Phase 3
Completed N=435
Comparison of NN1250 Versus Insulin Glargine in Subjects With Type 2 Diabetes
Source: ClinicalTrials.gov NCT01059799 ↗Enrolled (actual)
435
Serious AEs
3.7%
Results posted
Nov 2015
Primary outcomePrimary: Change in Glycosylated Haemoglobin (HbA1c) — -1.24; -1.35 percentage of glycosylated haemoglobin
Summary
This trial is conducted in Asia and Japan. The aim of this trial is to compare insulin degludec (NN1250) with insulin glargine both combined with oral antidiabetic drugs (OADs) in subjects with type 2 diabetes never treated with insulin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycosylated Haemoglobin (HbA1c) |
-1.24; -1.35 | — |
| SECONDARY Rate of Confirmed Hypoglycaemic Episodes |
298; 370 | — |
| SECONDARY Rate of Nocturnal Confirmed Hypoglycaemic Episodes |
78; 124 | — |
| SECONDARY Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) |
8.2; 8.0 | — |
Eligibility Criteria
Inclusion Criteria
- For Japan only: minimum age is 20 years
- Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
- Current treatment with monotherapy or combination of an insulin secretagouge (sulfonylurea or glinide) and metformin, with or without addition of alfa-glucosidase-inhibitors or a DPP-4 inhibitor with unchanged dosing for at least 3 months prior to visit 1. The dose(s) should as minimum be as stated: -Insulin secretagogue (sulfonylurea or glinide): Minimum half of the daily maximal dose according to local labelling -Metformin: alone or in combination (including fixed combination): Maximum tolerated dose - alfa-glucosidase-inhibitors: Minimum half of the daily maximal dose or maximum tolerated dose -DPP-4 (dipeptyl peptidase 4) inhibitor: According to local labelling
- HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
- Body Mass Index (BMI) no higher than 35.0 kg/m^2
Exclusion Criteria
- Use within the last 3 months prior to Visit 1 of: TZDs (thiazolidinediones), exenatide or liraglutide
- 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
- Uncontrolled treated/untreated severe hypertension (systolic blood pressure at least 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure at least 100 mmHg)
- Pregnancy, breast-feeding, or the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements (for Thailand: adequate contraceptive measures are: diaphragm, condom (by the partner), intrauterine device in place for last three months before trial starts, sponge, cap with spermicide, contraceptive patch, approved hormonal implant (i.e. Norplant), oral contraceptives taken without difficulty for the last three months before trial starts, post menopausal state or sterilisation.)
- Cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer)
Data sourced from ClinicalTrials.gov (NCT01059799). 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.