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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
insulin degludec
insulin degludec
insulin glargine
insulin aspart
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

SIBA (D)

SIBA (E)

IGlar

Arm Description

Outcomes

Primary Outcome Measures

Change in Glycosylated Haemoglobin (HbA1c)
Change from baseline in HbA1c after 16 weeks of treatment

Secondary Outcome Measures

Change in Fasting Plasma Glucose (FPG)
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)
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
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
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)
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)
Laboratory values at screening (Week -1) and at Week 16
Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)
Laboratory values at screening (Week -1) and at Week 16
Laboratory Safety Parameters (Biochemistry): Serum Creatinine
Laboratory values at screening (Week -1) and at Week 16
Vital Signs: Diastolic BP (Blood Pressure)
Values at baseline (Week 0) and at Week 16
Vital Signs: Systolic BP (Blood Pressure)
Values at baseline (Week 0) and at Week 16
Vital Signs: Pulse
Values at baseline (Week 0) and at Week 16
Physical Examination
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.

Full Information

First Posted
January 25, 2008
Last Updated
January 18, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00612040
Brief Title
Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Insulin Aspart in Subjects With Type 1 Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
178 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SIBA (D)
Arm Type
Experimental
Arm Title
SIBA (E)
Arm Type
Experimental
Arm Title
IGlar
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
insulin degludec
Intervention Description
Formulation 1: Treat-to-target dose titration scheme, injection s.c. (under the skin), once daily
Intervention Type
Drug
Intervention Name(s)
insulin degludec
Intervention Description
Formulation 2: Treat-to-target dose titration scheme, injection s.c. (under the skin), once daily
Intervention Type
Drug
Intervention Name(s)
insulin glargine
Intervention Description
Treat-to-target dose titration scheme, injection s.c., once daily
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
Treat-to-target dose titration scheme, injection s.c. (under the skin), 3 times daily
Primary Outcome Measure Information:
Title
Change in Glycosylated Haemoglobin (HbA1c)
Description
Change from baseline in HbA1c after 16 weeks of treatment
Time Frame
Week 0, Week 16
Secondary Outcome Measure Information:
Title
Change in Fasting Plasma Glucose (FPG)
Description
Change from baseline in FPG (expressed in mmol/L, 1 mg/dL = 18times mmol/L) after 16 weeks of treatment
Time Frame
Week 0, Week 16
Title
Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
Description
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.
Time Frame
Week 16
Title
Rate of Major and Minor Hypoglycaemic Episodes
Description
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.
Time Frame
Week 0 to Week 16 + 5 days follow up
Title
Rate of Nocturnal Major and Minor Hypoglycaemic Episodes
Description
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).
Time Frame
Week 0 to Week 16 + 5 days follow up
Title
Rate of Treatment Emergent Adverse Events (AEs)
Description
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.
Time Frame
Week 0 to Week 16 + 5 days follow up
Title
Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT)
Description
Laboratory values at screening (Week -1) and at Week 16
Time Frame
Week -1, Week 16
Title
Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT)
Description
Laboratory values at screening (Week -1) and at Week 16
Time Frame
Week -1, Week 16
Title
Laboratory Safety Parameters (Biochemistry): Serum Creatinine
Description
Laboratory values at screening (Week -1) and at Week 16
Time Frame
Week -1, Week 16
Title
Vital Signs: Diastolic BP (Blood Pressure)
Description
Values at baseline (Week 0) and at Week 16
Time Frame
Week 0, Week 16
Title
Vital Signs: Systolic BP (Blood Pressure)
Description
Values at baseline (Week 0) and at Week 16
Time Frame
Week 0, Week 16
Title
Vital Signs: Pulse
Description
Values at baseline (Week 0) and at Week 16
Time Frame
Week 0, Week 16
Title
Physical Examination
Description
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.
Time Frame
Week -1, Week 8, Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404-7596
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Hyattsville
State/Province
Maryland
ZIP/Postal Code
20782
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Keswick
State/Province
South Australia
ZIP/Postal Code
5035
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
East Ringwood
State/Province
Victoria
ZIP/Postal Code
3135
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Geelong
ZIP/Postal Code
3220
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Miranda
ZIP/Postal Code
2228
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Bad Kreuznach
ZIP/Postal Code
55545
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Dresden
ZIP/Postal Code
01219
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hamburg
ZIP/Postal Code
22607
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hohenmölsen
ZIP/Postal Code
06679
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Neuwied
ZIP/Postal Code
56564
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
St. Ingbert
ZIP/Postal Code
66386
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Bergen
ZIP/Postal Code
NO-5012
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Elverum
ZIP/Postal Code
2408
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Kristiansand S
ZIP/Postal Code
4604
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Oslo
ZIP/Postal Code
0586
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Stavanger
ZIP/Postal Code
4011
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Alingsås
ZIP/Postal Code
441 83
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Karlstad
ZIP/Postal Code
651 85
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Stockholm
ZIP/Postal Code
112 81
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Stockholm
ZIP/Postal Code
182 88
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Umeå
ZIP/Postal Code
901 85
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
21270174
Citation
Birkeland KI, Home PD, Wendisch U, Ratner RE, Johansen T, Endahl LA, Lyby K, Jendle JH, Roberts AP, DeVries JH, Meneghini LF. Insulin degludec in type 1 diabetes: a randomized controlled trial of a new-generation ultra-long-acting insulin compared with insulin glargine. Diabetes Care. 2011 Mar;34(3):661-5. doi: 10.2337/dc10-1925. Epub 2011 Jan 26.
Results Reference
result
PubMed Identifier
22150786
Citation
Home PD, Meneghini L, Wendisch U, Ratner RE, Johansen T, Christensen TE, Jendle J, Roberts AP, Birkeland KI. Improved health status with insulin degludec compared with insulin glargine in people with type 1 diabetes. Diabet Med. 2012 Jun;29(6):716-20. doi: 10.1111/j.1464-5491.2011.03547.x.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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