Efficacy and Safety of Insulin Degludec/Insulin Aspart in Insulin-naïve Subjects With Type 2 Diabetes Using Two Dosing Regimens
Status: | Completed |
---|---|
Conditions: | Diabetes, Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | June 2011 |
End Date: | April 2012 |
A Trial Comparing the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily in Insulin-naïve Subjects With Type 2 Diabetes Mellitus When Using Two Different Titration Algorithms (BOOST™: SIMPLE USE)
This trial is conducted in Asia and North America. The aim of this trial is to compare the
efficacy and safety of insulin degludec/insulin aspart (IDegAsp) once daily in insulin-naïve
subjects with type 2 diabetes mellitus when using two different titration algorithms (dose
individually adjusted) as add-on to subject's ongoing treatment with metformin.
efficacy and safety of insulin degludec/insulin aspart (IDegAsp) once daily in insulin-naïve
subjects with type 2 diabetes mellitus when using two different titration algorithms (dose
individually adjusted) as add-on to subject's ongoing treatment with metformin.
Inclusion Criteria:
- Type 2 diabetes (diagnosed clinically) for 24 weeks or longer prior to randomisation
(visit 2)
- Insulin naïve subjects (Allowed are: Previous short term insulin treatment no longer
than or equal to 14 days in total; Treatment during hospitalisation or during
gestational diabetes is allowed for periods longer than 14 days in total)
- Current treatment: Metformin alone or metformin in any combination of 1 or 2
additional OADs (oral anti-diabetic drug) including an insulin secretagogue
(sulfonylurea or glinide), dipeptidyl peptidase IV (DPP-IV) inhibitors,
alpha-glucosidase inhibitors or thiazolidinediones (TZDs) - all with unchanged dosing
for at least 12 weeks prior to randomisation (visit 2). Metformin dose, alone or in
combination (including fixed combination), must be at least 1000 mg daily
- HbA1c (glycosylated haemoglobin) 7.0-10.0% (both inclusive)
- BMI (Body Mass Index) below or equal to 45 kg/m^2
- Ability and willingness to adhere to the protocol including self measurement of
plasma glucose
Exclusion Criteria:
- Treatment with GLP-1 (glucagon like peptide) receptor agonists within the last 12
weeks prior to randomisation (visit 2)
- Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the
last 12 months) or hypoglycaemic unawareness as judged by the Investigator (trial
physician)
- Previous participation in this trial. Participation is defined as randomised.
Re-screening is allowed once during the recruitment period
- Known or suspected hypersensitivity to trial products or related products
- The receipt of any investigational drug within 4 weeks prior to randomisation (visit
2)
- Anticipated significant lifestyle changes during the study, e.g. shift work
(including permanent night/evening shift workers) as well as highly variable eating
habits
We found this trial at
24
sites
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