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| Sponsors and Collaborators: |
Sun Yat-sen University 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 |
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: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| 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 |
|---|---|
|
CSII: Active Comparator
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);
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Drug: Human Insulin (Novolin-R, Novo Nordisk) Device: H-Tron Plus V100; Disetronic Medical System, Burgdorf, Switzerland |
|
MDI: Active Comparator
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
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Other: Pre-meal Drug: Novolin-R Drug: Human Insulin NPH (Novolin-N, Novo Nordisk) |
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OHA: Active Comparator
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
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Drug: Gliclazide (Diamicron, Servier) Drug: Diamicron and Glucophage |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| China, Guangdong | |
| the first Affiliated Hospital of Sun Yat-Sen university | |
| Guangzhou, Guangdong, China, 510080 | |
| Principal Investigator: | Jianping Weng, MD,PHD | Ministry of Education |
More Information
| Study ID Numbers: | NECT-2004-WJP, GSTB-05100981-LYB |
| Study First Received: | September 4, 2005 |
| Last Updated: | March 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00147836 History of Changes |
| Health Authority: | China: Ministry of Health |
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type 2 diabetes mellitus therapy sulfonylureas metformin insulin |
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Hypoglycemic Agents Metabolic Diseases Gliclazide Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Insulin, Isophane Insulin |
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Hypoglycemic Agents Metabolic Diseases Gliclazide Physiological Effects of Drugs Metformin Diabetes Mellitus, Type 2 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions Insulin |