drugset / Trial / NCT01717911

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

NCT01717911

Phase 4 Unknown 160 enrolled Taipei Veterans General Hospital, Taiwan
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2010-09
Primary completion
2013-12
Completion
2018-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin Protein / enzyme biologic Other
Comparator Metformin Small molecule 850 mg Oral
Subject Sitagliptin Small molecule 100 mg Oral