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Comparison of Efficacy and Safety of Prandilin and NovoRapid in Newly Diagnosed Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
Comparison of Efficacy and Safety of Prandilin and NovoRapid Evaluated by Continuous Glucose Monitoring System in Newly Diagnosed Type 2 Diabetes

Clinical Trial Summary

To compare the effect of the rapid-acting insulin analogues (RAIAs) NovoRapid (aspart) and Prandilin (lispro) on glycemic variations by Continuous glucose monitoring system (CGMS) in continuous subcutaneous insulin infusion (CSII) with metformin intensive therapy in newly diagnosed type 2 diabetes mellitus (T2DM).

Clinical Trial Description

The study was designed as a single blind randomized control trial. A total of 110 newly type 2 diabetic diagnosed patients with hemoglobin A1c (HbA1c%) above 9% were hospitalized, and were randomly divided into two groups: NovoRapid group (group Asp) and Prandilin group (group Lis) in CSII, combined with metformin therapy. Treatments were maintained for 2-3 weeks after the glycaemic target was reached. To complete the assessment of general information, fasting C-peptide (C-P0), 2-h postprandial C-peptide (C-P2h), fasting insulin (Ins0), 2-h postprandial insulin (Ins2h), HbA1c% and fructosamine on the baseline and endpoint. 4 days continuous glucose monitoring (CGM) was performed on after three days stable glucose. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03226210
Study type Interventional
Source Nanjing First Hospital, Nanjing Medical University
Contact
Status Completed
Phase Phase 4
Start date February 1, 2015
Completion date July 1, 2016
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