Phase 2
Completed N=178
Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Insulin Aspart in Subjects With Type 1 Diabetes
Diabetes · Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT00612040 ↗
Enrolled (actual)
178
Serious AEs
2.3%
Results posted
Nov 2015
Primary outcomePrimary: Change in Glycosylated Haemoglobin (HbA1c) — -0.54; -0.57; -0.62 percentage of glycosylated haemoglobin
Summary
This trial is conducted in Europe, Oceania and the United States of America (USA). The aim of this trial is to compare two NN1250 (insulin degludec) formulations with each other and with insulin glargine, all in combination with insulin aspart in subjects with type 1 diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycosylated Haemoglobin (HbA1c) |
-0.54; -0.57; -0.62 | — |
| SECONDARY Change in Fasting Plasma Glucose (FPG) |
-2.06; -1.60; -0.54 | — |
| SECONDARY Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) |
9.27; 9.56; 9.04 | — |
| SECONDARY Rate of Major and Minor Hypoglycaemic Episodes |
46; 41; 36; 5838; 5305; 6637 | — |
| SECONDARY Rate of Nocturnal Major and Minor Hypoglycaemic Episodes |
17; 12; 18; 769; 546; 1082 | — |
| SECONDARY Rate of Treatment Emergent Adverse Events (AEs) |
653; 874; 914; 6; 12; 6 | — |
| SECONDARY Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) |
25.5; 22.7; 23.1; 25.0; 21.2; 23.1 | — |
| SECONDARY Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT) |
22.8; 21.7; 23.3; 23.3; 21.6; 23.9 | — |
| SECONDARY Laboratory Safety Parameters (Biochemistry): Serum Creatinine |
77.2; 76.6; 77.6; 77.2; 75.9; 77.9 | — |
| SECONDARY Vital Signs: Diastolic BP (Blood Pressure) |
76; 75; 74; 76; 75; 74 | — |
| SECONDARY Vital Signs: Systolic BP (Blood Pressure) |
124; 126; 124; 122; 125; 123 | — |
| SECONDARY Vital Signs: Pulse |
74; 72; 73; 74; 72; 72 | — |
| SECONDARY Physical Examination |
— | — |
Eligibility Criteria
Inclusion Criteria
- Type 1 diabetes for at least one year
- HbA1c 7-11% (both inclusive)
- Treated with insulin for at least six months - any regimen
Exclusion Criteria
- Any systemic treatment with products which in the Investigator's opinion could interfere with glucose or lipid metabolism (eg systemic corticosteroids) 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 (NCT00612040). 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.