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

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taipei Veterans General Hospital, Taiwan
• Treatments: Insulin; Insulin, Globin Zinc; Isophane Insulin, Human; Metformin; Sitagliptin Phosphate

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.