzed 72 participants 72 participants 144 participants
77.7  (15.2) 74.4  (13.5) 76.0  (14.4)
1.Primary Outcome
Title Changes in the Mean Value of HbA1c
Hide Description 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.
Time Frame baseline and 12, 24 and 36 weeks of the treatment
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Hide Analysis Population Description
Intention-to-Treat set
Arm/Group Title Subetta Placebo
Hide Arm/Group Description:

Short-acting and Long-acting human insulins + 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 I diabetes mellitus

Short-acting and Long-acting human insulins + 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 Number of Participants Analyzed 72 72
Mean (Standard Deviation)
Unit of Measure: percentage of HbA1c
12 weeks -0.71  (0.91) -0.49  (1.02)
24 weeks -0.66  (0.94) -0.27  (1.13)
36 weeks -0.59  (0.99) -0.20  (1.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Subetta, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments The p-value associated with "treatment" factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction.
Method Mixed Models Analysis
Comments [Not Specified]
2.Secondary Outcome
Title Change in Fasting Plasma Glucose (Based on the Data of Biochemical Analysis)
Hide Description [Not Specified]
Time Frame baseline and 4, 12, 24 and 36 weeks of the treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat set
Arm/Group Title Subetta Placebo
Hide Arm/Group Description:

Short-acting and Long-acting human insulins + 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 I diabetes mellitus

Short-acting and Long-acting human insulins + 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 Number of Participants Analyzed 72 72
Mean (Standard Deviation)
Unit of Measure: mmol / l
4 weeks -0.5  (5.1) 0.3  (4.6)
12 weeks -0.2  (4.8) 0.8  (4.9)
24 weeks -0.7  (4.9) 0.7  (5.4)
36 weeks -0.8  (4.8) 1.1  (5.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Subetta, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0432
Comments The p-value associated with "treatment" factor of changes from baseline to Week 4, 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction.
Method Mixed Models Analysis
Comments [Not Specified]
3.Secondary Outcome
Title Change in Average Daily Blood Glucose From a 7-point Patient Self-monitoring of Blood Glucose (SMBG)
Hide Description

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.

Time Frame baseline and 4, 8, 12, 18, 24, 30 and 36 weeks of the treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat. 2 patients (1 in Subetta group and 1 in Placebo group) was excluded from the analysis due to lake of diaries
Arm/Group Title Subetta Placebo
Hide Arm/Group Description:

Short-acting and Long-acting human insulins + 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 I diabetes mellitus

Short-acting and Long-acting human insulins + 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 Number of Participants Analyzed 71 71
Mean (Standard Deviation)
Unit of Measure: mmol / l
4 weeks -0.1  (1.4) 0.1  (1.8)
8 weeks -0.2  (1.7) -0.1  (2.0)
12 weeks -0.2  (1.6) -0.2  (2.0)
18 weeks -0.1  (2.2) -0.1  (1.9)
24 weeks -0.3  (1.7) 0.0  (2.0)
30 weeks 0.0  (1.8) -0.1  (1.8)
36 weeks -0.1  (1.9) 0.0  (2.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Subetta, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7344
Comments The p-value associated with "treatment" factor of changes from baseline to Week 4, 8, 12, 18, 24, 30 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction.
Method Mixed Models Analysis
Comments [Not Specified]
4.Secondary Outcome
Title Changes in Lipids (Concentrations of Plasma Total Cholesterol, HDL Cholesterol, LDL Cholesterol and Triglycerides)
Hide Description 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).
Time Frame baseline and 12, 24 and 36 weeks of the treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat set
Arm/Group Title Subetta Placebo
Hide Arm/Group Description:

Short-acting and Long-acting human insulins + 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 I diabetes mellitus

