GLP-1 Peptide Atlas, by Delfa

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CompletedPhase 4

Effect of Lixisenatide on Postprandial Plasma Glucose Compared to Sitagliptin in Combination With Insulin Glargine

A Randomized, Multicenter, Open-Label, Parallel-Group, 28 Days Phase IV Study Comparing The Postprandial Plasma Glucose Profile of Lixisenatide With That of Sitagliptin Add-On to Insulin Glargine in Type 2 Diabetes Mellitus

Lead sponsor

Sanofi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

136

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7-10%

Primary endpoint

•Postprandial glucose

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 IDNCT02200991

Org study IDLIXISL06651

Secondary IDU1111-1159-5323UTN

Timeline

Milestones

Study first posted2014-07-25estimated

Last update posted2016-10-05estimated

Study start2014-08 (month precision)

Primary completion2015-11actual (month precision)

Study completion2015-11actual (month precision)

Assets

Investigational agents

Lixisenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Type 2 diabetes mellitus, treated with Lantus±SU; ≥5-year after diagnosis

•Aged 20-75 years

•Hemoglobin A1C ≥7.0%-≤10.0%

•Fasting plasma glucose ≤180 mg/dL at screening

•Stable treatment (±20%) with Lantus for 3 months or more prior to screening.

•Sulfonylurea dose stable for 3 months or more prior to screening

Exclusion criteria

•Type 1 diabetes mellitus

•Pregnancy or lactation

•Hypersensitivity to Lixisenatide

•Severely uncontrolled glycemic situation

•History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery or inflammatory bowel disease

•History of metabolic acidosis, including diabetic ketoacidosis, within 1 year prior to screening

•History within the previous 6 months of myocardial infarction, stroke or heart failure requiring hospitalization or drug or alcohol abuse

•Uncontrolled/inadequately controlled hypertension at the time of screening, with a resting systolic blood pressure >180 mmHg or diastolic blood pressure >95 mmHg

•Amylase and/or lipase >3 times or aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase (ALP) >2 times the upper limit of the normal laboratory range

•End-stage renal disease and/or dialysis and clinically relevant history of gastrointestinal disease

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Endpoints (6)

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

Safety / tolerability / PK

Other clinical outcomes

Other (unclassified)

Glycemic / diabetes

3 endpoints

Primary/protocol endpoint

Change from baseline in postprandial plasma glucose at Day 29 after a standardized breakfast

Time frame:Day 29 after first intake of investigational product

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in maximum postprandial plasma glucose excursion at Day 29 after a standardized breakfast

Time frame:Day 29 after first intake of investigational product

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in plasma C-peptide levels at Day 29 after a standardized breakfast

Time frame:Day 29 after first intake of investigational product

C-peptide AUC

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Proportion of patients with adverse events

Time frame:Up to Day 33 from the first intake of investigational medicinal product

Treatment-emergent AEs (any)

threshold achievement, event

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Change in gastric emptying half life (13C-acetic acid breath test)

Time frame:Day 29 after first intake of investigational product

change from baseline, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Change from baseline in glucagon levels at Day 29 after a standardized breakfast

Time frame:Day 29 after first intake of investigational product

change from baseline, improvement

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

Reduction of postprandial glucose by lixisenatide vs sitagliptin treatment in Japanese patients with type 2 diabetes on background insulin glargine: A randomized phase IV study (NEXTAGE Study).
Diabetes, obesity & metabolism2017 Sep (month)PMID28345162doi:10.1111/dom.12945via clinicaltrials gov reference derived + pubmed nct search

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.