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CompletedNCT01471808Updated Sep 24, 2025

Effects of Different Early Intensive Therapies on Long-term β-cell Function

A Phase 4 interventional study of CSII and CSII, Metformin, Pioglitazone in Diabetes Mellitus, Type 2, sponsored by Sun Yat-sen University. Completed. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-09-24.

Sponsored by Sun Yat-sen University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
264
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
All
01

Study summary

The purpose of this study is to investigate and evaluate the effects of different oral antihyperglycaemic agents combined with short-term continuous subcutaneous insulin infusion(CSII)(1.CSII alone; 2.metformin and pioglitazone combined with CSII; 3. sitagliptin combined with CSII) on long-term glycemic control and β-cell function in newly diagnosed type 2 diabetic patients.

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus, Type 2

9,357 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 264 is above the median of 80 across 7,523 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • newly diagnosed type 2 diabetes
  • fasting blood glucose (FBG) level ranging from 7.0～16.7 mmol/L
  • body mass index (BMI) ranging from21～35kg/m2
  • Antihyperglycaemic and antihyperlipidemic medication-naive patients

Exclusion criteria

Exclusion Criteria:

  • having any severe acute or chronic diabetic complications
  • renal dysfunction, blood creatinine≥150µmol/L
  • blood aminotransferase level rising up(more than 2 times of the upper normal limit of ALT)
    • Any severe cardiac disease including congestive cardiac failure, unstable angina or myocardial infarct in 12 months
  • chronic or acute pancreatic disease
  • severe systematic diseases or malignant tumor
  • female patients incline to be pregnant
  • being treated with corticosteroid, immunosuppressing drugs or cytotoxic drugs
  • poor compliance
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
264 participants (actual)

Study arms

  • Active comparator
    CSII

    continuous subcutaneous insulin infusion

    Drug: CSII

  • Active comparator
    Metformin & Pioglitazone

    CSII combined with metformin and pioglitazone

    Drug: CSII, Metformin, Pioglitazone

  • Active comparator
    Sitagliptin

    CSII combined with sitagliptin 100mg/d

    Drug: CSII, Sitagliptin

Interventions

  • DrugCSII

    continuous subcutaneous insulin infusion for 2\~4 weeks

  • DrugCSII, Metformin, Pioglitazone

    CSII for 2\~4 weeks combined with metformin 1.5g/d and pioglitazone 30mg/d for 3 months.

  • DrugCSII, Sitagliptin

    CSII for 2\~4 weeks combined with sitagliptin 100mg/d for 3 months

06

What researchers measure

Primary outcomes

  1. proportions of 1 year remission of type 2 diabetes

    the remission rate after short intensive therapy in newly diagnosed type 2 diabetic patients

    Time frame: 1 years

Secondary outcomes

  1. the effects of different interventions on β-cell function in newly-diagnosed type 2 diabetic patients

    Time frame: 1 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Liu L, Ke W, Wan X, Zhang P, Cao X, Deng W, Li Y. Insulin requirement profiles of short-term intensive insulin therapy in patients with newly diagnosed type 2 diabetes and its association with long-term glycemic remission. Diabetes Res Clin Pract. 2015 May;108(2):250-7. doi: 10.1016/j.diabres.2015.02.011. Epub 2015 Feb 21. PubMed 25765670 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01471808
Lead sponsor
Sun Yat-sen University
Collaborators
Nanfang Hospital, Southern Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Peking University Shenzhen Hospital, First People's Hospital of Foshan
Responsible party
Yanbing Li (the director of the endocrinology department of the First Affiliated Hospital of Sun Yat-sen University, First Affiliated Hospital, Sun Yat-Sen University) — Principal investigator
First posted
Nov 16, 2011
Start date
Oct 2011
Primary completion
Dec 2018
Completion
Dec 2018
Last update
Sep 24, 2025

Study contacts

Yanbin Li, MD
principal investigator · Ministry of Education

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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