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

This study has been completed.
Sponsor:
Collaborators:
Ministry of Education, China
Guangdong Science and Technology Bureau, China
Hoffmann-La Roche
Novo Nordisk A/S
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00147836
First received: September 4, 2005
Last updated: March 31, 2008
Last verified: October 2007

September 4, 2005
March 31, 2008
September 2004
October 2007   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Glycemic control (fasting and postprandial glucose, GHbA1c), B-cell function and the remission rate
Complete list of historical versions of study NCT00147836 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
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Evaluation of the Effects of Different Interventions on Glycemic Control in Newly-Diagnosed Type 2 Diabetic Patients
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Human Insulin (Novolin-R, Novo Nordisk)
  • Device: H-Tron Plus V100; Disetronic Medical System, Burgdorf, Switzerland
  • Other: Pre-meal
  • Drug: Novolin-R
  • Drug: Human Insulin NPH (Novolin-N, Novo Nordisk)
  • Drug: Gliclazide (Diamicron, Servier)
  • Drug: Diamicron and Glucophage
  • Active Comparator: CSII
    Patients in continuous subcutaneous insulin infusion group received Human Insulin (Novolin-R, Novo Nordisk) with an insulin pump (H-Tron Plus V100; Disetronic Medical System, Burgdorf, Switzerland);
    Interventions:
    • Drug: Human Insulin (Novolin-R, Novo Nordisk)
    • Device: H-Tron Plus V100; Disetronic Medical System, Burgdorf, Switzerland
  • Active Comparator: MDI
    Patients in MDI group were treated with pre-meal Novolin-R, and Human Insulin NPH (Novolin-N, Novo Nordisk) at bedtime. Initial insulin doses were 0.4-0.5 IU/kg and total daily doses were divided into 50% of basal and 50% of bolus injection in CSII group and 30%-20%-20%-30% in multiple daily insulin injection group
    Interventions:
    • Other: Pre-meal
    • Drug: Novolin-R
    • Drug: Human Insulin NPH (Novolin-N, Novo Nordisk)
  • Active Comparator: OHA
    In oral hpoglycemic agents group, the patients with 20 kg/m2<BMI≤25kg/m2 were initiated with Gliclazide (Diamicron, Servier) 80mg Bid (maximum to 160mg Bid), the patients with 25kg/m2<BMI≤35kg/m2 were initiated with Metformin (Glucophage, BMS) 0.5 Bid (maximum to 2.0g/d), the combination of Diamicron and Glucophage was used in patients who could not achieve glycaemic control goal with one OHA or with FPG≥11.1mmol/l at randomization
    Interventions:
    • Drug: Gliclazide (Diamicron, Servier)
    • Drug: Diamicron and Glucophage

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
436
October 2007
October 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  1. having any severe acute or chronic complications
  2. renal dysfunction, blood creatinine≥150µmol/L
  3. blood aminotransferase level rising up(more than 2 times of the normal level)
  4. any severe cardiac disease including congestive cardiac failure, unstable angina and myocardial infarct in 12 months
  5. serious hypertension (systolic pressure≥180mmHg and/ or diastolic pressure≥110mmHg)
  6. chronic or acute pancreatic disease
  7. severe systematic diseases or malignant tumor
  8. allergic to the drugs using in the trial
  9. any factors interfering the result
  10. female patients incline to be pregnant
  11. being treated with corticosteroid, immunosuppressing drugs or cytotoxic drugs
  12. poor compliance
Both
25 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00147836
NECT-2004-WJP, GSTB-05100981-LYB
Yes
Not Provided
Sun Yat-sen University
  • Ministry of Education, China
  • Guangdong Science and Technology Bureau, China
  • Hoffmann-La Roche
  • Novo Nordisk A/S
Principal Investigator: Jianping Weng, MD,PHD Ministry of Education
Sun Yat-sen University
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP