DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT02713477

CompletedPhase 1

Postprandial Glucodynamic Response to Insulin Glargine/Lixisenatide Fixed Ratio Combination in Japanese Patients With Type 2 Diabetes Mellitus

A Randomized, Open Label, Placebo-controlled, 4-sequence, 4-period, 4-treatment Crossover Study to Investigate the Postprandial Glucodynamic Response to Single Dose of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Japanese Patients With Type 2 Diabetes Mellitus

Lead sponsor

Sanofi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

20

actual

Study population

Type 2 diabetes

Key I/E criterion

•BMI ≤35

Primary endpoint

•Measurement of plasma glucose concentrations

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 IDNCT02713477
Org study IDPDY14115
Secondary IDU1111-1176-6235UTN

Timeline

Milestones

Study first posted2016-03-18estimated
Last update posted2020-06-16actual
Study start2016-04 (month precision)
Primary completion2016-06actual (month precision)
Study completion2016-06actual (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

•Japanese male or female patients with T2DM diagnosed for at least 1 year prior to the time of screening as established in the medical history.
•Patients aged 20 to 75 years at screening.
•Body mass index ≤35 kg/m^2 at screening.
•Glycohemoglobin ≥7.0% and ≤10.0% at screening.
•Fasting C-peptide ≥0.6 ng/mL at screening.

Exclusion criteria

•Diabetes other than T2DM.
•History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening.
•History of hypoglycemia unawareness.
•Hemoglobinopathy or hemolytic anemia.
•History of myocardial infarction, stroke, or heart failure, history or presence of clinically significant diabetic retinopathy, history or presence of macular edema likely to require laser treatment within the study period.
•History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease.
•Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including, but not limited to gastroparesis and gastroesophageal reflux disease requiring medical treatment.
•Personal or family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (e.g., multiple endocrine neoplasia syndromes).
•If female, pregnancy or breast-feeding.

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

Endpoints (9)

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
5
Glycemic / diabetes
3
Other (unclassified)
1

Glycemic / diabetes

3 endpoints
Primary/protocol endpoint/low confidence

Measurement of plasma glucose concentrations

Time frame:1 day (D1) in each treatment period

descriptive

Secondary/protocol endpoint

Measurement of serum insulin concentrations

Time frame:1 day (D1) in each treatment period

concentration, descriptive

Secondary/protocol endpoint

Measurement of serum C-peptide concentrations

Time frame:1 day (D1) in each treatment period

concentration, descriptive

Safety / tolerability / PK

5 endpoints
Secondary/protocol endpoint

Measurement of plasma lixisenatide concentrations

Time frame:1 day (D1) in each treatment period

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Number of patients with hypoglycemic events

Time frame:Up to 2 weeks after each treatment

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of patients with adverse events

Time frame:Up to 2 weeks after each treatment

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Measurement of anti-lixisenatide antibodies

Time frame:2 days (prior to first dosing and end of study visit)

Immunogenicity (ADA)

descriptive

Secondary/protocol endpoint

Measurement of anti-insulin antibodies

Time frame:2 days (prior to first dosing and end of study visit)

descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Measurement of plasma glucagon concentrations

Time frame:1 day (D1) in each treatment period

concentration, descriptive

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.