ClinicalTrials.Veeva

Menu

Comparison of NN1250 With Sitagliptin in Subjects With Type 2 Diabetes Never Treated With Insulin (BEGIN™)

Novo Nordisk logo

Novo Nordisk

Status and phase

Completed
Phase 3

Conditions

Diabetes
Diabetes Mellitus, Type 2

Treatments

Drug: insulin degludec
Drug: sitagliptin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01046110
NN1250-3580
U1111-1111-7126 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment

458 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

458 participants in 2 patient groups

IDeg OD
Experimental group
Treatment:
Drug: insulin degludec
DPP-IV inhibitor
Experimental group
Treatment:
Drug: sitagliptin

Trial contacts and locations

93

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems