Phase 3
Completed N=465
Comparison of NN5401 With Insulin Glargine, Both in Combination With Oral Antidiabetic Drugs, in Subjects With Type 2 Diabetes
Source: ClinicalTrials.gov NCT01045447 ↗Enrolled (actual)
465
Serious AEs
3.9%
Results posted
Nov 2015
Primary outcomePrimary: Change in Glycosylated Haemoglobin (HbA1c) — -0.98; -1.00 percentage of glycosylated haemoglobin
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycosylated Haemoglobin (HbA1c) |
-0.98; -1.00 | — |
| SECONDARY Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) |
8.1; 8.4 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01045447). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.