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

NCT01471808 | Completed Phase 4 DMC

• 1 other identifier: 13560475186
• Study Type: interventional
• Target: 264
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

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

  1 years

Secondary Outcomes (1)

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

  1 years

Study Arms (3)

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

CSII DRUG

continuous subcutaneous insulin infusion for 2\~4 weeks

CSII

CSII, Metformin, Pioglitazone DRUG

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

Metformin & Pioglitazone

CSII, Sitagliptin DRUG

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

Sitagliptin

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Nanfang Hospital, Southern Medical University: collaborator
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• Peking University Shenzhen Hospital: collaborator
• First People's Hospital of Foshan: collaborator

Related Publications (1)

• 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.

  PMID: 25765670 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin; Pioglitazone; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Thiazolidinediones; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Triazoles; Pyrazines

Study Officials

• Yanbin Li, MD

  Ministry of Education

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: the director of the endocrinology department of the First Affiliated Hospital of Sun Yat-sen University

Study Record Dates

• First Submitted: November 8, 2011
• First Posted: November 16, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share