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
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: 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 August 21, 2014