Last updated on February 2018

-Cell Function and Glycemic Control in Newly Diagnosed Type 2 Diabetic Patients With Moderate Hyperglycemia


Brief description of study

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 -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 -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 -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.

Detailed Study Description

-Cell dysfunction and decreased insulin sensitivity are the main pathophysiological defects responsible for the development of hyperglycemia. There is a progressive deterioration in -cell function and mass in type 2 diabetics. Optimal metabolic control, especially early intensive glycemic control, plays a role in the prevention of progressive -cell dysfunction and possibly destruction of the -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 -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 -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 -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.

Clinical Study Identifier: NCT01717911

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Recruitment Status: Open


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