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

January 31, 2024 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Lauterberg, Germany, 37431
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

age: minimum 30, maximum 75 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: placebo
Single dose injected subcutaneously followed by a hypoglycaemic clamp by concentration measurement
Experimental: NNC 90-1170
Drug: liraglutide
Single dose of 7.5 mcg/kg, injected subcutaneously followed by a hypoglycaemic clamp by concentration measurement
Other Names:
  • NNC 90-1170

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Area under the Curve (AUC) glucagon

Secondary Outcome Measures

Outcome Measure
Adverse events
Glucose
Insulin secretion
Cortisol
Growth hormone
Adrenaline
Noradrenaline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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
  • 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

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Primary Completion (Actual)

November 1, 2001

Study Completion (Actual)

November 1, 2001

Study Registration Dates

First Submitted

January 6, 2012

First Submitted That Met QC Criteria

January 12, 2012

First Posted (Estimated)

January 13, 2012

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN2211-1224

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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