DelfaGLP-1 Atlas

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LixiRam

CompletedPhase 4

Safety Assessment of Lyxumia (Lixisenatide) and Sulfonylurea as Add-on Treatment to Basal Insulin in Uncontrolled Patients With Type 2 Diabetes Mellitus Who Elect to Fast During Ramadan

International, Randomized, Open Label Study to Compare the Safety and Efficacy of Lixisenatide vs. Sulfonylurea on Top of Basal Insulin Treatment in Type 2 Diabetes Mellitus Subjects Who Elect to Fast During Ramadan

Lead sponsor

Sanofi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

16

Recruiting sites

—

Enrollment

184

actual

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•Documented hypoglycemia

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 IDNCT02941367
Org study IDLPS14410
Secondary IDU1111-1172-3026UTN

Timeline

Milestones

Study first posted2016-10-21estimated
Study start2017-02-23actual
Primary completion2017-08-04actual
Study completion2017-08-04actual
Last update posted2022-04-25actual

Assets

Investigational agents

Lixisenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Patients with type 2 diabetes mellitus, diagnosed for at least 1 year at the time of the screening visit, insufficiently controlled with basal insulin + SU (≤50% max allowed dose) ±1 oral antidiabetic (OAD) drug.
•Patients who express the intention to fast during Ramadan.
•Signed informed consent.

Exclusion criteria

•At the time of screening age < legal age of majority.
•Glycated hemoglobin (HbA1c) at screening visit: <7.5% or >10%.
•Body mass index (BMI) <20kg/m^2.
•Treatment with basal insulin for less than 6 months prior to screening.
•Prior antidiabetic medication (basal insulin and OADs) not at stable dose (eg, same medication, frequency and <20% dose change) in the last 8 weeks prior to screening.
•Previous treatment with short or rapid acting insulin other than for short term use (≤10 days) in relation to hospitalization or an acute illness in the last 6 months prior to screening.
•Any discontinuation from a glucagon like peptide-1 receptor agonist (GLP-1 RA) due to safety/tolerability issue or lack of efficacy.
•Patient not willing to perform self-monitored plasma glucose (SMPG) as required by protocol and to follow the instructions provided.
•Type 1, gestational or secondary diabetes.
•History of diabetic ketoacidosis.
•History of hypoglycemia unawareness.
•Any medical contraindication for sustained and safe fasting.
•Pregnant or breast-feeding women.
•Women of childbearing potential (WOCB) not protected by highly effective contraceptive method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy.
•Known hypersensitivity/intolerance to lixisenatide (Lyxumia) or any of its excipients.
•All contraindications of the comparator and protocol mandated background therapies or warning/precaution of use (when appropriate) as displayed in the respective National Product Labeling.

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

Endpoints (7)

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
5
Weight & body composition
1
Safety / tolerability / PK
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Mean change in body weight

Time frame:Baseline, 0-4 weeks pre- and 0-4 weeks post-Ramadan

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

5 endpoints
Secondary/protocol endpoint

Mean change in HbA1c

Time frame:Baseline, 0-4 weeks pre- and 0-4 weeks post-Ramadan

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of patients with 2-hour post prandial glucose (2hPPG) <180 mg/dL (10 mmol/L)

Time frame:Last 14 days of Ramadan month

Postprandial glucose

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of patients with HbA1C <7%

Time frame:At 0-4 weeks pre- and 0-4 weeks post-Ramadan

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of patients with fasting plasma glucose (FPG) <130 mg/dL (7.22 mmol/L)

Time frame:At pre-Ramadan visit

Fasting glucose, change

threshold achievement, improvement

LOINC 1558-6

Secondary/protocol endpoint

Percentage of patients with HbA1c <7%, no weight gain and no documented symptomatic hypoglycemia (plasma glucose ≤70 mg/dL; 3.9 mmol/L)

Time frame:At 0-4 weeks pre- and 0-4 weeks post-Ramadan

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Documented hypoglycemia, Body weight, absolute change (kg)

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Percentage of patients with at least 1 documented symptomatic hypoglycemia event (plasma glucose ≤70 mg/dL; 3.9 mmol/L)

Time frame:Approximately 30 days (from start to end of Ramadan holy month)

Documented hypoglycemia

threshold achievement, event

Publications (3)

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.