Effect of Liraglutide on Glucagon Secretion in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01509742
First received: January 6, 2012
Last updated: August 30, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: NNC 90-1170
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Area under the Curve (AUC) glucagon [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insulin secretion [ Designated as safety issue: No ]
  • Glucose [ Designated as safety issue: No ]
  • Cortisol [ Designated as safety issue: No ]
  • Growth hormone [ Designated as safety issue: No ]
  • Adrenaline [ Designated as safety issue: No ]
  • Noradrenaline [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: April 2001
Study Completion Date: November 2001
Primary Completion Date: November 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NNC 90-1170 Drug: NNC 90-1170
Single dose of 7.5 mcg/kg, injected subcutaneously followed by a hypoglycaemic clamp by concentration measurement
Placebo Comparator: Placebo Drug: placebo
Single dose injected subcutaneously followed by a hypoglycaemic clamp by concentration measurement

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Accepts Healthy Volunteers:   No
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509742

Locations
Germany
Bad Lauterberg, Germany, 37431
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Peter Damsbo, MD Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01509742     History of Changes
Other Study ID Numbers: NN2211-1224
Study First Received: January 6, 2012
Last Updated: August 30, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014