Clinical trial NCT01570751: A Trial Comparing the Efficacy, Patient-reported Outcomes and Safety of Insulin Degludec 200 U/mL vs Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Requiring High-dose Insulin
Official title: A Trial Comparing the Efficacy, Patient-reported Outcomes and Safety of Insulin Degludec 200 U/mL vs Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Requiring High-dose Insulin
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: 2012-04-04
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in the United States of America (USA). The aim of the trial is to confirm the efficacy of IDeg (insulin degludec) versus IGlar (insulin glargine) in controlling glycaemia. Subjects are to continue their pre-trial metformin treatment.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Current treatment with once daily insulin glargine in vials with a daily dose equal to or above 65 U and equal to or below 100 U
* Current treatment with a stable dose of metformin plus/minus one additional oral antidiabetic drug (OAD) for at least 12 weeks
* Glycosylated haemoglobin (HbA1c) equal to or above 7.5%

Exclusion Criteria:

* Current treatment with insulin other than insulin glargine in vials
* Treatment with thiazolidinediones or glucagon-like peptide-1 (GLP-1) receptor agonists within 12 weeks
* Stroke; heart failure; myocardial infarction; unstable angina pectoris; coronary arterial bypass graft or angioplasty
* Suffer from cancer (except basal cell skin cancer and squamous-cell cancer)

Primary outcomes:
measure: Change From Baseline (Visit 18) in Glycosylated Haemoglobin (HbA1c) at the End of Each 16 Week Treatment Period
timeFrame: Week 0, week 16 of each treatment period.
Secondary outcomes:
measure: Change in Patient Reported Outcome (PRO) Scores From Baseline to the End of Each 16 Week Treatment Period
timeFrame: Week 0, week 16 of each treatment period.
measure: Change in PRO Scores From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B
timeFrame: Week 16, week 20
measure: Change From Baseline in Central Laboratory Measured Fasting Plasma Glucose (FPG) at the End of Each 16 Week Treatment Period
timeFrame: Week 0, week 16, week 32
measure: Change in FPG From the End of Treatment Period A Until After 4 Weeks of Treatment in Treatment Period B
timeFrame: Week 16, week 20
measure: Number of Adverse Events (AEs)
timeFrame: From baseline to the end of each 16 week treatment period.
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Fresno
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Greenbrae
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: San Ramon
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Bradenton
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Hialeah
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Homestead
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Kissimmee
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Miami Lakes
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Miami
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Miami
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Roswell
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Avon
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Lexington
country: United States
facility: Novo Nordisk Investigational Site
state: Kentucky
city: Madisonville
country: United States
facility: Novo Nordisk Investigational Site
state: Kentucky
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: Worcester
country: United States
facility: Novo Nordisk Investigational Site
state: Massachusetts
city: Southfield
country: United States
facility: Novo Nordisk Investigational Site
state: Michigan
city: Jefferson City
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Novo Nordisk Investigational Site
state: Nevada
city: Lawrenceville
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Albany
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Northport
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Staten Island
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Greenville
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Franklin
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Kettering
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Chattanooga
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Kingsport
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Nashville
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: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Kingsville
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Schertz
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Sugar Land
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Tacoma
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Milwaukee
country: United States
facility: Novo Nordisk Investigational Site
state: Wisconsin
city: Manati
country: Puerto Rico
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Warren ML, Chaykin LB, Jabbour S, Sheikh-Ali M, Hansen CT, Nielsen TSS, Norwood P. Insulin Degludec 200 Units/mL Is Associated With Lower Injection Frequency and Improved Patient-Reported Outcomes Compared With Insulin Glargine 100 Units/mL in Patients With Type 2 Diabetes Requiring High-Dose Insulin. Clin Diabetes. 2017 Apr;35(2):90-95. doi: 10.2337/cd15-0058.
citation: Warren ML, Brod M, Hakan-Bloch J, Sparre T, Chaykin LB. Patient-reported outcomes from a randomized, crossover trial comparing a pen injector with insulin degludec versus a pen injector with insulin glargine U100 in patients with type 2 diabetes. Curr Med Res Opin. 2019 Sep;35(9):1623-1629. doi: 10.1080/03007995.2019.1605769. Epub 2019 May 21.