Clinical trial NCT01135992: Switching From Insulin Glargine to Insulin Degludec in Subjects With Type 2 Diabetes Mellitus (BEGIN™)
Official title: A Trial Assessing the Implications of Switching From Insulin Glargine to Insulin Degludec in Subjects With Type 2 Diabetes Mellitus (BEGIN™: SIMPLIFY)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2010-06-03
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: HbA1c (Glycosylated Haemoglobin)
timeFrame: Week 4 and Week 16
Secondary outcomes:
measure: Fasting Plasma Glucose (FPG)
timeFrame: Week 4 and Week 16
measure: Change in Body Weight
timeFrame: Week 0, Week 4, Week 16
measure: Rate of Treatment Emergent Adverse Events (AEs)
timeFrame: Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)
measure: Rate of Confirmed Hypoglycaemic Episodes
timeFrame: Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)
measure: Rate of Nocturnal Confirmed Hypoglycaemic Episodes
timeFrame: Weeks 0-4 (IGlar), Weeks 4-16 (IDeg 3TW)
Other outcomes:
Locations:
city: Goodyear
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Arizona
city: Phoenix
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Arizona
city: Anaheim
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: California
city: Chino
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: California
city: Concord
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: California
city: Fresno
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: California
city: Greenbrae
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: California
city: Palm Springs
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: California
city: Kissimmee
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Florida
city: Chicago
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Illinois
city: Metairie
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Louisiana
city: Metairie
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Louisiana
city: Omaha
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Nebraska
city: Henderson
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Nevada
city: Dover
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: New Hampshire
city: Nashua
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: New Hampshire
city: Lawrenceville
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: New Jersey
city: Toms River
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: New Jersey
city: Albany
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: New York
city: Charlotte
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: North Carolina
city: Melrose Park
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Pennsylvania
city: Chattanooga
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Tennessee
city: Kingsport
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Tennessee
city: Austin
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Texas
city: Fort Worth
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Texas
city: Olympia
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Washington
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: