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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00147836
• Other study ID #: NECT-2004-WJP
• Secondary ID: GSTB-05100981-LY
• Status: Completed
• Phase: N/A
• First received: September 4, 2005
• Last updated: March 31, 2008
• Start date: September 2004
• Est. completion date: October 2007

Study information

• Verified date: October 2007
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 436
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Human Insulin (Novolin-R, Novo Nordisk)

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

Other:
• Pre-meal

Drug:
• Novolin-R

• Human Insulin NPH (Novolin-N, Novo Nordisk)

• Gliclazide (Diamicron, Servier)

• Diamicron and Glucophage

Locations

Country	Name	City	State
China	the first Affiliated Hospital of Sun Yat-Sen university	Guangzhou	Guangdong

Sponsors (5)

Lead Sponsor	Collaborator
Sun Yat-sen University	Guangdong Science and Technology Bureau, China, Hoffmann-La Roche, Ministry of Education, China, Novo Nordisk A/S

Country where clinical trial is conducted

China, 

References & Publications (1)

Li Y, Xu W, Liao Z, Yao B, Chen X, Huang Z, Hu G, Weng J. Induction of long-term glycemic control in newly diagnosed type 2 diabetic patients is associated with improvement of beta-cell function. Diabetes Care. 2004 Nov;27(11):2597-602. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glycemic control, the improvement of ß-cell l function and the remission rate after short intensive therapy in newly diagnosed type 2 diabetic patients		Oct. 2007	Yes
Secondary	the effects of different interventions (oral anti-hyperglycemic agents, multiple daily injections and continuous subcutaneous insulin infusion) on glycemic control, ß-cell function and the remission rate in newly-diagnosed type 2 diabetic patients		Oct. 2007	Yes