Effects of Short-term Intensive De-escalation Therapy on Long-term Regimen Simplification

NCT03958591 | Unknown Phase 4

• 1 other identifier: 2018YFC1314103
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 1

Brief Summary

Despite advances in diabetes management, many patients with type 2 diabetes 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. The investigators 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.

Conditions

Diabetes type2

Keywords

poorly controlled diabetes; intensive insulin therapy; wearable device

Outcome Measures

Primary Outcomes (1)

• the proportions of treatment simplification

  the proportions of patients who can maintain glycemic targets (HbA1c\<7%) with only combination of oral hypoglycemic agents

  24 weeks after the insulin treatment

Study Arms (3)

Intensive-de-escalation group with intelligent management

EXPERIMENTAL

Short-term continuous subcutaneous insulin infusion and thereafter the combination therapy of basal insulin, metformin and vildagliptin will be applied. Then the oral hypoglycemic therapies will be prescribed. Wearable devices and smart apps will be used to manage and follow-up patients.

Drug: CSII and thereafter combination therapy, followed up with wearable devices

Intensive-de-escalation group without intelligent management

EXPERIMENTAL

Short-term continuous subcutaneous insulin infusion and thereafter the combination therapy of basal insulin, metformin and vildagliptin will be applied. Then the oral hypoglycemic therapies will be prescribed. Traditional ways such as telephone contact will be used to follow-up patients.

Drug: CSII and thereafter combination therapy, followed up in traditional ways

Traditionally upgrading group

ACTIVE COMPARATOR

The combination therapy of basal insulin, metformin and vildagliptin for the entire 12 weeks and thereafter the oral hypoglycemic therapies will be applied. Traditional ways will be used to follow-up patients.

Drug: Traditionally upgrading therapy, followed up in traditional ways

Interventions

CSII and thereafter combination therapy, followed up with wearable devices DRUG

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 the participants.

Also known as: Intensive intelligence group

Intensive-de-escalation group with intelligent management

CSII and thereafter combination therapy, followed up in traditional ways DRUG

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 for follow up.

Also known as: Intensive group

Intensive-de-escalation group without intelligent management

Traditionally upgrading therapy, followed up in traditional ways DRUG

The participants will be applied the combination therapy of basal insulin, metformin and vildagliptin for the entire 12 weeks. Traditional ways will be used for follow up.

Also known as: Traditional group

Traditionally upgrading group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes diagnosed according to WHO criteria (1999); With a duration of 1\~10 years;
• 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);
• HbA1c of 7.5 to 13% and fasting C-peptide \>0.4 nmol/L;
• Age of 18 to 70 years;
• BMI of 20 to 35 kg/m²；
• 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.

You may not qualify if:

• Type 1 diabetes or specific types of diabetes;
• 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;
• Those who have acute diabetic complications (diabetic ketoacidosis, hyperosmotic hyperglycemia coma or lactic acidosis);
• 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);
• Those with ALT \>2.5 times of the upper limit of normal (ULN), bilirubin \> 1.5 times of ULN；
• 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;
• 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;
• Serious systemic disease or malignant tumor, chronic diarrhea, etc；
• 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；
• Any factors that may affect the participation of the subject in the study or the evaluation of the results；
• Pregnancy or planned pregnancy, lactation subjects.

Sponsors & Collaborators

• Yanbing Li: lead

Study Sites (1)

Department of endocrinology, FAH-SYSU

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Interventions

Wearable Electronic Devices

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Yanbing Li, Dr

  FAH-SYSU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lijuan Xu, Dr

CONTACT

020-87755766; xulijuan@mail.sysu.edu.cn

Lijuan Xu, Dr

CONTACT

020-87755766; jin9998@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: May 22, 2019
• Study Start: May 1, 2019
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2022
• Last Updated: April 8, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)