Intensive insulin strategy may ease diabetes drug burden
NCT ID NCT03958591
First seen Jun 24, 2026 · Last updated Sep 09, 2026 · Updated 3 times
Summary
This study tested whether a short period of intensive insulin therapy, followed by a combination of basal insulin, metformin, and vildagliptin, could help people with poorly controlled type 2 diabetes simplify their long-term treatment. The goal was to see if more participants could eventually manage their diabetes with just two oral medications. The trial enrolled 274 adults in China and used wearable devices to monitor progress.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- insulin, metformin, vildagliptin
- What this could lead to
- If successful, this approach could help people with type 2 diabetes manage their blood sugar with fewer medications, potentially using only two oral drugs instead of multiple injections.
- What could go wrong
- This is a completed Phase 4 trial, but results are not yet published. The approach may not work for everyone, and intensive insulin therapy carries risks like low blood sugar.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
276 people
The number who actually took part.
- Started
-
May 2019
- Finished
-
Mar 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Type 2 diabetes diagnosed according to WHO criteria (1999); With a duration of 1\~15 years; 2. With two or more oral hypoglycemic drugs, or basal insulin and 1-2 oral hypglycemic agents, used for at least 3 months; 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Department of endocrinology, FAH-SYSU
Guangzhou, Guangdong, 510080, China
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