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: | February 2010 |
End Date: | November 2010 |
A Trial Comparing Efficacy and Safety of NN1250 and Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™: EASY AM)
This trial is conducted in Africa, Asia, Europe, and North America. The aim of this clinical
trial is to compare the efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin
glargine (IGlar) in subjects with type 2 diabetes currently treated with metformin alone or
with metformin combined with an oral anti-diabetic drug (OAD) qualifying for intensified
treatment.
trial is to compare the efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin
glargine (IGlar) in subjects with type 2 diabetes currently treated with metformin alone or
with metformin combined with an oral anti-diabetic drug (OAD) qualifying for intensified
treatment.
Inclusion Criteria:
- Insulin naïve subject (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 three
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 secretaguogue (sulfonylurea 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
- Body Mass Index (BMI) below or equal to 45.0 kg/m^2
Exclusion Criteria:
- Use within the last 3 months prior to Visit 1 of: thiazoledinediones, 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 (for UK: adequate
contraceptive measures are defined as established use of oral, injected or implanted
hormonal methods of contraception, sterilisation, intrauterine device or intrauterine
system, or consistent use of barrier methods)
- Cancer and medical history of cancer hereof (except basal cell skin cancer or
squamous cell skin cancer)
We found this trial at
46
sites
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