Short-acting and Long-acting human insulins + 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 Number of Participants Analyzed 72 72
Mean (Standard Deviation)
Unit of Measure: mmol / l
Total cholesterol (12 weeks) 0.2  (1.0) 0.2  (0.9)
Total cholesterol (24 weeks) 0.1  (1.1) 0.4  (1.2)
Total cholesterol (36 weeks) 0.2  (1.0) 0.3  (1.2)
HDL cholesterol (12 weeks) 0.1  (0.3) 0.0  (0.3)
HDL cholesterol (24 weeks) 0.0  (0.3) 0.0  (0.3)
HDL cholesterol (36 weeks) 0.1  (0.3) 0.0  (0.3)
LDL cholesterol (12 weeks) 0.2  (0.8) 0.2  (0.6)
LDL cholesterol (24 weeks) 0.0  (0.9) 0.3  (0.9)
LDL cholesterol (36 weeks) 0.1  (0.8) 0.3  (0.9)
Triglycerides (12 weeks) -0.1  (0.6) 0.1  (0.8)
Triglycerides (24 weeks) -0.1  (0.6) 0.0  (0.6)
Triglycerides (36 weeks) -0.1  (0.6) 0.1  (0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Subetta, Placebo
Comments Analysis of Total cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2780
Comments The p-value associated with "treatment" factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction.
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Subetta, Placebo
Comments Analysis of HDL cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8114
Comments The p-value associated with "treatment" factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction.
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Subetta, Placebo
Comments Analysis of LDL cholesterol changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1619
Comments The p-value associated with "treatment" factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction.
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Subetta, Placebo
Comments Analysis of Triglycerides changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0764
Comments The p-value associated with "treatment" factor of changes from baseline to Week 12, 24 and 36 endpoint between Subetta and Placebo treatment groups. Model includes treatment, visit and treatment*visit interaction.
Method Mixed Models Analysis
Comments [Not Specified]
5.Secondary Outcome
Title Changes in Dosage of Insulin (Basal, Prandial and Total Daily Dose Insulin Measured in IU)
Hide Description 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.
Time Frame baseline and 36 weeks of the treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat set
Arm/Group Title Subetta Placebo
Hide Arm/Group Description:

Short-acting and Long-acting human insulins + 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 I diabetes mellitus

Short-acting and Long-acting human insulins + 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 Number of Participants Analyzed 72 72
Mean (Standard Deviation)
Unit of Measure: IU
Basal insulin (36 weeks) 0.4  (2.4) 0.9  (2.9)
Prandial insulin (36 weeks) -1.6  (6.9) -0.9  (4.5)
Total daily dose insulin (36 weeks) -1.2  (8.3) 0.0  (6.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Subetta, Placebo
Comments Analysis of basal insulin changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3107
Comments The p-value associated with comparison of changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Subetta, Placebo
Comments Analysis of prandial insulin changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5236
Comments The p-value associated with comparison of changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Subetta, Placebo
Comments Analysis of total daily dose insulin changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3847
Comments The p-value associated with comparison of changes from baseline to Week 36 endpoint between Subetta and Placebo treatment groups.
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Changes in Dosage of Total Insulin Measured in IU/kg of Body Weight
Hide Description 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.
Time Frame baseline and 36 weeks of the treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat set
Arm/Group Title Subetta Placebo
Hide Arm/Group Description:

Standard therapy of type I 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 I diabetes mellitus

Standard therapy of type I 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 Number of Participants Analyzed 72 72
Mean (Standard Deviation)
Unit of Measure: IU/kg
-0.02  (0.09) -0.01  (0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Subetta, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6716
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Satisfaction of Diabetes Treatment Based on Diabetes Treatment Satisfaction Questionnaire Data
Hide Description

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).

Time Frame 36 weeks of the treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat set. 6 patients (1 in the Subetta group and 5 in the Placebo group) was excluded from the analysis due to lake of questionnaires.
Arm/Group Title Subetta Placebo
Hide Arm/Group Description:

Short-acting and Long-acting human insulins + 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 I diabetes mellitus

Short-acting and Long-acting human insulins + 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 Number of Participants Analyzed 71 67
Mean (Standard Deviation)
Unit of Measure: score on a scale
Satisfaction 9.7  (6.6) 8.4  (6.5)
Hyperglycemia -0.7  (1.5) -0.6  (1.6)
Hypoglycemia -0.4  (1.6) -0.6  (1.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Subetta, Placebo
Comments Analysis of total Treatment Satisfaction score at Week 36 endpoint between Subetta and Placebo treatment groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2484
Comments The p-value associated with comparison of Week 36 endpoint between Subetta and Placebo treatment groups.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Subetta, Placebo
Comments Analysis of "Perceived Hyperglycaemia" question at Week 36 endpoint between Subetta and Placebo treatment groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7610
Comments The p-value associated with comparison of Week 36 endpoint between Subetta and Placebo treatment groups.
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Subetta, Placebo
Comments Analysis of "Perceived Hypoglycemia" question at Week 36 endpoint between Subetta and Placebo treatment groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3714
Comments The p-value associated with comparison of Week 36 endpoint between Subetta and Placebo treatment groups.
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Adverse/Serious adverse events were registered during 36 weeks of therapy and 30 days after the end of therapy.
Adverse Event Reporting Description Adverse/Serious adverse events were registered in patients of the Full Analysis Set (n=151, Safety Population)
 
Arm/Group Title Subetta Placebo
Hide Arm/Group Description

Standard therapy of type I 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 I diabetes mellitus

