Phase 2
Completed N=178
Comparison of Two NN5401 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes
Source: ClinicalTrials.gov NCT00614055 ↗Enrolled (actual)
178
Serious AEs
1.7%
Results posted
Nov 2015
Primary outcomePrimary: Change in Glycosylated Haemoglobin (HbA1c) — -1.31; -1.46; -1.29 percentage of glycosylated haemoglobin
Summary
This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (SIAC, insulin degludec/insulin aspart) formulations with each other and with insulin glargine, 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) |
-1.31; -1.46; -1.29 | — |
| SECONDARY Change in Fasting Plasma Glucose (FPG) |
-4.30; -4.10; -5.07 | — |
| SECONDARY Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) |
8.34; 8.31; 8.42 | — |
| SECONDARY Rate of Treatment Emergent Adverse Events (AEs) |
441; 310; 295; 11; 6; 0 | — |
| SECONDARY Rate of Major and Minor Hypoglycaemic Episodes |
0; 0; 0; 115; 240; 67 | — |
| SECONDARY Rate of Nocturnal Major and Minor Hypoglycaemic Episodes |
0; 0; 0; 6; 158; 17 | — |
| SECONDARY Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) |
31.9; 29.7; 33.7; 23.9; 23.2; 22.3 | — |
| SECONDARY Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT) |
24.8; 22.0; 24.0; 21.1; 20.0; 19.2 | — |
| SECONDARY Laboratory Safety Parameters (Biochemistry): Serum Creatinine |
76.4; 75.8; 77.4; 75.7; 74.9; 76.8 | — |
| SECONDARY Vital Signs: Diastolic Blood Pressure (BP) |
78; 78; 79; 76; 77; 77 | — |
| SECONDARY Vital Signs: Systolic Blood Pressure (BP) |
135; 133; 135; 129; 133; 129 | — |
| SECONDARY Vital Signs: Pulse |
73; 75; 75; 71; 69; 71 | — |
| 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 month at a stable maximum tolerated dose or at least half maximum 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) treatments within the previous three 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 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 (NCT00614055). 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.