Condition or disease | Intervention/treatment | Phase |
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Poorly Controlled Diabetes Mellitus Intensive-de-escalation Therapy Long-term Regimen Simplification | Drug: CSII and thereafter combination therapy with wearable devices Drug: CSII and thereafter combination therapy Drug: Traditionally upgrading therapy | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 408 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Effects of Short-Term Intensive De-escalation Therapy With Continuous Subcutaneous Insulin Infusion and Sequential Combination of Basal Insulin, Metformin And Vildagliptin on Long-term Regimen Simplification in Patients With Poorly Controlled Type 2 Diabetes-- a Multicenter, Open-labeled, Randomized Controlled Trial |
Estimated Study Start Date : | June 1, 2019 |
Estimated Primary Completion Date : | June 30, 2022 |
Estimated Study Completion Date : | December 31, 2022 |
Arm | Intervention/treatment |
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Experimental: Intensive-de-escalation group with intelligent management |
Drug: CSII and thereafter combination therapy with wearable devices
Short-term continuous subcutaneous insulin infusion and thereafter the combination therapy of basal insulin, metformin and vildagliptin; Wearable devices and smart apps will be used to manage and follow-up patients.
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Experimental: Intensive-de-escalation group without intelligent management |
Drug: CSII and thereafter combination therapy
Short-term continuous subcutaneous insulin infusion and thereafter the combination therapy of basal insulin, metformin and vildagliptin; Traditional ways such as telephone contact will be used to follow-up patients.
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Active Comparator: Traditionally upgrading group |
Drug: Traditionally upgrading therapy
Patients will be applied the combination therapy of basal insulin, metformin and vildagliptin for the entire 12 weeks. Traditional ways will be used to follow-up patients.
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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:
Capable of and willing to follow doctors' instructions to:
Self-monitor blood glucose according to the protocol;
Exclusion Criteria:
No Contacts or Locations Provided
Tracking Information | |||||
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First Submitted Date ICMJE | May 20, 2019 | ||||
First Posted Date ICMJE | May 22, 2019 | ||||
Last Update Posted Date | May 22, 2019 | ||||
Estimated Study Start Date ICMJE | June 1, 2019 | ||||
Estimated Primary Completion Date | June 30, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
the proportions of treatment simplification [ Time Frame: 24 weeks after the insulin treatment ] the proportions of patients who can maintain glycemic targets (HbA1c<7%) with only combination of oral 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 Short-term Intensive De-escalation Therapy on Long-term Regimen Simplification in Patients With Poorly Controlled Type 2 Diabetes | ||||
Official Title ICMJE | Effects of Short-Term Intensive De-escalation Therapy With Continuous Subcutaneous Insulin Infusion and Sequential Combination of Basal Insulin, Metformin And Vildagliptin on Long-term Regimen Simplification in Patients With Poorly Controlled Type 2 Diabetes-- a Multicenter, Open-labeled, Randomized Controlled Trial | ||||
Brief Summary | Despite advances in diabetes management, many T2DM patients in China fail to achieve optimal glycemic control. One of the possible reasons is associated with the delay in therapeutic decision making that lags behind glycemic rise. We design this study and presume that using vildagliptin and metformin in combination with basal insulin as sequential treatment after intensive insulin therapy, might better modulate the dual islet hormone dysfunction than traditionally stepwise upgrading therapy pattern in patients with poorly controlled T2DM, and thus lead to a glucose normalization, β-cell function improvement and therapy simplification. | ||||
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 | ||||
* 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 |
408 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 31, 2022 | ||||
Estimated Primary Completion Date | June 30, 2022 (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 | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03958591 | ||||
Other Study ID Numbers ICMJE | 2018YFC1314103 | ||||
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 | Yanbing Li | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Sun Yat-sen University | ||||
Verification Date | May 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |