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
Information source: Novo Nordisk
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes; Diabetes Mellitus, Type 2
Intervention: insulin detemir (Drug); insulin aspart (Drug); insulin NPH (Drug); human soluble insulin (Drug); metformin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Novo Nordisk Official(s) and/or principal investigator(s):
Lili Pan, Study Director, Affiliation: Novo Nordisk China
Overall contact:
Public Access to Clinical Trials - Novo Nordisk, Phone: Please Contact NN via email, Email: clinicaltrials@novonordisk.com
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 with or without metformin in Chinese patients with type 2 diabetes.
Clinical Details
Official title: A 2-week, Randomised, Controlled, Open-label, Two-group Parallel, Multi-centre Trial Comparing Efficacy and Safety of Insulin Detemir Plus Insulin Aspart and NPH Insulin Plus Human Soluble Insulin Both in a Basal Bolus Regimen With or Without Metformin in Chinese Inpatients With Type 2 Diabetes Currently Treated With Insulin Qualifying for Intensified Treatment
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change from baseline in mean 8-point plasma glucose (PG)
Secondary outcome: Change from baseline in fasting plasma glucose (FPG)Change from baseline in mean 2-hour post prandial plasma glucose (2hPPG) of 3 meals Change from baseline in mean value of pre-lunch, pre-dinner and bedtime PG Percentage of subjects achieving PG targets Change from baseline in fructosamine Incidence of hypoglycaemic episodes
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.)
Locations and Contacts
Public Access to Clinical Trials - Novo Nordisk, Phone: Please Contact NN via email, Email: clinicaltrials@novonordisk.com
Beijing, Beijing 100034, China; Recruiting
Additional Information
Clinical Trials at Novo Nordisk
Starting date: November 2011
Last updated: December 8, 2011
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