Type 2 DiabetesPhase 4CAMACSNCT01574508
Continuous Subcutaneous Insulin Infusion strAtegy Versus Multiple Daily Insulin Injections strAtegy
A Phase 4 study testing Transient Continuous Subcutaneous Insulin Infusion and Transient Multiple Daily Insulin Injections in people with Type 2 Diabetes, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The current study will compare the different efficacy of two transient intensive insulin treatment strategies: Continuous subcutaneous insulin infusion (CSII) and multiple daily insulin injections (MDI) in patients who are not well controlled with oral hypoglycaemic agents. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Transient Continuous Subcutaneous Insulin Infusion and Transient Multiple Daily Insulin Injections
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Dec 2011to Dec 2014
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Using at least two kinds of oral hypoglycaemic agents, one of which must be insulin secretagogues (at least half of the maximum permitted daily dose); or at least two kinds of oral hypoglycaemic agents, one of which must be insulin secretagogues (at least half of the maximum permitted daily dose), plus once daily basic insulin treatment (daily dosage < 30IU);
- The anti-diabetic therapy is stable within 3 months before study screening;
- Age: 25-65years, both gender, BMI: 20-35kg/m2;
- Good compliance with the follow-up
- Signed informed consent
- HbA1c ≥ 8.0 % and ≤ 12%
Who cannot join
- Having the history of using insulin therapy twice daily or MDI or insulin pump (except the insulin therapy during gestational diabetes mellitus)
- For once daily insulin therapy: daily dose insulin therapy dosage > 30IU
- Having the history of using GLP-1 for therapy within 3 months before screening
- Women in pregnancy or under breast feeding
- Having acute diabetic complications within 6 months before screening or having severe chronic diabetic complications at screening
- Allergic to study drugs
Show all 9Show fewer
- Severe liver dysfunction, including serum alanine aminotransferase concentration more than 2.5 times above upper limit of normal range, abnormal renal function (GFR < 60ml/min)
- Other severe conditions which will put the patients in high risk during the study
- Recently drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin hospital, Shanghai Jiao-Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Guang Ning, Professor, 8621-64370045 ext. 665344, feifei1116@hotmail.com
Guang Ning, Professor
About this study
The current study will compare the different efficacy of two transient intensive insulin treatment strategies: Continuous subcutaneous insulin infusion (CSII) and multiple daily insulin injections (MDI) in patients who are not well controlled with oral hypoglycaemic agents.
- Conditions
- Type 2 Diabetes
- Being tested
- Transient Continuous Subcutaneous Insulin Infusion, Transient Multiple Daily Insulin Injections
- Keywords
- efficacy, safety, intensive insulin therapy
- 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.
Transient Continuous Subcutaneous Insulin InfusionDrug
Also called CSII
Patients will be given Continuous Subcutaneous Insulin Infusion during two weeks confinement in the hospital. The initial dosage will be body weight (kg)*0.5, and will be adjusted according to the 7 points glucose monitoring records in the hospital.
Transient Multiple Daily Insulin InjectionsDrug
Also called MDI
Patients will be given Transient multiple daily insulin injections during two weeks confinement in the hospital. The initial dosage will be body weight (kg)*0.5, and will be adjusted according to the 7 points glucose monitoring records in the hospital
| Study group | Role | What they receive |
|---|---|---|
| Continuous Subcutaneous Insulin Infusion | Experimental | CSII Receives: Drug: Transient Continuous Subcutaneous Insulin Infusion |
| Multiple Daily Insulin Injections | Active comparator | MDI Receives: Drug: Transient Multiple Daily Insulin Injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated hemoglobin levels
The different influence of two intensive insulin treatment strategies: CSII and MDI on the change of glycated hemoglobin levels during two weeks intensive insulin treatment period and 1 year after the intensive treatment.
Measured: During 2 weeks intensive insulin treatment period and 1 year after the intensive treatment.
Glycated albumin levels
The different influence of two intensive insulin treatment strategies: CSII and MDI on the change of glycated albumin levels during two weeks intensive insulin treatment period and 1 year after the intensive treatment.
Measured: During 2 weeks intensive insulin treatment period and 1 year after the intensive treatment.
Secondary outcomes (6)
The glucose levels
The different influence of CSII and MDI on the change of plasma glucose levels during 2 weeks intensive treatment and 1 year after treatment
Measured: During 2 weeks intensive treatment and 1 year after treatment
Episode of hypoglycemia
The different influence of CSII and MDI on Episode of hypoglycemia during 2 weeks of intensive treatment and 1 year after treatment
Measured: During 2 weeks of intensive treatment and 1 year after treatment
Body weight
The different influence of CSII and MDI on Body weight during 2 weeks intensive treatment and 1 year after treatment
Measured: During 2 weeks intensive treatment and 1 year after treatment
Biochemical parameters and inflammatory factors
The different influence of CSII and MDI on the change of biochemical parameters and inflammatory factors during 2 weeks intensive treatment and 1 year after treatment
Measured: During 2 weeks intensive treatment and 1 year after treatment
C peptide levels
The different influence of CSII and MDI on the change of C peptide levels during 2 weeks intensive treatment period and 1 year after treatment
Measured: During 2 weeks intensive treatment and 1 year after treatment
Number of participants with adverse events
The number of Participants with adverse events in different intensive treatment strategies (CSII or MDI) during 2 weeks intensive treatment period and 1 year after treatment.
