Comparison of NN1250 With Insulin Glargine in Type 1 Diabetes

Completed · Phase 3

Conditions studied: Diabetes, Diabetes Mellitus, Type 1

In brief

This trial is conducted in Europe and in the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of NN1250 (insulin degludec) in subjects with type 1 diabetes.

Key facts

Study ID

NCT01079234

Run by

Novo Nordisk A/S

People needed

493

Starts

2010-03-01

Expected to finish

2011-05-01

Last updated by the study team

2017-02-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 1 diabetes for 12 months or longer, hereof the last 3 months with injection based therapies
• Current treatment with any basal insulin (e.g. insulin glargine, insulin detemir, NPH insulin) using one or two daily injections and with three or more daily meal-time insulin injections (e.g. insulin aspart, insulin lispro, insulin glulisine, human insulin) used as bolus insulin therapy
• HbA1c maximum 10.0 % by central laboratory analysis
• Body Mass Index (BMI) below or equal to 35.0 kg/m\^2
• Ability to self-manage insulin therapy as assessed by confirmation (verbal confirmation at screening visit) of a changed insulin dose in the preceding two months prior to screening
• Ability and willingness to adhere to the protocol including performance of self measured plasma glucose (SMPG) profiles and self adjustment of insulin doses

You may not qualify if…

• Use within the last 3 months prior to Visit 1 of any antidiabetic glucose lowering drug other than insulin
• 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 above or equal to 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure above or equal to 100 mmHg)
• Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
• Cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer)

Where it is running

• Novo Nordisk Investigational Site — Fresno, California, United States
• Novo Nordisk Investigational Site — Huntington Beach, California, United States
• Novo Nordisk Investigational Site — Long Beach, California, United States
• Novo Nordisk Investigational Site — Redondo Beach, California, United States
• Novo Nordisk Investigational Site — Walnut Creek, California, United States
• Novo Nordisk Investigational Site — Aurora, Colorado, United States
• Novo Nordisk Investigational Site — Denver, Colorado, United States
• Novo Nordisk Investigational Site — DeLand, Florida, United States
• Novo Nordisk Investigational Site — Hollywood, Florida, United States
• Novo Nordisk Investigational Site — Miami, Florida, United States
• Novo Nordisk Investigational Site — Lawrenceville, Georgia, United States
• Novo Nordisk Investigational Site — Roswell, Georgia, United States
• Novo Nordisk Investigational Site — Nampa, Idaho, United States
• Novo Nordisk Investigational Site — Crystal Lake, Illinois, United States
• Novo Nordisk Investigational Site — Des Moines, Iowa, United States
• Novo Nordisk Investigational Site — Des Moines, Iowa, United States
• Novo Nordisk Investigational Site — Baltimore, Maryland, United States
• Novo Nordisk Investigational Site — Jefferson City, Missouri, United States
• Novo Nordisk Investigational Site — Springfield, Missouri, United States
• Novo Nordisk Investigational Site — St Louis, Missouri, United States
• Novo Nordisk Investigational Site — Omaha, Nebraska, United States
• Novo Nordisk Investigational Site — Nashua, New Hampshire, United States
• Novo Nordisk Investigational Site — Flemington, New Jersey, United States
• Novo Nordisk Investigational Site — Smithtown, New York, United States
• Novo Nordisk Investigational Site — Encino, California, United States

Full record on ClinicalTrials.gov

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