19 completed, 1 terminated. 5 Phase 1, 4 Phase 3, 4 Phase 4, 3 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 5 | Completed 5 |
| Phase 3 | 4 | Completed 4 |
| Phase 4 | 4 | Completed 3, Terminated 1 |
| Phase 2 | 3 | Completed 3 |
Follow biphasic human insulin 30: new trials by email Literature Review of biphasic human insulin 30 trials Research Report on biphasic human insulin 30
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 |
|---|---|---|---|---|---|---|
| Pharmacokinetic (PK) Bioequivalence and Pharmacodynamics (PD) of Julphar Insulin 30/70 and Huminsulin® Profil III human biphasic insulin, human biphasic insulin, reference - Diabetes Mellitus | Phase 1 | Completed | Julphar Gulf Pharmaceutical Industries | 73 | 2016-02-01 | 2016-08-02 |
| Comparing the Efficacy and Safety of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 on Blood Sugar Control in Subjects With Type 2 Diabetes biphasic insulin aspart 30, biphasic human insulin 30, metformin - Diabetes, Diabetes Mellitus, Type 2 | Phase 4 | Completed | Novo Nordisk A/S | 145 | 2008-12-01 | 2015-03-04 |
| Observational Study to Evaluate Safety and Efficacy of Insulin Therapy in Type 2 Diabetes Mellitus Subjects Failing on Oral Anti-diabetic Agents soluble human insulin, biphasic human insulin, insulin NPH - Diabetes, Diabetes Mellitus, Type 2 | Completed | Novo Nordisk A/S | 1667 | 2008-06-01 | 2016-11-07 | |
| Safety and Efficacy of Biphasic Human Insulin Compared to EX1000 in Type 2 Diabetes EX1000, biphasic human insulin - Diabetes, Diabetes Mellitus, Type 2 | Phase 2 | Completed | Novo Nordisk A/S | 397 | 2008-06-01 | 2015-04-14 |
| Safety and Effect of Biphasic Insulin Aspart 50 in Patients With Type 2 Diabetes Mellitus. biphasic insulin aspart, biphasic human insulin - Diabetes, Diabetes Mellitus, Type 2 | Phase 3 | Completed | Novo Nordisk A/S | 81 | 2007-04-01 | 2023-11-02 |
| Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 in Type 2 Diabetes biphasic insulin aspart 30, biphasic human insulin 30 - Diabetes, Diabetes Mellitus, Type 2 | Phase 1 | Completed | Novo Nordisk A/S | 24 | 2007-03-01 | 2017-01-06 |
| Observational Study on Efficacy, Safety and Convenience of Using Mixtard® 30 NovoLet® Alone or Combined With OHA in Treatment of Type 2 Diabetes in Routine Clinical Practice biphasic human insulin 30 - Diabetes, Diabetes Mellitus, Type 2 | Completed | Novo Nordisk A/S | 1935 | 2006-11-01 | 2016-12-13 | |
| Bioequivalence of Two Mixtard® 30 Formulations in Healthy Subjects biphasic human insulin 30 - Diabetes, Healthy | Phase 1 | Completed | Novo Nordisk A/S | 45 | 2006-05-01 | 2015-03-18 |
| Comparison of Insulin Aspart Produced by Current Process and the NN2000 Process in Healthy Japanese biphasic human insulin 30 - Diabetes, Healthy | Phase 1 | Completed | Novo Nordisk A/S | 34 | 2004-11-20 | 2017-03-01 |
| Observational Study With Mixtard® 30 NovoLet® to Assess Patient Satisfaction biphasic human insulin 30 - Diabetes, Diabetes Mellitus, Type 1 | Completed | Novo Nordisk A/S | 1330 | 2004-03-15 | 2017-02-28 | |
