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

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin aspart; Drug: insulin NPH

Study type: Interventional

Funder types: Industry

Identifiers

NCT00494988

ANA-1635

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)