Phase 3
Completed N=296
Comparison of NN5401 With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes
Source: ClinicalTrials.gov NCT01272193 ↗Enrolled (actual)
296
Serious AEs
2.7%
Results posted
Nov 2015
Primary outcomePrimary: Change in Glycosylated Haemoglobin (HbA1c) — -1.35; -1.22 percentage of glycosylated haemoglobin
Summary
This trial is conducted in Japan. The aim of this trial is to investigate the efficacy and safety of NN5401 (insulin degludec/insulin aspart) with insulin glargine in subjects with type 2 diabetes in Japan. Depending on pre-trial oral anti-diabetic drugs (OADs), subjects continued at the same dose and dosing frequency.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycosylated Haemoglobin (HbA1c) |
-1.35; -1.22 | — |
| SECONDARY Mean Increment of 9-point Self Measured Plasma Glucose Profile (SMPG) at the Main Evening Meal |
1.4; 4.7 | — |
| SECONDARY Rate of Treatment Emergent Adverse Events (AEs) |
334; 368; 7; 4; 1; 0 | — |
| SECONDARY Rate of Confirmed Hypoglycaemic Episodes |
191; 271 | — |
| SECONDARY Rate of Nocturnal Confirmed Hypoglycaemic Episodes |
39; 53 | — |
| SECONDARY Change in Body Weight |
0.7; 0.7 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
- HbA1c 7.0-10.0% (both inclusive) by central laboratory analysis
- Body Mass Index (BMI) below or equal to 35.0 kg/m^2
- Insulin naive subject and ongoing treatment with 1 or more oral antidiabetic drugs (OADs) for at least 12 weeks prior to randomisation with at least recommended maintenance dose according to local, approved labelling Allowed are: a. Previous short term insulin treatment up to 14 days; b. Treatment during hospitalization or during gestational diabetes is allowed for periods longer than 14 days)
Exclusion Criteria
- Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, mono amino oxidase (MAO) inhibitors
- Use of glucagon-like peptide-1 (GLP-1) receptor agonists, buformine and/or rosiglitazone within the last 12 weeks prior to randomisation
- 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
Data sourced from ClinicalTrials.gov (NCT01272193). 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.