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NCT03958591CompletedPhase 4

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

Impact of Short-term Intensive De-escalation Therapeutic Strategy on Long-term Regimen Simplification in Poorly Controlled Type 2 Diabetes: a National Multicenter, Prospective, Randomized Trial

Source: ClinicalTrials.gov · Last updated 8 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
276 (actual)
First submitted
20 May 2019
Start date
1 May 2019
Primary completion date
1 Jan 2025
Lead sponsor
Yanbing Li
NCT number
NCT03958591

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 276
  • From 1 May 2019 to the primary completion date, 1 Jan 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 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;

Other illness

  • Type 1 diabetes or specific types of diabetes;
  • Serious systemic disease or malignant tumor, chronic diarrhea, etc;

Lab values

  • Those with ALT \>2.5 times of the upper limit of normal (ULN), bilirubin \> 1.5 times of ULN;
  • 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;

Other

  • 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 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;
  • 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.

Who the study is looking for

  • Type 2 diabetes diagnosed according to WHO criteria (1999); With a duration of 1\~15 years;
  • With two or more oral hypoglycemic drugs, or basal insulin and 1-2 oral hypglycemic agents, used for at least 3 months;
  • 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.

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department of endocrinology, FAH-SYSU
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.