Type 2 DiabetesNCT03694470
Characteristics of Patients With Type 2 Diabetes Mellitus (CVD-RNDR)
An observational study of Type 2 Diabetes, run by AstraZeneca at 1 site in Russia.
Trial summary
This observational retrospective study will describe characteristics of patients with type 2 diabetes mellitus (T2DM) who were initiating use or treatment with sodium-glucose co-transporter-2 (SGLT-2) inhibitors and other diabetes medications (other glucose lowering drugs) in 2015-17 based on National Russian Diabetes… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 10,000 participants
- Where
- 1 siteRussia
- Study dates
- 15 Apr 2018to 30 Jun 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Data of T2DM patients consecutively included in the RNDR from January 2015 to October 2017 will be included in this retrospective analysis. New users will be defined as individuals with T2DM either receiving a prescription of a SGLT-2 inhibitor or other GLD during the study period. Individuals with a previous issued/dispensed prescription of that medicine class during the preceding 1 year are not defined as new users. The year of the first issued prescription of the included medication classes during the study period will be denoted the index year. The group of other GLD will include all diabetes medicines, allowing combinations and monotherapy use except use of SGLT-2 inhibitors. The class SGLT-2 inhibitors include mainly dapagliflozin, empagliflozin and canagliflozin. Since SGLT-2 inhibitors are relatively recently introduced on the market the population size and follow-up time is limited. Approximately 22,000 patients registered in RNDR will be included.
Who may be able to join
- New user receiving or dispensed prescription of SGLT-2 inhibitor medication or other GLD treatments oral as well as injectable, including fixed-dose combination (FDC) products containing these medication groups;
- T2DM diagnosis on or prior to the index year;
- ≥ 18 years old at index year.
Who cannot join
- Patients with a T1DM diagnosis on or prior to index year and only insulin use in the year prior to index;
- Patients with a gestational diabetes in the index year or 1 year prior to index.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Study to Describe Characteristics of Patients With Type 2 Diabetes Mellitus Who Were Initiating Use or Treatment With Sodium-glucose Co-transporter-2 Inhibitors and Other Diabetes Medications (Other Glucose Lowering Drugs) in 2015-17 Based on National Russian Diabetes Registry Data
This observational retrospective study will describe characteristics of patients with type 2 diabetes mellitus (T2DM) who were initiating use or treatment with sodium-glucose co-transporter-2 (SGLT-2) inhibitors and other diabetes medications (other glucose lowering drugs) in 2015-17 based on National Russian Diabetes Registry data.
- Conditions
- Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who were new users of SGLT-2 inhibitors in 2015, 2016, 2017
The proportion of patients who were new users of SGLT-2 inhibitors in 2015, 2016 2017 among T2DM patients initiated use of antidiabetic treatment in these years according to Russian National Diabetes Registry data.
Measured: 2015-2017
Secondary outcomes (2)
Number of participants with abdominal laboratory values
Number of participants with abdominal laboratory values glycosylated haemoglobin (Hb1Ac), total Cholesterol, low Density Lipids (LDL), high Density Lipids (HDL), creatinine, estimated Glomerular Filtration Rate (EGFR)
Measured: 2015-2017
Number of participants with co-morbidities
Number of participants with co-morbidities: myocardial infarction (MI), stroke (ischemic or hemorrhagic )Transient Ischemic Attack (TIA)Peripheral Artery Disease (PAD), Heart Failure, Hypertension, Hyperlipidemia, Neuropathy, Nephropathy, Retinopathy, Therapies, Diabetes medications, Hypertension medications, Diuretics, Lipid lowering drugs, Anti-platelets.
Measured: 2015-2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start15 Apr 2018
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Retrospective
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03694470
- Sponsor's protocol ID
- D1690R00048
- Status last verified
- Jun 2019
- First submitted
- 3 Sep 2018
- Last updated
- 10 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study to Describe Characteristics of Patients With Type 2 Diabetes Mellitus Who Were Initiating Use or Treatment With Sodium-glucose Co-transporter-2 Inhibitors and Other Diabetes Medications (Other Glucose Lowering Drugs) in 2015-17 Based on National Russian Diabetes Registry Data
- ClinicalTrials.gov ID
- NCT03694470
- Acronym / sponsor ID
- D1690R00048
- Conditions
- Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 3 Oct 2018 (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 observational retrospective study will describe characteristics of patients with type 2 diabetes mellitus (T2DM) who were initiating use or treatment with sodium-glucose co-transporter-2 (SGLT-2) inhibitors and other diabetes medications (other glucose lowering drugs) in 2015-17 based on National Russian Diabetes Registry data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Data of T2DM patients consecutively included in the RNDR from January 2015 to October 2017 will be included in this retrospective analysis. New users will be defined as individuals with T2DM either receiving a prescription of a SGLT-2 inhibitor or other GLD during the study period. Individuals with a previous issued/dispensed prescription of that medicine class during the preceding 1 year are not defined as new users. The year of the first issued prescription of the included medication classes during the study period will be denoted the index year. The group of other GLD will include all diabetes medicines, allowing combinations and monotherapy use except use of SGLT-2 inhibitors. The class SGLT-2 inhibitors include mainly dapagliflozin, empagliflozin and canagliflozin. Since SGLT-2 inhibitors are relatively recently introduced on the market the population size and follow-up time is limited. Approximately 22,000 patients registered in RNDR will be included.
Key inclusion criteria (3 listed)
- New user receiving or dispensed prescription of SGLT-2 inhibitor medication or other GLD treatments oral as well as injectable, including fixed-dose combination (FDC) products containing these medication groups;
- T2DM diagnosis on or prior to the index year;
- ≥ 18 years old at index year.
Key exclusion criteria (2 listed)
- Patients with a T1DM diagnosis on or prior to index year and only insulin use in the year prior to index;
- Patients with a gestational diabetes in the index year or 1 year prior to index.
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
The proportion of patients who were new users of SGLT-2 inhibitors in 2015, 2016, 2017
Time frame: 2015-2017
The proportion of patients who were new users of SGLT-2 inhibitors in 2015, 2016 2017 among T2DM patients initiated use of antidiabetic treatment in these years according to Russian National Diabetes Registry data.
2 secondary outcomes
Number of participants with abdominal laboratory values
Time frame: 2015-2017
Number of participants with co-morbidities
Time frame: 2015-2017
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 10 Jun 2019.
- CSR SynopsisLink provided by the sponsor.
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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.
1 site 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, run by AstraZeneca at 1 site 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 3 inclusion and 2 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 10 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The proportion of patients who were new users of SGLT-2 inhibitors in 2015, 2016, 2017 (time frame: 2015-2017). 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 10 Jun 2019.