Type 2 Diabetes MellitusNCT03209089
Type 2 Diabetes Mellitus Patients' Characteristics and Management by General Practitioners and Endocrinologists
An observational study of Type 2 Diabetes Mellitus, run by AstraZeneca at 20 sites in Russia.
Trial summary
This is a multi-centre observational, ambispective study, which will retrospectively and prospectively collect clinical variables and socio-demographic data from medical records of patients with type 2 diabetes mellitus (T2DM) initiated with dapagliflozin by general practitioners (GPs) and endocrinologists in… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- How many people
- 907 participants
- Where
- 20 sitesRussia
- Study dates
- 7 Aug 2017to 15 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 900 male and female T2DM outpatients, who were managed by GPs or endocrinologists in 45 outpatient sites.
Who may be able to join
- Age 18 and older;
- Established diagnosis of T2DM (ICD-10 code E11.2-E11.9)
- The current treatment with dapagliflozin prescribed at least 1 month before the FSI;
- Written voluntary informed consent has been provided
- Management in outpatient setting.
Who cannot join
- Type 1 diabetes
- Current participation in a clinical trial
- Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language, psychiatric disturbances).
- Presence of serious/severe co-morbidities in the opinion of the investigator, which may limit treatment approach as usual.
- Treatment with drugs affecting glucose homeostasis (e.g., systemic glucocorticosteroids) within 3 months before to the 1st Visit
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Russia20 sites
Research Site
Belgorod Region, Shebekino, Russian Federation, D1690R00037
Research Site
Belgorod Region, Volokonovsky R-n, P. Volokonovka, Russian Federation, D1690R00037
Research Site
Gis-Khrustalny, Russian Federation, D1690R00037
Research Site
Izhevsk, Russian Federation, D1690R00037
Research Site
Kazan', Russian Federation, D1690R00037
Research Site
Lipetsk, Russian Federation, D1690R00037
Research Site
N. Novgorod Region, Russian Federation, D1690R00037
Research Site
Nizhny Novgorod, Russian Federation, D1690R00037
Research Site
Novomoskovsk, Russian Federation, D1690R00037
Research Site
Novosibirsk, Russian Federation, D1690R00037
Research Site
Perm, Russian Federation, D1690R00037
Research Site
Ryazan, Russian Federation, D1690R00037
Research Site
Saint Petersburg, Russian Federation, D1690R00037
Research Site
Samara, Russian Federation, D1690R00037
Research Site
Tambov Region, Russian Federation, D1690R00037
Research Site
Volzhsk, Russian Federation, D1690R00037
Research Site
Voronezh, Russian Federation, D1690R00037
Research Site
Voronezh Region, Novovoronezh, Russian Federation, D1690R00037
Research Site
Yaroslavl, Russian Federation, D1690R00037
Research Site
Yoshkar-Ola, Russian Federation, D1690R00037
About this study
Official title: A Non-Interventional Study on Type 2 Diabetes Mellitus Patient's Characteristics and Management by General Practitioners and Endocrinologists in the Russian Population (THESEUS)
This is a multi-centre observational, ambispective study, which will retrospectively and prospectively collect clinical variables and socio-demographic data from medical records of patients with type 2 diabetes mellitus (T2DM) initiated with dapagliflozin by general practitioners (GPs) and endocrinologists in real-life setting. It is anticipated that patient recruitment will last 8 months (from Q3 2017 to Q1 2018) and each patient will be followed during the second visit 6±3 months later after the first visit. There are 2 time points:
- Baseline data: baseline data are defined as data available within 3 months prior to the first dose of dapagliflozin. In case of presence of multiple data values within baseline period the most recent pre-dose value will be selected
- Follow-up data: any post-baseline data will be considered as follow-up but the primary analysis will be focused on data available at 6±3 months after the first visit. In case of discontinuation dapagliflozin, data will be collected at routine visit within 3-month time frame after the last dose
Read the detailed description
Study design:
This is a multi-centre observational, ambispective study, which will retrospectively and prospectively collect clinical variables and socio-demographic data from medical records of patients with T2DM initiated with dapagliflozin by GPs and endocrinologists in real-life setting.
Only patients, who provide written consent to participate in the study will be enrolled into this study. All patients will be unique with no overlap between endocrinologists and GPs. All consecutive patients managed by GPs or endocrinologists who meet inclusion criteria will be included. All GPs and endocrinologists, who manage T2DM on sites, will be participating investigators.
