Diabetes MellitusNCT02578563
Prospective Diabetes Registry of Patients With Type 2 Diabetes Mellitus on SGLT 2 Inhibitor Therapy in Singapore
An observational study of Diabetes Mellitus, run by AstraZeneca at 1 site in Singapore.
Trial summary
To evaluate clinical effectiveness and safety of Singaporean Type 2 Diabetes mellitus patients administered SGLT 2 inhibitor monotherapy or in combination with other commonly used hypoglycaemic drugs in real life clinical settings. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 201 participants
- Where
- 1 siteSingapore
- Study dates
- 12 Feb 2016to 31 Dec 2018
- How long will I take part?
- 1 Year
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Simple random sample.
Who may be able to join
- Patients should meet all of the following criteria at Day 0:
- Outpatient equal to or more than 18 years of age
- Diagnosed as T2DM and treated with antidiabetic medicines at least 3 months and suitable for SGLT2 inhibitor as current treatment judged by PI with HbA1c > 7.0 %
- Will provide completed and signed written informed consents Each participating investigator, will be asked to recruit a fixed number of patients ranging from 10 to 40 depending on site specificities.
Who cannot join
- Patients, with the following criteria will be excluded at Day 0:
- Hypersensitivity to any SGLT2 inhibitor or any of the components in the formulation
- Patients with Type 1 diabetes
- Female patients with gestational diabetes during pregnancy
- Female patients who are pregnant, intending to become pregnant or breastfeeding
- Severe medical condition(s) that in the view of the investigator prohibits participation in the study e.g. cancer, end stage liver disease, end stage renal failure (non-diabetes related)
- Use of other investigational drugs at the time of enrolment
- Renal Function: <30ml/min/1.73m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SGLT2 Inhibitor Registry in Singapore
To evaluate clinical effectiveness and safety of Singaporean Type 2 Diabetes mellitus patients administered SGLT 2 inhibitor monotherapy or in combination with other commonly used hypoglycaemic drugs in real life clinical settings.
To evaluate real life clinical effectiveness and safety of Sodium-Glucose Co-Transporter inhibitor- 2 in Singaporean Type 2 diabetes mellitus patients treated on an outpatient basis in clinical practice setting. The study would also assess treatment patterns with SGLT2 inhibitor patient relevant outcomes in whole population as well as pre identified patient subgroups.
Primary analysis to be done at 1 year and extended analysis at 2 years.
Read the detailed description
T2DM is associated with overweight/obesity and high fasting plasma glucose (FPG) in White patients, whereas Asian patients are more predisposed to high abdominal fat distribution and high postprandial glucose (PPG) levels, thought to contribute1-4. In response to identical meals, Asian subjects exhibit greater glycemic response than do White subjects4,5. According to the Diabetic Society of Singapore, one out of nine people aged 18 to 69 has diabetes, that's about 11.3% of the population or more than 400,000 people \& this is expected to rise with the increasing prevalence of a sedentary lifestyle and high-calorie dietary intake.
SGLT2 inhibitors offers a novel insulin-independent approach to lowering hyperglycaemia and improving metabolic control of type 2 diabetes: they reduce renal glucose reabsorption by inhibition of SGLT2 transporters in the proximal tubule of the kidney, resulting in urinary glucose excretion. Since SGLT2 inhibition is independent of β-cell function or insulin sensitivity, this treatment approach could have applications throughout the natural history of diabetes.6
The reductions in fasting plasma glucose concentration and bodyweight during the treatment with the SGLT2 i, are sustained. Early weight loss, is partly due to a mild osmotic diuresis caused by SGLT2 I, however, the gradual progressive reduction in bodyweight thereafter, with decreased waist circumference, is consistent with a reduction of fat mass. This reduction is potentially attributable to the loss of excess energy through glucose excretion in the urine, an effect supported by the increased urinary glucose/creatinine ratio in patients assigned to SGLT2i.6
Many trials shows that SGLT2 i can improve glycaemic control in patients who have inadequate control with metformin. The drug acts independently of insulin, lowers weight, and is not associated with risk of hypoglycaemia. Safety and tolerability of the drugs were also confirmed. Therefore, addition of SGLT2i to metformin provides a new therapeutic option for treatment of type 2 diabetes.6
Data collection will be done by AZ medical personnel or Pharmacy interns, it will be a paper data collection and will be handed over to the CRO company for data entry \& analysis..Data analysis will be done by an independent CRO company namely BioQuest Solutions.
