Clinical trial NCT01364428: Comparison of Two Insulin Degludec Formulations in Subjects With Type 2 Diabetes Mellitus
Official title: A Trial Comparing the Efficacy and Safety of Insulin Degludec 200 U/mL and Insulin Degludec 100 U/mL in Subjects With Type 2 Diabetes Mellitus (BEGIN™: COMPARE)
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: 2011-06-02
Enrollment: 373
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in the United States of America (USA). The aim of this trial is to compare the efficacy and safety of two different formulations of insulin degludec (IDeg) in subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes (diagnosed clinically) for minimum 24 weeks prior to randomisation (visit 2)
* Current treatment with basal-only insulin (no prandial insulin) consisting of either insulin detemir once daily (OD), insulin glargine OD or neutral protamine hagedorn (NPH) insulin OD/twice daily (BID) for at least 12 weeks prior to randomisation (visit 2), in combination with stable doses of OAD(s) (metformin, insulin secretagogue (sulfonylurea or glinide), alpha-glucosidase inhibitor, pioglitazone or dipeptidyl peptidase IV (DPP-IV) inhibitor in any approved (according to label) dose or combination. Stable OAD doses are defined as unchanged doses for at least 12 weeks prior to randomisation (visit 2)
* HbA1c (glycosylated haemoglobin) between 7.0-10.0% (both inclusive) by central laboratory analysis
* Body mass index (BMI) below or equal to 45 kg/m\^2
* Ability and willingness to adhere to the protocol including self-measured plasma glucose (SMPG) according to the protocol

Exclusion Criteria:

* Treatment with rosiglitazone within the last 12 weeks prior to randomisation (visit 2)
* Treatment with glucagon like peptide-1 (GLP-1) receptor agonists within the last 12 weeks prior to randomisation (visit 2)
* Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator (trial physician)
* Previous participation in this trial. Participation is defined as randomised. Re-screening is allowed once during the recruitment period
* Known or suspected hypersensitivity to trial products or related products
* The receipt of any investigational drug within 4 weeks prior to randomisation (visit 2)

Primary outcomes:
measure: Change in Glycosylated Haemoglobin (HbA1c)
timeFrame: Week 0, Week 22
Secondary outcomes:
measure: Change in Fasting Plasma Glucose (FPG)
timeFrame: Week 0, Week 22
measure: Rate of Treatment Emergent Adverse Events (AEs)
timeFrame: Week 0 to Week 22 + 7 days follow up
measure: Rate of Confirmed Hypoglycaemic Episodes
timeFrame: Week 0 to Week 22 + 7 days follow up
measure: Rate of Nocturnal Confirmed Hypoglycaemic Episodes
timeFrame: Week 0 to Week 22 + 7 days follow up
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Goodyear
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Mesa
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Concord
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Greenbrae
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Montclair
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: National City
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Palm Springs
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Bradenton
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Clearwater
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Kissimmee
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Miami
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Tampa
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Springfield
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Evansville
country: United States
facility: Novo Nordisk Investigational Site
state: Indiana
city: Metairie
country: United States
facility: Novo Nordisk Investigational Site
state: Louisiana
city: Slidell
country: United States
facility: Novo Nordisk Investigational Site
state: Louisiana
city: Rockville
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: Waltham
country: United States
facility: Novo Nordisk Investigational Site
state: Massachusetts
city: Detroit
country: United States
facility: Novo Nordisk Investigational Site
state: Michigan
city: Jefferson City
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Novo Nordisk Investigational Site
state: Nebraska
city: Lawrenceville
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Toms River
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Staten Island
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: West Seneca
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Greensboro
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Greenville
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Canton
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Franklin
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Melrose Park
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Brentwood
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Chattanooga
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Chattanooga
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Hurst
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Irving
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Round Rock
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Olympia
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Renton
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Bode BW, Chaykin LB, Sussman AM, Warren ML, Niemeyer M, Rabol R, Rodbard HW. Efficacy and Safety of Insulin Degludec 200 U/mL and Insulin Degludec 100 U/mL in Patients with Type 2 Diabetes (Begin: Compare). Endocr Pract. 2014 Aug;20(8):785-91. doi: 10.4158/EP13411.OR.