Phase 2
Completed N=245
Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes
Source: ClinicalTrials.gov NCT00611884 ↗Enrolled (actual)
245
Serious AEs
0.8%
Results posted
Nov 2015
Primary outcomePrimary: Change in Glycosylated Haemoglobin (HbA1c) — -1.26; -1.28; -1.46; -1.49 percentage of glycosylated haemoglobin
Summary
This trial is conducted in Africa, Asia and North America. The aim of this trial is to compare two insulin degludec (NN1250, SIBA) 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) |
-1.26; -1.28; -1.46; -1.49 | — |
| SECONDARY Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) |
8.30; 8.55; 8.45; 8.42 | — |
| SECONDARY Rate of Major and Minor Hypoglycaemic Episodes |
0; 0; 6; 0; 89; 60 | — |
| SECONDARY Rate of Nocturnal Major and Minor Hypoglycaemic Episodes |
0; 0; 6; 0; 6; 12 | — |
| SECONDARY Rate of Treatment Emergent Adverse Events (AEs) |
594; 430; 488; 622; 6; 0 | — |
| SECONDARY Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) |
34.6; 29.2; 30.9; 32.9; 25.7; 24.7 | — |
| SECONDARY Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT) |
26.7; 22.5; 23.9; 24.2; 23.3; 21.8 | — |
| SECONDARY Laboratory Safety Parameters (Biochemistry): Serum Creatinine |
74.5; 75.4; 73.2; 72.4; 76.1; 76.6 | — |
| SECONDARY Vital Signs: Diastolic Blood Pressure (BP) |
81; 82; 80; 79; 79; 82 | — |
| SECONDARY Vital Signs: Systolic Blood Pressure (BP) |
129; 131; 129; 127; 126; 131 | — |
| SECONDARY Vital Signs: Pulse |
79; 79; 79; 76; 77; 78 | — |
| 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 maximeum 14 days within the last 3 months)
- Treatment with one or two oral anti-diabetic drug (OADs): metformin, sulphonylurea (SU) (or 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 the summary of product characteristics (SPC) or locally approved PI
- HbA1c 7.0-11.0 % (both inclusive)
- Body Mass Index (BMI) 23-42 kg/m^2 [lb/in^2 x 703] (both inclusive)
Exclusion Criteria
- Metformin contraindication according to local practice
- Thiazolidinedione (TZD) treatment within 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) three 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 drug
Data sourced from ClinicalTrials.gov (NCT00611884). 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.