Comparison of Hypoglycaemic Response Between NN1250 and Insulin Glargine in Type 1 Diabetics
Primary Purpose
Diabetes, Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 1
Locations
Austria
Study Type
Interventional
Intervention
insulin degludec
insulin glargine
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Inclusion Criteria:
- Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
- Body mass index 18.0-28.0 kg/m^2 (both inclusive)
Exclusion Criteria:
- Use of insulin glargine within 3 months prior to first dosing of investigational product in this trial
- Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
- Smoker
- Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months)
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
IDeg
IGlar
Arm Description
Outcomes
Primary Outcome Measures
Baseline-adjusted hypoglycaemic symptoms score at nadir plasma glucose concentration
Secondary Outcome Measures
Baseline-adjusted hypoglycaemic symptoms score at each level of plasma glucose
Time from start of hypoglycaemic induction until each level of plasma glucose is reached
Time to increase from nadir plasma glucose to a plasma glucose concentration of 3.9 mmol/L
Hypoglycaemic symptoms score during recovery from hypoglycaemia
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01002768
Brief Title
Comparison of Hypoglycaemic Response Between NN1250 and Insulin Glargine in Type 1 Diabetics
Official Title
A Trial Investigating the Hypoglycaemic Response to NN1250 in Subjects With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (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 iss conducted in Europe. The aim of this clinical trial is to evaluate the hypoglycaemic response (the response to low blood sugar) to NN1250 (insulin degludec) in subjects with type 1 diabetes.
The trial is designed as a two-period, crossover trial where the trial participant is randomised to one of two treatment periods.
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 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IDeg
Arm Type
Experimental
Arm Title
IGlar
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
insulin degludec
Intervention Description
Day 1-4: Once daily subcutaneous (under the skin) injection similar to 80% of individual basal insulin requirement. Day 5: Three times the individual basal insulin requirement.
Intervention Type
Drug
Intervention Name(s)
insulin glargine
Intervention Description
Day 1-4: Once daily subcutaneous (under the skin) injection similar to 80% of individual basal insulin requirement. Day 5: Three times the individual basal insulin requirement.
Primary Outcome Measure Information:
Title
Baseline-adjusted hypoglycaemic symptoms score at nadir plasma glucose concentration
Time Frame
Within 0-46 hours after last trial product administration
Secondary Outcome Measure Information:
Title
Baseline-adjusted hypoglycaemic symptoms score at each level of plasma glucose
Time Frame
Within 0-46 hours after last trial product administration
Title
Time from start of hypoglycaemic induction until each level of plasma glucose is reached
Time Frame
Within 0-46 hours after last trial product administration
Title
Time to increase from nadir plasma glucose to a plasma glucose concentration of 3.9 mmol/L
Time Frame
Within 0-46 hours after last trial product administration
Title
Hypoglycaemic symptoms score during recovery from hypoglycaemia
Time Frame
Within 0-46 hours after last trial product administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
Body mass index 18.0-28.0 kg/m^2 (both inclusive)
Exclusion Criteria:
Use of insulin glargine within 3 months prior to first dosing of investigational product in this trial
Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
Smoker
Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months)
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
Graz
ZIP/Postal Code
8010
Country
Austria
12. IPD Sharing Statement
Citations:
PubMed Identifier
24057153
Citation
Koehler G, Heller S, Korsatko S, Roepstorff C, Rasmussen S, Haahr H, Pieber TR. Insulin degludec is not associated with a delayed or diminished response to hypoglycaemia compared with insulin glargine in type 1 diabetes: a double-blind randomised crossover study. Diabetologia. 2014 Jan;57(1):40-9. doi: 10.1007/s00125-013-3056-0. Epub 2013 Sep 22.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Comparison of Hypoglycaemic Response Between NN1250 and Insulin Glargine in Type 1 Diabetics
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