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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00614055
First received: January 30, 2008
Last updated: February 9, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin degludec/insulin aspart
Drug: insulin glargine
Drug: metformin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

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


Secondary Outcome Measures:
  • Change in Fasting Plasma Glucose (FPG) [ Time Frame: Week 0, Week 16 ]
    Change from baseline in FPG after 16 weeks of treatment

  • Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) [ Time Frame: Week 16 ]
    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.

  • 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.

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

  • 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 06:00 (excluded).

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

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

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

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

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

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

  • Physical Examination [ Time Frame: Week 0, Week 8, Week 16 ]
    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.


Enrollment: 178
Study Start Date: January 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Insulin glargine Drug: insulin glargine
Treat-to-target dose titration scheme, injection s.c., once daily
Drug: metformin
Tablets, 1500-2000 mg/day
Experimental: SIAC 30 (B) Drug: insulin degludec/insulin aspart
Formulation 1: Treat-to-target dose titration scheme, injection s.c., once daily
Drug: metformin
Tablets, 1500-2000 mg/day
Experimental: SIAC 45 (B) Drug: insulin degludec/insulin aspart
Formulation 2: Treat-to-target dose titration scheme, injection s.c., once daily
Drug: metformin
Tablets, 1500-2000 mg/day

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00614055

Locations
France
Novo Nordisk Investigational Site
Alès, France, 30100
Novo Nordisk Investigational Site
Brest, France, 29609
Novo Nordisk Investigational Site
LA ROCHELLE cedex, France, 17019
Novo Nordisk Investigational Site
Le Creusot, France, 71200
Novo Nordisk Investigational Site
Mont de Marsan, France, 40024
Novo Nordisk Investigational Site
Venissieux, France, 69200
Germany
Novo Nordisk Investigational Site
Bad Kreuznach, Germany, 55545
Novo Nordisk Investigational Site
Bad Mergentheim, Germany, 97980
Novo Nordisk Investigational Site
Dormagen, Germany, 41539
Novo Nordisk Investigational Site
Hohenmölsen, Germany, 06679
Novo Nordisk Investigational Site
Neuss, Germany, 41460
Novo Nordisk Investigational Site
Neuwied, Germany, 56564
Norway
Novo Nordisk Investigational Site
Elverum, Norway, 2408
Novo Nordisk Investigational Site
Hamar, Norway, 2317
Novo Nordisk Investigational Site
Kongsvinger, Norway, 2212
Novo Nordisk Investigational Site
Oslo, Norway, 0586
Novo Nordisk Investigational Site
Stavanger, Norway, 4011
Novo Nordisk Investigational Site
Tromsø, Norway, 9038
Romania
Novo Nordisk Investigational Site
Bucharest, Romania, 011234
Novo Nordisk Investigational Site
Bucharest, Romania, 020042
Novo Nordisk Investigational Site
Bucharest, Romania, 020475
Novo Nordisk Investigational Site
Bucharest, Romania, 020992
Novo Nordisk Investigational Site
Bucharest, Romania
Spain
Novo Nordisk Investigational Site
Almería, Spain, 04001
Novo Nordisk Investigational Site
Partida de Bacarot, Spain, 03114
Novo Nordisk Investigational Site
Sevilla, Spain, 41010
Novo Nordisk Investigational Site
Valencia, Spain, 46014
Novo Nordisk Investigational Site
Valladolid, Spain, 47011
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00614055     History of Changes
Other Study ID Numbers: NN5401-1791
2007-002476-33 ( EudraCT Number )
Study First Received: January 30, 2008
Results First Received: October 16, 2015
Last Updated: February 9, 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
Metformin
Insulin Aspart
Insulin, Long-Acting
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 25, 2017