Comparison of NN5401 With Insulin Glargine, Both in Combination With Oral Antidiabetic Drugs, in Subjects With Type 2 Diabetes
Status: | Completed |
---|---|
Conditions: | Diabetes, Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | January 2010 |
End Date: | October 2010 |
A Trial Comparing Efficacy and Safety of NN5401 With Insulin Glargine, Both in Combination With Oral Antidiabetic Drugs in Subjects With Type 2 Diabetes (BOOST™ : INTENSIFY BASAL)
This trial is conducted in Africa, Asia, Europe and the United States of America (USA).
The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with
insulin glargine in patients with type 2 diabetes inadequately controlled with insulin and
oral anti-diabetic drugs (OADs). Subjects continued their ongoing treatment with OADs in the
trial.
The aim of this clinical trial is to compare NN5401 (insulin degludec/insulin aspart) with
insulin glargine in patients with type 2 diabetes inadequately controlled with insulin and
oral anti-diabetic drugs (OADs). Subjects continued their ongoing treatment with OADs in the
trial.
Inclusion Criteria:
- Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
- Treatment with basal insulin regimen (insulin detemir, insulin glargine or neutral
protamine Hagedorn [NPH] insulin) once daily (OD), for at least 3 months
- Ongoing treatment with: metformin with or without other oral antidiabetic drugs
(OADs) for at least 3 months prior to randomisation
- HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
- BMI maximum 40.0 kg/m^2
Exclusion Criteria:
- Treatment with insulin regimens other than a basal insulin regimen (insulin detemir
or insulin glargine or NPH insulin) OD within 3 months prior to Visit 1
- Treatment with glucagon-like peptide 1 (GLP-1) receptor agonists within 3 months
prior to visit 1
- Current rosiglitazone users
- Cardiovascular disease, within the last 6 months prior to visit 1, defined as:
stroke; decompensated heart failure New York Heart Association (NYHA) class III or
IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass
graft or angioplasty
- Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least
180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
- Impaired liver function, defined as alanine aminotransferase (ALAT) at least 2.5
times upper limit of normal (one retest analysed at the central laboratory within a
week of receipt of the result is permitted with the result of the last sample being
conclusive)
- Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
contraceptive measures according to local requirements
- Cancer and medical history of cancer hereof (except basal cell skin cancer or
squamous cell skin cancer)
We found this trial at
23
sites
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