NCT01508923

Brief Summary

This trial is conducted in Europe. The aim of this trial is to determine the effect of NNC 90-1170 (liraglutide) on glucose and hormonal profiles, fasting gluconeogenesis and insulin secretion 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
17

participants targeted

Target at below P25 for phase_2 diabetes

Timeline
Completed

Started May 2001

Shorter than P25 for phase_2 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

May 1, 2001

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2002

Completed
9.9 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 12, 2012

Completed
Last Updated

January 24, 2017

Status Verified

January 1, 2017

Enrollment Period

9 months

First QC Date

January 9, 2012

Last Update Submit

January 23, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • 24-hour glucose profiles after three fixed meals

Secondary Outcomes (9)

  • 24-hour insulin profiles after three fixed meals

  • First phase insulin and maximal insulin secretory capacity

  • EGR (endogenous glucose release) expressed in mg/kg/min

  • GNG (gluconeogenesis) expressed in mg/kg/min

  • 24-hour glucagon profiles after three fixed meals

  • +4 more secondary outcomes

Study Arms (2)

Treatment period 1

EXPERIMENTAL
Drug: liraglutideDrug: placebo

Treatment period 2

PLACEBO COMPARATOR
Drug: liraglutideDrug: placebo

Interventions

liraglutideDRUG

6 mcg/kg injected subcutaneously daily in each treatment period in random order. In total, subjects are treated 9-10 days

Also known as: NNC 90-1170
Treatment period 1Treatment period 2
placeboDRUG

6 mcg/kg injected subcutaneously daily in each treatment period in random order. In total, subjects are treated 9-10 days

Treatment period 1Treatment period 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes mellitus
  • Diet treated and/or subjects in monotherapy with max. 50 % of maximal dose of sulphonylurea (SU). In addition, subjects in treatment with metformin and/or repaglinide could be included
  • Body Mass Index (BMI) maximum 35 kg/m\^2
  • Fasting plasma glucose 7-15 mmol/l, both inclusive

You may not qualify if:

  • Impaired liver function
  • Impaired renal function
  • Anaemia
  • Cardiac disease
  • Uncontrolled treated/untreated hypertension
  • Recurrent major hypoglycaemia as judged by the Investigator
  • Known or suspected allergy to trial product or related products
  • Females of child bearing potential who are pregnant, breast-feeding or have intention of becoming pregnant or are not using adequate contraceptive measures
  • Current treatment with thiazolidinediones or chronic daily use of insulin (more than 7 days) within three months in the absence of intercurrent illness
  • Loss of more than 400 ml blood during the three months prior to study start
  • Allergy to paracetamol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Århus C, 8000, Denmark

Location

Related Publications (1)

  • Degn KB, Juhl CB, Sturis J, Jakobsen G, Brock B, Chandramouli V, Rungby J, Landau BR, Schmitz O. One week's treatment with the long-acting glucagon-like peptide 1 derivative liraglutide (NN2211) markedly improves 24-h glycemia and alpha- and beta-cell function and reduces endogenous glucose release in patients with type 2 diabetes. Diabetes. 2004 May;53(5):1187-94. doi: 10.2337/diabetes.53.5.1187.

    PMID: 15111485RESULT

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 2
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 9, 2012

First Posted

January 12, 2012

Study Start

May 1, 2001

Primary Completion

February 1, 2002

Study Completion

February 1, 2002

Last Updated

January 24, 2017

Record last verified: 2017-01

Locations

DK(1)