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Trial · Interventional

CompletedPhase 2Registry data

Effect of Liraglutide on Glucose Profiles and Gastric Emptying in Subjects With Type 2 Diabetes

NCTNCT01508923 (opens ClinicalTrials.gov in a new tab)Other idNN2211-1332
Open at ClinicalTrials.govAsk about this trial

Overview

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

Denmark

Start
May 2001
Primary completion
Feb 2002
Completion
Feb 2002
First posted
12 Jan 2012 (estimated)
Last update posted
24 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
200120022003
  1. Ph 2

    Effect of Liraglutide on Glucose Profiles and Gastric Emptying in Subjects With Type 2 Diabetes

    NCT01508923

    May 2001 to Feb 2002

Registry summary

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

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.

Interventions

  • liraglutideDrug
  • placeboDrug

Arms2

  • Experimental

    Treatment period 1

  • Placebo comparator

    Treatment period 2

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 24-hour glucose profiles after three fixed meals

Secondary outcomes(9)

  1. 24-hour insulin profiles after three fixed meals

  2. First phase insulin and maximal insulin secretory capacity

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

  4. GNG (gluconeogenesis) expressed in mg/kg/min

  5. 24-hour glucagon profiles after three fixed meals

  6. 24-hour FFA (free fatty acids) profiles after three fixed meals

  7. 4-hour paracetamol profiles after two fixed meals

  8. 30-hour NNC 90-1170 profile

  9. 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 · 2004

14 results

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.

Degn et al. 2004Diabetescited by 328

PMID 15111485DOI 10.2337/diabetes.53.5.1187PUB-15111485

Full text at the publisher14 results
Publisher pageSee results (14)

Eligibility

Who could join, as posted.

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

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