Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Insulin Aspart in Subjects With Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00612040
First received: January 25, 2008
Last updated: November 27, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
Drug: insulin degludec
Drug: insulin glargine
Drug: insulin aspart
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Change from baseline in FPG (expressed in mmol/L, 1 mg/dL = 18times mmol/L) after 16 weeks of treatment

  • Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    Estimate of the overall mean of SMPG (expressed in mmol/L, 1 mg/dL = 18times mmol/L) 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 Major and Minor Hypoglycaemic Episodes [ Time Frame: Week 0 to Week 16 + 5 days follow up ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).

  • Rate of Treatment Emergent Adverse Events (AEs) [ Time Frame: Week 0 to Week 16 + 5 days follow up ] [ Designated as safety issue: No ]
    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.

  • Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) [ Time Frame: Week -1, Week 16 ] [ Designated as safety issue: No ]
    Laboratory values at screening (Week -1) and at Week 16

  • Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT) [ Time Frame: Week -1, Week 16 ] [ Designated as safety issue: No ]
    Laboratory values at screening (Week -1) and at Week 16

  • Laboratory Safety Parameters (Biochemistry): Serum Creatinine [ Time Frame: Week -1, Week 16 ] [ Designated as safety issue: No ]
    Laboratory values at screening (Week -1) and at Week 16

  • Vital Signs: Diastolic BP (Blood Pressure) [ Time Frame: Week 0, Week 16 ] [ Designated as safety issue: No ]
    Values at baseline (Week 0) and at Week 16

  • Vital Signs: Systolic BP (Blood Pressure) [ Time Frame: Week 0, Week 16 ] [ Designated as safety issue: No ]
    Values at baseline (Week 0) and at Week 16

  • Vital Signs: Pulse [ Time Frame: Week 0, Week 16 ] [ Designated as safety issue: No ]
    Values at baseline (Week 0) and at Week 16

  • Physical Examination [ Time Frame: Week -1, Week 8, Week 16 ] [ Designated as safety issue: No ]
    Physical examination was performed at screening (week -1), 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: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SIBA (D) Drug: insulin degludec
Formulation 1: Treat-to-target dose titration scheme, injection s.c. (under the skin), once daily
Drug: insulin aspart
Treat-to-target dose titration scheme, injection s.c. (under the skin), 3 times daily
Experimental: SIBA (E) Drug: insulin degludec
Formulation 2: Treat-to-target dose titration scheme, injection s.c. (under the skin), once daily
Drug: insulin aspart
Treat-to-target dose titration scheme, injection s.c. (under the skin), 3 times daily
Experimental: IGlar Drug: insulin glargine
Treat-to-target dose titration scheme, injection s.c., once daily
Drug: insulin aspart
Treat-to-target dose titration scheme, injection s.c. (under the skin), 3 times daily

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00612040

Locations
United States, Hawaii
Novo Nordisk Clinical Trial Call Center
Honolulu, Hawaii, United States, 96814
United States, Iowa
Novo Nordisk Clinical Trial Call Center
Des Moines, Iowa, United States, 50314
United States, Maryland
Novo Nordisk Clinical Trial Call Center
Hyattsville, Maryland, United States, 20782
United States, Tennessee
Novo Nordisk Clinical Trial Call Center
Chattanooga, Tennessee, United States, 37404
United States, Texas
Novo Nordisk Clinical Trial Call Center
Dallas, Texas, United States, 75230
United States, Washington
Novo Nordisk Clinical Trial Call Center
Renton, Washington, United States, 98057
Australia
Miranda, Australia, 2228
Germany
Hamburg, Germany, 22607
Norway
Elverum, Norway, 2408
Sweden
Stockholm, Sweden, 112 81
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00612040     History of Changes
Other Study ID Numbers: NN1250-1835  2007-002474-60 
Study First Received: January 25, 2008
Results First Received: October 16, 2015
Last Updated: November 27, 2015
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency
Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin
Insulin Glargine
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2016