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

September 19, 2025 updated by: Yanbing Li, Sun Yat-sen University

Effects of Oral Hypoglycemic Agents Combined With Short-term CSII on Glycemic Control in Newly-diagnosed Type 2 Diabetic Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

264

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CSII
continuous subcutaneous insulin infusion
Drug: CSII
continuous subcutaneous insulin infusion for 2~4 weeks
Active Comparator: Metformin & Pioglitazone
CSII combined with metformin and pioglitazone
Drug: CSII, Metformin, Pioglitazone
CSII for 2~4 weeks combined with metformin 1.5g/d and pioglitazone 30mg/d for 3 months.
Active Comparator: Sitagliptin
CSII combined with sitagliptin 100mg/d
Drug: CSII, Sitagliptin
CSII for 2~4 weeks combined with sitagliptin 100mg/d for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
proportions of 1 year remission of type 2 diabetes
Time Frame: 1 years
the remission rate after short intensive therapy in newly diagnosed type 2 diabetic patients
1 years

Secondary Outcome Measures

Outcome Measure
Time Frame
the effects of different interventions on β-cell function in newly-diagnosed type 2 diabetic patients
Time Frame: 1 years
1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
First People's Hospital of Foshan
Peking University Shenzhen Hospital
Nanfang Hospital, Southern Medical University

Investigators

  • Principal Investigator: Yanbin Li, MD, Ministry of Education

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

November 8, 2011

First Submitted That Met QC Criteria

November 15, 2011

First Posted (Estimated)

November 16, 2011

Study Record Updates

Last Update Posted (Estimated)

September 24, 2025

Last Update Submitted That Met QC Criteria

September 19, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13560475186

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on CSII

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe