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

NCT ID: NCT00147836

Last Updated: 2008-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 436 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2007-10-31

Brief 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.

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

type 2 diabetes mellitus; therapy; sulfonylureas; metformin; insulin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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);

Group Type: ACTIVE_COMPARATOR

Human Insulin (Novolin-R, Novo Nordisk)

Intervention Type: DRUG

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

Intervention Type: DEVICE

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

Group Type: ACTIVE_COMPARATOR

Pre-meal

Intervention Type: OTHER

Novolin-R

Intervention Type: DRUG

Human Insulin NPH (Novolin-N, Novo Nordisk)

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

Gliclazide (Diamicron, Servier)

Intervention Type: DRUG

Diamicron and Glucophage

Intervention Type: DRUG

Interventions

Human Insulin (Novolin-R, Novo Nordisk)

Intervention Type: DRUG

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

Intervention Type: DEVICE

Pre-meal

Intervention Type: OTHER

Novolin-R

Intervention Type: DRUG

Human Insulin NPH (Novolin-N, Novo Nordisk)

Intervention Type: DRUG

Gliclazide (Diamicron, Servier)

Intervention Type: DRUG

Diamicron and Glucophage

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Education, China

OTHER_GOV

Sponsor Role: collaborator

Guangdong Science and Technology Bureau, China

UNKNOWN

Sponsor Role: collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Principal Investigators

Jianping Weng, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

Ministry of Education

Locations

the first Affiliated Hospital of Sun Yat-Sen university

Guangzhou, Guangdong, China

Countries

China

References

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. doi: 10.2337/diacare.27.11.2597.

Reference Type: BACKGROUND

PMID: 15504992 (View on PubMed)

Weng J, Li Y, Xu W, Shi L, Zhang Q, Zhu D, Hu Y, Zhou Z, Yan X, Tian H, Ran X, Luo Z, Xian J, Yan L, Li F, Zeng L, Chen Y, Yang L, Yan S, Liu J, Li M, Fu Z, Cheng H. Effect of intensive insulin therapy on beta-cell function and glycaemic control in patients with newly diagnosed type 2 diabetes: a multicentre randomised parallel-group trial. Lancet. 2008 May 24;371(9626):1753-60. doi: 10.1016/S0140-6736(08)60762-X.

Reference Type: DERIVED

PMID: 18502299 (View on PubMed)

Other Identifiers

GSTB-05100981-LYB

Identifier Type: -

Identifier Source: secondary_id

NECT-2004-WJP

Identifier Type: -

Identifier Source: org_study_id