Type 2 Diabetes MellitusPhase 4NCT04120623
Therapeutic Effect of Dapagliflozin Combined With CSII on Newly Diagnosed Type 2 Diabetes Mellitus
A Phase 4 study testing Dapagliflozin 10 MG and Insulin Aspart in people with Type 2 Diabetes Mellitus, run by Nanjing First Hospital, Nanjing Medical University.
Trial summary
To compare the effect of dapagliflozin combined with CSII and CSII alone on glucose profile in newly diagnosed type 2 diabetes mellitus by continuous glucose monitoring system. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Dapagliflozin 10 MG and Insulin Aspart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 28 Feb 2020
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- volunteer to participate and be able to sign informed consent prior to the trial.
- patients with type 2 diabetes or type 1 diabetes, aged 18-80 years old.
- No acute complications such as diabetic ketoacidosis, diabetic hyperosmolar syndrome, etc.
- Subjects are able and willing to monitor peripheral blood sugar and regularity of diet and exercise.
Who cannot join
- Patients with insulin allergy.
- Impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value; Serum creatinine was 1.3 times higher than the upper limit of normal.
- Drug abuse and alcohol dependence in the past 5 years.
- Systemic hormone therapy was used in the last three months.
- Patients with poor compliance and irregular diet and exercise.
- Patients with pregnancy, lactation or pregnancy intention.
- Any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Therapeutic Effect of Dapagliflozin Combined With CSII on Newly Diagnosed Type 2 Diabetes Mellitus With Continuous Glucose Monitoring System
To compare the effect of dapagliflozin combined with CSII and CSII alone on glucose profile in newly diagnosed type 2 diabetes mellitus by continuous glucose monitoring system.
Read the detailed description
To compare the effect of dapagliflozin combined with continuous subcutaneous insulin infusion (CSII) and CSII alone on glucose profile in newly diagnosed type 2 diabetes mellitus by continuous glucose monitoring system.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Dapagliflozin 10 MG, Insulin Aspart
- Keywords
- Continuous Glucose Monitoring System (CGMS), Dapagliflozin, Continuous Subcutaneous Insulin Infusion ( CSII)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10 MGDrug
Also called Dapagliflozin combined with CSII
Dapagliflozin 10 MG combined with Insulin Aspart infused by continuous subcutaneous insulin infusion ( CSII).
Insulin AspartDrug
Also called CSII alone
Insulin Aspart is infused through continuous subcutaneous insulin infusion ( CSII)
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin combined with CSII | Experimental | Dapagliflozin 10MG combined with Aspart infused by CSII as glucose lowering therapy. Receives: Drug: Dapagliflozin 10 MG |
| CSII alone | Active comparator | Aspart infused by CSII alone as glucose lowering therapy. Receives: Drug: Insulin Aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effect of dapagliflozin combined with CSII on glucose profile
To compare the effect of dapagliflozin combined with CSII and CSII alone on glucose profile(the mean amplitude of glycemic excursions(MAGE),The 24-hrs mean glucose(MG) ) in newly diagnosed type 2 diabetes mellitus by continuous glucose monitoring system
Measured: 5 weeks
Secondary outcomes (3)
the effects of dapagliflozin combined with CSII on weight
To compare the effect of dapagliflozin combined with CSII and CSII alone on weight in kilogram
Measured: 5 weeks
the effects of dapagliflozin combined with CSII on blood pressure
To compare the effect of dapagliflozin combined with CSII and CSII alone on blood pressure in mmHg
Measured: 5 weeks
the effects of dapagliflozin combined with CSII on lipid metabolism(total cholesterol in mmol/l, total glyceride in mmol/l)
To compare the effect of dapagliflozin combined with CSII and CSII alone on lipid metabolism(total cholesterol in mmol/l, total glyceride in mmol/l)
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start1 Oct 2019 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion28 Feb 2020 (estimated)
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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianhua Ma, Study director, Nanjing First Hospital, Affiliated to Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120623
- Sponsor's protocol ID
- KY20190926-03
- Status last verified
- Sep 2019
- First submitted
- 29 Sep 2019
- Last updated
- 9 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Dapagliflozin Combined With CSII on Newly Diagnosed Type 2 Diabetes Mellitus With Continuous Glucose Monitoring System
- ClinicalTrials.gov ID
- NCT04120623
- Acronym / sponsor ID
- KY20190926-03
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Continuous Glucose Monitoring System (CGMS), Dapagliflozin, Continuous Subcutaneous Insulin Infusion ( CSII)
- 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
- 1 Oct 2019 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 28 Feb 2020 (estimated)
- First posted
- 9 Oct 2019 (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.
To compare the effect of dapagliflozin combined with CSII and CSII alone on glucose profile in newly diagnosed type 2 diabetes mellitus by continuous glucose monitoring system.
Detailed description
To compare the effect of dapagliflozin combined with continuous subcutaneous insulin infusion (CSII) and CSII alone on glucose profile in newly diagnosed type 2 diabetes mellitus by continuous glucose monitoring system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin combined with CSII | Experimental | Drug: Dapagliflozin 10 MGDapagliflozin 10MG combined with Aspart infused by CSII as glucose lowering therapy. |
| CSII alone | Active comparator | Drug: Insulin AspartAspart infused by CSII alone as glucose lowering therapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- volunteer to participate and be able to sign informed consent prior to the trial.
- patients with type 2 diabetes or type 1 diabetes, aged 18-80 years old.
- No acute complications such as diabetic ketoacidosis, diabetic hyperosmolar syndrome, etc.
- Subjects are able and willing to monitor peripheral blood sugar and regularity of diet and exercise.
Key exclusion criteria (7 listed)
- Patients with insulin allergy.
- Impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value; Serum creatinine was 1.3 times higher than the upper limit of normal.
- Drug abuse and alcohol dependence in the past 5 years.
- Systemic hormone therapy was used in the last three months.
- Patients with poor compliance and irregular diet and exercise.
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 |
|---|---|---|
| Dapagliflozin 10 MGAlso: Dapagliflozin combined with CSIIDapagliflozin 10 MG combined with Insulin Aspart infused by continuous subcutaneous insulin infusion ( CSII). | Drug | Dapagliflozin combined with CSII |
| Insulin AspartAlso: CSII aloneInsulin Aspart is infused through continuous subcutaneous insulin infusion ( CSII) | Drug | CSII alone |
Primary outcome
the effect of dapagliflozin combined with CSII on glucose profile
Time frame: 5 weeks
To compare the effect of dapagliflozin combined with CSII and CSII alone on glucose profile(the mean amplitude of glycemic excursions(MAGE),The 24-hrs mean glucose(MG) ) in newly diagnosed type 2 diabetes mellitus by continuous glucose monitoring system
3 secondary outcomes
the effects of dapagliflozin combined with CSII on weight
Time frame: 5 weeks
the effects of dapagliflozin combined with CSII on blood pressure
Time frame: 5 weeks
the effects of dapagliflozin combined with CSII on lipid metabolism(total cholesterol in mmol/l, total glyceride in mmol/l)
Time frame: 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Jianhua Ma study director
Nanjing First Hospital, Affiliated to Nanjing Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapagliflozin 10 MG and Insulin Aspart in people with Type 2 Diabetes Mellitus, 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 7 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 9 Oct 2019. 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?
Contact Jianhua Ma, Doctor (8625-52887091 ext. +8618951670116, majianhua196503@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the effect of dapagliflozin combined with CSII on glucose profile (time frame: 5 weeks). 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 9 Oct 2019.