Comparison of NN1250 With Sitagliptin in Subjects With Type 2 Diabetes Never Treated With Insulin
Completed · Phase 3
Conditions studied: Diabetes, Diabetes Mellitus, Type 2
In brief
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).
Key facts
- Study ID
- NCT01046110
- Run by
- Novo Nordisk A/S
- People needed
- 458
- Starts
- 2010-01-01
- Expected to finish
- 2010-11-01
- Last updated by the study team
- 2017-03-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Novo Nordisk Investigational Site — Concord, California, United States
- Novo Nordisk Investigational Site — Fresno, California, United States
- Novo Nordisk Investigational Site — Greenbrae, California, United States
- Novo Nordisk Investigational Site — La Jolla, California, United States
- Novo Nordisk Investigational Site — Long Beach, California, United States
- Novo Nordisk Investigational Site — Mission Hills, California, United States
- Novo Nordisk Investigational Site — Palm Springs, California, United States
- Novo Nordisk Investigational Site — Torrance, California, United States
- Novo Nordisk Investigational Site — Walnut Creek, California, United States
- Novo Nordisk Investigational Site — Denver, Colorado, United States
- Novo Nordisk Investigational Site — Clearwater, Florida, United States
- Novo Nordisk Investigational Site — Inverness, Florida, United States
- Novo Nordisk Investigational Site — Kissimmee, Florida, United States
- Novo Nordisk Investigational Site — Miami, Florida, United States
- Novo Nordisk Investigational Site — Miami, Florida, United States
- Novo Nordisk Investigational Site — Miami, Florida, United States
- Novo Nordisk Investigational Site — Ocala, Florida, United States
- Novo Nordisk Investigational Site — Ponte Vedra, Florida, United States
- Novo Nordisk Investigational Site — Tampa, Florida, United States
- Novo Nordisk Investigational Site — Columbus, Georgia, United States
- Novo Nordisk Investigational Site — Decatur, Georgia, United States
- Novo Nordisk Investigational Site — Dunwoody, Georgia, United States
- Novo Nordisk Investigational Site — Roswell, Georgia, United States
- Novo Nordisk Investigational Site — Chicago, Illinois, United States
- Novo Nordisk Investigational Site — Huntsville, Alabama, United States
Full record on ClinicalTrials.gov
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