Type I Diabetes MellitusPhase 4NCT01868594
Clinical Trial of Efficacy and Safety of Subetta in the Combined Treatment of Patients With Type I Diabetes Mellitus
A Phase 4 study testing Subetta in people with Type I Diabetes Mellitus, run by Materia Medica Holding at 15 sites in Russia.
Trial 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 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type I Diabetes Mellitus
- What is being tested?
- Subetta
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 15 sitesRussia
- Study dates
- 7 May 2013to 10 Jul 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
Show all 42Show fewer
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Russia15 sites
State Healthcare Institution of Moscow "Central research institute of gastroenterology" of Department of health care of Moscow
Moscow, 111123
State Educational Institution of Higher Professional Education "Moscow State Medical Academy named after I.M. Sechenov"
Moscow, 119991
Nonstate Health Care Institution "Central Clinical Hospital №2 named after N.A. Semashko of Public Limited Company "Russian Railways"
Moscow, 129128
Municipal budgetary authority "Khimki Central Clinical Hospital"
Moscow Region, 141400
The State Budgetary Institution of Health Care of the Nizhny Novgorod Region "City clinical hospital No. 10 "
Nizhny Novgorod, 603011
Nizhny Novgorod regional State Budgetary Health Institution " Nizhny Novgorod regional Clinical Hospital named after N.A. Semashko "
Nizhny Novgorod, 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, 344022
Private company "Polyclinic Complex"
Saint Petersburg, 190013
St. Petersburg State Budgetary Health Care Institution "City Polyclinic №6"
Saint Petersburg, 191482
St. Petersburg State Budgetary Health Care Institution "Saint Venerable Martyr Elizaveta Municipal Hospital"
Saint Petersburg, 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
Saint Petersburg, 197022
St. Petersburg Sate Budgetary Institution "Consultative-Diagnostic Polyclinic №1 of Coastal Area"
Saint Petersburg, 197183
Co.Ltd " Diabet Center"
Samara, 443067
Independent Health Care Institution of Voronezh Region "Voronezh Regional Clinical Consultative-Diagnostic Center"
Voronezh, 394018
State Budgetary Health Care Institution of Yaroslavl Region "Regional Сlinical Hospital"
Yaroslavl, 150062
About this study
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 I Diabetes Mellitus
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 diabetes mellitus.
Read the 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, including basal insulin (using long acting medications) and prandial insulin (short and ultra short acting medications), and with poor glycemic control (HbA1c=7.0-10.0%). 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.
HbA1c, fasting plasma glucose, microalbuminuria, estimated glomerular filtration rate, ophthalmoscopy, blood pressure measurement, patient self-monitoring of blood glucose, frequency of hypoglycemia, endocrinologist examination were performed within screening period. Patients without severe diabetes complications are randomized in 2 groups.
If a patient meets inclusion criteria and does not show exclusion criteria he/she is randomized in one of 2 groups: Group 1 - patients receiving standard type I diabetes mellitus therapy + Subetta at a dose of 1 tablet 4 times a day; Group 2 - the group receiving standard type I diabetes mellitus therapy + Placebo under the regimen used for Subetta. The invented names of the drugs containing basal and prandial (meal) insulin 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±1 and 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.
- Conditions
- Type I Diabetes Mellitus
- Being tested
- Subetta, Placebo
- Keywords
- Combined treatment of patients with type I diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SubettaDrug
Each Subetta tablet contains a mixture of affinity purified polyclonal antibodies to β-subunit of the rINS (6 mg) and antibodies to eNOS (6 mg) in released-active form produced by the patented technology in accordance with the applicable European Pharmacopeia requirements.
Standard therapy of type I diabetes mellitus + Subetta (1 tablet 4 times a day) for 36 weeks.
Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).
PlaceboDrug
Placebo (identical to Subetta in shape and taste tablet containing exсipients). Standard therapy of type I diabetes mellitus + Placebo (1 tablet 4 times a day) for 36 weeks.
Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime).
| Study group | Role | What they receive |
|---|---|---|
| Subetta group | Experimental | Patients with poor glycemic control (HbA1c=7.0-10.0%) in basal-bolus insulin regimen with a stable basal insulin dose (permissible fluctuations are ±10%) during the previous 3 months are included Receives: Drug: Subetta |
| Placebo group | Placebo comparator | Patients with poor glycemic control (HbA1c=7.0-10.0%) in basal-bolus insulin regimen with a stable basal insulin dose (permissible fluctuations are ±10%) during the previous 3 months are included. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Mean Value of HbA1c
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.
Measured: baseline and 12, 24 and 36 weeks of the treatment
Secondary outcomes (6)
Change in Fasting Plasma Glucose (Based on the Data of Biochemical Analysis)
Measured: baseline and 4, 12, 24 and 36 weeks of the treatment
Change in Average Daily Blood Glucose From a 7-point Patient Self-monitoring of Blood Glucose (SMBG)
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.
Measured: baseline and 4, 8, 12, 18, 24, 30 and 36 weeks of the treatment
Changes in Lipids (Concentrations of Plasma Total Cholesterol, HDL Cholesterol, LDL Cholesterol and Triglycerides)
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).
Measured: baseline and 12, 24 and 36 weeks of the treatment
Changes in Dosage of Insulin (Basal, Prandial and Total Daily Dose Insulin Measured in IU)
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.
Measured: baseline and 36 weeks of the treatment
Changes in Dosage of Total Insulin Measured in IU/kg of Body Weight
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.
