GLP-1 Peptide Atlas, by Delfa

Withdrawn

Non-interventional, Post Marketing Surveillance Study of Xultophy™ (Insulin Degludec/Liraglutide) to Evaluate Long Term Safety and Efficacy in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in India

A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Post Marketing Surveillance Study of Xultophy™ (Insulin Degludec/Liraglutide) to Evaluate Long Term Safety and Efficacy in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in India

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

—

actual

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•Treatment-emergent AEs (any)

Identifiers

Registered as

NCT IDNCT03070704

Org study IDNN9068-4331

Secondary IDU1111-1185-0871WHO

Timeline

Milestones

Study first posted2017-03-03actual

Study start2017-08-16estimated

Last update posted2017-09-05actual

Primary completion2019-03-01estimated

Study completion2019-08-16estimated

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

Based on the clinical judgement of their treating physician, patients with type 2 diabetes mellitus will be initiated on Xultophy™ according to routine clinical practice

Inclusion criteria

•Informed consent obtained before any study-related activities. Study-related activities are any procedures that are related to the recording of data and determining the suitability for the study according to the protocol. Some specific historical data collected before informed consent is obtained can be used as baseline data (HbA1c, FPG/FBG and others)

•The decision to initiate treatment with commercially available Xultophy™ has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study

•Male or female, age at least 18 years at the time of signing the informed consent

•Patients diagnosed with type 2 diabetes mellitus

•Patients who are scheduled to start treatment with Xultophy™ based on the clinical judgement of their treating physician

Exclusion criteria

•Known or suspected hypersensitivity to Xultophy™, any of the active substances, any of the excipients or any related products

•Previous participation in this study. Participation is defined as signed informed consent

•Mental incapacity, unwillingness or language barriers hindering adequate understanding or cooperation

•Females who are pregnant, breast-feeding or intend to become pregnant within the following 12 months

•Patients who are participating in other studies or clinical trials.

•Any disorder which in the opinion of the Physician might jeopardise subject's safety or compliance with the protocol

Endpoints (10)

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

Safety / tolerability / PK

Glycemic / diabetes

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change in body weight

Time frame:Year 0, Year 1

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint

Change from baseline in the level of glycosylated haemoglobin (HbA1c)

Time frame:Year 0, Year 1

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in the level of Fasting Plasma/Blood Glucose (FPG/FBG) from baseline

Time frame:Year 0, Year 1

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Percentage of patients achieving the target level of HbA1c below 7%

Time frame:Year 1

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Safety / tolerability / PK

6 endpoints

Primary/protocol endpoint

Incidence of treatment emergent Adverse Events (AEs)

Time frame:Year 0-1

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Serious Adverse Events (SAEs)

Time frame:Year 0-1

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Number of Serious Adverse Drug Reactions (SADRs)

Time frame:Year 0-1

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Number of Adverse Drug Reactions (ADRs)

Time frame:Year 0-1

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of confirmed hypoglycaemic episodes

Time frame:Year 0-1

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of patients withdrawn due to ineffective therapy

Time frame:Year 1

Discontinuation due to AE

event count, event

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.