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

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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

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

Exclusion criteria

  • having any severe acute or chronic complications
  • renal dysfunction, blood creatinine≥150µmol/L
  • blood aminotransferase level rising up(more than 2 times of the normal level)
  • any severe cardiac disease including congestive cardiac failure, unstable angina and myocardial infarct in 12 months
  • serious hypertension (systolic pressure≥180mmHg and/ or diastolic pressure≥110mmHg)
  • chronic or acute pancreatic disease
  • severe systematic diseases or malignant tumor
  • allergic to the drugs using in the trial
  • any factors interfering the result
  • female patients incline to be pregnant
  • being treated with corticosteroid, immunosuppressing drugs or cytotoxic drugs
  • poor compliance

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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