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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
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
History of Changes
  Purpose

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.


Condition Intervention
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 436
Study Start Date: September 2004
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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);
 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
 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
 Drug: Gliclazide (Diamicron, Servier) Drug: Diamicron and Glucophage

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00147836

Locations
China, Guangdong
the first Affiliated Hospital of Sun Yat-Sen university
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Sun Yat-sen University
Ministry of Education, China
Guangdong Science and Technology Bureau, China
Hoffmann-La Roche
Novo Nordisk
Investigators
Principal Investigator: Jianping Weng, MD,PHD Ministry of Education
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00147836     History of Changes
Other Study ID Numbers: NECT-2004-WJP, GSTB-05100981-LYB
Study First Received: September 4, 2005
Last Updated: March 31, 2008
Health Authority: China: Ministry of Health

Keywords provided by Sun Yat-sen University:
type 2 diabetes mellitus
therapy
sulfonylureas
metformin
insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Gliclazide
 Insulin
Hypoglycemic Agents
Insulin, NPH
Metformin
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013