DelfaGLP-1 Atlas

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CompletedPhase 2Results posted

Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Combination Versus Insulin Glargine Alone on Top of Metformin in Type 2 Diabetic Patients

A Randomized, 24-week, Open-label, 2-arm Parallel-group, Multicenter Study Comparing the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine on Top of Metformin in Type 2 Diabetic Patients

Lead sponsor

Sanofi

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

70

Recruiting sites

—

Enrollment

323

actual

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•HbA1c, change

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 IDNCT01476475
Org study IDACT12374
Secondary ID2011-002090-36
Secondary IDU1111-1121-7111UTN

Timeline

Milestones

Study first posted2011-11-22estimated
Last update posted2017-02-10actual
Results first posted2017-02-10actual
Study start2011-11 (month precision)
Primary completion2012-12actual (month precision)
Study completion2012-12actual (month precision)

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

•Participants with type 2 diabetes mellitus diagnosed for at least 1 year.
•Metformin treatment at a stable dose of at least 1.5 g/day for at least 3 months prior to screening.

Exclusion criteria

•Age < legal age of adulthood (18 years).
•Screening HbA1c <7% or >10%.
•Screening FPG >250 mg/dL (>13.9 mmol/L).
•Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.
•Type 1 diabetes mellitus.
•Treatment with glucose-lowering agent(s) other than metformin in a period of 3 months prior to screening.
•Use of insulin within the last 6 months.
•Previous use of insulin, except for episode(s) of short-term treatment (≤15 consecutive days) due to intercurrent illness.
•Amylase and/or lipase >3 times the upper limit of the normal laboratory range (ULN) at screening.
•Calcitonin ≥20 pg/ml (5.9 pmol/l) at screening.
•Alanine Transferase (ALT) >3 ULN at screening.
•History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy.
•Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predisposes to MTC (e.g. multiple endocrine neoplasia syndromes).
•Uncontrolled or inadequately controlled hypertension at the time of screening with a resting supine systolic or diastolic blood pressure >180 mmHg or >110 mmHg, respectively.
•Within the last 6 months prior to screening: history of heart failure requiring hospitalization, myocardial infarction, or stroke. Planned coronary, carotid or peripheral artery revascularisation procedures.
•Body Mass Index (BMI) ≤20 or >40 kg/m^2.
•Any previous treatment with lixisenatide

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

Endpoints (14)

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
11
Safety / tolerability / PK
2
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in Body Weight From Baseline to Week 24

Time frame:Baseline, Week 24

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), kg95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination-0.97—
Insulin Glargine0.48—
LS Mean Difference-1.4495% CI-2.110 – -0.773p<0.0001ANCOVA

Glycemic / diabetes

11 endpoints
Primary/protocol endpoint

Change in HbA1c From Baseline to Week 24

Time frame:Baseline, Week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (least_squares_mean), percentage of hemoglobin95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination-1.82—
Insulin Glargine-1.64—
Least square (LS) mean difference-0.1795% CI-0.312 – -0.037ANCOVA
LS Mean Difference-0.1795% CI-0.312 – -0.037p0.0130ANCOVA
Secondary/protocol endpoint

Change in 2-hour Postprandial Plasma Glucose (PPG) From Baseline to Week 24

Time frame:Baseline, Week 24

Postprandial glucose

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), mmol/L95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination-7.49—
Insulin Glargine-4.33—
LS Mean Difference-3.1795% CI-3.832 – -2.504p<0.0001ANCOVA
Secondary/protocol endpoint

Change in 2-hour Plasma Glucose Excursion From Baseline to Week 24

Time frame:Baseline, Week 24

Postprandial glucose

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), mmol/L95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination-3.91—
Insulin Glargine-0.67—
LS Mean Difference-3.2495% CI-3.895 – -2.592p<0.0001ANCOVA
Secondary/protocol endpoint

Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profiles From Baseline to Week 24

Time frame:Baseline, Week 24

Postprandial glucose

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), mmol/L95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination-3.23—
Insulin Glargine-2.93—
LS Mean Difference-0.3095% CI-0.550 – -0.058p0.0154ANCOVA
Secondary/protocol endpoint/low confidence

Average Daily Insulin Glargine Dose at Week 24

Time frame:Week 24

descriptive, improvement

Posted result

GroupValue (least_squares_mean), Units (U)95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination36.08—
Insulin Glargine39.32—
LS Mean Difference-3.2495% CI-6.592 – 0.114p0.0583ANCOVA
Secondary/protocol endpoint

Change in FPG From Baseline to Week 24

Time frame:Baseline, Week 24

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (least_squares_mean), mmol/L95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination-3.35—
Insulin Glargine-3.51—
Secondary/protocol endpoint

Percentage of Participants With HbA1c ≤6.5 % or <7.0 % at Week 24

Time frame:Week 24

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), percentage of participants95% CI
Insulin Glargine/Lixisenatide Fixed Ratio CombinationHbA1c ≤6.5%71.9—
HbA1c <7.0%84.4—
Insulin GlargineHbA1c ≤6.5%64.6—
HbA1c <7.0%78.3—
Secondary/protocol endpoint

Change in 30-minute and 1-hour PPG From Baseline to Week 24

Time frame:Baseline, Week 24

Postprandial glucose

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), mmol/L95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination30-minute PPG (n=151, 153)-5.01—
1-hour PPG (n=150, 153)-5.94—
Insulin Glargine30-minute PPG (n=151, 153)-3.76—
1-hour PPG (n=150, 153)-4.10—
Secondary/protocol endpoint

Change in 30 Minute and 1-hour Plasma Glucose Excursion From Baseline to Week 24

Time frame:Baseline, Week 24

Postprandial glucose

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), mmol/L95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination30-minute plasma glucose excursion (n=151, 152)-1.47—
1-hour plasma glucose excursion (n=150, 152)-2.34—
Insulin Glargine30-minute plasma glucose excursion (n=151, 152)-0.05—
1-hour plasma glucose excursion (n=150, 152)-0.44—
Secondary/protocol endpoint

Percentage of Participants Reaching HbA1c <7% at Week 24 With no Documented Symptomatic Hypoglycemia During 24-week Treatment Period

Time frame:Baseline up to Week 24

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), percentage of participants95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination67.5—
Insulin Glargine59.0—
Secondary/protocol endpoint

Percentage of Participants Reaching HbA1c <7% With no Body Weight Gain at Week 24

Time frame:Week 24

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), percentage of participants95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination56.3—
Insulin Glargine37.3—

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Percentage of Participants Requiring Rescue Therapy During 24-week Treatment Period

Time frame:Baseline up to Week 24

threshold achievement, event

Posted result

GroupValue (number), percentage of participants95% CI
Insulin Glargine/Lixisenatide Fixed Ratio Combination0—
Insulin Glargine0.6—
Secondary/protocol endpoint

Percentage of Participants With Documented Symptomatic and Severe Symptomatic Hypoglycemia

Time frame:First dose of study drug up to 3 days after the last dose administration (maximum of 219 days)

Severe hypoglycemia

threshold achievement, event

componentsDocumented hypoglycemia, Severe hypoglycemia

Posted result

GroupValue (number), percentage of participants95% CI
Insulin Glargine/Lixisenatide Fixed Ratio CombinationDocumented symptomatic hypoglycemia21.7—
Severe Symptomatic Hypoglycemia0.0—
Insulin Glargine (Lantus® SoloSTAR®)Documented symptomatic hypoglycemia22.8—
Severe Symptomatic Hypoglycemia0.0—

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 tableClinicalTrials.gov results section

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.