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NCT01206101

Efficacy and Safety of Liraglutide in Subjects With Type 1 Diabetes Undergoing Islet Cell Transplantation

Terminated Phase 2 Results posted Last updated 30 March 2017
What this trial tests

Phase 2 trial testing liraglutide in Diabetes in 3 participants. Terminated before completion.

Timeline
21 March 2012
Primary endpoint
3 June 2013
3 June 2013

Quick facts

Lead sponsorNovo Nordisk A/S
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment3
Start date21 March 2012
Primary completion3 June 2013
Estimated completion3 June 2013
Sites16 locations across France, United Kingdom, Germany, Canada, Switzerland, United States

Drugs / interventions tested

Conditions studied

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

18 and older, any sex, with Diabetes or Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from week 0 to week 52.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Liraglutide
Serious: 0/2 (0%)
Deaths:
Liraglutide Placebo
Serious: 0/1 (0%)
Deaths:
Other adverse events (13 terms — click to expand)

ReactionSystemLiraglutideLiraglutide Placebo
NauseaGastrointestinal disorders
Gastric ulcerGastrointestinal disorders
VomitingGastrointestinal disorders
FatigueGeneral disorders
PyrexiaGeneral disorders
PharyngitisInfections and infestations
Computerised tomogram abnormalInvestigations
Decreased appetiteMetabolism and nutrition disorders
HypoglycaemiaMetabolism and nutrition disorders
Musculoskeletal chest painMusculoskeletal and connective tissue disorders
HeadacheNervous system disorders
DepressionPsychiatric disorders
Nasal congestionRespiratory, thoracic and mediastinal disorders

Data from ClinicalTrials.gov NCT01206101 adverse events section.

Sponsor's own description

This trial is conducted in Europe and North America. The aim of this trial is to investigate if liraglutide treatment can increase the proportion of insulin-independent subjects one year after islet cell transplantation who required only one (single-donor) islet cell transplant.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of liraglutide

Trials testing the same drug.

Other recruiting trials for Diabetes

Currently open trials in the same condition.

Other Novo Nordisk A/S trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01206101.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing