DelfaGLP-1 Atlas

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Lead-In

Completed

A Post Marketing Surveillance (PMS) Study of Liraglutide in Subjects With Type 2 Diabetes Mellitus in India

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

1,386

actual

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•Number of serious adverse drug reactions (SADRs) during the study period

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 IDNCT01212133
Org study IDNN2211-3865
Secondary IDU1111-1114-9324WHO

Timeline

Milestones

Study first posted2010-09-30estimated
Last update posted2016-12-16estimated
Study start2010-11 (month precision)
Primary completion2012-04actual (month precision)
Study completion2012-04actual (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

SexAll
Healthy volunteersNot accepted
Sampling methodNon probability sample

Study population text

Subjects with type 2 diabetes, including newly-diagnosed subjects, who are considered to need treatment with liraglutide are eligible for the study

Inclusion criteria

•Subjects with type 2 diabetes, including newly-diagnosed patients / those already receiving other anti-diabetic medications including GLP-1 analogues, who require treatment with liraglutide according to the clinical judgment of their treating physician
•Subjects who are capable of giving study-specific signed informed consent before any collection of information

Exclusion criteria

•Subjects with type 1 diabetes
•Subjects who are or have previously been on liraglutide
•Subjects who have previously been enrolled in the study
•Subjects who are participating in another clinical trial
•Subjects with a hypersensitivity to liraglutide or to any of the excipients (Disodium phosphate dihydrate, propylene glycol, phenol, water for injections)
•Subjects who are pregnant, breast feeding or have the intention of becoming pregnant within the following 6 months

Endpoints (4)

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.

Safety / tolerability / PK

4 endpoints
Primary/protocol endpoint

The number of serious adverse drug reactions (SADRs) during the study period

Time frame:during 26 weeks of treatment

event count, event

Secondary/protocol endpoint

The number of adverse drug reactions (ADR) during the study period

Time frame:during 26 weeks of treatment

event count, event

Secondary/protocol endpoint

The number of serious adverse events (SAE) during the study period

Time frame:during 26 weeks of treatment

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Frequency of hypoglycaemic episodes

Time frame:during 26 weeks of treatment

Documented hypoglycemia

event count, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.