Self-control Trial to Evaluate the Remission Rate in Newly Diagnosed Type 2 Diabetes Patients After Treatment With Insulin Aspart

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes

• Registration Number: NCT00494988
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Asia. The aim of this trial is evaluate the remission rate in newly diagnosed subjects with type 2 diabetes after short-term intensive treatment with insulin aspart and insulin NPH.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2006-04
• Study Completion: 2006-04
• Study First Submitted: 2007-06-29
• Study First Submitted QC: 2007-06-29
• Study First Posted: 2007-07-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-03
• Last Update Posted: 2016-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Type 2 diabetes newly diagnosed within 6-12 months
• FBG: 11.1-17.0 mmol/L
• Body mass index (BMI) larger than 25.0 kg/m2

Exclusion Criteria

• Known or suspected allergy to trial product(s) or related products
• Recurrent major hypoglycaemia as judged by the Investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Remission rate	after 24 weeks

Secondary Outcome Measures

Name	Time	Method
HbA1c
blood glucose profiles