Switching From Insulin Glargine to Insulin Degludec in Subjects With Type 2 Diabetes Mellitus (BEGIN™)

Completed · Phase 3

Conditions studied: Diabetes, Diabetes Mellitus, Type 2

In brief

This trial is conducted in the United States of America (USA). The aim of this clinical trial is to assess the implications of switching from insulin glargine (IGlar) to insulin degludec (IDeg) in subjects with type 2 diabetes mellitus.

Key facts

Study ID

NCT01135992

Run by

Novo Nordisk A/S

People needed

143

Starts

2010-06-01

Expected to finish

2010-11-01

Last updated by the study team

2016-01-22

Who can join

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

You may qualify if…

• Type 2 diabetes mellitus (diagnosed clinically) for at least 6 months
• HbA1c maximum 10 % by central laboratory analysis
• Current treatment with basal-oral therapy (BOT) (no prandial insulin ever) consisting of: at least three months with insulin glargine once daily (average prescribed dose must have been unchanged (within plus/minus 10%) for four weeks prior to Visit 1 as confirmed by patient records or verbal confirmation by the subject) in combination with stable (unchanged doses for at least 3 months prior to Visit 1) OAD (metformin, insulin secretagogues, pioglitazone, sitagliptin or alpha-glucosidase-inhibitor) treatment in any approved (according to label) dose or combination

You may not qualify if…

• Use within the last three months prior to Visit 1 of: Exenatide, Liraglutide or Thiazoledinediones (TZDs) other than Pioglitazone
• Cardiovascular disease (CVD) 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 within the last six months prior to Visit 1
• Recurrent severe hypoglycaemia (more than one severe hypoglycaemic episode during the last 12 months), or hypoglycaemic unawareness as judged by the Investigator, or hospitalisation for diabetic ketoacidosis during the previous six months
• Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
• Previous participation in this trial. Participation is defined as started on trial medication. Rescreening of screening failures is allowed only once within the limits of the recruitment period
• Known or suspected hypersensitivity to trial products or related products

Where it is running

• Novo Nordisk Clinical Trial Call Center — Goodyear, Arizona, United States
• Novo Nordisk Clinical Trial Call Center — Phoenix, Arizona, United States
• Novo Nordisk Clinical Trial Call Center — Anaheim, California, United States
• Novo Nordisk Clinical Trial Call Center — Chino, California, United States
• Novo Nordisk Clinical Trial Call Center — Concord, California, United States
• Novo Nordisk Clinical Trial Call Center — Fresno, California, United States
• Novo Nordisk Clinical Trial Call Center — Greenbrae, California, United States
• Novo Nordisk Clinical Trial Call Center — Palm Springs, California, United States
• Novo Nordisk Clinical Trial Call Center — Kissimmee, Florida, United States
• Novo Nordisk Clinical Trial Call Center — Chicago, Illinois, United States
• Novo Nordisk Clinical Trial Call Center — Metairie, Louisiana, United States
• Novo Nordisk Clinical Trial Call Center — Metairie, Louisiana, United States
• Novo Nordisk Clinical Trial Call Center — Omaha, Nebraska, United States
• Novo Nordisk Clinical Trial Call Center — Henderson, Nevada, United States
• Novo Nordisk Clinical Trial Call Center — Dover, New Hampshire, United States
• Novo Nordisk Clinical Trial Call Center — Nashua, New Hampshire, United States
• Novo Nordisk Clinical Trial Call Center — Lawrenceville, New Jersey, United States
• Novo Nordisk Clinical Trial Call Center — Toms River, New Jersey, United States
• Novo Nordisk Clinical Trial Call Center — Albany, New York, United States
• Novo Nordisk Clinical Trial Call Center — Charlotte, North Carolina, United States
• Novo Nordisk Clinical Trial Call Center — Melrose Park, Pennsylvania, United States
• Novo Nordisk Clinical Trial Call Center — Pittsburgh, Pennsylvania, United States
• Novo Nordisk Clinical Trial Call Center — Chattanooga, Tennessee, United States
• Novo Nordisk Clinical Trial Call Center — Kingsport, Tennessee, United States
• Novo Nordisk Clinical Trial Call Center — Austin, Texas, United States

Full record on ClinicalTrials.gov

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