| Comparison of Efficacy and Safety of Repaglinide Combined With Insulin NPH Versus Biphasic Human Insulin 30 Alone in Inadequately Controlled Subjects With Type 2 Diabetes repaglinide, biphasic human insulin 30, insulin NPH - Diabetes, Diabetes Mellitus, Type 2 | Phase 4 | Terminated | Novo Nordisk A/S | 40 | 2003-09-16 | 2017-02-20 |
| Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or 2 Diabetes biphasic insulin aspart, biphasic human insulin - Diabetes, Diabetes Mellitus, Type 1 | Phase 3 | Completed | Novo Nordisk A/S | 219 | 2003-07-08 | 2017-02-24 |
| NovoLet® Surveillance Study on Using Human Insulin System in Indonesia biphasic human insulin, isophane human insulin, human soluble insulin - Diabetes, Diabetes Mellitus, Type 1 | Completed | Novo Nordisk A/S | 1981 | 2003-02-11 | 2017-02-28 | |
| Efficacy and Safety of NovoMix® 30 in Subjects With Type 2 Diabetes biphasic insulin aspart, biphasic human insulin - Diabetes, Diabetes Mellitus, Type 2 | Phase 4 | Completed | Novo Nordisk A/S | 292 | 2002-08-19 | 2017-02-24 |
| Frequency of Episodes of Hypoglycaemia During Treatment With Biphasic Insulin Aspart 30 in Type 2 Diabetes biphasic human insulin 30, biphasic insulin aspart 30 - Diabetes, Diabetes Mellitus, Type 2 | Phase 4 | Completed | Novo Nordisk A/S | 170 | 2002-06-01 | 2017-01-06 |
| Glycaemic Control of Biphasic Insulin Aspart 70 and 30 in Subjects With Type 2 Diabetes biphasic insulin aspart 30, biphasic insulin aspart 70, biphasic human insulin 30 - Diabetes, Diabetes Mellitus, Type 2 | Phase 2 | Completed | Novo Nordisk A/S | 31 | 2002-05-01 | 2017-01-05 |
| Comparison of Biphasic Human Insulin 30 With Biphasic Insulin Aspart in Subjects With Diabetes biphasic insulin aspart 50, biphasic insulin aspart 70, biphasic human insulin 30 - Diabetes, Diabetes Mellitus, Type 1 | Phase 3 | Completed | Novo Nordisk A/S | 666 | 2000-03-01 | 2017-01-04 |
| Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or Type 2 Diabetes biphasic insulin aspart, biphasic human insulin - Diabetes, Diabetes Mellitus, Type 1 | Phase 3 | Completed | Novo Nordisk A/S | 303 | 1998-04-01 | 2017-01-04 |
| Pharmacokinetics, Pharmacodynamics and Safety of Biphasic Insulin Aspart 30 in Type 2 Diabetes biphasic insulin aspart 30, biphasic human insulin 30 - Diabetes, Diabetes Mellitus, Type 2 | Phase 2 | Completed | Novo Nordisk A/S | 13 | 1997-04-01 | 2017-01-04 |
| Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 in Healthy Volunteers biphasic insulin aspart 30, biphasic human insulin 30 - Diabetes, Healthy | Phase 1 | Completed | Novo Nordisk A/S | 24 | 1995-11-01 | 2017-01-04 |
Diabetes Mellitus (20) · Diabetes Mellitus, Type 2 (16) · Diabetes Mellitus, Type 1 (5)
Novo Nordisk A/S (19) · Julphar Gulf Pharmaceutical Industries (1)
United Kingdom (6) · Germany (4) · Indonesia (3) · China (2) · Ireland (2) · Japan (2) · Netherlands (2) · Austria (1) · Belgium (1) · Denmark (1) · France (1) · Greece (1) · India (1) · Norway (1) · Philippines (1)
PMID 11009049, PMID 11978684, PMID 12017398, PMID 12027927, PMID 17277042, PMID 18269638, PMID 19487640, PMID 19527481
2005 (1), 2015 (1)