ß-Cell Function and Glycemic Control of Basal Insulin, Metformin or Sitagliptin in Newly Diagnosed Type 2 Diabetic Patients With Moderate Hyperglycemia

NCT01717911 Phase 4 UNKNOWN

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.

Details

Lead sponsor	Taipei Veterans General Hospital, Taiwan
Phase	Phase 4
Status	UNKNOWN
Enrolment	160
Start date	2010-09
Completion	2018-12

Conditions

• Type 2 Diabetes

Interventions

• Insulin
• Metformin
• Sitagliptin

Primary outcomes

• The primary outcome was the comparison of A1C change. — Dec. 2013
  The primary outcome was the comparison of A1C change.

Countries

Taiwan