Comparison of NN1250 With Sitagliptin in Subjects With Type 2 Diabetes Never Treated With Insulin
Status: | Completed |
---|---|
Conditions: | Diabetes, Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | January 2010 |
End Date: | November 2010 |
A Trial Comparing Efficacy and Safety of NN1250 With Sitagliptin in Insulin Naive Subjects With Type 2 Diabetes (BEGIN™ : EARLY)
This trial will be conducted in Africa, Asia, North America and South America. The aim of
this clinical trial is to compare NN1250 (insulin degludec) with sitagliptin, as add-on to
subject's own current oral antidiabetic (OAD) treatment, in subjects with type 2 diabetes
inadequately controlled with 1-2 OADs (metformin, sulphonylurea, glinides or pioglitazone).
this clinical trial is to compare NN1250 (insulin degludec) with sitagliptin, as add-on to
subject's own current oral antidiabetic (OAD) treatment, in subjects with type 2 diabetes
inadequately controlled with 1-2 OADs (metformin, sulphonylurea, glinides or pioglitazone).
Inclusion Criteria:
- Type 2 diabetes (diagnosed clinically) for at least 6 months
- Ongoing treatment with 1 or 2 of the following OADs (metformin, insulin secretagogue
(sulphonylurea or glinides) or pioglitazone) in any combination 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 or maximum tolerated
dose (at least 1000 mg daily) -Insulin secretagogue (sulfonylurea or glinide):
minimum half of the maximal daily dose according to local labelling -Pioglitazone:
minimum half of the maximal daily dose according to local labelling or maximum
tolerated dose
- Body Mass Index (BMI) below or equal to 40.0 kg/m^2
- HbA1c 7.5-11.0 % (both inclusive) by central laboratory analysis
Exclusion Criteria:
- Use within the last 3 months prior to Visit 1 of: exenatide, liraglutide,
rosiglitazone or acarbose
- 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)
- Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the
last 12 months) or hypoglycaemic unawareness as judged by the Investigator or
hospitalisation for diabetic ketoacidosis during the previous 6 months
- Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate
- Cancer and medical history hereof (except basal cell skin cancer or squamous cell
skin cancer)
We found this trial at
43
sites
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