Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes
Status: | Completed |
---|---|
Conditions: | Diabetes, Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | March 2010 |
End Date: | December 2010 |
A 26-week Randomised, Confirmatory, Controlled, Open Label, Multicentre, Multinational Treat-to-target Trial Comparing the Efficacy and Safety of SIBA 200 U/ml Three Times Weekly Injected in the Evening and Insulin Glargine Once Daily in a Population of Insulin naïve Subjects With Type 2 Diabetes Mellitus Currently Treated With OADs Qualifying for Intensified Treatment (BEGIN™: EASY™)
This trial was conducted in Europe and North America. The aim of this clinical trial was to
compare NN1250 (insulin degludec (IDeg)), a soluble insulin basal analogue (SIBA), with
insulin glargine (IGlar), as add-on to subject's ongoing treatment with metformin and/or
DPP-4 (dipeptyl peptidase 4) inhibitors, in patients with type 2 diabetes being treated with
oral anti-diabetic drugs (OADs).
compare NN1250 (insulin degludec (IDeg)), a soluble insulin basal analogue (SIBA), with
insulin glargine (IGlar), as add-on to subject's ongoing treatment with metformin and/or
DPP-4 (dipeptyl peptidase 4) inhibitors, in patients with type 2 diabetes being treated with
oral anti-diabetic drugs (OADs).
Inclusion Criteria:
- Type 2 diabetes (diagnosed clinically) for at least 6 months
- Insulin naïve subjects (allowed are: previous short term insulin treatment up to 14
days; treatment during hospitalisation or during gestational diabetes is allowed for
periods longer than 14 days)
- Current treatment: metformin monotherapy or metformin in any combination with insulin
secretagogues (sulphonylurea (SU) or glinide), DPP-4 inhibitor,
alpha-glucosidase-inhibitor (acarbose) with unchanged dosing for at least 3 months
prior to visit 1 with the minimum doses stated: -Metformin: alone or in combination
(including fixed combination) 1500 mg daily or maximum tolerated dose (at least 1000
mg daily)-Insulin secretagogue (sulfonylurea (SU) or glinide): minimum half of the
daily maximal dose according to local labelling -DPP-4 inhibitor: minimum half of the
daily maximal dose according to local labelling -alpha-glucosidase-inhibitor
(acarbose): minimum half of the daily maximal dose or maximum tolerated dose
- HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis
- BMI (Body Mass Index) below or equal to 45.0 kg/m^2
Exclusion Criteria:
- Use within the last 3 months prior to Visit 1 of: Thiazoledinediones (TZDs),
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, 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 or
squamous cell skin cancer)
We found this trial at
49
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials