ß-cell function and glycemic control in newly diagnosed type 2 diabetic patients with moderate hyperglycemia

Conditions: Type 2 Diabetes

Summary: we have found that a 6-month course of insulin therapy after a short-term intensive insulin therapy could shorten the period of hyperglycemia to preserve ß-cell function and further improve long-term glycemic control in recently diagnosed type 2 diabetes with severe hyperglycemia (\>300 mg/dl, with hba1c level around 9-11%) in our previous study. we thus hypothesized that a 6-month course of basal insulin therapy could also help to preserve ß-cell function in newly diagnosed type 2 diabetes with moderate hyperglycemia (200-300 mg/dl). this prospective study is outpatient-based to evaluate whether 6-month basal insulin therapy versus oral anti-diabetic treatment (metformin and sitagliptin) soon after the diagnosis of type 2 diabetes with moderate hyperglycemia (200-300 mg/dl) is associated with better ß-cell function reservation. we skip a short-term intensive admission course of insulin therapy as our previous study in newly diagnosed type 2 diabetes with severe hyperglycemia.

ß-cell dysfunction and decreased insulin sensitivity are the main pathophysiological defects responsible for the development of hyperglycemia. there is a progressive deterioration in ß-cell function and mass in type 2 diabetics. optimal metabolic control, especially early intensive glycemic control, plays a role in the prevention of progressive ß-cell dysfunction and possibly destruction of the ß-cells with worsening of diabetes. we have found that a 6-month course of insulin therapy after a short-term intensive insulin therapy could shorten the period of hyperglycemia to preserve ß-cell function and further improve long-term glycemic control in recently diagnosed type 2 diabetes with severe hyperglycemia (\>300 mg/dl, with hba1c level around 9-11%) in our previous study. we thus hypothesized that a 6-month course of basal insulin therapy could also help to preserve ß-cell function in newly diagnosed type 2 diabetes with moderate hyperglycemia (200-300 mg/dl). this prospective study is outpatient-based to evaluate whether 6-month basal insulin therapy versus oral anti-diabetic treatment (metformin and sitagliptin) soon after the diagnosis of type 2 diabetes with moderate hyperglycemia (200-300 mg/dl) is associated with better ß-cell function reservation. we skip a short-term intensive admission course of insulin therapy as our previous study in newly diagnosed type 2 diabetes with severe hyperglycemia. this study also can assess what readily available parameter would predict which patients will achieve long-term successful glycemic control after correction of glucose toxicity. our results will provide evidence that a 6-month course of basal insulin therapy could shorten the exposure to moderate hyperglycemia and further improve beta-cell function to achieve long-term glycemic control.

Eligibility criteria:
inclusion criteria: 1. recently diagnosed type 2 diabetic patients. 2. fasting plasma glucose between 200-300 mg/dl (a1c level between 7% and 10%). 3. those who age between 30 and 80 years old and can inject insulin by themselves. exclusion criteria: 1. previous treated with anti-diabetic medication 2. pregnant or nursing women. 3. impaired liver function (alt \> 120 u/l) 4. impaired renal function (serum creatinine \>1.5 mg/dl in male, \>1.4 mg/dl in female ) 5. recently suffered from mi or cva. 6. patients are acute intercurrent illness. 7. 2-hour c-peptide level \< 1.8 ng/ml.

Keywords: newly diagnosed type 2 diabetes insulin, metformin, sitagliptin beta-cell function, glycemic control