The investigators designed this prospective, randomized control study to compare the efficacy and safety between the basal insulin glargine therapy and metformin-based OADs after correction of the glucose toxicity with a short period of intensive insulin therapy.
Detailed Description: OBJECTIVE-Type 2 diabetes is associated with defects in insulin secretion and insulin sensitivity. 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 whether basal insulin glargine or metformin-based OADs for further management would have a long-term benefit in newly diagnosed type 2 diabetes after short-term intensive insulin therapy. RESEARCH DESIGN AND METHODS-Newly diagnosed type 2 diabetic patients (fasting blood glucose \>200 mg/dL or random blood glucose \>300 mg/dL) will be hospitalized and treated with intensive insulin injection for 10 to 14 days. HbA1c were measured before intensive insulin injection. After discharge, patients will be randomized to receive basal insulin injection or metformin-based OADs for further management. Patients will be followed in our clinics and adjust their medication according to their blood glucose levels. HbA1c were measured 6 months later.After the six-month intervention, these patients were continually followed up for another six months. Subjects received an oral glucose tolerance test (OGTT) after the intensive insulin therapy and at the end of the 6th and 12th month. EXPECTED RESULTS-We will expect that basal insulin glargine,compared with metformin-based OAD treatment,could more effectively maintain adequate glycemic control in newly diagnosed type 2 diabetes after short-term intensive insulin therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
47
the First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Glycosylated Hemoglobin (HbA1c) at month 6
Time frame: month 6
Change From Baseline in Glycosylated Hemoglobin at month 6
Time frame: Baseline and month 6
Glycosylated Hemoglobin at month 12
Time frame: month 12
Change From Baseline in Glycosylated Hemoglobin at month 12
Time frame: Baseline and month 12
Number of Participants With Glycosylated Hemoglobin ≤ 7%
Time frame: month 6
Number of Participants With Glycosylated Hemoglobin ≤ 7%
Time frame: month 12
Number of Participants With Glycosylated Hemoglobin ≤ 6.5%
Time frame: month 6
Number of Participants With Glycosylated Hemoglobin ≤ 6.5%
Time frame: month 12
Fasting Plasma Glucose at week 2
Time frame: week 2
Fasting Plasma Glucose at week 4
Time frame: week 4
Fasting Plasma Glucose at week 8
Time frame: week 8
Fasting Plasma Glucose at week 12
Time frame: week 12
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Fasting Plasma Glucose at week 16
Time frame: week 16
Fasting Plasma Glucose at week 20
Time frame: week 20
Fasting Plasma Glucose at week 24
Time frame: week 24
Fasting Plasma Glucose at week 32
Time frame: week 32
Fasting Plasma Glucose at week 40
Time frame: week 40
Fasting Plasma Glucose at week 48
Time frame: week 48
Homeostasis model assessment (HOMA)-β at month 6
Time frame: month 6
Insulinogenic index at month 6
Time frame: month 6
HOMA-IR at month 6
Time frame: month 6
Matsuda index at month 6
Time frame: month 6
Basal disposition index at month 6
Time frame: month 6
Early-phase disposition index at month 6
Time frame: month 6
Homeostasis model assessment (HOMA)-β at month 12
Time frame: month 12
Insulinogenic index at month 12
Time frame: month 12
HOMA-IR at month 12
Time frame: month 12
Matsuda index at month 12
Time frame: month 12
Basal disposition index at month 12
Time frame: month 12
Early-phase disposition index at month 12
Time frame: month 12
Diabetes Treatment Satisfaction Questionnaire status (DTSQs) version score
Time frame: month 6
DTSQs score at month 12
Time frame: month 12
Audit of Diabetes Dependent Quality of Life (ADDQoL) score
Time frame: month 6
ADDQoL score at month 12
Time frame: month 12
Cost at month 6
Time frame: month 6
Number of Participants with Hypoglycemia
Time frame: up to 6 month
Number of hypoglycemia episodes
Time frame: up to 6 month
Number of Participants with severe Hypoglycemia
Time frame: up to 6 month
Number of severe hypoglycemia episodes
Time frame: up to 6 month
Change From Baseline in Body Weight (month 6)
Time frame: Baseline and month 6
Change From Baseline in Body Weight (month 12)
Time frame: Baseline and month 12