- Conditions
- Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the HbA1c level after 1 year
to assess whether the therapy initiated with SGLT2 inhibitors at baseline is able to reduce the HbA1c after 1 year.
Measured: baseline to 1 year
Secondary outcomes (10)
Change from baseline in FPG level at 6months
By assessment of the other lipid level reduction from baseline lab value to the last lab value
Measured: Blood samples are collected pre-dose, 6 months post-dose
Change from baseline in FPG level at 12months
By assessment of the other lipid level reduction from baseline lab value to the last lab value
Measured: Blood samples are collected pre-dose, 12 months post-dose
Change from baseline in weight at 6months
By assessment of the other weight reduction from baseline value to the last value
Measured: weight is measured pre-dose, 6 months post-dose
Change from baseline in weight at 12 months
By assessment of the other weight reduction from baseline value to the last value
Measured: weight is measured pre-dose, 12 months post-dose
Change from baseline in BP at 6 months
By assessment of the other BP reduction from baseline value to the last value
Measured: BP is measured pre-dose, 6 months post-dose
Change from baseline in BP at 12 months
By assessment of the other BP reduction from baseline value to the last value
Measured: BP is measured pre-dose, 12 months post-dose
Change from baseline in Lipids at 6 months
By assessment of the other lipid level reduction from baseline lab value to the last lab value
Measured: Blood samples are collected pre-dose, 6 months post-dose
Change from baseline in Lipids at 12 months
By assessment of the other lipid level reduction from baseline lab value to the last lab value
Measured: Blood samples are collected pre-dose, 12 months post-dose
Change from baseline in Waist circumference at 6 months
By assessment of the other waist circumference reduction from baseline value to the last value
Measured: waist circumference is measured pre-dose, 6 months post-dose
Change from baseline in Waist circumference at 12 months
By assessment of the other waist circumference reduction from baseline value to the last value
Measured: waist circumference is measured pre-dose, 12 months post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study start12 Feb 2016
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 201 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578563
- Sponsor's protocol ID
- D1843R00258
- Status last verified
- Dec 2019
- First submitted
- 29 Sep 2015
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
REFERENCES 1. Wang JS, et al. Diabetes Metab Res Rev. 2011;27:79-84 2. Bonora E, et al. Diabetes Care. 2001;24:2023-2029 3. Peter R, et al. Diabet Med. 2006;23:990-995 4. Venn BS, et al. Diabet Med. 2010;27:1205-1208 5. Henry CJ, et al. Br J Nutr. 2008;99:840-845 6. Bailey CJ, et al. Lancet. 2010;375:2223-33
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SGLT2 Inhibitor Registry in Singapore
- ClinicalTrials.gov ID
- NCT02578563
- Acronym / sponsor ID
- D1843R00258
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 19 Oct 2015 (estimated)
- 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.
To evaluate clinical effectiveness and safety of Singaporean Type 2 Diabetes mellitus patients administered SGLT 2 inhibitor monotherapy or in combination with other commonly used hypoglycaemic drugs in real life clinical settings.
To evaluate real life clinical effectiveness and safety of Sodium-Glucose Co-Transporter inhibitor- 2 in Singaporean Type 2 diabetes mellitus patients treated on an outpatient basis in clinical practice setting. The study would also assess treatment patterns with SGLT2 inhibitor patient relevant outcomes in whole population as well as pre identified patient subgroups.
Primary analysis to be done at 1 year and extended analysis at 2 years.
Detailed description
T2DM is associated with overweight/obesity and high fasting plasma glucose (FPG) in White patients, whereas Asian patients are more predisposed to high abdominal fat distribution and high postprandial glucose (PPG) levels, thought to contribute1-4. In response to identical meals, Asian subjects exhibit greater glycemic response than do White subjects4,5. According to the Diabetic Society of Singapore, one out of nine people aged 18 to 69 has diabetes, that's about 11.3% of the population or more than 400,000 people \& this is expected to rise with the increasing prevalence of a sedentary lifestyle and high-calorie dietary intake.
