Status:
TERMINATED
Comparing Efficacy and Safety of Insulin Detemir Plus Insulin Aspart and NPH Insulin Plus Human Soluble Insulin With or Without Metformin in Chinese Patients With Type 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This trial is conducted in Asia. The aim of this trial is to compare efficacy and safety of insulin detemir plus insulin aspart and NPH insulin plus human soluble insulin both in a basal bolus regimen...
Eligibility Criteria
Inclusion
- Type 2 diabetes mellitus (diagnosed clinically) for at 12 months or longer
- Currently treated with basal insulin once daily or premixed insulin twice daily for at least 3 months with or without OAD(s), and total daily insulin dose less than 1.4 IU (U)/kg (If treated with metformin, unchanged total daily dose of at least 1000 mg for at least 3 months)
- Body Mass Index (BMI) equal to 40 kg/m\^2 or below
- HbA1c (glycosylated haemoglobin A1c) between 7.0% and 10.0% by central laboratory analysis
- Plan to be admitted for optimising glycaemic control at least 2 days prior to the randomisation
Exclusion
- Treatment with thiazolidinediones (TZD) or Glucagon-Like Peptide-1 (GLP-1) receptor agonists within the last 3 months prior to the screening
- Anticipated change after the randomisation in concomitant medication known to interfere with glucose metabolism, such as systemic corticosteroids, beta-blockers and mono amine oxidase (MAO) inhibitors
- Previous participation in this trial (participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period.)
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT01486966
Start Date
November 1 2011
End Date
June 1 2012
Last Update
March 17 2017
Active Locations (6)
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1
Novo Nordisk Investigational Site
Beijing, Beijing Municipality, China, 100034
2
Novo Nordisk Investigational Site
Chongqing, Chongqing Municipality, China, 400016
3
Novo Nordisk Investigational Site
Wuxi, Jiangsu, China, 214023
4
Novo Nordisk Investigational Site
Nanchang, Jiangxi, China, 330006