NCT01511692

Brief Summary

This trial is conducted in Europe and Oceania. The aim of this trial is to assess the effects of liraglutide on energy intake in subjects with type 2 diabetes.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P50-P75 for phase_1 diabetes

Timeline
Completed

Started Nov 2005

Longer than P75 for phase_1 diabetes

Geographic Reach
2 countries

2 active sites

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

November 1, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 19, 2012

Completed
Last Updated

January 25, 2017

Status Verified

January 1, 2017

Enrollment Period

1.8 years

First QC Date

January 12, 2012

Last Update Submit

January 24, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • The energy intake at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10

Secondary Outcomes (7)

  • The energy intake at a standardised buffet meal without a preload paradigm quantified using Foodworks 2.10

  • Macronutrient distribution of food consumed at a standardised buffet meal with a preload paradigm quantified using Foodworks 2.10

  • Macronutrient distribution of food consumed at a standardised buffet meal without a preload paradigm quantified using Foodworks 2.10

  • Total duration of eating at the buffet meal (satiation)

  • Weight

  • +2 more secondary outcomes

Study Arms (3)

Lira --> placebo

EXPERIMENTAL
Drug: liraglutideDrug: placebo

Placebo --> glim

PLACEBO COMPARATOR
Drug: placeboDrug: glimepiride

Glim --> lira

ACTIVE COMPARATOR
Drug: liraglutideDrug: glimepiride

Interventions

liraglutideDRUG

1.8 mg/day injected subcutaneously for 4 weeks

Glim --> liraLira --> placebo
placeboDRUG

Liraglutide placebo, injected subcutaneously for 4 weeks

Lira --> placebo
glimepirideDRUG

Dose individually adjusted, administered orally for 4 weeks

Glim --> liraPlacebo --> glim

Eligibility Criteria

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

You may qualify if:

  • Type 2 diabetes mellitus
  • Diet-treated subjects and/or subjects with type 2 diabetes in OAD (oral anti-diabetic drug) mono-therapy
  • HbA1c for diet-treated subjects: HbA1c between 6.5-10.0% (both inclusive) and for OAD treated subjects: HbA1c between 6.5-9.5% (both inclusive)
  • Body mass index (BMI) between 27-40 kg/m\^2 (both inclusive)
  • Subjects should have a stable body weight for at least 3 months prior to screening (as documented by a weight within 3 to 6 months, prior to screening that is within 15% of the screening weight)
  • Euthyroid subjects
  • Subjects should be unrestrained eaters

You may not qualify if:

  • Recurrent severe hypoglycaemia
  • Impaired liver function
  • Impaired renal function
  • Cardiac problems
  • Uncontrolled treated/untreated hypertension
  • Known or suspected allergy to trial products or related products
  • Use of any drug (except for OADs), which in the investigator's opinion could interfere with the subject's glucose level or body weight
  • Active hepatitis B and/or active hepatitis C
  • Positive HIV (human immunodeficiency virus) antibodies
  • Known or suspected abuse of alcohol or narcotics
  • Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, cola drinks, chocolate) as judged by the Investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novo Nordisk Investigational Site

Adelaide, South Australia, 5005, Australia

Location

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Location

Related Publications (1)

  • Horowitz M, Flint A, Jones KL, Hindsberger C, Rasmussen MF, Kapitza C, Doran S, Jax T, Zdravkovic M, Chapman IM. Effect of the once-daily human GLP-1 analogue liraglutide on appetite, energy intake, energy expenditure and gastric emptying in type 2 diabetes. Diabetes Res Clin Pract. 2012 Aug;97(2):258-66. doi: 10.1016/j.diabres.2012.02.016. Epub 2012 Mar 24.

    PMID: 22446097RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

Liraglutideglimepiride

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 12, 2012

First Posted

January 19, 2012

Study Start

November 1, 2005

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

January 25, 2017

Record last verified: 2017-01

Locations

DE(1)AU(1)