SGLT2 inhibitors offers a novel insulin-independent approach to lowering hyperglycaemia and improving metabolic control of type 2 diabetes: they reduce renal glucose reabsorption by inhibition of SGLT2 transporters in the proximal tubule of the kidney, resulting in urinary glucose excretion. Since SGLT2 inhibition is independent of β-cell function or insulin sensitivity, this treatment approach could have applications throughout the natural history of diabetes.6
The reductions in fasting plasma glucose concentration and bodyweight during the treatment with the SGLT2 i, are sustained. Early weight loss, is partly due to a mild osmotic diuresis caused by SGLT2 I, however, the gradual progressive reduction in bodyweight thereafter, with decreased waist circumference, is consistent with a reduction of fat mass. This reduction is potentially attributable to the loss of excess energy through glucose excretion in the urine, an effect supported by the increased urinary glucose/creatinine ratio in patients assigned to SGLT2i.6
Many trials shows that SGLT2 i can improve glycaemic control in patients who have inadequate control with metformin. The drug acts independently of insulin, lowers weight, and is not associated with risk of hypoglycaemia. Safety and tolerability of the drugs were also confirmed. Therefore, addition of SGLT2i to metformin provides a new therapeutic option for treatment of type 2 diabetes.6
Data collection will be done by AZ medical personnel or Pharmacy interns, it will be a paper data collection and will be handed over to the CRO company for data entry \& analysis..Data analysis will be done by an independent CRO company namely BioQuest Solutions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Simple random sample.
Key inclusion criteria (4 listed)
- Outpatient equal to or more than 18 years of age
- Diagnosed as T2DM and treated with antidiabetic medicines at least 3 months and suitable for SGLT2 inhibitor as current treatment judged by PI with HbA1c > 7.0 %
- Will provide completed and signed written informed consents Each participating investigator, will be asked to recruit a fixed number of patients ranging from 10 to 40 depending on site specificities.
Key exclusion criteria (8 listed)
- Hypersensitivity to any SGLT2 inhibitor or any of the components in the formulation
- Patients with Type 1 diabetes
- Female patients with gestational diabetes during pregnancy
- Female patients who are pregnant, intending to become pregnant or breastfeeding
- Severe medical condition(s) that in the view of the investigator prohibits participation in the study e.g. cancer, end stage liver disease, end stage renal failure (non-diabetes related)
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
Change from baseline in the HbA1c level after 1 year
Time frame: baseline to 1 year
to assess whether the therapy initiated with SGLT2 inhibitors at baseline is able to reduce the HbA1c after 1 year.
10 secondary outcomes
Change from baseline in FPG level at 6months
Time frame: Blood samples are collected pre-dose, 6 months post-dose
Change from baseline in FPG level at 12months
Time frame: Blood samples are collected pre-dose, 12 months post-dose
Change from baseline in weight at 6months
Time frame: weight is measured pre-dose, 6 months post-dose
Change from baseline in weight at 12 months
Time frame: weight is measured pre-dose, 12 months post-dose
Change from baseline in BP at 6 months
Time frame: BP is measured pre-dose, 6 months post-dose
Change from baseline in BP at 12 months
Time frame: BP is measured pre-dose, 12 months post-dose
Change from baseline in Lipids at 6 months
Time frame: Blood samples are collected pre-dose, 6 months post-dose
Change from baseline in Lipids at 12 months
Time frame: Blood samples are collected pre-dose, 12 months post-dose
Change from baseline in Waist circumference at 6 months
Time frame: waist circumference is measured pre-dose, 6 months post-dose
Change from baseline in Waist circumference at 12 months
Time frame: waist circumference is measured pre-dose, 12 months post-dose
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 2 Jan 2020.
- Results publicationREFERENCES 1. Wang JS, et al. Diabetes Metab Res Rev. 2011;27:79-84 2. Bonora E, et al. Diabetes Care. 2001;24:2023-2029 3. Peter R, et al. Diabet Med. 2006;23:990-995 4. Venn BS, et al. Diabet Med. 2010;27:1205-1208 5. Henry CJ, et al. Br J Nutr. 2008;99:840-845 6. Bailey CJ, et al. Lancet. 2010;375:2223-33
- 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 Diabetes Mellitus, run by AstraZeneca at 1 site in Singapore.
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 4 inclusion and 8 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 2 Jan 2020. 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 Singapore. 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?
Change from baseline in the HbA1c level after 1 year (time frame: baseline to 1 year). 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 NCT02578563, 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 2 Jan 2020.