Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Insulin glargine (HOE901), insulin glargine (HOE901), Lantus® (insulin glargine), Lantus, Lantus (insulin glargine), Insulin glargine (U300), INSULIN GLARGINE (U300), Lantus (insulin glargine [rDNA origin] injection)
Insulin glargine · 38 trials · 9 indications
Blood samples were collected at indicated timepoints for analysis of HbA1c. Baseline was defined as the last available pre-dose assessment (on or before Day 1).
Absolute mean change in HbA1c from baseline to Week 26; HbA1c is expressed in % (unit)
Change in glycated hemoglobin (HbA1c) from baseline to Week 30
Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Adjusted least squares (LS) mean and standard error (SE) were obtained from Mixed-effect model with repeated measures (MMRM) to account for missing data using all available post baseline data during the 26 week treatment period.
Change in HbA1c was calculated by subtracting baseline value from Week 52 value.
Change in HbA1c was calculated by subtracting baseline value from Month 6 value. Adjusted least-square (LS) means and standard errors (SE) were obtained using analysis of covariance (ANCOVA) after multiple imputations of missing data using post-baseline HbA1c data available on the main 6-month randomized period.
Adjusted least square (LS) means were obtained from analysis of covariance (ANCOVA) after multiple imputation of missing data including post baseline HbA1c data during the 26-week randomized period.
Primary outcome was to test superiority of FRC versus Lixisenatide and non-inferiority versus Insulin glargine. Change in HbA1c was calculated by subtracting baseline value from Week 30 value.
Change in HbA1c was calculated by subtracting baseline value from Week 30 value.
Only measurements performed before initiation of rescue therapy were considered in the analysis.
The rate of "all hypoglycemia" was calculated from "all hypoglycemia" episodes which occurred during the 24-week on-treatment period and consisted of: - symptomatic hypoglycemia episodes validated by the study investigator based on entries in patients' diaries, - low continuous glucose monitoring system (CGMS) excursions (interstitial glucose \<70 mg/dL \[3.9 mmol/L\]) confirmed by fingerstick blood glucose (FSBG) \<70 mg/dL, - low FSBG readings (values \<70 mg/dL) performed at other times.
Number of participants with a first occurrence of one of the above events. The outcome's evaluation is based on the number of such positively-adjudicated first events occurring for patients assigned to the study groups. Assessments of the above events were reviewed by the Event Adjudication Committee who was kept blinded to the group assignment of participants. Statistical analysis is performed on the time from randomization to the first occurrence of the events. Number of participants with a composite endpoint (i.e. with first occurrence of CV death, nonfatal MI or nonfatal stroke) is provided in the first row of the statistical table.
Number of participants with a first occurrence of one of the above events (revascularization procedures included coronary artery bypass graft, percutaneous transluminal coronary angioplasty (PTCA) i.e. balloon, PTCA with stent, other percutaneous intervention, carotid angioplasty with/without stent, carotid endarterectomy, peripheral angioplasty with or without stent, peripheral vascular surgery, and limb amputation due to vascular disease). The outcome's evaluation is based on the number of such positively-adjudicated first events occurring for patients assigned to the study groups. Assessments of the above events were reviewed by the Event Adjudication Committee who was kept blinded to the group assignment of participants. Statistical analysis is performed on the time from randomization to the first occurrence of the events. Number of participants with a composite endpoint (i.e. with first occurrence of the events) is provided in the first row of the statistical table.
Change in HbA1c was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using last observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug till before the introduction of rescue medication and up to 14 days after the last injection of investigational medicinal product (IMP).
