17 completed, 2 terminated. 13 Phase 3, 4 Phase 4, 2 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 13 | Completed 12, Terminated 1 |
| Phase 4 | 4 | Completed 3, Terminated 1 |
| Phase 1 | 2 | Completed 2 |
Follow Insulin glargine (HOE901): new trials by email Literature Review of Insulin glargine (HOE901) trials Research Report on Insulin glargine (HOE901)
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Comparison of the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine in Patients With Type 2 Diabetes Insufficiently Controlled on Basal Insulin Insulin glargine/Lixisenatide (HOE901/AVE0010), Insulin glargine (HOE901), Metformin - Type 2 Diabetes Mellitus | Phase 3 | Completed | Sanofi | 426 | 2019-02-19 | 2022-07-19 |
| Evaluation of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Patients With Type 2 Diabetes Insufficiently Controlled With Oral Antidiabetic Drug(s) Insulin glargine/Lixisenatide (HOE901/AVE0010), Insulin glargine (HOE901), Lixisenatide (AVE0010) - Type 2 Diabetes Mellitus | Phase 3 | Completed | Sanofi | 878 | 2019-02-15 | 2022-07-19 |
| Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes (LixiLan-India) INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010), INSULIN GLARGINE (HOE901), Metformin - Type 2 Diabetes Mellitus | Phase 3 | Completed | Sanofi | 247 | 2018-06-19 | 2022-04-25 |
| Efficacy and Safety of Soliqua Versus Lantus in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents Insulin glargine/Lixisenatide, Insulin glargine (HOE901), Background therapy - Type 2 Diabetes Mellitus | Phase 3 | Terminated | Sanofi | 241 | 2018-02-20 | 2022-03-28 |
| Comparison of Two Treatment Regimens in Patients With Type 2 Diabetes After Short-term Intensive Insulin Therapy INSULIN GLARGINE (HOE901), Insulin Glulisine, Biphasic insulin aspart 30 - Type 2 Diabetes Mellitus | Phase 4 | Completed | Sanofi | 384 | 2018-01-20 | 2022-04-25 |
| Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking Insulin Alone or With Other Oral Antidiabetic Agents Sotagliflozin, Insulin glargine (HOE901), Placebo - Type 2 Diabetes Mellitus | Phase 3 | Completed | Lexicon Pharmaceuticals | 571 | 2017-09-15 | 2021-05-11 |
| Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine Insulin aspart, NovoLog/NovoRapid, Insulin glargine (HOE901) - Type 1 Diabetes Mellitus-Type 2 Diabetes Mellitus | Phase 3 | Completed | Sanofi | 597 | 2017-08-02 | 2022-03-28 |
| Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (LixiLan) to Insulin Glargine Alone on Top of Oral Anti-diabetic Drugs (OADs) With Type 2 Diabetes in Japan Insulin glargine/lixisenatide (HOE901/AVE0010), Insulin glargine (HOE901), Oral anti-diabetic drugs - Type 2 Diabetes Mellitus | Phase 3 | Completed | Sanofi | 521 | 2016-05-23 | 2020-06-16 |
| Efficacy and Safety of Insulin Glargine/ Lixisenatide Fixed Ratio Combination Compared to Insulin Glargine Alone and Lixisenatide Alone on Top of Metformin in Patients With T2DM Insulin glargine/lixisenatide Fixed Ratio Combination, Insulin glargine (HOE901), Lixisenatide (AVE0010) - Type 2 Diabetes | Phase 3 | Completed | Sanofi | 1170 | 2014-02-01 | 2017-05-09 |
| Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes Insulin glargine/lixisenatide (HOE901/AVE0010), Insulin glargine (HOE901), Metformin (Background Drug) - Type 2 Diabetes | Phase 3 | Completed | Sanofi | 736 | 2014-01-01 | 2017-05-09 |
| Evaluation of the Prandial Treatment Adjustment Effect Via Continuous Glucose Monitoring on Type 2 Diabetes Mellitus (DM) Patients Uncontrolled With a Basal Insulin or Premix Once a Day INSULIN GLARGINE (HOE901), INSULIN GLULISINE (HMR1964) - Diabetes Mellitus, Type 2 | Phase 4 | Completed | Sanofi | 219 | 2012-12-01 | 2016-07-13 |
| Comparison of a New Formulation of Insulin Glargine With Lantus® Both in Combination With Oral Antihyperglycemic Drug(s) in Japanese Patients With Type 2 Diabetes Mellitus Insulin glargine new formulation (HOE901), Insulin glargine (HOE901) - Type 2 Diabetes Mellitus | Phase 3 | Completed | Sanofi | 240 | 2012-09-01 | 2014-06-05 |
| Repeated Dose Study With a New Insulin Glargine Formulation and Lantus® on 24-hour Glucose Profile in Japanese Patients With Type 1 Diabetes Mellitus insulin glargine (HOE901), insulin glargine- new formulation (HOE901) - Type 1 Diabetes Mellitus | Phase 1 | Completed | Sanofi | 20 | 2012-09-01 | 2013-08-19 |
| Efficacy and Safety of Insulin Glargine Versus. Neutral Protamine Hagedorn (NPH) Insulin in Children With Type 1 Diabetes Above 6 Years Old. Insulin glargine (HOE901), NPH insulin - Type 1 Diabetes Mellitus | Phase 3 | Completed | Sanofi | 162 | 2011-02-01 | 2014-04-01 |
| Euglycemic Clamp Dose-response Study Comparing a New Insulin Glargine Formulation With Lantus® Insulin glargine (HOE901) - Type 1 Diabetes Mellitus | Phase 1 | Completed | Sanofi | 24 | 2010-08-01 | 2011-10-31 |
| 6-month Comparison of Morning Lantus Versus Neutral Protamine Hagedorn Insulin in Young Children With Type 1 Diabetes Insulin glargine (HOE901), Neutral Protamine Hagedorn (NPH) insulin, Insulin lispro - Type 1 Diabetes Mellitus | Phase 3 | Completed | Sanofi | 125 | 2009-10-01 | 2012-06-27 |
| Effectiveness and Safety of Two Approaches to the Management of Type 2 Diabetes Mellitus in Australian Primary Care INSULIN GLARGINE (HOE901), Oral Anti Diabetics (OAD) - Diabetes Mellitus, Type 2 | Phase 4 | Terminated | Sanofi | 25 | 2009-07-01 | 2011-11-10 |
| Comparison of a Basal Plus One Insulin Regimen With a Biphasic Insulin Regimen in Type 2 Diabetes Patients INSULIN GLARGINE (HOE901), Insulin aspart, Insulin Glulisine - Diabetes Mellitus, Type 2 | Phase 4 | Completed | Sanofi | 463 | 2009-07-01 | 2013-01-08 |
| The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention) insulin glargine (HOE901), omega-3 polyunsaturated fatty acids (PUFA), placebo - Diabetes Mellitus, Non-Insulin-Dependent | Phase 3 | Completed | Sanofi | 12537 | 2003-08-01 | 2013-01-31 |
Diabetes Mellitus, Type 2 (14) · Diabetes Mellitus, Type 1 (4) · Glucose Intolerance (1)
Sanofi (18) · Lexicon Pharmaceuticals (1)
United States (7) · Hungary (6) · Australia (5) · China (5) · Germany (5) · Poland (5) · Russia (5) · Canada (4) · Chile (4) · Czechia (4) · Japan (4) · Mexico (4) · Romania (4) · Spain (4) · United Kingdom (4)
Christine van Schalkwyk, MD (1) · Hertzel Gerstein, M.D. (1) · Salim Yusuf, M.D. (1) · Suman Wason, MD (1)
PMID 29923298, PMID 29974618, PMID 30550345, PMID 31114694, PMID 35101326, PMID 36999231, PMID 22686415, PMID 22686416, PMID 23564916, PMID 23656980, PMID 23999452, PMID 24574355, PMID 24684774, PMID 24768457, PMID 24771090, PMID 24898834, PMID 25041275, PMID 26055218, PMID 26518765, PMID 26662838, PMID 26681720, PMID 27527848, PMID 27650977, PMID 27887605, PMID 27974345, PMID 28368516, PMID 28386990, PMID 28403644, PMID 28432746, PMID 28837885, PMID 28842165, PMID 28895655, PMID 29143919, PMID 30012324, PMID 30160030, PMID 30203580, PMID 30218434, PMID 30262460, PMID 30337280, PMID 30425095, PMID 31124299, PMID 31235487, PMID 31359368, PMID 31727687, PMID 31848983, PMID 31928076, PMID 32019855, PMID 32130661, PMID 32291880, PMID 33432547
2008 (1), 2009 (1), 2016 (1), 2017 (1)