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Comparison of Two NN5401 Formulations Versus Biphasic Insulin Aspart 30, All in Combination With Metformin in Subjects With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT00613951
Recruitment Status : Completed
First Posted : February 13, 2008
Results First Posted : December 1, 2015
Last Update Posted : March 20, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (Soluble Insulin Analogue Combination [SIAC], insulin degludec/insulin aspart) formulations with each other and with biphasic insulin aspart 30, all in combination with metformin in insulin naive subjects with type 2 diabetes.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: insulin degludec/insulin aspart Drug: biphasic insulin aspart Drug: metformin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 16 Week Randomised, Open Labelled, 3-armed, Parallel Group, Treat-to-target Trial Comparing Twice Daily (BID) Injections of SIAC 30 (B), SIAC 45 (B) and NovoMix®30, All in Combination With Metformin in Subjects With Type 2 Diabetes Failing on OAD Treatment
Study Start Date : January 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

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Arms and Interventions
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Arm Intervention/treatment
Experimental: SIAC 30 (B) Drug: insulin degludec/insulin aspart
Formulation B: Treat-to-target dose titration scheme, injection s.c., twice daily

Drug: metformin
Tablets, 1500-2000 mg/daily
Experimental: SIAC 45 (B) Drug: insulin degludec/insulin aspart
Formulation B: Treat-to-target dose titration scheme, injection s.c., twice daily

Drug: metformin
Tablets, 1500-2000 mg/daily
Active Comparator: BIAsp 30 Drug: biphasic insulin aspart
Treat-to-target dose titration scheme, injection s.c., twice daily

Drug: metformin
Tablets, 1500-2000 mg/daily


Outcome Measures
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Primary Outcome Measures :
  1. Change in Glycosylated Haemoglobin (HbA1c) [ Time Frame: Week 0, Week 16 ]
    Change from baseline in HbA1c after 16 weeks of treatment


Secondary Outcome Measures :
  1. Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) [ Time Frame: Week 16 ]
    Estimate of the overall 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, before bedtime, at 4 am and before breakfast.

  2. Rate of Major and Minor Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 16 + 5 days follow up ]
    Observed 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.

  3. Rate of Nocturnal Major and Minor Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 16 + 5 days follow up ]
    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 05:59 (included).

  4. Rate of Treatment Emergent Adverse Events (AEs) [ Time Frame: Week 0 to Week 16 + 5 days follow up ]
    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.

  5. Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) [ Time Frame: Week -4, Week 16 ]
    Laboratory values at screening (Week -4) and at Week 16

  6. Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT) [ Time Frame: Week -4, Week 16 ]
    Laboratory values at screening (Week -4) and at Week 16

  7. Laboratory Safety Parameters (Biochemistry): Serum Creatinine [ Time Frame: Week -4, Week 16 ]
    Laboratory values at screening (Week -4) and at Week 16

  8. Vital Signs: Diastolic Blood Pressure (BP) [ Time Frame: Week 0, Week 16 ]
    Values at baseline (Week 0) and at Week 16

  9. Vital Signs: Systolic Blood Pressure (BP) [ Time Frame: Week 0, Week 16 ]
    Values at baseline (Week 0) and at Week 16

  10. Vital Signs: Pulse [ Time Frame: Week 0, Week 16 ]
    Values at baseline (Week 0) and at Week 16

  11. Physical Examination [ Time Frame: Week -4, Week 8, Week 16 ]
    Physical examination was performed at screening (week -4), 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 months at a stable maximally tolerated dose or at least half maximally 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) treatment within previous 3 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 (except for conditions associated with type 2 diabetes) that, in the opinion of the investigator, may confound the results of the trial or pose additional risk in administering trial product
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00613951


Locations
Finland
Novo Nordisk Investigational Site
Helsinki, Finland, 00260
Novo Nordisk Investigational Site
Kuopio, Finland, 70210
Novo Nordisk Investigational Site
Lahti, Finland, 15110
Novo Nordisk Investigational Site
Pori, Finland, FI-28100
France
Novo Nordisk Investigational Site
Bar-Le-Duc, France, 55000
Novo Nordisk Investigational Site
GRENOBLE cedex, France, 38043
Novo Nordisk Investigational Site
Hayange, France, 57700
Novo Nordisk Investigational Site
LA ROCHELLE cedex, France, 17019
Novo Nordisk Investigational Site
Nanterre, France, 92014
Novo Nordisk Investigational Site
NEVERS cedex, France, 58033
Novo Nordisk Investigational Site
Pointe à Pitre, France, 97159
Germany
Novo Nordisk Investigational Site
Berlin, Germany, 12163
Novo Nordisk Investigational Site
Pirna, Germany, 01796
Novo Nordisk Investigational Site
Riesa, Germany, 01587
Novo Nordisk Investigational Site
Saarbrücken, Germany, 66121
Novo Nordisk Investigational Site
St. Ingbert, Germany, 66386
Novo Nordisk Investigational Site
Völklingen, Germany, 66333
Novo Nordisk Investigational Site
Wangen, Germany, 88239
Poland
Novo Nordisk Investigational Site
Bydgoszcz, Poland, 85-822
Novo Nordisk Investigational Site
Gniewkowo, Poland, 88-140
Novo Nordisk Investigational Site
Nysa, Poland, 48-300
Novo Nordisk Investigational Site
Plock, Poland, 09-400
Novo Nordisk Investigational Site
Szczecin, Poland, 70-483
Novo Nordisk Investigational Site
Tychy, Poland, 43-100
Novo Nordisk Investigational Site
Warszawa, Poland, 02-507
Novo Nordisk Investigational Site
Wroclaw, Poland, 50-127
Spain
Novo Nordisk Investigational Site
Almería, Spain, 04001
Novo Nordisk Investigational Site
Barcelona, Spain, 08035
Novo Nordisk Investigational Site
Granada, Spain, 18012
Novo Nordisk Investigational Site
Madrid, Spain, 28034
Novo Nordisk Investigational Site
San Juan, Spain, 03550
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

Publications of Results:

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00613951     History of Changes
Other Study ID Numbers: NN5401-1792
2007-002462-35 ( EudraCT Number )
First Posted: February 13, 2008    Key Record Dates
Results First Posted: December 1, 2015
Last Update Posted: March 20, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin aspart, insulin aspart protamine drug combination 30:70
 Insulin
Metformin
Insulin Aspart
Insulin, Long-Acting
Biphasic Insulins
Hypoglycemic Agents
Physiological Effects of Drugs