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出境医 / 临床实验 / Effects of Short-term Intensive De-escalation Therapy on Long-term Regimen Simplification in Patients With Poorly Controlled Type 2 Diabetes

Effects of Short-term Intensive De-escalation Therapy on Long-term Regimen Simplification in Patients With Poorly Controlled Type 2 Diabetes

Study Description
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.

Condition or disease Intervention/treatment Phase
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 Design
Layout table for study information
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
Arms and Interventions
Arm Intervention/treatment
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.

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.

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.

Outcome Measures
Primary Outcome Measures :
  1. 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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Type 2 diabetes diagnosed according to WHO criteria (1999); With a duration of 1~10 years;
  2. With two or more oral hypoglycemic drug used for at least 3 months, including at least one insulin secretagogue in half-max dosage (eg. Glibenclamide 7.5mg/d, gliclazide 60mg/d, glimepiride 3mg/d, glipizide 10mg/d, repaglinide 6mg/d, nateglinide 360mg/d and DPP-4 inhibitor with regular doses);
  3. HbA1c of 7.5 to 13% and fasting C-peptide >0.4 nmol/L;
  4. Age of 18 to 70 years;
  5. BMI of 20 to 35 kg/m²;
  6. Capable of and willing to follow doctors' instructions to:

    • Self-monitor blood glucose according to the protocol;

      • Follow the protocol and have regular visits as required; ③ Record and maintain the research diary, as required by the protocol; ④ Keep contact with the investigators and receive phone calls during the study.

Exclusion Criteria:

  1. Type 1 diabetes or specific types of diabetes;
  2. Those who have received premixed insulin therapy and/or basal - meal insulin and/or basal insulin-oral hypoglycemic agents treatment accumulation for 7 days or more, and those who have received CSII therapy in the last one year, and those who have received GLP-1 analogue within 3 months before screening;
  3. Those who have acute diabetic complications (diabetic ketoacidosis, hyperosmotic hyperglycemia coma or lactic acidosis);
  4. Those who have severe diabetic microvascular complications (proliferative retinopathy, clinical proteinuria, and glomerular filtration rate less than 45 ml/min, uncontrolled diabetic neuropathy and obvious diabetic autonomic neuropathy);
  5. Those with ALT >2.5 times of the upper limit of normal (ULN), bilirubin > 1.5 times of ULN;
  6. Those with known macrovascular disease: Patients with acute cerebrovascular accident, acute coronary syndrome, unstable angina, peripheral artery disease who have received vascular intervention or amputation in the 12 months before enrollment; Or chronic cardiac dysfunction with cardiac function grade III or above;
  7. Those with poor blood pressure control (systolic blood pressure≥160mmHg and/or sitting diastolic blood pressure ≥110mmHg) and inability to control under 160/110mmhg within 1 week;
  8. Serious systemic disease or malignant tumor, chronic diarrhea, etc;
  9. Those with drugs that may affect blood glucose for a cumulative time of more than 1 week within 12 weeks, such as oral/venous glucocorticoid, growth hormone, estrogen/ progesterone, high-dose diuretics, antipsychotic drugs. However, low-dose diuretics for antihypertensive purposes (HCTZ < 25mg/d, indapamide < 1.5mg/d) and physiologic dose of thyroid hormone for replacement therapy are not included;
  10. Any factors that may affect the participation of the subject in the study or the evaluation of the results;
  11. Pregnancy or planned pregnancy, lactation subjects.
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
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
 (submitted: May 20, 2019)
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
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
Condition  ICMJE
  • Poorly Controlled Diabetes Mellitus
  • Intensive-de-escalation Therapy
  • Long-term Regimen Simplification
Intervention  ICMJE
  • 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.
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Intensive-de-escalation group with intelligent management
    Intervention: Drug: CSII and thereafter combination therapy with wearable devices
  • Experimental: Intensive-de-escalation group without intelligent management
    Intervention: Drug: CSII and thereafter combination therapy
  • Active Comparator: Traditionally upgrading group
    Intervention: Drug: Traditionally upgrading therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 20, 2019)
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:

  1. Type 2 diabetes diagnosed according to WHO criteria (1999); With a duration of 1~10 years;
  2. With two or more oral hypoglycemic drug used for at least 3 months, including at least one insulin secretagogue in half-max dosage (eg. Glibenclamide 7.5mg/d, gliclazide 60mg/d, glimepiride 3mg/d, glipizide 10mg/d, repaglinide 6mg/d, nateglinide 360mg/d and DPP-4 inhibitor with regular doses);
  3. HbA1c of 7.5 to 13% and fasting C-peptide >0.4 nmol/L;
  4. Age of 18 to 70 years;
  5. BMI of 20 to 35 kg/m²;
  6. Capable of and willing to follow doctors' instructions to:

    • Self-monitor blood glucose according to the protocol;

      • Follow the protocol and have regular visits as required; ③ Record and maintain the research diary, as required by the protocol; ④ Keep contact with the investigators and receive phone calls during the study.

Exclusion Criteria:

  1. Type 1 diabetes or specific types of diabetes;
  2. Those who have received premixed insulin therapy and/or basal - meal insulin and/or basal insulin-oral hypoglycemic agents treatment accumulation for 7 days or more, and those who have received CSII therapy in the last one year, and those who have received GLP-1 analogue within 3 months before screening;
  3. Those who have acute diabetic complications (diabetic ketoacidosis, hyperosmotic hyperglycemia coma or lactic acidosis);
  4. Those who have severe diabetic microvascular complications (proliferative retinopathy, clinical proteinuria, and glomerular filtration rate less than 45 ml/min, uncontrolled diabetic neuropathy and obvious diabetic autonomic neuropathy);
  5. Those with ALT >2.5 times of the upper limit of normal (ULN), bilirubin > 1.5 times of ULN;
  6. Those with known macrovascular disease: Patients with acute cerebrovascular accident, acute coronary syndrome, unstable angina, peripheral artery disease who have received vascular intervention or amputation in the 12 months before enrollment; Or chronic cardiac dysfunction with cardiac function grade III or above;
  7. Those with poor blood pressure control (systolic blood pressure≥160mmHg and/or sitting diastolic blood pressure ≥110mmHg) and inability to control under 160/110mmhg within 1 week;
  8. Serious systemic disease or malignant tumor, chronic diarrhea, etc;
  9. Those with drugs that may affect blood glucose for a cumulative time of more than 1 week within 12 weeks, such as oral/venous glucocorticoid, growth hormone, estrogen/ progesterone, high-dose diuretics, antipsychotic drugs. However, low-dose diuretics for antihypertensive purposes (HCTZ < 25mg/d, indapamide < 1.5mg/d) and physiologic dose of thyroid hormone for replacement therapy are not included;
  10. Any factors that may affect the participation of the subject in the study or the evaluation of the results;
  11. Pregnancy or planned pregnancy, lactation subjects.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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