Measured: baseline and 36 weeks of the treatment
Satisfaction of Diabetes Treatment Based on Diabetes Treatment Satisfaction Questionnaire Data
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).
Measured: 36 weeks of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study start7 May 2013
- Primary completionJul 2016
- Study completion10 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type I Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Materia Medica Holding
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868594
- Sponsor's protocol ID
- MMH-SU-003
- Status last verified
- May 2019
- First submitted
- 27 May 2013
- Last updated
- 30 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Mkrtumyan A, Romantsova T, Vorobiev S, Volkova A, Vorokhobina N, Tarasov S, Putilovskiy M, Andrianova E, Epstein O. Efficacy and safety of Subetta add-on therapy in type 1 diabetes mellitus: The results of a multicenter, double-blind, placebo-controlled, randomized clinical trial. Diabetes Res Clin Pract. 2018 Aug;142:1-9. doi: 10.1016/j.diabres.2018.04.044. Epub 2018 May 26.
PubMed 29807102
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 I Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01868594
- Acronym / sponsor ID
- MMH-SU-003
- Conditions
- Type I Diabetes Mellitus
- Keywords
- Combined treatment of patients with type I diabetes mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Materia Medica HoldingIndustry (pharma, biotech, devices)
- Study start
- 7 May 2013 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- 10 Jul 2016 (actual)
- First posted
- 4 Jun 2013 (estimated)
- Results
- Posted 4 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 diabetes mellitus.
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, including basal insulin (using long acting medications) and prandial insulin (short and ultra short acting medications), and with poor glycemic control (HbA1c=7.0-10.0%). 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.
HbA1c, fasting plasma glucose, microalbuminuria, estimated glomerular filtration rate, ophthalmoscopy, blood pressure measurement, patient self-monitoring of blood glucose, frequency of hypoglycemia, endocrinologist examination were performed within screening period. Patients without severe diabetes complications are randomized in 2 groups.
If a patient meets inclusion criteria and does not show exclusion criteria he/she is randomized in one of 2 groups: Group 1 - patients receiving standard type I diabetes mellitus therapy + Subetta at a dose of 1 tablet 4 times a day; Group 2 - the group receiving standard type I diabetes mellitus therapy + Placebo under the regimen used for Subetta. The invented names of the drugs containing basal and prandial (meal) insulin 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±1 and 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subetta group | Experimental | Drug: SubettaPatients with poor glycemic control (HbA1c=7.0-10.0%) in basal-bolus insulin regimen with a stable basal insulin dose (permissible fluctuations are ±10%) during the previous 3 months are included |
| Placebo group | Placebo comparator | Drug: PlaceboPatients with poor glycemic control (HbA1c=7.0-10.0%) in basal-bolus insulin regimen with a stable basal insulin dose (permissible fluctuations are ±10%) during the previous 3 months are included. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (42 listed)
- 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:
- Heart rhythm disorder:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SubettaEach Subetta tablet contains a mixture of affinity purified polyclonal antibodies to β-subunit of the rINS (6 mg) and antibodies to eNOS (6 mg) in released-active form produced by the patented technology in accordance with the applicable European Pharmacopeia requirements. Standard therapy of type I diabetes mellitus + Subetta (1 tablet 4 times a day) for 36 weeks. Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime). | Drug | Subetta group |
| PlaceboPlacebo (identical to Subetta in shape and taste tablet containing exсipients). Standard therapy of type I diabetes mellitus + Placebo (1 tablet 4 times a day) for 36 weeks. Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime). | Drug | Placebo group |
Primary outcome
Changes in the Mean Value of HbA1c
Time frame: baseline and 12, 24 and 36 weeks of the treatment
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.
6 secondary outcomes
Change in Fasting Plasma Glucose (Based on the Data of Biochemical Analysis)
Time frame: baseline and 4, 12, 24 and 36 weeks of the treatment
Change in Average Daily Blood Glucose From a 7-point Patient Self-monitoring of Blood Glucose (SMBG)
Time frame: baseline and 4, 8, 12, 18, 24, 30 and 36 weeks of the treatment
Changes in Lipids (Concentrations of Plasma Total Cholesterol, HDL Cholesterol, LDL Cholesterol and Triglycerides)
Time frame: baseline and 12, 24 and 36 weeks of the treatment
Changes in Dosage of Insulin (Basal, Prandial and Total Daily Dose Insulin Measured in IU)
Time frame: baseline and 36 weeks of the treatment
Changes in Dosage of Total Insulin Measured in IU/kg of Body Weight
Time frame: baseline and 36 weeks of the treatment
Satisfaction of Diabetes Treatment Based on Diabetes Treatment Satisfaction Questionnaire Data
Time frame: 36 weeks of the treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29807102Mkrtumyan A, Romantsova T, Vorobiev S, Volkova A, Vorokhobina N, Tarasov S, Putilovskiy M, Andrianova E, Epstein O. Efficacy and safety of Subetta add-on therapy in type 1 diabetes mellitus: The results of a multicenter, double-blind, placebo-controlled, randomized clinical trial. Diabetes Res Clin Pract. 2018 Aug;142:1-9. doi: 10.1016/j.diabres.2018.04.044. Epub 2018 May 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Subetta in people with Type I Diabetes Mellitus, run by Materia Medica Holding at 15 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Mean Value of HbA1c (time frame: baseline and 12, 24 and 36 weeks of the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01868594, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2019.