Patients will undergo clinical assessment and receive the standard medical care as usual determined by the treating doctor based on their clinical judgement and national guidelines. Patients will not receive experimental treatment as a consequence of their participation in the observational study.
It is anticipated that patient recruitment will last for 8 months (from Q3 2017 to Q1 2018) and each patient will be followed during the second visit 6±3 months later after the first visit.
There are 2 time points:
- Baseline data: baseline data are defined as data available within 3 months prior to the first dose of dapagliflozin. In case of presence of multiple data values within baseline period the most recent pre-dose value will be selected
- Follow-up data: any post-baseline data will be considered as follow-up but the primary analysis will be focused on data available at 6±3 months after the first visit. In case of discontinuation dapagliflozin, data will be collected at routine visit within 3-month time frame after the last dose.
Data Source(s):
Baseline data will be collected during Visit 1 from the T2DM patient medical records, including disease history of patient, and during follow-up data during Visit 2 (after 6±3 months from Visit 1).
Study Population:
It is planned to include 900 male and female T2DM outpatients 18 years and older, who were managed by GPs or endocrinologists in 45 outpatient sites.
- Conditions
- Type 2 Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic parameters before dapagliflozin initiation in T2DM patients managed by GPs
mean age
Measured: 3 months before dapagliflozin initiation
demographic characteristics of T2DM patients managed by GPs
age distribution
Measured: 3 months before dapagliflozin initiation
demographic characteristics of T2DM patients managed by GPs
gender distribution
Measured: 3 months before dapagliflozin initiation
clinical characteristics of T2DM patients managed by GPs
mean duration of T2DM
Measured: 3 months before dapagliflozin initiation
clinical characteristics of T2DM patients managed by GPs
HbA1c (mean and distribution)
Measured: 3 months before dapagliflozin initiation
clinical characteristics of T2DM patients managed by GPs
Weight (mean)
Measured: 3 months before dapagliflozin initiation
clinical characteristics of T2DM patients managed by GPs
SBP (mean and distribution)
Measured: 3 months before dapagliflozin initiation
clinical characteristics of T2DM patients managed by GPs
DBP (mean and distribution)
Measured: 3 months before dapagliflozin initiation
clinical characteristics of T2DM patients managed by GPs
Proportion of T2DM patients with diabetic complications
Measured: 3 months before dapagliflozin initiation
clinical characteristics of T2DM patients managed by GPs
Proportion of patients with T2DM treatment intensification during 3 months before inclusion in the study
Measured: 3 months before dapagliflozin initiation
clinical characteristics of T2DM patients managed by GPs
Proportion of patients with different treatment regimen
Measured: 3 months before dapagliflozin initiation
clinical characteristics of T2DM patients managed by GPs
Proportion of patients on treatment with different classes of antidiabetic therapy
Measured: 3 months before dapagliflozin initiation
clinical characteristics of T2DM patients managed by GPs
Proportion of patients on different classes of concomitant therapy
Measured: 3 months before dapagliflozin initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start7 Aug 2017
- Primary completion15 Apr 2019
- Study completion15 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 907 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vladimir Bulatov, MD, PhD, Study director, AstraZeneca Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209089
- Sponsor's protocol ID
- D1690R00037
- Status last verified
- Mar 2020
- First submitted
- 19 Jun 2017
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Interventional Study on Type 2 Diabetes Mellitus Patient's Characteristics and Management by General Practitioners and Endocrinologists in the Russian Population (THESEUS)
- ClinicalTrials.gov ID
- NCT03209089
- Acronym / sponsor ID
- D1690R00037
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 907 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2017 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 6 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-centre observational, ambispective study, which will retrospectively and prospectively collect clinical variables and socio-demographic data from medical records of patients with type 2 diabetes mellitus (T2DM) initiated with dapagliflozin by general practitioners (GPs) and endocrinologists in real-life setting. It is anticipated that patient recruitment will last 8 months (from Q3 2017 to Q1 2018) and each patient will be followed during the second visit 6±3 months later after the first visit. There are 2 time points:
- Baseline data: baseline data are defined as data available within 3 months prior to the first dose of dapagliflozin. In case of presence of multiple data values within baseline period the most recent pre-dose value will be selected
- Follow-up data: any post-baseline data will be considered as follow-up but the primary analysis will be focused on data available at 6±3 months after the first visit. In case of discontinuation dapagliflozin, data will be collected at routine visit within 3-month time frame after the last dose
Detailed description
Study design:
This is a multi-centre observational, ambispective study, which will retrospectively and prospectively collect clinical variables and socio-demographic data from medical records of patients with T2DM initiated with dapagliflozin by GPs and endocrinologists in real-life setting.