Measured: During 2 weeks intensive treatment and 1 year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2013 (estimated)
- Study completionDec 2014 (estimated)
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 Shanghai Jiao Tong University School of MedicineThe 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
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guang Ning, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574508
- Sponsor's protocol ID
- CCEMD012
- Acronym
- CAMACS
- Status last verified
- May 2013
- First submitted
- 25 Jan 2012
- Last updated
- 6 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Subcutaneous Insulin Infusion strAtegy Versus Multiple Daily Insulin Injections strAtegy
- ClinicalTrials.gov ID
- NCT01574508
- Acronym / sponsor ID
- CAMACS / CCEMD012
- Conditions
- Type 2 Diabetes
- Keywords
- efficacy, safety, intensive insulin therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 10 Apr 2012 (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.
The current study will compare the different efficacy of two transient intensive insulin treatment strategies: Continuous subcutaneous insulin infusion (CSII) and multiple daily insulin injections (MDI) in patients who are not well controlled with oral hypoglycaemic agents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Subcutaneous Insulin Infusion | Experimental | Drug: Transient Continuous Subcutaneous Insulin InfusionCSII |
| Multiple Daily Insulin Injections | Active comparator | Drug: Transient Multiple Daily Insulin InjectionsMDI |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Using at least two kinds of oral hypoglycaemic agents, one of which must be insulin secretagogues (at least half of the maximum permitted daily dose); or at least two kinds of oral hypoglycaemic agents, one of which must be insulin secretagogues (at least half of the maximum permitted daily dose), plus once daily basic insulin treatment (daily dosage < 30IU);
- The anti-diabetic therapy is stable within 3 months before study screening;
- Age: 25-65years, both gender, BMI: 20-35kg/m2;
- Good compliance with the follow-up
- Signed informed consent
Key exclusion criteria (9 listed)
- Having the history of using insulin therapy twice daily or MDI or insulin pump (except the insulin therapy during gestational diabetes mellitus)
- For once daily insulin therapy: daily dose insulin therapy dosage > 30IU
- Having the history of using GLP-1 for therapy within 3 months before screening
- Women in pregnancy or under breast feeding
- Having acute diabetic complications within 6 months before screening or having severe chronic diabetic complications at screening
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 |
|---|---|---|
| Transient Continuous Subcutaneous Insulin InfusionAlso: CSIIPatients will be given Continuous Subcutaneous Insulin Infusion during two weeks confinement in the hospital. The initial dosage will be body weight (kg)*0.5, and will be adjusted according to the 7 points glucose monitoring records in the hospital. | Drug | Continuous Subcutaneous Insulin Infusion |
| Transient Multiple Daily Insulin InjectionsAlso: MDIPatients will be given Transient multiple daily insulin injections during two weeks confinement in the hospital. The initial dosage will be body weight (kg)*0.5, and will be adjusted according to the 7 points glucose monitoring records in the hospital | Drug | Multiple Daily Insulin Injections |
Primary outcome
Glycated hemoglobin levels
Time frame: During 2 weeks intensive insulin treatment period and 1 year after the intensive treatment.
The different influence of two intensive insulin treatment strategies: CSII and MDI on the change of glycated hemoglobin levels during two weeks intensive insulin treatment period and 1 year after the intensive treatment.
Glycated albumin levels
Time frame: During 2 weeks intensive insulin treatment period and 1 year after the intensive treatment.
The different influence of two intensive insulin treatment strategies: CSII and MDI on the change of glycated albumin levels during two weeks intensive insulin treatment period and 1 year after the intensive treatment.
6 secondary outcomes
The glucose levels
Time frame: During 2 weeks intensive treatment and 1 year after treatment
Episode of hypoglycemia
Time frame: During 2 weeks of intensive treatment and 1 year after treatment
Body weight
Time frame: During 2 weeks intensive treatment and 1 year after treatment
Biochemical parameters and inflammatory factors
Time frame: During 2 weeks intensive treatment and 1 year after treatment
C peptide levels
Time frame: During 2 weeks intensive treatment and 1 year after treatment
Number of participants with adverse events
Time frame: During 2 weeks intensive treatment and 1 year after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2013.
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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.
Ruijin hospital, Shanghai Jiao-Tong University School of Medicine
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Transient Continuous Subcutaneous Insulin Infusion and Transient Multiple Daily Insulin Injections in people with Type 2 Diabetes, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 6 inclusion and 9 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 6 May 2013. 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 China. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated hemoglobin levels (time frame: During 2 weeks intensive insulin treatment period and 1 year after the intensive treatment.). The study lists 2 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 6 May 2013.