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

Sun Yat-sen University

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Human Insulin NPH (Novolin-N, Novo Nordisk); Drug: Novolin-R; Other: Pre-meal; Device: H-Tron Plus V100; Disetronic Medical System, Burgdorf, Switzerland; Drug: Diamicron and Glucophage; Drug: Human Insulin (Novolin-R, Novo Nordisk); Drug: Gliclazide (Diamicron, Servier)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00147836

NECT-2004-WJP

GSTB-05100981-LYB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 436 patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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436 participants in 3 patient groups

CSII

Active Comparator group

Description:

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);

Treatment:

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

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

MDI

Active Comparator group

Description:

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

Treatment:

Other: Pre-meal

Drug: Novolin-R

Drug: Human Insulin NPH (Novolin-N, Novo Nordisk)

OHA

Active Comparator group

Description:

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

Treatment:

Drug: Gliclazide (Diamicron, Servier)

Drug: Diamicron and Glucophage