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: | November 2010 |
A Trial Comparing Efficacy and Safety of NN1250 and Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™: LOW VOLUME)
This trial is conducted in South Africa, Europe and North America. The aim of this trial is
to compare efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin glargine
(IGlar), as add-on to subject's ongoing treatment with metformin and/or dipeptyl peptidase 4
(DPP-4) inhibitors, in patients with type 2 diabetes being treated with oral anti-diabetic
drugs (OADs) qualifying for intensified treatment.
to compare efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin glargine
(IGlar), as add-on to subject's ongoing treatment with metformin and/or dipeptyl peptidase 4
(DPP-4) inhibitors, in patients with type 2 diabetes being treated with oral anti-diabetic
drugs (OADs) 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 an
insulin secretagogue (sulfonylurea or glinide), DPP-4 inhibitor,
alpha-glucosidase-inhibitors (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 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-inhibitors (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) maximum 45.0 kg/m^2
- Type 2 diabetes (diagnosed clinically) for at least 6 months
- Ability and willingness to adhere to the protocol including performance of self
monitored plasma glucose (SMPG) profiles according to the protocol
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 [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
53
sites
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