Type2 DiabetesPhase 4NCT03631134
Effect of SGLT2 Inhibitor on Blood Glucose Profile in Type 2 Diabetic Patients Using Basal Insulin
A Phase 4 study testing SGLT2 inhibitor in people with Type2 Diabetes, run by Nanjing First Hospital, Nanjing Medical University.
Trial summary
The change of glycemic variation and insulin dose after adding SGLT2 inhibitor in type 2 diabetic patients treated with basal insulin was observed in a single center. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- SGLT2 inhibitor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2018to 30 Jan 2019
- Phase
- Phase 4
- 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
Who may be able to join
- Patients with T2DM, which was defined bypublished Criteria of World Health Organization in 1999;
- Patients were using glargine with or without oral hypoglycemic drugs and having a stable dose of glargine for more than 2 month would be recruited into this study;
- Patients had relatively constant diet and exercise in 2 month before the study.
- Fasting blood glucose was between 6.1 and 16mmolL, and postprandial (or random) blood glucose <22.2mmol/L
Who cannot join
- Patients with severe cardiovascular diseases, such as stroke, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention, and heart failure;
- Patients with severe infectious diseases;
- Patients with acute complications of diabetes on admission, such as diabetic ketoacidosis, diabetic hyperosmolar nonketotic coma, and lactic acidosis;
- Patients with history of psychiatric disorders and were unsuitable to use CGMS;
- Patients used GLP-1 analogues，SGLT2 or more than once insulin injection in the past 3 months
- Any other situations that made patients unsuitable to participate in the study, such as alcoholism and drug abuse.
About this study
Official title: Effect of SGLT2 Inhibitor on Blood Glucose Profile in Type 2 Diabetic Patients Using Basal
The change of glycemic variation and insulin dose after adding SGLT2 inhibitor in type 2 diabetic patients treated with basal insulin was observed in a single center.
- Conditions
- Type2 Diabetes
- Being tested
- SGLT2 inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT2 inhibitorDrug
Patients will be gave SGLT2 inhibitor 10mg per day
| Study group | Role | What they receive |
|---|---|---|
| SGLT2i treatment | Experimental | The patients who are using basal insulin therapy with or without oral hypoglycemic drugs will be added SGLT2 inhibitor treatment Receives: Drug: SGLT2 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of glycemic variation
Changes of glycemic variation assessed by CGM before and after SGLT2 inhibitor adding
Measured: Week 1-5
Secondary outcomes (1)
Change of insulin dose
Change of insulin dose before and after SGLT2 inhibitor adding
Measured: Week 1-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start15 Aug 2018 (estimated)
- Primary completion15 Jan 2019 (estimated)
- Study completion30 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631134
- Sponsor's protocol ID
- KY20170904-02
- Status last verified
- Aug 2018
- First submitted
- 12 Aug 2018
- Last updated
- 15 Aug 2018
- 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 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of SGLT2 Inhibitor on Blood Glucose Profile in Type 2 Diabetic Patients Using Basal
- ClinicalTrials.gov ID
- NCT03631134
- Acronym / sponsor ID
- KY20170904-02
- Conditions
- Type2 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 15 Aug 2018 (estimated)
- Primary completion
- 15 Jan 2019 (estimated)
- Study completion
- 30 Jan 2019 (estimated)
- First posted
- 15 Aug 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.
The change of glycemic variation and insulin dose after adding SGLT2 inhibitor in type 2 diabetic patients treated with basal insulin was observed in a single center.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SGLT2i treatment | Experimental | Drug: SGLT2 inhibitorThe patients who are using basal insulin therapy with or without oral hypoglycemic drugs will be added SGLT2 inhibitor treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with T2DM, which was defined bypublished Criteria of World Health Organization in 1999;
- Patients were using glargine with or without oral hypoglycemic drugs and having a stable dose of glargine for more than 2 month would be recruited into this study;
- Patients had relatively constant diet and exercise in 2 month before the study.
- Fasting blood glucose was between 6.1 and 16mmolL, and postprandial (or random) blood glucose <22.2mmol/L
Key exclusion criteria (6 listed)
- Patients with severe cardiovascular diseases, such as stroke, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention, and heart failure;
- Patients with severe infectious diseases;
- Patients with acute complications of diabetes on admission, such as diabetic ketoacidosis, diabetic hyperosmolar nonketotic coma, and lactic acidosis;
- Patients with history of psychiatric disorders and were unsuitable to use CGMS;
- Patients used GLP-1 analogues，SGLT2 or more than once insulin injection in the past 3 months
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 |
|---|---|---|
| SGLT2 inhibitorPatients will be gave SGLT2 inhibitor 10mg per day | Drug | SGLT2i treatment |
Primary outcome
Changes of glycemic variation
Time frame: Week 1-5
Changes of glycemic variation assessed by CGM before and after SGLT2 inhibitor adding
1 secondary outcome
Change of insulin dose
Time frame: Week 1-5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SGLT2 inhibitor in people with Type2 Diabetes, run by Nanjing First Hospital, Nanjing Medical University.
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 6 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: status not confirmed, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Results are not available in the source record.
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 of glycemic variation (time frame: Week 1-5). 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 15 Aug 2018.