Comparison of Insulin Detemir, Insulin Aspart and Biphasic Insulin Aspart 30 With OAD Treatment in Type 2 Diabetes
Information source: Novo Nordisk
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2
Intervention: biphasic insulin aspart (Drug); insulin detemir (Drug); insulin aspart (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Novo Nordisk
Official(s) and/or principal investigator(s):
Jens Larsen, MD, Study Director, Affiliation: Novo Nordisk A/S
This trial is conducted in Europe.
The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood
glucose levels) of insulin detemir, insulin aspart and biphasic insulin aspart 30, when added
to current OAD treatment in type 2 diabetes and to verify the safety of use ( number and
severity of episodes of hypoglycaemia, body weight and side effects).
Official title: 3 Year Efficacy and Safety Comparison of Adding Insulin Detemir, Biphasic Insulin Aspart 30 or Insulin Aspart to Oral Antidiabetic Drug Treatment in Type 2 Diabetes.
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Proportion of subjects who achieve HbA1c = 6.5% without hypoglycaemia
Efficacy and durability of the insulin regimens
Quality of Life
Minimum age: 18 Years.
Maximum age: N/A.
- Type 2 Diabetes
- Insulin naive
- On OAD treatment
- BMI = 40. 0 kg/m2
- HbA1c7. 0%-10% (both inclusive)
- Proliferative retinopathy
- Recurrent major hypoglycaemia
- Cardial problems
- Uncontrolled hypertension
- Impaired hepatic or renal function
Locations and Contacts
Oxford, United Kingdom
Clinical Trials at Novo Nordisk
Starting date: November 2004
Ending date: July 2009
Last updated: February 13, 2008