- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00614055
Comparison of Two NN5401 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes
February 9, 2017 updated by: Novo Nordisk A/S
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
178
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alès, France, 30100
- Novo Nordisk Investigational Site
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Brest, France, 29609
- Novo Nordisk Investigational Site
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LA ROCHELLE cedex, France, 17019
- Novo Nordisk Investigational Site
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Le Creusot, France, 71200
- Novo Nordisk Investigational Site
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Mont de Marsan, France, 40024
- Novo Nordisk Investigational Site
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Venissieux, France, 69200
- Novo Nordisk Investigational Site
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Bad Kreuznach, Germany, 55545
- Novo Nordisk Investigational Site
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Bad Mergentheim, Germany, 97980
- Novo Nordisk Investigational Site
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Dormagen, Germany, 41539
- Novo Nordisk Investigational Site
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Hohenmölsen, Germany, 06679
- Novo Nordisk Investigational Site
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Neuss, Germany, 41460
- Novo Nordisk Investigational Site
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Neuwied, Germany, 56564
- Novo Nordisk Investigational Site
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Elverum, Norway, 2408
- Novo Nordisk Investigational Site
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Hamar, Norway, 2317
- Novo Nordisk Investigational Site
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Kongsvinger, Norway, 2212
- Novo Nordisk Investigational Site
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Oslo, Norway, 0586
- Novo Nordisk Investigational Site
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Stavanger, Norway, 4011
- Novo Nordisk Investigational Site
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Tromsø, Norway, 9038
- Novo Nordisk Investigational Site
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Bucharest, Romania, 020042
- Novo Nordisk Investigational Site
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Bucharest, Romania, 020475
- Novo Nordisk Investigational Site
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Bucharest, Romania
- Novo Nordisk Investigational Site
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Bucharest, Romania, 011234
- Novo Nordisk Investigational Site
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Bucharest, Romania, 020992
- Novo Nordisk Investigational Site
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Almería, Spain, 04001
- Novo Nordisk Investigational Site
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Partida de Bacarot, Spain, 03114
- Novo Nordisk Investigational Site
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Sevilla, Spain, 41010
- Novo Nordisk Investigational Site
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Valencia, Spain, 46014
- Novo Nordisk Investigational Site
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Valladolid, Spain, 47011
- Novo Nordisk Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Insulin glargine
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Tablets, 1500-2000 mg/day
Treat-to-target dose titration scheme, injection s.c., once daily
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Experimental: SIAC 30 (B)
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Tablets, 1500-2000 mg/day
Formulation 1: Treat-to-target dose titration scheme, injection s.c., once daily
Formulation 2: Treat-to-target dose titration scheme, injection s.c., once daily
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Experimental: SIAC 45 (B)
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Tablets, 1500-2000 mg/day
Formulation 1: Treat-to-target dose titration scheme, injection s.c., once daily
Formulation 2: Treat-to-target dose titration scheme, injection s.c., once daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Glycosylated Haemoglobin (HbA1c)
Time Frame: Week 0, Week 16
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Change from baseline in HbA1c after 16 weeks of treatment
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Week 0, Week 16
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Rate of Treatment Emergent Adverse Events (AEs)
Time Frame: Week 0 to Week 16 + 5 days follow up
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Corresponds to rate of AEs per 100 patient years of exposure.
Severity assessed by investigator.
Mild: no or transient symptoms, no interference with subject's daily activities.
Moderate: marked symptoms, moderate interference with subject's daily activities.
Severe: considerable interference with subject's daily activities, unacceptable.
Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.
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Week 0 to Week 16 + 5 days follow up
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Change in Fasting Plasma Glucose (FPG)
Time Frame: Week 0, Week 16
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Change from baseline in FPG after 16 weeks of treatment
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Week 0, Week 16
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Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
Time Frame: Week 16
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Mean of SMPG after 16 weeks of treatment.
Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, bedtime, at 4 am and before breakfast.
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Week 16
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Rate of Major and Minor Hypoglycaemic Episodes
Time Frame: Week 0 to Week 16 + 5 days follow up
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Rate of Major and Minor hypoglycaemic episodes per 100 patient years of exposure (PYE).
Major if unable to treat her/himself.
Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.
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Week 0 to Week 16 + 5 days follow up
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Rate of Nocturnal Major and Minor Hypoglycaemic Episodes
Time Frame: Week 0 to Week 16 + 5 days follow up
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Rate of nocturnal Major and Minor hypoglycaemic episodes per 100 patient years of exposure (PYE).
Major if unable to treat her/himself.
Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L.
Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 06:00 (excluded).
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Week 0 to Week 16 + 5 days follow up
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Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)
Time Frame: Week -4, Week 16
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Values at screening (Week -4) and at Week 16
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Week -4, Week 16
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Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)
Time Frame: Week -4, Week 16
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Values at screening (Week -4) and at Week 16
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Week -4, Week 16
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Laboratory Safety Parameters (Biochemistry): Serum Creatinine
Time Frame: Week -4, Week 16
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Values at screening (Week -4) and at Week 16
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Week -4, Week 16
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Vital Signs: Diastolic Blood Pressure (BP)
Time Frame: Week 0, Week 16
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Values at baseline (Week 0) and at Week 16
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Week 0, Week 16
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Vital Signs: Systolic Blood Pressure (BP)
Time Frame: Week 0, Week 16
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Values at baseline (Week 0) and at Week 16
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Week 0, Week 16
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Vital Signs: Pulse
Time Frame: Week 0, Week 16
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Values at baseline (Week 0) and at Week 16
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Week 0, Week 16
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Physical Examination
Time Frame: Week 0, Week 8, Week 16
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Physical examination is performed at baseline (Week 0) and after 8 and 16 weeks of treatment.
If any new findings or deterioration in previous findings were observed during the trial, these were recorded as AEs and are therefore not presented separately as no analysis was performed.
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Week 0, Week 8, Week 16
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
January 30, 2008
First Submitted That Met QC Criteria
January 30, 2008
First Posted (Estimate)
February 13, 2008
Study Record Updates
Last Update Posted (Actual)
March 20, 2017
Last Update Submitted That Met QC Criteria
February 9, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Insulin
- Insulin, Globin Zinc
- Insulin Aspart
- Insulin, Long-Acting
- Insulin degludec, insulin aspart drug combination
- Metformin
- Insulin Glargine
Other Study ID Numbers
- NN5401-1791
- 2007-002476-33 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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