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| Sponsor: | Taipei Veterans General Hospital,Taiwan |
|---|---|
| Information provided by: | Taipei Veterans General Hospital,Taiwan |
| ClinicalTrials.gov Identifier: | NCT00506194 |
Purpose
We designed this prospective, randomized control study to compare the benefits between the insulin therapy and OADs after correction of the glucose toxicity with a short period of intensive insulin therapy.
| Condition | Intervention |
|---|---|
|
Type 2 Diabetes |
Drug: Insulin Drug: OAD |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Short-Term Intensive Insulin Therapy Induction of Long-Term Glycemic Control Is Associated With Improvement of ß-Cell Function in Newly Diagnosed Type 2 Diabetic Patients |
| Estimated Enrollment: | 60 |
| Study Start Date: | October 2005 |
| Estimated Study Completion Date: | December 2011 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: INSULIN
Insulin therapy was initiated at a 75% total daily dose in the last day hospitalization with insulatard. Two third of daily dose was admmistrated before breakfask and the other was admmistrated at bedtime. Insulin doses were titrated every 3 days to achieve target FPG and pre-supper blood glucose values between 90 and 130 mg/dl. Bedtime insulin doses were titrated based on FPG values and the pre breakfast dose was titrated base on presupper blood glucose.
|
Drug: Insulin
Other Name: Insulatard, Actrapid, Lantus, monotard
|
|
Active Comparator: OAD
Subject in other OAD group was visited every two weeks in the two months and the every four weeks. The subjects will start with Gliclazide-MR 30mg before breakfast, The dosage was titrated based on the fasting blood glucose on the visiting day with the same target. Decreased by 30mg if blood glucose was <70mg /dl, decreased by 15 mg if blood glucose was 70-90mg/dl, no change if blood glucose was 90-130mg/dl, increased by 15 mg if blood glucose was 131-160 mg/dl, increased by 30 mg if blood glucose >160mg/dl. When the Gliclazide-MR dose each to the maximum dose of 60 mg twice daily, Metformin was added. The titration of Metformin was use 250mg for an adjust dosage with the same target.
|
Drug: OAD
Gliclazide-MR, Metformin, Glimepiride
Other Name: Diamicron-MR, Glucophage, Amaryl
|
OBJECTIVE—Type 2 diabetes is associated with defects in insulin secretion and insulin action. Hyperglycemia may aggravate these defects, a feature known as glucose toxicity. Previous studies have shown that acute correction of hyperglycemia in subjects with long-standing type 2 diabetes gives only short-term improvement in glycemic control after discontinuation of insulin. The current study attempts to identify any characteristics of patients with newly diagnosed type 2 diabetes (fasting glucose >300mg/dL) who would have a long-term benefit, in terms of glycemic control, from a brief course of insulin therapy.
RESEARCH DESIGN AND METHODS—Newly diagnosed type 2 diabetic patients with severe hyperglycemia (fasting blood glucose >300 mg/dL or random blood glucose >400 mg/dL) will be hospitalized and treated with intensive insulin injection for 10 to 14 days. Oral glucose tolerance will be performed after one week of intensive insulin treatment. After discharge, patients will be randomized to receive insulin injection or oral anti-diabetic drug for further management. Patients will be followed in our clinics and adjust their medication according to their blood glucose levels. Oral glucose tolerance test will be repeated 6 months later, whereas the insulin sensitivity and -cell function will be evaluated again.
EXPECTED RESULTS—We will respect that short-term intensive insulin therapy can induce lone-term glycemic control in newly diagnosed type 2 diabetes with severe hyperglycemia.
Eligibility| Ages Eligible for Study: | 30 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Harn-Shen Chen, MD, PhD | 886-2-28757515 | chenhs@vghtpe.gov.tw |
| Contact: Cho-yu Chan, MD | 886-2-28757434 | cychan@vghtpe.gov.tw |
| Taiwan | |
| Division of Endocrinology and Metabolism, Department of Medicine | Recruiting |
| Taipei, Taiwan, 112 | |
| Contact: Harn-Shen Chen, MD, PhD 886-2-28757515 chenhs@vghtpe.gov.tw | |
| Contact: Cho-yu Chan, MD 886-2-28757434 cychan@vghtpe.gov.tw | |
| Principal Investigator: Han-Shen Chen, MD, PhD | |
| Principal Investigator: | Harn-Shen Chen, MD, PhD | Division of endocrinology and metabolism, Department of medicien, Taipei Veterans General Hospital |
More Information
| ClinicalTrials.gov Identifier: | NCT00506194 History of Changes |
| Other Study ID Numbers: | VGH 94-09-09 |
| Study First Received: | July 24, 2007 |
| Last Updated: | July 24, 2007 |
| Health Authority: | Taiwan: Institutional Review Board |
|
type 2 diabetes oral glucose tolerance test insulin oral anti-diabetic drug ß-cell function |
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
