Phase 3
N=687
Comparison of NN1250 With Insulin Glargine in Type 2 Diabetes
Diabetes · Diabetes Mellitus, Type 2
Bottom Line
View on ClinicalTrials.gov: NCT01006291 ↗Enrolled (actual)
687
Serious AEs
2.6%
Results posted
Nov 2015
Primary outcome: Primary: Change in Glycosylated Haemoglobin (HbA1c) — -1.28; -1.07; -1.26 percentage of glycosylated haemoglobin
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- insulin degludec (Drug); insulin glargine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novo Nordisk A/S
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycosylated Haemoglobin (HbA1c) |
-1.28; -1.07; -1.26 | — |
| SECONDARY Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) |
7.9; 8.0; 7.8 | — |
| SECONDARY Rate of Confirmed Hypoglycaemic Episodes |
364; 363; 348 | — |
| SECONDARY Rate of Nocturnal Confirmed Hypoglycaemic Episodes |
63; 56; 75 | — |
Summary
This trial is conducted in Africa, Asia, Europe and South America. The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg) with insulin glargine (IGlar) in patients with type 2 diabetes. Subjects treated with oral antidiabetic drug(s) (OAD(s)) should continue their current OAD treatment at the stable, prerandomisation dose level and dosing frequency.
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
- Current treatment: oral anti-diabetic drug(s) (OAD(s)) alone, basal insulin alone or the combination of OAD(s) and basal insulin. Allowed OADs are: Metformin, insulin secretagogues (sulphonylureas (SU) or glinides), pioglitazone with unchanged dosing for at least 3 months prior to Visit 1
- HbA1c: OADs only users 7.0-11.0 % (both inclusive), basal insulin with/without OADs users 7.0-10.0% (both inclusive) by central laboratory analysis
- Body Mass Index (BMI) below or equal to 40.0 kg/m^2
Exclusion Criteria
- Cancer and medical history of cancer hereof
- Use within the last 3 months prior to Visit 1 of: glucagon-like peptide-1(GLP-1) receptor agonist (exenatide, liraglutide), rosiglitazone, dipeptidyl peptidase IV (DPP-IV) inhibitors, alpha-glucosidase-inhibitors
- 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, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
- Cancer and medical history of cancer hereof (except basal cell skin cancer and squamous cell skin cancer)
Data sourced from ClinicalTrials.gov (NCT01006291). 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.