Effects of Different Early Intensive Therapies on Long-te... | NCT01471808

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

NCT01471808

Sponsor

Sun Yat-sen University

Status

Completed

Last Update Posted

Sep 24, 2025Actual

Enrollment

264Actual

Phase

Phase 4

Conditions

Diabetes Mellitus, Type 2

Interventions

CSII
CSII, Metformin, Pioglitazone
CSII, Sitagliptin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Dec 2018Actual

Completion Date

Dec 2018Actual

First Submitted Date

Nov 8, 2011

First Submission Date that Met QC Criteria

Nov 15, 2011

First Posted Date

Nov 16, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2025

Last Update Posted Date

Sep 24, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yanbing Li, the director of the endocrinology department of the First Affiliated Hospital of Sun Yat-sen University, First Affiliated Hospital, Sun Yat-Sen UniversityPrincipal Investigator

Lead Sponsor

Sun Yat-sen UniversityOTHER

Collaborators

Name	Class
Nanfang Hospital, Southern Medical University	OTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	OTHER
Peking University Shenzhen Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

264Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CSII	Active Comparator	continuous subcutaneous insulin infusion	Drug: CSII
Metformin & Pioglitazone	Active Comparator	CSII combined with metformin and pioglitazone	Drug: CSII, Metformin, Pioglitazone
Sitagliptin	Active Comparator	CSII combined with sitagliptin 100mg/d	Drug: CSII, Sitagliptin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CSII	Drug	continuous subcutaneous insulin infusion for 2~4 weeks	CSII

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Yanbin Li, MD	Ministry of Education	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25765670	Derived	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.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D008687	Metformin
D000077205	Pioglitazone
D000068900	Sitagliptin Phosphate

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals
D045162