DelfaGLP-1 Atlas

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TerminatedPhase 2Results posted

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

A 52 Week Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multi-Center, Multinational Trial In Islet Cell Transplant Subjects With Type 1 Diabetes Mellitus To Determine If The Early Use Of Liraglutide As An Adjunct To Standard Care Increases The Proportion Of Subjects Achieving Insulin Independence After First Transplantation

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

16

Recruiting sites

—

Enrollment

3

actual

Study population

Type 1 diabetes

Key I/E criterion

—

Primary endpoint

•Proportion Of Insulin-independent Subjects After Receiving Only One

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01206101
Org study IDNN2211-3619
Secondary ID2009-013090-18
Secondary IDU1111-1114-8952WHO

Timeline

Milestones

Study first posted2010-09-21estimated
Study start2012-03-21actual
Primary completion2013-06-03actual
Study completion2013-06-03actual
Results first posted2014-07-03estimated
Last update posted2017-03-30actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Type 1 diabetes mellitus for at least 5 years
•Candidate for islet cell transplantation based upon local accepted practice and guidelines
•Reduced awareness of hypoglycaemia

Exclusion criteria

•Treatment with any anti-diabetic medication other than insulin including insulin pump within 4 weeks of trial start
•Any previous organ transplantation
•A history of acute idiopathic or chronic pancreatitis
•Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma (FMTC)

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
8
Safety / tolerability / PK
2
Other (unclassified)
2

Glycemic / diabetes

8 endpoints
Primary/registry result/low confidence

Proportion Of Insulin-independent Subjects After Receiving Only One (Single-Donor) Islet Cell Transplant

Time frame:At week 52 after initial transplantation

threshold achievement, improvement

Primary/protocol endpoint

Proportion Of Insulin-independent Subjects After Receiving Only One (Single-Donor) Islet Cell Transplant

Time frame:At week 52 after initial transplantation

threshold achievement, improvement

Secondary/registry result

Proportion of Subjects With HbA1c Below Or Equal to 6.5% At Week 52 That Are Free From Severe Hypoglycaemic Events

Time frame:From week 0 to week 52 after initial transplantation

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/registry result/low confidence

Proportion of Insulin-Independent Subjects

Time frame:At 52 weeks after initial transplantation

threshold achievement, improvement

Secondary/registry result

Glucose Level Variability And Hypoglycaemia Duration Derived From The Continuous Glucose Monitoring System (CGMS)

Time frame:At 12 weeks pre-transplant, at 24 weeks post-transplant, 52 weeks post-transplant and 56 weeks (4 weeks after withdrawal of liraglutide or liraglutide placebo)

CGM time-below-range

change from baseline, improvement

Secondary/protocol endpoint

Proportion of Subjects With HbA1c Below Or Equal to 6.5% At Week 52 That Are Free From Severe Hypoglycaemic Events

Time frame:From week 0 to week 52 after initial transplantation

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Proportion of Insulin-Independent Subjects

Time frame:At 52 weeks after initial transplantation

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Glucose Level Variability And Hypoglycaemia Duration Derived From The Continuous Glucose Monitoring System (CGMS)

Time frame:At 12 weeks pre-transplant, at 24 weeks post-transplant, 52 weeks post-transplant and 56 weeks (4 weeks after withdrawal of liraglutide or liraglutide placebo)

CGM time-below-range

change from baseline, improvement

componentsCGM time-below-range, CGM time-above-range

Safety / tolerability / PK

2 endpoints
Secondary/registry result

Number of Hypoglycaemic Episodes

Time frame:During week 0 to week 52

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of Hypoglycaemic Episodes

Time frame:During week 0 to week 52

Documented hypoglycemia

event count, event

Other (unclassified)

2 endpoints
Secondary/registry result/low confidence

Change in Islet Cell Yield During Culture

Time frame:From 0 hours pre-culture to 24 hours to 72 hours

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in Islet Cell Yield During Culture

Time frame:From 0 hours pre-culture to 24 hours to 72 hours

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.