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Completed

NCT Number: NCT00147836

Evaluation of the Effects of Different Interventions on Glycemic Control in Newly-Diagnosed Type 2 Diabetic Patients

The purpose of this study is to investigate and evaluate the effects of different interventions (1.continuous subcutaneous insulin infusion,2.multiple daily injections, 3.anti-hyperglycemic agents) on glycemic control, B-cell function and the remission rate in newly-diagnosed type 2 diabetic patients.

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Key information

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the first Affiliated Hospital of Sun Yat-Sen university

Guangzhou, Guangdong, 510080, China

About this study

ß-Cell dysfunction and decreased insulin sensitivity are the main pathophysiological defects responsible for the development of hyperglycemia. With continuous presence of insulin resistance, progressive loss of ß-cell function is the crucial defect. Hyperglycemia has deleterious effect on β-cell function, which is partially reversible by adequate glycemic control. In newly diagnosed type 2 diabetic patients with severe hyperglycemia, 2 weeks continuous subcutaneous insulin infusion (CSII) can induce adequate glycemic control with improvement of β-cell function. Nearly half of the patients can maintain euglycemia longer than 12 months by transient CSII. The improvement of β-cell function, especially the restoration of the first-phase insulin response is related to sustained euglycemia in the newly diagnosed type 2 diabetic patients. But it is unclear whether any other interventions (such as oral hypoglycemic agents and multiple daily injections) inducing optimal glycemic control in a short period of time can have the same effect. As a multicenter, open-label, randomized, parallel-group study will be needed to further prove and clarify the findings.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • informed consents be given before treatment
  • the newly-diagnosed type 2 diabetic patients
  • fasting blood glucose (FBG) level ranging from 7.0~16.7 mmol/L
  • age ranging from 25~70 years old
  • body mass index (BMI) ranging from20~35kg/m2
  • never be treated with any anti-hyperglycemic agents or anti-hyperlipidemic agents

Exclusion criteria

  • having any severe acute or chronic complications
  • renal dysfunction, blood creatinine≥150µmol/L
  • blood aminotransferase level rising up(more than 2 times of the normal level)
  • any severe cardiac disease including congestive cardiac failure, unstable angina and myocardial infarct in 12 months
  • serious hypertension (systolic pressure≥180mmHg and/ or diastolic pressure≥110mmHg)
  • chronic or acute pancreatic disease
  • severe systematic diseases or malignant tumor
  • allergic to the drugs using in the trial
  • any factors interfering the result
  • female patients incline to be pregnant
  • being treated with corticosteroid, immunosuppressing drugs or cytotoxic drugs
  • poor compliance

Treatment and study plan

Human Insulin (Novolin-R, Novo Nordisk)

Drug

H-Tron Plus V100; Disetronic Medical System, Burgdorf, Switzerland

Device

Pre-meal

Other

Novolin-R

Drug

Human Insulin NPH (Novolin-N, Novo Nordisk)

Drug

Gliclazide (Diamicron, Servier)

Drug

Diamicron and Glucophage

Drug

Primary outcomes

  1. glycemic control, the improvement of β-cell l function and the remission rate after short intensive therapy in newly diagnosed type 2 diabetic patients

    Time frame: Oct. 2007

Secondary outcomes

  1. the effects of different interventions (oral anti-hyperglycemic agents, multiple daily injections and continuous subcutaneous insulin infusion) on glycemic control, β-cell function and the remission rate in newly-diagnosed type 2 diabetic patients

    Time frame: Oct. 2007

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • Guangdong Science and Technology Bureau, China
  • Hoffmann-La Roche
  • Ministry of Education, China
  • Novo Nordisk A/S

Registry information

Official study title

Evaluation of the Effects of Oral Anti-Hyperglycemic Agents, Multiple Daily Injections or Continuous Subcutaneous Insulin Infusion on Glycemic Control, B-Cell Function and the Remission Rate in Newly-Diagnosed Type 2 Diabetic Patients

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Sep 7, 2005
Registry last updated
Apr 1, 2008

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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