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Trial · Interventional

CompletedPhase 1Registry data

Effect of Liraglutide Compared to Glimepiride on Appetite in Subjects With Type 2 Diabetes

NCTNCT01511692 (opens ClinicalTrials.gov in a new tab)Other idNN2211-1589Other id2006-000377-30
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
43 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
2 countries

Australia, Germany

Start
Nov 2005
Primary completion
Sept 2007
Completion
Sept 2007
First posted
19 Jan 2012 (estimated)
Last update posted
25 Jan 2017 (estimated)
Conditions
Diabetes · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2005200620072008
  1. Ph 1

    Effect of Liraglutide Compared to Glimepiride on Appetite in Subjects With Type 2 Diabetes

    NCT01511692

    Nov 2005 to Sept 2007

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • liraglutideDrug
  • placeboDrug
  • placeboDrug
  • glimepirideDrug

Arms3

  • Experimental

    Lira --> placebo

  • Placebo comparator

    Placebo --> glim

  • Active comparator

    Glim --> lira

Primary outcomes1

Outcomes the sponsor listed as primary.

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

Secondary outcomes(7)

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

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

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

  4. Total duration of eating at the buffet meal (satiation)

  5. Weight

  6. Waist circumference

  7. Adverse events

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2012

11 results

Effect of the once-daily human GLP-1 analogue liraglutide on appetite, energy intake, energy expenditure and gastric emptying in type 2 diabetes.

Horowitz et al. 2012Diabetes research and clinical practicecited by 140

PMID 22446097DOI 10.1016/j.diabres.2012.02.016PUB-22446097

Full text at the publisher11 results
Publisher pageSee results (11)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Exclusion Criteria: * 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

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