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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01471808

Enrollment

264

Registered

2011-11-16

Start date

2011-10-31

Completion date

2018-12-31

Last updated

2025-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

25 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026