| Arm | Type | Description |
|---|---|---|
| iGlarLixi | EXPERIMENTAL | Participants self-administered iGlarLixi (100 units per milliliter \[U/mL\] insulin glargine + 100 or 50 microgram \[mcg\]/mL lixisenatide respectively) subcutaneous (SC) injection once daily on top of metformin +/- sodium-glucose co-transporter 2 inhibitor (SGLT-2i) for 24 weeks. Dose was individually adjusted. |
| IDegAsp | ACTIVE_COMPARATOR | Participants self-administered IDegAsp (100 U/mL of insulin degludec + insulin aspart with a ratio of 70:30) SC injection once daily on top of metformin +/- SGLT-2i for 24 weeks. Dose was individually adjusted. |
| iGlarlixi DAILY | EXPERIMENTAL | Titration Group 1: Addition of 1 unit per day until pre-stated fasting self-monitoring plasma glucose (SMBG) level is reached |
| iGlarlixi WEEKLY | ACTIVE_COMPARATOR | Titration Group 2: Algorithm of weekly adjustment until pre-stated fasting self-monitoring plasma glucose (SMBG) level is reached |
| Soliqua (insulin glargine/lixisenatide) | EXPERIMENTAL | iGlarLixi (insulin glargine/lixisenatide) will be self-administered subcutaneously once daily in the morning with or without metformin for 30 weeks |
| Lantus (insulin glargine) | ACTIVE_COMPARATOR | Insulin glargine will be self-administered subcutaneously once daily at any time of the day with or without metformin for 30 weeks |
| Lyxumia (lixisenatide) | ACTIVE_COMPARATOR | Lixisenatide will be self-administered subcutaneously once daily according to the locally approved label on top of metformin for 24 weeks. Injection time should be determined on the day of randomization, and should remain about the same until the end of the treatment period. |
| Tested Drug | EXPERIMENTAL | Insulin glargine/lixisenatide fixed ratio combination (FRC) |
| Control Drug | ACTIVE_COMPARATOR | Insulin glargine (Lantus®) |
| Toujeo - insulin glargine (U300) | EXPERIMENTAL | Toujeo - Insulin glargine (U300) will be administered subcutaneously once in the evening on top of the non-insulin antihyperglycemic drugs for 29 weeks |
| Lantus - insulin glargine | ACTIVE_COMPARATOR | Lantus - Insulin glargine will be administered subcutaneously once in the evening on top of the non-insulin antihyperglycemic drugs for 29 weeks |
| Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) | EXPERIMENTAL | Core period: FRC injected subcutaneously once daily (QD) for 26 weeks on top of oral anti-diabetic drug (OAD) therapy. Dose individually adjusted. Single arm extension period: Participants who completed core treatment period and met eligibility criteria entered in extension treatment period and received same treatment (FRC injected subcutaneously QD on top of OAD therapy) for 26 weeks (up to Week 52). Dose individually adjusted. |
| GLP-1 Receptor Agonist | ACTIVE_COMPARATOR | Core period: GLP-1 RA receptor agonist (liraglutide QD, exenatide twice daily \[BID\], exenatide extended-release QW, albiglutide QW, or dulaglutide QW) injected subcutaneously for 26 weeks on top of OAD therapy. GLP-1 RAs were administered as per local labeling at the same dose schedule as prior to randomization. |
| LixiLan | EXPERIMENTAL | LixiLan (insulin glargine/lixisenatide) is injected subcutaneously (under the skin) once daily. Dose is individually adjusted. Background therapy with OADs (except dipeptidyl-peptidase-4 inhibitor) should be continued during the treatment period. |
| insulin glargine | ACTIVE_COMPARATOR | Insulin glargine (HOE901) is injected subcutaneously (under the skin) once daily. Dose is individually adjusted. Background therapy with OADs (except dipeptidyl-peptidase-4 inhibitor) should be continued during the treatment period. |
| lixisenatide | ACTIVE_COMPARATOR | Lixisenatide (AVE0010) is injected subcutaneously (under the skin) once daily. It will be initiated with Dose 1 for 1 week and then continue with Dose 2 for 1 week followed by the maintenance dose of Dose 3 up to the end of treatment period. Background therapy with OADs (except dipeptidyl-peptidase-4 inhibitor) should be continued during the treatment period. |
| HOE901-U300 | EXPERIMENTAL | HOE901-U300 (Insulin glargine 300 Units/milliliter \[U/mL\]) Subcutaneous(SC) injection once daily for 12 months. |
| Lantus | ACTIVE_COMPARATOR | Lantus (Insulin glargine 100 U/mL) SC injection once daily for 12 months. |
| MyStar DoseCoach | EXPERIMENTAL | MyStar DoseCoach - Device-supported treat-to-target regimen. Insulin glargine is administered subcutaneously on top of potential background therapy using oral anti-diabetic drug(s) or GLP1 RA injectable antihyperglycemic drug(s). |
