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

Part of paid clinical trials in Duarte, California.

Sponsor
Novo Nordisk A/S
Study ID
NCT01206101
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • liraglutide — DRUG
    Dose escalation of liraglutide up to 1.2 to 1.8 mg before islet cell transplant until the planned number of transplanted subjects is complete or subject is transplanted. After islet cell transplant, subjects continue to receive the reached liraglutide dose for 52 weeks. Injected subcutaneously(under the skin) once daily.
  • placebo — DRUG
    Dose escalation escalation of liraglutide up to 1.2 to 1.8 mg before islet cell transplant until the planned number of transplanted subjects is complete or subject is transplanted. After islet cell transplant, subjects continue to receive the reached liraglutide placebo dose for 52 weeks. Injected subcutaneously (under the skin) once daily.

Study Details

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.

Key Dates

Start date
Mar 21, 2012
Status verified
Feb 2017
Primary completion
Jun 3, 2013
Completion
Jun 3, 2013

Study Design

Enrollment
3 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Liraglutide
  • Placebo Comparator: Liraglutide placebo

Primary Outcome Measure

Proportion Of Insulin-independent Subjects After Receiving Only One (Single-Donor) Islet Cell Transplant [ Time Frame: At week 52 after initial transplantation ]

Locations (4)

FacilityCityStateZIPSite coordinators
Novo Nordisk Investigational SiteDuarteCalifornia91010-
Novo Nordisk Investigational SiteChicagoIllinois60612-
Novo Nordisk Investigational SiteBostonMassachusetts02114-
Novo Nordisk Investigational SiteMadisonWisconsin53792-0001-

Find similar trials in Duarte, CA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Novo Nordisk Investigational Site· Duarte, CANovo Nordisk Investigational Site· Chicago, ILNovo Nordisk Investigational Site· Boston, MANovo Nordisk Investigational Site· Madison, WI

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