Phase 2
Completed N=182
Comparison of Two NN5401 Formulations Versus Biphasic Insulin Aspart 30, All in Combination With Metformin in Subjects With Type 2 Diabetes
Source: ClinicalTrials.gov NCT00613951 ↗Enrolled (actual)
182
Serious AEs
1.1%
Results posted
Dec 2015
Primary outcomePrimary: Change in Glycosylated Haemoglobin (HbA1c) — -1.79; -1.87; -1.84 percentage of glycosylated haemoglobin
Summary
This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (Soluble Insulin Analogue Combination [SIAC], insulin degludec/insulin aspart) formulations with each other and with biphasic insulin aspart 30, all in combination with metformin in insulin naive subjects with type 2 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycosylated Haemoglobin (HbA1c) |
-1.79; -1.87; -1.84 | — |
| SECONDARY Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) |
7.52; 7.44; 7.52 | — |
| SECONDARY Rate of Major and Minor Hypoglycaemic Episodes |
0; 0; 0; 287; 679; 730 | — |
| SECONDARY Rate of Nocturnal Major and Minor Hypoglycaemic Episodes |
0; 0; 0; 39; 79; 108 | — |
| SECONDARY Rate of Treatment Emergent Adverse Events (AEs) |
298; 545; 379; 0; 0; 11 | — |
| SECONDARY Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) |
33.0; 31.4; 36.9; 22.9; 22.5; 23.6 | — |
| SECONDARY Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT) |
23.6; 25.2; 26.4; 22.6; 22.9; 23.1 | — |
| SECONDARY Laboratory Safety Parameters (Biochemistry): Serum Creatinine |
72.7; 75.8; 74.8; 73.6; 76.3; 78.1 | — |
| SECONDARY Vital Signs: Diastolic Blood Pressure (BP) |
80; 81; 81; 78; 79; 76 | — |
| SECONDARY Vital Signs: Systolic Blood Pressure (BP) |
134; 138; 137; 128; 135; 133 | — |
| SECONDARY Vital Signs: Pulse |
74; 76; 75; 73; 73; 77 | — |
| SECONDARY Physical Examination |
— | — |
Eligibility Criteria
Inclusion Criteria
- Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
- Insulin naïve type 2 diabetes subjects (as diagnosed clinically) for at least 3 months (no previous insulin treatment or previous short term insulin treatment maximum 14 days within the last 3 months)
- Treatment with one or two oral anti-diabetic drugs (OADs): metformin, sulfonylurea, other insulin secretagogue (e.g. repaglinide, nateglinide), alpha-glucosidase inhibitors for at least 2 months at a stable maximally tolerated dose or at least half maximally allowed dose according to locally approved summary of product characteristics (SPC)
- HbA1c, 7.0-11.0 % (both inclusive)
- Body Mass Index (BMI), 25.0-37.0 kg/m^2 (both inclusive)
Exclusion Criteria
- Metformin contraindication according to local practice
- Thiazolidinedione (TZD) treatment within previous 3 months prior to Visit 1
- Any systemic treatment with products, which in the investigator's opinion could interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) within 3 months prior to randomisation
- Subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system (except for conditions associated with type 2 diabetes) that, in the opinion of the investigator, may confound the results of the trial or pose additional risk in administering trial product
Data sourced from ClinicalTrials.gov (NCT00613951). 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.