Status:
COMPLETED
Clinical Trial of Efficacy and Safety of Subetta in the Combined Treatment of Patients With Type I Diabetes Mellitus
Lead Sponsor:
Materia Medica Holding
Conditions:
Type I Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is: * to assess clinical efficacy of Subetta in the combined treatment of type I diabetes mellitus; * to assess safety of Subetta in the combined treatment of type I diabete...
Detailed Description
Patients with type I diabetes mellitus are included in the trial. It is concerned those patients, who by the time of the trial receive basal bolus insulin therapy of type I diabetes mellitus, includin...
Eligibility Criteria
Inclusion
- Diagnosed type I diabetes mellitus (according to WHO criteria, 1999 - 2006).
- Disease duration no less than 6 months.
- Patient's age from 18 to 65 years inclusive.
- Level of glycosylated hemoglobin 7.0- 10.0 %.
- Glomerular filtration rate ≥ 60 ml/ min/1.73m\^2.
- Stable dose of basal insulin for the last 3 months. (Permissible fluctuations are ±10%.)
- 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.
- Availability of signed patient information sheet (Informed Consent form) for participation in the clinical trial.
Exclusion
- Acute diabetes mellitus complications for 3 months prior to inclusion in the trial (diabetic ketoacidosis, hyperosmolar hyperglycemic state, lacticemia, severe hypoglycemia and hypoglycemic coma).
- Diabetic retinopathy, preproliferative, proliferative or terminal stages (based on the results of oculist examination during screening period or 6 months prior to the trial).
- Diabetic nephropathy, proteinuria stage, chronic kidney disease on 3, 4 or 5 stage.
- Diabetic microangiopathy:
- ishemic heart disease (medical history of a sudden coronary death with successful reanimation, medical history of myocardial infarction, stable exertional angina III or IV FC; unstable angina; post-infarction 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).
- 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.
- 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.
- Severe concomitant pathology including clinically significant cardiovascular diseases of III - IV functional class (according to New York Heart Association classification, 1964), nervous and endocrine system diseases, including morbid obesity (body mass index≥40.0 kg/m2), renal insufficiency, liver failure.
- Medical history of pancreatectomy or transplantation of pancreatic/islet cells.
- Medical history of renal transplantation.
- Malignant neoplasms/suspected malignant neoplasms.
- Exacerbations or decompensation of chronic diseases affecting a patient's ability to participate in the clinical trial.
- Level of fasting triglycerides \>5.64 mmol/L.
- Medical history of bariatric surgical operations.
- Medical history of polyvalent allergy.
- Allergy/ intolerance to any of the components of medications used in the treatment.
- Intake of medicines listed in the section "Prohibited concomitant treatment" for 3 months prior to the inclusion in the trial.
- Pregnancy, breast-feeding.
- Drug addiction, alcohol usage in the amount exceeding 2 units of alcohol per day.
- Mental disorders of a patient.
- Night work.
- Participation in other clinical trials in the course of 3 months prior to the inclusion in the trial.
- 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.
- Other factors impeding patient's participation in the trial (for example, planned business trips or journeys).
- 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.
- 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.
Key Trial Info
Start Date :
May 7 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2016
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01868594
Start Date
May 7 2013
End Date
July 10 2016
Last Update
May 30 2019
Active Locations (15)
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1
State Healthcare Institution of Moscow "Central research institute of gastroenterology" of Department of health care of Moscow
Moscow, Russia, 111123
2
State Educational Institution of Higher Professional Education "Moscow State Medical Academy named after I.M. Sechenov"
Moscow, Russia, 119991
3
Nonstate Health Care Institution "Central Clinical Hospital №2 named after N.A. Semashko of Public Limited Company "Russian Railways"
Moscow, Russia, 129128
4
Municipal budgetary authority "Khimki Central Clinical Hospital"
Moscow Region, Russia, 141400