| Routine Titration | ACTIVE_COMPARATOR | Routine Titration - Routine titration defined by the Investigator. Insulin glargine is administered subcutaneously on top of potential background therapy using oral anti-diabetic drug(s) or GLP1 RA injectable antihyperglycemic drug(s). |
| Cohort 1 (INSIGHT titration algorithm) | EXPERIMENTAL | INSULIN GLARGINE (U300): self-titration of insulin glargine 300 units/mL (U300) will be increased daily by 1 unit until fasting SMPG reaches the target range of 4.4 to 5.6 mmol/L |
| Cohort 2 (EDITION titration algorithm) | EXPERIMENTAL | INSULIN GLARGINE (U300): titration of insulin glargine 300 units/mL (U300) will be adjusted weekly or not more than every 3 days to achieve the target range of fasting SMPG of 4.4 to 5.6 mmol/L |
| New formulation of insulin glargine | EXPERIMENTAL | once daily in the evening on-top of mealtime insulin |
| NPH insulin | ACTIVE_COMPARATOR | injection once daily at bedtime or twice daily in the morning and at bedtime |
| Combination insulin glargine and sitagliptin | EXPERIMENTAL | Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 \< Fasting Plasma Glucose (FPG) ≤ 100 mg/dL (3.9 \<FPG ≤ 5.5 mmol/L). Sitagliptin: stable dose of 100 mg once a day administered with or without food. |
| 1 | EXPERIMENTAL | Sequence 1 (Lantus + Apidra first, then Premix): Subjects randomized to this sequence will receive ApidraTM administered three times per day 0-15 minutes before main meals using a fixed bolus regimen following titration based on preprandial blood glucose values; as well as Lantus qd for 12 weeks. After the first 12 weeks, subjects will cross over to the premix insulin for a further treatment of 12 weeks. |
| 2 | EXPERIMENTAL | Sequence 2 (Premix first, then Lantus + Apidra): Subjects randomized to this sequence will receive premix insulin (either Humalog Mix 75/25 or Novolog Mix 70/30, depending on which insulin they were taking at entry into the study) once or twice per day for 12 weeks. After the first 12 weeks, subjects will cross over to the Lantus plus Apidra sequence for a further treatment of 12 weeks. |
| 3 | EXPERIMENTAL | Insulin Glargine + 1 to 3 bolus of Insulin Glulisine + Metformin + Insulin secretagogue |
| Insulin glargine + omega-3 polyunsaturated fatty acids | EXPERIMENTAL | * Insulin glargine once daily by subcutaneous injection in a titrated regimen targeting a fasting plasma glucose (FPG) level of ≤95 mg/dL (5.3 mmol/L) * One capsule of omega-3 polyunsaturated fatty acids once daily |
| Insulin glargine + placebo | EXPERIMENTAL | * Insulin glargine once daily by subcutaneous injection in a titrated regimen targeting a fasting plasma glucose (FPG) level of ≤95 mg/dL (5.3 mmol/L) * One capsule of placebo once daily |
| Standard care + omega-3 polyunsaturated fatty acids | EXPERIMENTAL | • One capsule of omega-3 polyunsaturated fatty acids once daily |
| Standard care + placebo | PLACEBO_COMPARATOR | • One capsule of placebo once daily |
| Lispro mix | ACTIVE_COMPARATOR | Humalog Mix 75/25 (lispro mix) administered subcutaneously 15 minutes before the evening meal for 24 weeks. The initial dosage was 10 units /day for 7 days. This was followed by titration every 7 days by increasing the dosage until control was established. Insulin dosages were increased according to a subject's glucose values determined by self-monitoring blood glucose (SMBG). The starting dosage of metformin or sulfonylurea was the dosage the subject was taking when randomized. The dosage was to remain unchanged during the course of the study. The administration schedule was left to the discretion of the investigator. |
| Insulin glargine/ lixisenatide dose 1 Test 1 | EXPERIMENTAL | Test 1 will be administered thru subcutaneous (SC) injection into one peri-umbilical site of the abdomen 1 hour prior to breakfast under fasted condition |
| Insulin glargine/ lixisenatide dose 2 Test 2 | EXPERIMENTAL | Test 2 will be administered thru SC injection into one peri-umbilical site of the abdomen 1 hour prior to breakfast under fasted condition |
| Placebo - Reference 1 | PLACEBO_COMPARATOR | Reference 1 will be administered thru SC injection into one peri-umbilical site of the abdomen 1 hour prior to breakfast under fasted condition |
| Insulin glargine (Lantus) - Reference 2 | OTHER | Reference 2 will be administered thru SC injection into one peri-umbilical site of the abdomen 1 hour pior to breakfast under fasted condition |
