Clinical trial NCT00614055: Comparison of Two NN5401 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes
Official title: A 16 Week Randomised, Open Labelled, 3 Armed, Parallel Group, Treat-to-target Trial Comparing Once Daily Injection of SIAC 30 (B), SIAC 45 (B) and Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes Failing on OAD Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-02-13
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. The aim of this trial is to compare two NN5401 (SIAC, insulin degludec/insulin aspart) formulations with each other and with insulin glargine, all in combination with metformin in insulin naive subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
* Insulin naïve type 2 diabetes subjects (as diagnosed clinically) for at least 3 months (no previous insulin treatment or previous short term insulin treatment maximum 14 days within the last 3 months)
* Treatment with one or two oral anti-diabetic drugs (OADs): metformin, sulfonylurea, other insulin secretagogue (e.g. repaglinide, nateglinide), alpha-glucosidase inhibitors for at least 2 month at a stable maximum tolerated dose or at least half maximum allowed dose according to locally approved summary of product characteristics (SPC)
* HbA1c, 7.0 - 11.0 % (both inclusive)
* Body Mass Index (BMI), 25.0 - 37.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Metformin contraindication according to local practice
* Thiazolidinedione (TZD) treatments within the previous three months prior to Visit 1
* Any systemic treatment with products, which in the investigator's opinion could interfere with glucose or lipid metabolism (e.g. systemic corticosteroids) within 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 Treatment Emergent Adverse Events (AEs)
timeFrame: Week 0 to Week 16 + 5 days follow up
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: Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)
timeFrame: Week -4, Week 16
measure: Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)
timeFrame: Week -4, Week 16
measure: Laboratory Safety Parameters (Biochemistry): Serum Creatinine
timeFrame: Week -4, Week 16
measure: Vital Signs: Diastolic Blood Pressure (BP)
timeFrame: Week 0, Week 16
measure: Vital Signs: Systolic Blood Pressure (BP)
timeFrame: Week 0, Week 16
measure: Vital Signs: Pulse
timeFrame: Week 0, Week 16
measure: Physical Examination
timeFrame: Week 0, Week 8, Week 16
Other outcomes:
Locations:
city: Alès
country: France
facility: Novo Nordisk Investigational Site
city: Brest
country: France
facility: Novo Nordisk Investigational Site
city: LA ROCHELLE cedex
country: France
facility: Novo Nordisk Investigational Site
city: Le Creusot
country: France
facility: Novo Nordisk Investigational Site
city: Mont de Marsan
country: France
facility: Novo Nordisk Investigational Site
city: Venissieux
country: France
facility: Novo Nordisk Investigational Site
city: Bad Kreuznach
country: Germany
facility: Novo Nordisk Investigational Site
city: Bad Mergentheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Dormagen
country: Germany
facility: Novo Nordisk Investigational Site
city: Hohenmölsen
country: Germany
facility: Novo Nordisk Investigational Site
city: Neuss
country: Germany
facility: Novo Nordisk Investigational Site
city: Neuwied
country: Germany
facility: Novo Nordisk Investigational Site
city: Elverum
country: Norway
facility: Novo Nordisk Investigational Site
city: Hamar
country: Norway
facility: Novo Nordisk Investigational Site
city: Kongsvinger
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: Tromsø
country: Norway
facility: Novo Nordisk Investigational Site
city: Bucharest
country: Romania
facility: Novo Nordisk Investigational Site
city: Bucharest
country: Romania
facility: Novo Nordisk Investigational Site
city: Bucharest
country: Romania
facility: Novo Nordisk Investigational Site
city: Bucharest
country: Romania
facility: Novo Nordisk Investigational Site
city: Bucharest
country: Romania
facility: Novo Nordisk Investigational Site
city: Almería
country: Spain
facility: Novo Nordisk Investigational Site
city: Partida de Bacarot
country: Spain
facility: Novo Nordisk Investigational Site
city: Sevilla
country: Spain
facility: Novo Nordisk Investigational Site
city: Valencia
country: Spain
facility: Novo Nordisk Investigational Site
city: Valladolid
country: Spain
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Heise T, Tack CJ, Cuddihy R, Davidson J, Gouet D, Liebl A, Romero E, Mersebach H, Dykiel P, Jorde R. A new-generation ultra-long-acting basal insulin with a bolus boost compared with insulin glargine in insulin-naive people with type 2 diabetes: a randomized, controlled trial. Diabetes Care. 2011 Mar;34(3):669-74. doi: 10.2337/dc10-1905. Epub 2011 Feb 1.
citation: Ma Z, Parkner T, Christiansen JS, Laursen T. IDegAsp: a novel soluble insulin analogs combination. Expert Opin Biol Ther. 2012 Nov;12(11):1533-40. doi: 10.1517/14712598.2012.722203. Epub 2012 Sep 4.
citation: Liebl A, Davidson J, Mersebach H, Dykiel P, Tack CJ, Heise T. A novel insulin combination of insulin degludec and insulin aspart achieves a more stable overnight glucose profile than insulin glargine: results from continuous glucose monitoring in a proof-of-concept trial. J Diabetes Sci Technol. 2013 Sep 1;7(5):1328-36. doi: 10.1177/193229681300700524.