| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Newly Diagnosed Type 2 Diabetes Simplified Short-term Intensive Insulin Therapy Glycemic Remission | Drug: Simplified intensive insulin therapy regimen Drug: Traditional Short-term Intensive insulin therapy | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 330 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Induction of Long-term Glycemic Remission Via Structured Simplified Short-term Intensive Insulin Therapy in Patients With Newly Diagnosed Type 2 Diabetes: a Multiple Centered, Randomised Controlled Trial. |
| Estimated Study Start Date : | June 1, 2019 |
| Estimated Primary Completion Date : | December 31, 2021 |
| Estimated Study Completion Date : | December 31, 2022 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Simplified regimen group
Short-term continuous subcutaneous insulin infusion will be adminstrated to maintained euglycemia for 1 week,Then subsequent therapy using basal insulin plus metformin will be administrated. After withdrawal of the medicine, wearable devices and smart apps will be used for long-term management.
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Drug: Simplified intensive insulin therapy regimen
Short-term continuous subcutaneous insulin infusion to maitain near normoglycemica for 1 week, thereafter basal insulin and metformin were subsequently used. Wearable devices and smart apps will be used for lifestyle modification.
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Active Comparator: Routine group
Inpaitent short-term continuous subcutaneous insulin infusion will be administered to maintained euglycemia for 2 weeks, Then subjects will be follow-up routinely.
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Drug: Traditional Short-term Intensive insulin therapy
Short-term continuous subcutaneous insulin infusion will be initiate to maitain near normoglycemica for 2 weeks, then patients will be ordinarily follow-up
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| China, Guangdong | |
| endocrinology department of the first affiliated hospital of Sun Yat-sen University | |
| Guangzhou, Guangdong, China, 510080 | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 1, 2019 | ||||
| First Posted Date ICMJE | June 4, 2019 | ||||
| Last Update Posted Date | June 4, 2019 | ||||
| Estimated Study Start Date ICMJE | June 1, 2019 | ||||
| Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
remission rate [ Time Frame: 24 weeks after withdrawal of the medical intervention ] Remission is defined as fasting plasma glucose less than 7mmol/L and GHbA1c less than 7% without any hypoglycemic agents
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Structured Simplified Short-term Intensive Insulin Therapy on Long-term Glycemic Remission | ||||
| Official Title ICMJE | Induction of Long-term Glycemic Remission Via Structured Simplified Short-term Intensive Insulin Therapy in Patients With Newly Diagnosed Type 2 Diabetes: a Multiple Centered, Randomised Controlled Trial. | ||||
| Brief Summary | Short-term intensive insulin therapy is shown to induced glycemic remission, but traditionally patients were hospitalized for 2-4 weeks in order to receive the therapy, the long inpatient period precluded the wide application of the thrapy. This study aims to invesitgate whether simplified regimen is non-inferior to traditional regimen in achieving long-term glycemic remisson. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE |
330 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | December 31, 2022 | ||||
| Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | |||||
| Listed Location Countries ICMJE | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03972982 | ||||
| Other Study ID Numbers ICMJE | 2018YFC1314102 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Yanbing Li, Sun Yat-sen University | ||||
| Study Sponsor ICMJE | Sun Yat-sen University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Sun Yat-sen University | ||||
| Verification Date | June 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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