Standard therapy of type I 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

All-Cause Mortality
Subetta Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Subetta Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/76 (2.63%)   3/75 (4.00%) 
Infections and infestations     
Parotid abscess  1  0/76 (0.00%)  1/75 (1.33%) 
Injury, poisoning and procedural complications     
Fracture of humerus  1  1/76 (1.32%)  0/75 (0.00%) 
Metabolism and nutrition disorders     
Type I diabetes mellitus with ketoacidosis  1  0/76 (0.00%)  1/75 (1.33%) 
Vascular disorders     
Hypertension arterial  1  1/76 (1.32%)  0/75 (0.00%) 
Chronic venous insufficiency  1  0/76 (0.00%)  1/75 (1.33%) 
Varicose veins of lower extremities  1  0/76 (0.00%)  1/75 (1.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Subetta Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   16/76 (21.05%)   18/75 (24.00%) 
Blood and lymphatic system disorders     
Inflammation of inguinal lymphonodus on the right  1  0/76 (0.00%)  1/75 (1.33%) 
Endocrine disorders     
Goiter  1  1/76 (1.32%)  0/75 (0.00%) 
Subclinical hypothyreoidism  1  1/76 (1.32%)  0/75 (0.00%) 
Gastrointestinal disorders     
Bacterial food poisoning  1  1/76 (1.32%)  0/75 (0.00%) 
Heartburn  1 [1]  1/76 (1.32%)  0/75 (0.00%) 
Epigastric pain  1  0/76 (0.00%)  1/75 (1.33%) 
Dentalgia  1  0/76 (0.00%)  1/75 (1.33%) 
General disorders     
Increase in body temperature to 38.5 C  1  0/76 (0.00%)  2/75 (2.67%) 
Increase in body temperature up to 38.2 С  1  0/76 (0.00%)  1/75 (1.33%) 
Hepatobiliary disorders     
Diabetic hepatosis  1  1/76 (1.32%)  0/75 (0.00%) 
Immune system disorders     
Allergic reactions  1  0/76 (0.00%)  1/75 (1.33%) 
Infections and infestations     
Angina  1  0/76 (0.00%)  1/75 (1.33%) 
Acute respiratory viral infection  1  5/76 (6.58%)  3/75 (4.00%) 
Acute respiratory disease  1  0/76 (0.00%)  3/75 (4.00%) 
Acute bronchitis  1  0/76 (0.00%)  3/75 (4.00%) 
Parodontosis  1  0/76 (0.00%)  1/75 (1.33%) 
Epididymitis  1  0/76 (0.00%)  1/75 (1.33%) 
Injury, poisoning and procedural complications     
Contusion of the hand  1  0/76 (0.00%)  1/75 (1.33%) 
Investigations     
Palpitations  1  1/76 (1.32%)  0/75 (0.00%) 
Increased blood pressure to 150/90 mm Hg, headache, nausea  1  0/76 (0.00%)  1/75 (1.33%) 
Increased body temperature  1  0/76 (0.00%)  1/75 (1.33%) 
Metabolism and nutrition disorders     
Fasting hyperglycemia  1  2/76 (2.63%)  3/75 (4.00%) 
Ketoacidosis  1  0/76 (0.00%)  2/75 (2.67%) 
Musculoskeletal and connective tissue disorders     
Pain in the shoulder  1  0/76 (0.00%)  1/75 (1.33%) 
Heavy legs  1  1/76 (1.32%)  0/75 (0.00%) 
Leg cramps  1  1/76 (1.32%)  0/75 (0.00%) 
Cervicalgia  1  0/76 (0.00%)  2/75 (2.67%) 
Nervous system disorders     
Headache  1  5/76 (6.58%)  2/75 (2.67%) 
Pregnancy, puerperium and perinatal conditions     
Pregnancy  1  1/76 (1.32%)  0/75 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Vasomotor rhinitis  1  0/76 (0.00%)  1/75 (1.33%) 
Throat irritation  1  0/76 (0.00%)  1/75 (1.33%) 
Vascular disorders     
Increased blood pressure  1  1/76 (1.32%)  0/75 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
[1]
exacerbation of chronic gastritis
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Michael Putilovskiy, MD, PhD, Clinical Research and Medical Information Director
Organization: Materia Medica Holding
Phone: +74952761571 ext 302
Responsible Party: Materia Medica Holding
ClinicalTrials.gov Identifier: NCT01868594     History of Changes
Other Study ID Numbers: MMH-SU-003
First Submitted: May 27, 2013
First Posted: June 4, 2013
Results First Submitted: November 7, 2017
Results First Posted: March 4, 2019
Last Update Posted: May 30, 2019