Back to resultsEffect of Liraglutide on Glucagon Secretion in Subjects With Type 2 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
liraglutide
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes
Eligibility Criteria
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
NNC 90-1170
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Area under the Curve (AUC) glucagon
Secondary Outcome Measures
Insulin secretion
Glucose
Cortisol
Growth hormone
Adrenaline
Noradrenaline
Adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01509742
Brief Title
Effect of Liraglutide on Glucagon Secretion in Subjects With Type 2 Diabetes
Official Title
Effect of NNC 90-1170 on Hypoglycaemic Counterregulation During Stepwise Hypoglycaemic Clamp in Type 2 Diabetic Subjects. A Double-blind, Placebo-controlled, Randomised, 2-period Cross-over Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
November 2001 (Actual)
Study Completion Date
November 2001 (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. The aim of this trial is to examine the effect of NNC 90-1170 on the hypoglycaemic counterregulation in subjects with type 2 diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NNC 90-1170
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
liraglutide
Other Intervention Name(s)
NNC 90-1170
Intervention Description
Single dose of 7.5 mcg/kg, injected subcutaneously followed by a hypoglycaemic clamp by concentration measurement
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Single dose injected subcutaneously followed by a hypoglycaemic clamp by concentration measurement
Primary Outcome Measure Information:
Title
Area under the Curve (AUC) glucagon
Secondary Outcome Measure Information:
Title
Insulin secretion
Title
Glucose
Title
Cortisol
Title
Growth hormone
Title
Adrenaline
Title
Noradrenaline
Title
Adverse events
10. Eligibility
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Bad Lauterberg
ZIP/Postal Code
37431
Country
Germany
12. IPD Sharing Statement
Citations:
Citation
Nauck MA, El-Ouaghlidi A, Hompesch M, Jacobsen J, Elbroend B. No Impairment of Hypoglycaemia Counterregulation via Glucagon with the long-acting GLP-1 Derivative, NN2211, in Subjects with Type 2-Diabetes. Diabetologia 2003; 46 (Suppl 2): A285
Results Reference
result
Citation
Nauck MA, El-Ouaghlidi A, Hompesch M, Jacobsen J, Elbroend B. No Impairment of Hypoglycemia Counterregulation via Glucagon with NN2211, a GLP-1 Derivative, in Subjects with Type 2-Diabetes. Diabetes 2003; 52 (Suppl 1): A128
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Effect of Liraglutide on Glucagon Secretion in Subjects With Type 2 Diabetes
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