| Sequence 1 | EXPERIMENTAL | Reference (insulin glargine) -Test1 (insulin glargine - new formulation), both dose will be adjusted individually to achieve the target glycemic goal |
| Sequence 2 | EXPERIMENTAL | Test1 - Reference , both dose will be adjusted individually to achieve the target glycemic goal |
| Insulin glargine / New insulin glargine formulation | EXPERIMENTAL | * Period 1: Insulin glargine * Period 2: New insulin glargine formulation * Period 3: New insulin glargine formulation * Period 4: New insulin glargine formulation Duration of treatment: 1 day at each period |
| Name | Type | Description |
|---|---|---|
| Insulin glargine/Lixisenatide | DRUG | solution, by subcutaneous injection |
| IDegAsp | DRUG | solution, by subcutaneous injection |
| Metformin | DRUG | Tablet, orally |
| SGLT2 inhibitor | DRUG | Tablet, orally |
| INSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010 | DRUG | Pharmaceutical form: Solution for injection Route of administration: Subcutaneous |
| Insulin glargine/Lixisenatide (HOE901/AVE0010) | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
| Insulin glargine (HOE901) | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
| Lixisenatide (AVE0010) | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
| Insulin Glulisine (HMR1964) | DRUG | Pharmaceutical form: Injection Route of administration: Subcutaneous |
| Insulin glargine (U300) | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
| Insulin glargine | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
| Non-insulin antihyperglycemic drugs | DRUG | Pharmaceutical form: capsule/tablet Route of administration: oral |
| Insulin glargine/lixisenatide fixed ratio combination | DRUG | Pharmaceutical form: solution for injection Route of administration: subcutaneous |
| liraglutide | DRUG | Pharmaceutical form: solution for injection Route of administration: subcutaneous |
| exenatide | DRUG | Pharmaceutical form: solution for injection Route of administration: subcutaneous |
| exenatide extended-release | DRUG | Pharmaceutical form: solution for injection Route of administration: subcutaneous |
| albiglutide | DRUG | Pharmaceutical form: solution for injection Route of administration: subcutaneous |
| dulaglutide | DRUG | Pharmaceutical form: solution for injection Route of administration: subcutaneous |
| Background therapy: Oral Anti-diabetic Drug (Metformin, Pioglitazone, SGLT2 inhibitor) | DRUG | Pharmaceutical form: tablet Route of administration: oral If previously taken, doses to remain stable through the study. |
| Oral anti-diabetic drugs | DRUG | Pharmaceutical form: tablet Route of administration: oral |
| Insulin glargine U100 (HOE901) | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
| Insulin glargine,300 U/mL | DRUG | Subcutaneous injection in the morning or evening using a prefilled pen. Dose titration to achieve fasting self-monitored plasma glucose (SMPG) from 90 to 130 milligram/deciliter (mg/dL) (5.0 to 7.2 millimol per liter \[mmol/L\]) |
| Insulin glargine (100 units /mL) | DRUG | Subcutaneous injection in the morning or evening using a prefilled pen. Dose titration to achieve fasting SMPG from 90 to 130 mg/dL (5.0 to 7.2 mmol/L) |
| Background therapy | DRUG | Fast-acting mealtime insulin analogs |
| MyStar DoseCoach | DEVICE | Glucose meter |
| Insulin Glargine (HOE901 - U300) | DRUG | Self-administered by subcutaneous (SC) injection in the evening using a pre-filled pen. Dose titration to achieve fasting self-monitored plasma glucose (SMPG) from 90 to 130 mg/dL (5.0 to 7.2 mmol/L). |
| Insulin Glargine (HOE901 - U100) | DRUG | Self-administered by SC injection in the evening using a pre-filled pen. Dose titration to achieve fasting SMPG from 90 to 130 mg/dL (5.0 to 7.2 mmol/L). |
| Metformin (Background Drug) | DRUG | Pharmaceutical form: Tablet; Route of administration: Oral administration |
| Insulin glargine new formulation (HOE901) | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
| Insulin glargine (HOE901) (Lantus) | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
| Lantus (Insulin glargine) | DRUG | Lantus (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) | DRUG | HOE901-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. |
| NPH insulin | DRUG | Pharmaceutical form:aqueous solution for injection Route of administration: Subcutaneous |
