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Lantus

Phase 3

Diabetes Mellitus | Small molecule | Metabolic |Sanofi|Last Updated: Mar 23, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials2
Total Enrollment490

FDA Designations

No designations recorded

Clinical trial landscape

Lantus · 4 trials · 3 indications

Phase 3 3Phase 1 1
NCT01499095Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Basal Insulin With Oral Antidiabetic TherapyType 2 Diabetes Mellitus
COMPLETED811 Analytics
NCT00046501Compare Blood Sugar Level Between Lantus in the Morning and Other Insulins in Type 1 Diabetes AdolescentsDiabetes Mellitus
COMPLETED250 Analytics
NCT00046462Determine Whether Glycemic Control is Different Between Lantus & a 3rd Oral Agent When Failure With Other TreatmentDiabetes Mellitus
COMPLETED240 Analytics
PHASE3COMPLETED
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes on Basal Insulin With Oral Antidiabetic Therapy
Type 2 Diabetes Mellitus
NCT01499095811
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PHASE3COMPLETED
Compare Blood Sugar Level Between Lantus in the Morning and Other Insulins in Type 1 Diabetes Adolescents
Diabetes Mellitus
NCT00046501250
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PHASE3COMPLETED
Determine Whether Glycemic Control is Different Between Lantus & a 3rd Oral Agent When Failure With Other Treatment
Diabetes Mellitus
NCT00046462240
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Study Endpoints

Primary Endpoints

Change in HbA1c From Baseline to Month 6 Endpoint
Baseline, Month 6

Only measurements performed before initiation of rescue therapy were considered in the analysis.

to measure change in glycemic control as measured by hemoglobin A1c (A1c).
from baseline to endpoint (last available post-treatment assessment)
To determine the difference in glycemic control as measured by HbA1C between substituting the TZD with insulin glargine and adding a third oral agent in patients who fail a TZD/sulfonylurea or TZD/metformin combination therapy
During the Study Conduct
Efficacy: 8-point blood glucose measurements.
Safety / tolerability: hypoglycemia

Secondary Endpoints

Percentage of Participants With At Least One Severe and/or Confirmed Nocturnal Hypoglycemia From Start of Week 9 to Month 6 Endpoint
Week 9 Up to Month 6
Change in Average Preinjection Self-Monitored Plasma Glucose (SMPG) From Baseline to Month 6 Endpoint
Baseline, Month 6
Change in Variability of Preinjection SMPG From Baseline to Month 6 Endpoint
Baseline, Month 6
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
HOE901-U300EXPERIMENTAL -
LantusACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Lantus (Insulin glargine)DRUGLantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months in combination with oral antidiabetic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).
HOE901-U300 (new formulation of insulin glargine)DRUGHOE901-U300 (new insulin glargine 300 units per milliliter \[U/mL\]) subcutaneous (SC) injection once daily (evening) for 12 months in combination with oral antidiabetic drug(s). Dose titration seeking fasting plasma glucose 4.4 - 5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter \[mg/dL\]). After 6 months participants were proposed to participate to the administration substudy and to receive either HOE901-U300 once daily at intervals of 24 +/- 3 hours (adaptable dosing intervals) or to continue once daily injections of HOE901-U300 every 24 hours (fixed dosing intervals) up to Month 9.
Lantus (insulin glargine [rDNA origin] injection)DRUG -
Humulin NDRUG -
Humulin LDRUG -
LisproDRUG -
MetforminDRUG -
GlyburideDRUG -
ThiazolidinedioneDRUG -
Lantus® (insulin glargine)DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites213

Inclusion criteria : * Participants with type 2 diabetes mellitus * Substudy inclusion criteria: * Completion of the 6-month study period in main study (Visit 10) * Randomized and treated with insulin glargine new formulation during the 6- month treatment period (Baseline - Month 6) Exclusion...

Countries:United StatesCanadaChileFinlandFranceGermanyHungaryMexicoPortugalRomaniaRussiaSouth AfricaSpain
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Frequently asked questions about Lantus

What is Lantus used for?

Lantus is used for hyperglycemia, type 2 diabetes mellitus, and diabetes mellitus. It is a small molecule developed by Sanofi for the metabolic therapeutic area. Lantus is an investigational drug currently in Phase 3 clinical development for these indications.

Who makes Lantus?

Lantus is developed by Sanofi, a company traded under the ticker SNY. Sanofi is conducting clinical trials to evaluate Lantus for the treatment of diabetes mellitus and hyperglycemia.

What phase is Lantus in?

Lantus is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Sanofi is evaluating Lantus for the treatment of type 2 diabetes mellitus and other diabetes-related conditions.

What clinical trials is Lantus in?

Lantus has completed several clinical trials, including NCT00046462, NCT00046501, NCT00348972, and NCT01499095. These trials studied Lantus for diabetes mellitus, hyperglycemia, and type 2 diabetes mellitus, with total enrollment of 811 participants across the studies.

Is Lantus the same as insulin glargine?

Lantus is a form of insulin glargine. A clinical trial compared a new formulation of insulin glargine with Lantus in patients with type 2 diabetes on basal insulin with oral antidiabetic therapy, indicating that Lantus is an insulin glargine product.