Clinical trial NCT00612040: Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Insulin Aspart in Subjects With Type 1 Diabetes
Official title: A 16 Week Randomised, Open Labelled, 3-armed, Treat-to-target, Parallel Group Trial Comparing SIBA (D) Once Daily + NovoRapid®, SIBA (E) Once Daily + NovoRapid® and Insulin Glargine Once Daily + NovoRapid®, All in a Basal/Bolus Regimen in Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-02-11
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe, Oceania and the United States of America (USA). The aim of this trial is to compare two NN1250 (insulin degludec) formulations with each other and with insulin glargine, all in combination with insulin aspart in subjects with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes for at least one year
* HbA1c 7-11% (both inclusive)
* Treated with insulin for at least six months - any regimen

Exclusion Criteria:

* Any systemic treatment with products which in the Investigator's opinion could interfere with glucose or lipid metabolism (eg systemic corticosteroids) 3 months prior to randomisation
* Subject has a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, neurological, genitourinary, or haematological system that, in the opinion of the Investigator, may confound the results of the trial or pose additional risk in administering trial product

Primary outcomes:
measure: Change in Glycosylated Haemoglobin (HbA1c)
timeFrame: Week 0, Week 16
Secondary outcomes:
measure: Change in Fasting Plasma Glucose (FPG)
timeFrame: Week 0, Week 16
measure: Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
timeFrame: Week 16
measure: Rate of Major and Minor Hypoglycaemic Episodes
timeFrame: Week 0 to Week 16 + 5 days follow up
measure: Rate of Nocturnal Major and Minor Hypoglycaemic Episodes
timeFrame: Week 0 to Week 16 + 5 days follow up
measure: Rate of Treatment Emergent Adverse Events (AEs)
timeFrame: Week 0 to Week 16 + 5 days follow up
measure: Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)
timeFrame: Week -1, Week 16
measure: Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)
timeFrame: Week -1, Week 16
measure: Laboratory Safety Parameters (Biochemistry): Serum Creatinine
timeFrame: Week -1, Week 16
measure: Vital Signs: Diastolic BP (Blood Pressure)
timeFrame: Week 0, Week 16
measure: Vital Signs: Systolic BP (Blood Pressure)
timeFrame: Week 0, Week 16
measure: Vital Signs: Pulse
timeFrame: Week 0, Week 16
measure: Physical Examination
timeFrame: Week -1, Week 8, Week 16
Other outcomes:
Locations:
city: Walnut Creek
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Honolulu
country: United States
facility: Novo Nordisk Investigational Site
state: Hawaii
city: Idaho Falls
country: United States
facility: Novo Nordisk Investigational Site
state: Idaho
city: Des Moines
country: United States
facility: Novo Nordisk Investigational Site
state: Iowa
city: Hyattsville
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
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: Renton
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Wollongong
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: Keswick
country: Australia
facility: Novo Nordisk Investigational Site
state: South Australia
city: East Ringwood
country: Australia
facility: Novo Nordisk Investigational Site
state: Victoria
city: Geelong
country: Australia
facility: Novo Nordisk Investigational Site
city: Miranda
country: Australia
facility: Novo Nordisk Investigational Site
city: Aschaffenburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Bad Kreuznach
country: Germany
facility: Novo Nordisk Investigational Site
city: Dresden
country: Germany
facility: Novo Nordisk Investigational Site
city: Hamburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Hohenmölsen
country: Germany
facility: Novo Nordisk Investigational Site
city: Neuwied
country: Germany
facility: Novo Nordisk Investigational Site
city: St. Ingbert
country: Germany
facility: Novo Nordisk Investigational Site
city: Bergen
country: Norway
facility: Novo Nordisk Investigational Site
city: Bergen
country: Norway
facility: Novo Nordisk Investigational Site
city: Elverum
country: Norway
facility: Novo Nordisk Investigational Site
city: Kristiansand S
country: Norway
facility: Novo Nordisk Investigational Site
city: Oslo
country: Norway
facility: Novo Nordisk Investigational Site
city: Stavanger
country: Norway
facility: Novo Nordisk Investigational Site
city: Alingsås
country: Sweden
facility: Novo Nordisk Investigational Site
city: Karlstad
country: Sweden
facility: Novo Nordisk Investigational Site
city: Lund
country: Sweden
facility: Novo Nordisk Investigational Site
city: Stockholm
country: Sweden
facility: Novo Nordisk Investigational Site
city: Stockholm
country: Sweden
facility: Novo Nordisk Investigational Site
city: Umeå
country: Sweden
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Birkeland KI, Home PD, Wendisch U, Ratner RE, Johansen T, Endahl LA, Lyby K, Jendle JH, Roberts AP, DeVries JH, Meneghini LF. Insulin degludec in type 1 diabetes: a randomized controlled trial of a new-generation ultra-long-acting insulin compared with insulin glargine. Diabetes Care. 2011 Mar;34(3):661-5. doi: 10.2337/dc10-1925. Epub 2011 Jan 26.
citation: Home PD, Meneghini L, Wendisch U, Ratner RE, Johansen T, Christensen TE, Jendle J, Roberts AP, Birkeland KI. Improved health status with insulin degludec compared with insulin glargine in people with type 1 diabetes. Diabet Med. 2012 Jun;29(6):716-20. doi: 10.1111/j.1464-5491.2011.03547.x.