NCT01509742

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_1 diabetes

Timeline
Completed

Started Apr 2001

Typical duration for phase_1 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2001

Completed
10.2 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 13, 2012

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

7 months

First QC Date

January 6, 2012

Last Update Submit

January 31, 2024

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Area under the Curve (AUC) glucagon

Secondary Outcomes (7)

  • Insulin secretion

  • Glucose

  • Cortisol

  • Growth hormone

  • Adrenaline

  • +2 more secondary outcomes

Study Arms (2)

NNC 90-1170

EXPERIMENTAL
Drug: liraglutide

Placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

liraglutideDRUG

Single dose of 7.5 mcg/kg, injected subcutaneously followed by a hypoglycaemic clamp by concentration measurement

Also known as: NNC 90-1170
NNC 90-1170
placeboDRUG

Single dose injected subcutaneously followed by a hypoglycaemic clamp by concentration measurement

Placebo

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
age: minimum 30, maximum 75 years

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Bad Lauterberg im Harz, 37431, Germany

Location

Related Publications (2)

  • 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

    RESULT

  • 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

    RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2012

First Posted

January 13, 2012

Study Start

April 1, 2001

Primary Completion

November 1, 2001

Study Completion

November 1, 2001

Last Updated

February 1, 2024

Record last verified: 2024-01

Locations

DE(1)