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OpenTrials
Completed

NCT Number: NCT01471808

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CSII

Drug

continuous subcutaneous insulin infusion for 2~4 weeks

CSII, Metformin, Pioglitazone

Drug

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

CSII, Sitagliptin

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: 1 years

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Nov 16, 2011
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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