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Effekter af kortvarig intensiv de-eskaleringsterapi på langsigtet regimeforenkling

2. november 2026 opdateret af: Yanbing Li

Effekter af kortvarig intensiv deeskaleringsterapi på langsigtet regimeforenkling hos patienter med dårligt kontrolleret type 2-diabetes - et multicenter, åbent, randomiseret kontrolleret forsøg

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.

Studieoversigt

Detaljeret beskrivelse

This is a multicenter, randomized, controlled, open-label, clinical superiority trial. The participants will be recruited from 10 centers in China. The enrolled participants will be randomly assigned into 3 groups.

Group CIW (CSII with wearables):Continuous subcutaneous insulin infusion (CSII) will be applied to the participants for 1-2 weeks and thereafter the combination therapy of basal insulin, metformin and vildagliptin for the next 10 weeks and then insulin will be suspended. The participants are wearing wearables.

Group CI (CSII without wearbles): CSII will be applied to the participants for 1-2 weeks and thereafter the combination therapy of basal insulin, metformin and vildagliptin for the next 10 weeks and then insulin will be suspended.

Group BI (Basal insulin treatment): The participants will be applied the combination therapy of basal insulin, vildagliptin and metformin for the entire 12 weeks and then insulin will be suspended.

Participants will then receive combination therapy of metformin and vildagliptin. If the participants cannot tolerate metformin, then acarbose (50-100mg tid) or SGLT2 inhibitor can be instead used. If glucose is not well controlled, sulfonylureas or glinides can be added as a rescue treatment.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

276

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Guangdong
      • Guangzhou, Guangdong, Kina, 510080
        • Department of endocrinology, FAH-SYSU

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: CSII with wearables

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 will be used.

Short-term continuous subcutaneous insulin infusion and thereafter the combination therapy of basal insulin, metformin and vildagliptin; Wearable devices will be used during the follow-up.

Eksperimentel: CSII without wearbles

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.

Short-term continuous subcutaneous insulin infusion and thereafter the combination therapy of basal insulin, metformin and vildagliptin.

Aktiv komparator: Basal insulin group

The combination therapy of basal insulin, metformin and vildagliptin for the entire 12 weeks and thereafter the oral hypoglycemic therapies will be applied.

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
the proportions of treatment de-escalation
Tidsramme: From enrollment to the end of treatment at week 36

the proportions of patients who can use only combination of two oral hypoglycemic agents

From enrollment to the end of treatment at week 36

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

  • Ledende efterforsker: Yanbing Li, Dr, FAH-SYSU

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

22. juli 2019

Primær færdiggørelse (Faktiske)

1. september 2025

Studieafslutning (Faktiske)

31. maj 2026

Datoer for studieregistrering

Først indsendt

20. maj 2019

Først indsendt, der opfyldte QC-kriterier

20. maj 2019

Først opslået (Faktiske)

22. maj 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. november 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 2018YFC1314103

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Ingen

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