Only patients, who provide written consent to participate in the study will be enrolled into this study. All patients will be unique with no overlap between endocrinologists and GPs. All consecutive patients managed by GPs or endocrinologists who meet inclusion criteria will be included. All GPs and endocrinologists, who manage T2DM on sites, will be participating investigators.
Patients will undergo clinical assessment and receive the standard medical care as usual determined by the treating doctor based on their clinical judgement and national guidelines. Patients will not receive experimental treatment as a consequence of their participation in the observational study.
It is anticipated that patient recruitment will last for 8 months (from Q3 2017 to Q1 2018) and each patient will be followed during the second visit 6±3 months later after the first visit.
There are 2 time points:
- Baseline data: baseline data are defined as data available within 3 months prior to the first dose of dapagliflozin. In case of presence of multiple data values within baseline period the most recent pre-dose value will be selected
- Follow-up data: any post-baseline data will be considered as follow-up but the primary analysis will be focused on data available at 6±3 months after the first visit. In case of discontinuation dapagliflozin, data will be collected at routine visit within 3-month time frame after the last dose.
Data Source(s):
Baseline data will be collected during Visit 1 from the T2DM patient medical records, including disease history of patient, and during follow-up data during Visit 2 (after 6±3 months from Visit 1).
Study Population:
It is planned to include 900 male and female T2DM outpatients 18 years and older, who were managed by GPs or endocrinologists in 45 outpatient sites.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 900 male and female T2DM outpatients, who were managed by GPs or endocrinologists in 45 outpatient sites.
Key inclusion criteria (5 listed)
- Age 18 and older;
- Established diagnosis of T2DM (ICD-10 code E11.2-E11.9)
- The current treatment with dapagliflozin prescribed at least 1 month before the FSI;
- Written voluntary informed consent has been provided
- Management in outpatient setting.
Key exclusion criteria (5 listed)
- Type 1 diabetes
- Current participation in a clinical trial
- Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language, psychiatric disturbances).
- Presence of serious/severe co-morbidities in the opinion of the investigator, which may limit treatment approach as usual.
- Treatment with drugs affecting glucose homeostasis (e.g., systemic glucocorticosteroids) within 3 months before to the 1st Visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demographic parameters before dapagliflozin initiation in T2DM patients managed by GPs
Time frame: 3 months before dapagliflozin initiation
mean age
demographic characteristics of T2DM patients managed by GPs
Time frame: 3 months before dapagliflozin initiation
age distribution
demographic characteristics of T2DM patients managed by GPs
Time frame: 3 months before dapagliflozin initiation
gender distribution
clinical characteristics of T2DM patients managed by GPs
Time frame: 3 months before dapagliflozin initiation
mean duration of T2DM
clinical characteristics of T2DM patients managed by GPs
Time frame: 3 months before dapagliflozin initiation
HbA1c (mean and distribution)
clinical characteristics of T2DM patients managed by GPs
Time frame: 3 months before dapagliflozin initiation
Weight (mean)
clinical characteristics of T2DM patients managed by GPs
Time frame: 3 months before dapagliflozin initiation
SBP (mean and distribution)
clinical characteristics of T2DM patients managed by GPs
Time frame: 3 months before dapagliflozin initiation
DBP (mean and distribution)
clinical characteristics of T2DM patients managed by GPs
Time frame: 3 months before dapagliflozin initiation
Proportion of T2DM patients with diabetic complications
clinical characteristics of T2DM patients managed by GPs
Time frame: 3 months before dapagliflozin initiation
Proportion of patients with T2DM treatment intensification during 3 months before inclusion in the study
clinical characteristics of T2DM patients managed by GPs
Time frame: 3 months before dapagliflozin initiation
Proportion of patients with different treatment regimen
clinical characteristics of T2DM patients managed by GPs
Time frame: 3 months before dapagliflozin initiation
Proportion of patients on treatment with different classes of antidiabetic therapy
clinical characteristics of T2DM patients managed by GPs
Time frame: 3 months before dapagliflozin initiation
Proportion of patients on different classes of concomitant therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
- D1690R00037 Study Report SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Vladimir Bulatov, MD, PhD study director
AstraZeneca Russia
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus, run by AstraZeneca at 20 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 5 inclusion and 5 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 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Demographic parameters before dapagliflozin initiation in T2DM patients managed by GPs (time frame: 3 months before dapagliflozin initiation). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2020.