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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
Sponsor:
Information provided by (Responsible Party):
Materia Medica Holding

Brief Summary:

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

Detailed Description:

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
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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).

Drug: Subetta
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).

Drug: Placebo



Primary Outcome Measures :
  1. Changes in the mean value of HbA1c [ Time Frame: In 12, 24 and 36 weeks of the treatment as compared to the baseline ]

Secondary Outcome Measures :
  1. 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

  2. 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.


  3. Mean value of C-peptide [ Time Frame: In 12, 24 and 36 weeks of the treatment as compared to the baseline ]
  4. Proportion of patients with increased and reduced level of C-peptide [ Time Frame: In 36 weeks of the treatment as compared to the baseline ]
  5. 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).

  6. 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.

    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.


  7. Proportion of patients with changed daily dose of per oral blood sugar- lowering drugs [ Time Frame: In 36 weeks of the treatment ]
  8. 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 ]
  9. 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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosed type II diabetes mellitus (according to WHO criteria, 1999 - 2006).
  2. Patient's age from 18 to 65 years inclusive.
  3. Level of glycosylated hemoglobin 7.0- 10.0 %.
  4. Dose of basal insulin ≥10 units/day combined with metformin or with metformin and sulfonylurea derivatives during not less than 3 months prior to inclusion in the trial.
  5. Body-weight index ≥25.0 and ≤40.0kg/m^2.
  6. Constant body weight (without fluctuations > 10% during not less than 3 months prior to inclusion in the trial).
  7. Glomerular filtration rate ≥ 60 ml/ min/1.73m^2.
  8. Stable dose of basal insulin for the last 3 months.(Permissible fluctuations are ±10%.)
  9. Usage of contraceptive methods by both gender patients of reproductive age during the trial and within 30 days after ending the participation in the trial.
  10. Availability of signed patient information sheet (Informed Consent form) for participation in the clinical trial.

Exclusion Criteria:

  1. Acute diabetes mellitus complications for 3 months prior to inclusion in the trial (diabetic ketoacidosis, hyperosmolar hyperglycemic state, lacticemia, severe hypoglycemia and hypoglycemic coma).
  2. Diabetic retinopathy, preproliferative, proliferative or terminal stages (based on the results of oculist examination during screening period or 6 months prior to the trial).
  3. Diabetic nephropathy, proteinuria stage, chronic kidney disease on 3, 4 or 5 stage.
  4. Diabetic microangiopathy:

    • ishemic heart disease (medical history of a sudden coronary death with successful reanimation, medical history of miocardial infarction, stable exertional angina III or IV FC; instable angina; postinfarction cardiosclerosis; chronic heart failure III or IV FC);
    • cerebrovascular diseases (medical history of acute cerebrovascular accident; progressive vascular leukoencephalopathy; vascular dementia);
    • chronic obliterative peripheral vascular diseases (clinically significant);
    • diabetic neuroosteoarthropathy;
    • diabetic foot (clinically significant).
  5. Heart rhythm disorder:

    • II-III atrioventricular block;
    • sick sinus syndrome;
    • long QT interval syndrome;
    • complete left bundle branch block;
    • block of 2/3 bundle branches;
    • WPW syndrome;
    • ventricular arrhythmia of III grade according Laun-Wolf;
    • paroxysmal supraventricular tachycardia;
    • paroxysmal/recurrent ventricular tachycardia;
    • atrial flutter and fibrillation;
    • ventricular flutter and fibrillation;
    • heart pacemaker implant.
  6. Uncontrolled arterial hypertension characterized by the following blood tension values: systolic blood pressure over 160 mm Hg and/or diastolic blood pressure over 100 mm Hg.
  7. Severe concomitant pathology including clinically significant cardio- vascular diseases of III - IV functional class (according to New York Heart Association classification, 1964), nervous and endocrine system diseases, including morbid obesity (body build index≥40.0 kg/m^2), renal insufficiency, liver failure.
  8. Medical history of pancreatectomy or transplantation of pancreatic/islet cells.
  9. Medical history of renal transplantation.
  10. Malignant neoplasms/suspected malignant neoplasms.
  11. Exacerbations or decompensation of chronic diseases affecting a patient's ability to participate in the clinical trial.
  12. The results of analysis of liver enzymes (alanine aminotransferase, aspartate aminotransferase) more than threefold exceeding of upper limit of normal values.
  13. Level of fasting triglycerides >5.64 mmol/L.
  14. Medical history of bariatric surgical operations.
  15. Medical history of polyvalent allergy
  16. Allergy/ intolerance to any of the components of medications used in the treatment.
  17. Intake of medicines listed in the section "Prohibited concomitant treatment" for 3 months prior to the inclusion in the trial.
  18. Pregnancy, breast-feeding.
  19. Drug addiction, alcohol usage in the amount exceeding 2 units of alcohol per day.
  20. Mental disorders of a patient.
  21. Night work.
  22. Participation in other clinical trials in the course of 3 months prior to the inclusion in the trial.
  23. Patients, who from the investigator's point of view, will fail to comply with the observation requirements of the trial or with the intake regimen of the investigated medicines.
  24. Other factors impeding patient's participation in the trial (for example, planned business trips or journeys).
  25. Patient is related to the research personnel of the investigative site, who are directly involved in the trial or are the immediate relative of the researcher. The immediate relative includes husband/wife, parents, children or brothers (or sisters), regardless of whether they are natural or adopted.
  26. Patient works for OOO "NPF "Materia Medica Holding" (i.e. is the company's employee, temporary contract worker or appointed official responsible for the carrying out the research) or the immediate relative.

Information from the National Library of Medicine

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


Locations
Russian Federation
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
Smolensk, Russian Federation, 214019
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
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
St.Petersburg, Russian Federation, 192177
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
Sponsors and Collaborators
Materia Medica Holding

Responsible Party: Materia Medica Holding
ClinicalTrials.gov Identifier: NCT01868646     History of Changes
Other Study ID Numbers: MMH-SU-004
First Posted: June 4, 2013    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2016

Keywords provided by Materia Medica Holding:
Combined Treatment of Patients With Type II Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases