Data updated: May 26, 2026
RYZODEG 70/30 (insulin aspart)
Metabolic
Approved 2015-09-25
3
Indications
--
Phase 3 Trials
10
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2015-09-25
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
RYZODEG 70/30 Approval History
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
9 FDA actions from 2015 to 2022 · 2 indication expansions
Jun 2016 SUPPL
Label
Mar 2016 SUPPL
Mfg
What RYZODEG 70/30 Treats
3 FDA approvalsOriginally approved for its first indication in 2015 . Covers 3 distinct patient populations.
- Other (3)
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Clinical Trial Registry
103 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07068295 | NN1471-5026 U1111-1283-0507, 2024-520230-29 | Ph 1 | completed | A Study to Test How Insulin NNC0471-0119 H Works in the Body in Participants With Type 2 Diabetes When Given by an Insulin Pump |
| NCT07076199 ONWARDS 11 | NN1436-8182 U1111-1310-7017, 2024-519945-31 | Ph 3 | recruiting | A Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes |
| NCT04880850 ONWARDS 4 results posted | NN1436-4480 U1111-1247-5269, 2020-000474-16 | Ph 3 | completed | A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, Insulin Glargine, Both in Combination With Mealtime Insulin, in People With Type 2 Diabetes Who Use Daily Insulin and Mealtime Insulin (ONWARDS 4) |
| NCT04588259 results posted | NN1218-4357 U1111-1197-8289 | Ph 3 | completed | Research Study to Compare a New Medicine "Fast-acting Insulin Aspart" to Another Medicine "Insulin Aspart" in Chinese People With Diabetes |
| NCT04848480 ONWARDS 6 results posted | NN1436-4625 U1111-1251-7315, 2020-002374-27 | Ph 3 | completed | A Research Study to Compare a New Weekly Insulin, Insulin Icodec, and an Available Daily Insulin, Insulin Degludec, Both in Combination With Mealtime Insulin in People With Type 1 Diabetes (ONWARDS 6) |
| NCT02546401 BOLUS | RB 15-027 2015-000915-42 | Ph 3 | completed | Comparison of Insulin's Injection Before or After the Meal in Type 1 Diabetic Patients Treated With Insulin Pump |
| NCT05013229 | NN1535-4593 U1111-1260-8295, 2020-005309-18 | Ph 3 | completed | A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Insulin Glargine Taken Daily With Insulin Aspart (COMBINE 3) |
| NCT04124302 | Mixed Meal Bolus | Ph 4 | completed | The Impact of Two Different Insulin Dose Calculation on Postprandial Glycemia After Mixed Meal. |
| NCT06809621 | NN1471-7712 U1111-1306-8005, 2024-513472-18 | Ph 1 | completed | A Study to Test How Insulin NNC0471-0119 H Works in the Body in Participants With Type 1 Diabetes When Given by an Insulin Pump |
| NCT02462161 SNIFF-Quick | IRB00026106 5P50AG005136-30 | Ph 1 | completed | Study of Nasal Insulin to Fight Forgetfulness - Short-Acting Insulin Aspart |
| NCT04538352 TRANSITION-T2D results posted | 20-853 | Ph 4 | completed | Transition From Basal/Bolus to Once-weekly Subcutaneous Semaglutide and Basal Insulin in Patients With T2D |
| NCT06558708 | GZR101-T2D-202 | Ph 2 | recruiting | A Trial Comparing Efficacy, Tolerability, and Safety of GZR101 Injection Once Daily (OD) and GZR33-70 Injection OD |
| NCT04012138 InSaKa | RC19_0048 | Ph 4 | completed | Insulin Dextrose Infusion vs Nebulized Salbutamol vs Combination of Salbutamol and Insulin Dextrose in Acute Hyperkalemia |
| NCT03874715 GEMELLI X results posted | EFC15178 U1111-1197-7811, 136342 | Ph 3 | completed | Comparison of SAR341402 to NovoLog in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine |
| NCT03660553 results posted | 20180541 | Ph 4 | terminated | Simplified Insulin Regimen for the Elderly |
| NCT04019821 | SuperBolus | Ph 4 | completed | Super-Bolus: Effects on Postprandial Glycemia After High Glycemic Index Meal |
| NCT02408120 results posted | IRB00078695 | Ph 4 | completed | Benefits of Insulin Supplementation for Correction of Hyperglycemia in Patients With Type 2 Diabetes |
| NCT00913497 results posted | 2009-089 | Ph 4 | completed | The Effect of Insulin Glulisine Compared With Insulin Aspart on Breakfast Post Prandial Glucose Levels in Prepubertal Children |
| NCT03737240 results posted | IRB00104726 | Ph 3 | completed | IDegLira HIGH Trial |
| NCT03659799 | FiAsp-Exercise | Ph 4 | completed | Comparison of FiAsp and Aspart During Postprandial Exercise in Adults With Type 1 Diabetes |
| NCT03377699 EXPECT results posted | NN1250-4300 U1111-1191-3018, 2017-000048-17 | Ph 3 | completed | Research Study Comparing Insulin Degludec to Insulin Detemir, Together With Insulin Aspart, in Pregnant Women With Type 1 Diabetes |
| NCT03689374 SUSTAIN 11 results posted | NN9535-4386 U1111-1200-0164, 2017-003219-20 | Ph 3 | completed | A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes |
| NCT03202875 | PDY12695 2012-002355-42, U1111-1127-2950 | Ph 1 | completed | A Study to Compare Pharmacokinetics (PK) and Pharmacodynamics (PD) of SAR341402 to Insulin Aspart in Subjects With Type 1 Diabetes Mellitus |
| NCT03436498 | PDY15083 U1111-1200-1241 | Ph 1 | completed | Safety Assessment of SAR341402 and NovoLog® Used in Continuous Subcutaneous Insulin Infusion for Type 1 Diabetes Mellitus Patients |
| NCT03916601 | PDY15084 2017-002482-22, U1111-1197-7984 | Ph 1 | completed | Comparison of Exposure and Activity of SAR341402 Mix 70/30 to NovoLog Mix 70/30, NovoMix 30 and SAR341402 Rapid-acting Solution in Patients With Type 1 Diabetes Mellitus |
| NCT02910518 | BEQ13941 2016-001498-34, U1111-1183-8636 | Ph 1 | completed | A Study to Demonstrate Bioequivalence Between Insulin Glulisine U300 and Insulin Glulisine U100 After a Single Subcutaneous Dose Using the Euglycemic Clamp Technique, in Patients With Type 1 Diabetes Mellitus |
| NCT03211858 GEMELLI1 results posted | EFC15081 2017-000091-28, U1111-1191-5775 | Ph 3 | completed | Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine |
| NCT00591227 results posted | 07070902 | Ph 4 | completed | Management of Diabetes in the Emergency Room: a Randomized Trial of an Insulin Protocol. |
| NCT03268005 onset 9 results posted | NN1218-4113 U1111-1180-0636, 2016-000878-38 | Ph 3 | completed | Research Study Comparing a New Medicine "Fast-acting Insulin Aspart" to Another Already Available Medicine "NovoRapid"/"NovoLog" in People With Type 2 Diabetes |
| NCT01293396 HUCKEPACK2 results posted | ENM-DA-008 2008-008486-35 | Ph 4 | completed | Comparison of Premixed Insulins Aspart 30, Aspart 70 and Aspart on Postprandial Lipids |
| NCT03511521 results posted | STU00207079 | Ph 4 | terminated | Use of NPH Versus Basal Bolus Insulin for Steroid Induced Hyperglycemia |
| NCT03430856 results posted | TREGO-DM2-03-I-01 | Ph 2, Ph 3 | completed | Comparison of Insulin Tregopil (IN-105) With Insulin Aspart in Type 2 Diabetes Mellitus Patients |
| NCT03449433 results posted | 16911 I8B-MC-ITSL, 2017-003459-47 | Ph 1 | completed | A Meal Test Study of LY900014 in Participants With Type 1 Diabetes Mellitus |
| NCT02825251 Onset® 5 results posted | NN1218-3854 2010-024054-11, U1111-1118-2480 | Ph 3 | completed | Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart Compared to NovoRapid® in Adults With Type 1 Diabetes |
| NCT02906917 results posted | NN5401-4266 2015-004768-12, U1111-1175-7895 | Ph 3 | completed | A 38 Week Trial Comparing Effect and Safety of Insulin Degludec/Insulin Aspart vs. Insulin Glargine Plus Insulin Aspart in Subjects With Type 2 Diabetes Treated With Basal Insulin With or Without Oral Antidiabetic Treatment in Need of Treatment Intensification |
| NCT01966978 SIMPLE results posted | STU 072013-030 | Ph 4 | completed | The Effect of Simple Basal Insulin Titration, Metformin Plus Liraglutide for Type 2 Diabetes With Very Elevated HbA1c - The SIMPLE Study |
| NCT01513473 BEGIN™ results posted | NN1250-3561 2011-003148-39, P/44/2010 | Ph 3 | completed | A Trial Investigating the Efficacy and Safety of Insulin Degludec in Children and Adolescents With Type 1 Diabetes Mellitus |
| NCT01831765 onset® 1 results posted | NN1218-3852 2010-024049-53, U1111-1118-2442 | Ph 3 | completed | Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes |
| NCT02500706 onset®8 results posted | NN1218-4131 2015-001047-36, U1111-1167-9495 | Ph 3 | completed | Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Adults With Type 1 Diabetes |
| NCT01835431 results posted | NN5401-3816 2012-003566-41, U1111-1133-0958 | Ph 3 | completed | A Trial Investigating the Efficacy and Safety of Insulin Degludec/Insulin Aspart Once Daily Plus Insulin Aspart for the Remaining Meals Versus Insulin Detemir Once or Twice Daily Plus Meal Time Insulin Aspart in Children and Adolescents With Type 1 Diabetes Mellitus |
| NCT02670915 onset®7 results posted | NN1218-4101 2014-002568-33, U1111-1158-1170 | Ph 3 | completed | Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Children and Adolescents With Type 1 Diabetes |
| NCT02933853 | NN1218-4265 2016-000200-28, U1111-1178-3964 | Ph 1 | completed | A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects With Type 2 Diabetes Mellitus |
| NCT03215498 | NN1218-4349 2016-004306-34, U1111-1189-1545 | Ph 1 | completed | A Research Study of How Faster-acting Insulin Aspart Moves Into, Through, and Out of the Body and How it Works in the Body When Given Through an Insulin Pump to People With Type 1 Diabetes |
| NCT01526733 results posted | Halo-117-401 | Ph 4 | completed | Randomized, Double Blind, 2 Way Crossover Study of CSII With, Versus Without, Pretreatment With Human Hyaluronidase |
| NCT01194245 results posted | HALO-117-205 | Ph 2 | completed | Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Participants With Type 1 Diabetes Mellitus |
| NCT02453685 results posted | BIASP-4157 2014-003708-62, U1111-1158-7280 | Ph 4 | completed | A Study to Compare Insulin Intensification of Biphasic Insulin Aspart 30 and Insulin Analogues (Insulin Glargine and Insulin Aspart) in Insulin naïve Type 2 Diabetic Patients |
| NCT01819129 onset® 2 results posted | NN1218-3853 2010-024051-93, U1111-1118-2509 | Ph 3 | completed | Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes |
| NCT02269735 | 2640-001 | Ph 1 | completed | A Three-part Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of MK-2640 in Healthy Participants (Part I) and Participants With Type 1 Diabetes Mellitus (Parts II and III) (MK-2640-001) |
| NCT02034513 SWITCH 1 results posted | NN1250-3995 U1111-1129-9668, 2012-001930-32 | Ph 3 | completed | A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, Both With Insulin Aspart as Mealtime Insulin in Subjects With Type 1 Diabetes |
| NCT02003677 | NN1218-3891 2011-002626-46, U1111-1121-8758 | Ph 1 | completed | A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp in Geriatric and Younger Adult Subjects With Type 1 Diabetes |
Showing 50 of 103 trials
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
RYZODEG 70/30 FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.