| Neutral Protamine Hagedorn (NPH) insulin | DRUG | NPH insulin 100 U/mL commercial (Huminsulin Basal) solution for injection available as both disposable pen devices (Huminsulin Basal Pen) each containing 300 U and as 10 mL vials each containing 1000 U Dose: titrated to achieve glycemic targets as described above for insulin glargine |
| Insulin lispro | DRUG | Insulin lispro used as the principal bolus insulin; regular human insulin permitted. Administration: multiple injection before meals and/or at bedtime at the discretion of the Investigator. |
| Sitagliptin | DRUG | Oral administration. 100mg film-coated tablets. |
| insulin glulisine | DRUG | Sequence 2 (Premix first, then Lantus + Apidra): Subjects randomized to this sequence will receive premix insulin (either Humalog Mix 75/25 or Novolog Mix 70/30, depending on which insulin they were taking at entry into the study) once or twice per day for 12 weeks. After the first 12 weeks, subjects will cross over to the Lantus plus Apidra sequence for a further treatment of 12 weeks. |
| insulin secretagogue | DRUG | sulfonylurea or glinide |
| omega-3 polyunsaturated fatty acids (PUFA) | DRUG | Gelatin capsules (containing icosapent ethyl esters 465 mg and doconexent ethyl esters 375 mg) for oral administration |
| placebo | DRUG | Matching placebo gelatin capsules (containing olive oil) for oral administration |
| reusable pen device for insulin injection | DEVICE | - |
| Lantus (insulin glargine [rDNA origin] injection) | DRUG | - |
| Humulin N | DRUG | - |
| Humulin L | DRUG | - |
| Lispro | DRUG | - |
| Glimepiride | DRUG | Glimepiride 3 or 4 mg |
| Insulin monotherapy with premixed insulin NPH 30/70 | DRUG | Given before breakfast and before dinner, target of pre-prandial BG ≤ 100 mg/dl |
| Glyburide | DRUG | - |
| Thiazolidinedione | DRUG | - |
| 75% insulin lispro protamine suspension and 25 % insulin lispro injection | DRUG | suspension for subcutaneous injection |
| NPH human insulin | DRUG | - |
| Insulin glargine /lixisenatide Fixed Ratio Combination | DRUG | FRC was self-administered by subcutaneous (SC) injection within 1 hour before breakfast using pen-type injector (Tactipen®): 100 U/ml insulin glargine and 50 mcg Lixisenatide (ratio of 2 U/1 mcg). The initial dose was 10 U/5 mcg and then dose was adjusted weekly to reach and maintain fasting self-monitored plasma glucose (SMPG) of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L. |
| Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010 | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
| Insulin glargine HOE901 | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
| insulin glargine- new formulation (HOE901) | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
| Lantus® (insulin glargine) | DRUG | - |
Inclusion Criteria: * Participant had at least 18 of age inclusive, at the time of signing the informed consent. * Participants who were diagnosed with T2DM for at least 1 year before the screening visit * Participants who were treated for at least 3 months prior to the screening visit with a stabl...
Lantus is used for diabetes mellitus, type 2 diabetes mellitus, and hyperglycemia. It is a small molecule metabolic therapy developed by Sanofi. Lantus is an insulin glargine product that helps control blood sugar levels in patients with these conditions.
Lantus works as a long-acting insulin analog that provides basal glycemic control. It binds to insulin receptors, promoting glucose uptake in peripheral tissues and inhibiting hepatic glucose production. This helps maintain stable blood sugar levels over a 24-hour period.
Lantus is developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is responsible for the research, development, and commercialization of Lantus for metabolic indications.
Lantus is in Phase 3 clinical development. It has completed two Phase 3 trials and one Phase 1 trial. Lantus is an investigational drug and is not yet approved by regulatory authorities. It remains in clinical development for diabetes mellitus and related conditions.
Lantus has completed several clinical trials. NCT00046462 compared glycemic control between Lantus and a third oral agent. NCT00046501 compared blood sugar levels between morning Lantus and other insulins in adolescents. NCT00348972 studied Lantus in prediabetes. NCT01499095 compared a new insulin glargine formulation with Lantus in type 2 diabetes.
Lantus is a brand name for insulin glargine, a long-acting insulin analog. It is used to manage blood sugar in diabetes. Lantus is developed by Sanofi and is being studied in clinical trials for various metabolic conditions.