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Last Updated: September 27, 2021

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CLINICAL TRIALS PROFILE FOR INSULIN SUSP ISOPHANE RECOMBINANT HUMAN

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Biosimilar Clinical Trials for insulin susp isophane recombinant human

This table shows clinical trials for biosimilars. See the next table for all clinical trials
Trial ID Title Status Sponsor Phase Start Date Summary
NCT02631928 ↗ Pharmacokinetic (PK) Bioequivalence and Pharmacodynamics (PD) of Julphar Insulin 30/70 and Huminsulin® Profil III Completed Profil Institut für Stoffwechselforschung GmbH Phase 1 2016-02-01 This study in healthy volunteers aims to demonstrate similar PK and PD properties of the new human biphasic insulin, Julphar Insulin 30/70 and an already approved reference insulin, Huminsulin® Profil III. All participants will receive both study treatments on two separate dosing days.
NCT02631928 ↗ Pharmacokinetic (PK) Bioequivalence and Pharmacodynamics (PD) of Julphar Insulin 30/70 and Huminsulin® Profil III Completed Julphar Gulf Pharmaceutical Industries Phase 1 2016-02-01 This study in healthy volunteers aims to demonstrate similar PK and PD properties of the new human biphasic insulin, Julphar Insulin 30/70 and an already approved reference insulin, Huminsulin® Profil III. All participants will receive both study treatments on two separate dosing days.
NCT02634528 ↗ Pharmacokinetic (PK) Bioequivalence and Pharmacodynamics (PD) of Julphar Insulin N and Huminsulin® Basal Recruiting Profil Institut für Stoffwechselforschung GmbH Phase 1 2016-11-01 This study in healthy volunteers aims to demonstrate similar PK and PD properties of the new human isophane Insulin, Julphar Insulin N, and the already approved reference Insulin, Huminsulin® Basal. All participants will receive both study treatments on two separate dosing days.
NCT02634528 ↗ Pharmacokinetic (PK) Bioequivalence and Pharmacodynamics (PD) of Julphar Insulin N and Huminsulin® Basal Recruiting Julphar Gulf Pharmaceutical Industries Phase 1 2016-11-01 This study in healthy volunteers aims to demonstrate similar PK and PD properties of the new human isophane Insulin, Julphar Insulin N, and the already approved reference Insulin, Huminsulin® Basal. All participants will receive both study treatments on two separate dosing days.
>Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for insulin susp isophane recombinant human

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00658099 ↗ Observational Study of Type 2 Diabetes Patients Failing on Oral Anti-diabetic Agents Initiated on Levemir® or Insulatard® Completed Novo Nordisk A/S N/A 2007-11-01 This trial is conducted in Europe. The aim of this observational study is to evaluate the change in weight in type 2 diabetes patients using Levemir® or Insulatard® under normal clinical practice conditions.
NCT00665808 ↗ Observational Study on Treatment Satisfaction of Levemir® Versus Protaphane® During "Real-life" Usage in Germany Completed Novo Nordisk A/S N/A 2007-10-01 This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The purpose of this NON INTERVENTIONAL OBSERVATIONAL STUDY is to primarily investigate treatment satisfaction when using Levemir® versus Protaphane® in combination with OADs in daily settings.
NCT01122979 ↗ Evaluation of the Safety and Efficacy of Insulin Glargine + Glulisine or Insulin Regular + NPH Insulin (Isophane Insulin) Use in Type 2 Diabetes Mellitus Patients With Moderate Renal Failure. Completed Sanofi Phase 4 2010-07-01 Primary Objective: >To obtain an estimation for both treatment groups of the proportion of patients that reach the target of HbA1c <= 7% without confirmed nocturnal hypoglycaemia in each treatment group. Secondary Objectives: - Glycemic control, measured by HbA1c and FPG (fasting plasma glucose) at baseline and after each period of treatment. - Incidence of confirmed symptomatic and nocturnal hypoglycemia. - Incidence of confirmed severe hypoglycemia (< 36mg/dL or need of help to recover). >Weight variation for each period of treatment. - Creatinine clearance at baseline and after each period of treatment. - Overall safety: Incidence of adverse events.
NCT01680185 ↗ Sensor-Augmented Insulin-Pump Therapy in New-onset Diabetes After Transplantation Active, not recruiting Medical University of Vienna Phase 3 2012-08-01 The SAPT-NODAT study will test the hypotheses that intensive subcutaneous insulin treatment with short acting insulin, applied continuously through an insulin pump, (i) improves glycemic control, (ii) reduces the prevalence of NODAT and prediabetes, and (iii) offers further β-cell protection, in comparison to the standard of care control group, and the basal insulin treatment group. In the SAPT-NODAT study, we will employ sensor-augmented insulin-pump technology, which performs like a semi-closed loop to prevent hypoglycemic events. Patients in the SAPT-NODAT study will be followed through 24 months post-transplantation.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for insulin susp isophane recombinant human

Condition Name

Condition Name for insulin susp isophane recombinant human
Intervention Trials
Diabetes Mellitus, Type 2 3
Diabetes Mellitus 3
Hyperglycemia 2
Diabetes 2
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Condition MeSH

Condition MeSH for insulin susp isophane recombinant human
Intervention Trials
Diabetes Mellitus 6
Diabetes Mellitus, Type 2 3
Hyperglycemia 2
Renal Insufficiency 1
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Clinical Trial Locations for insulin susp isophane recombinant human

Trials by Country

Trials by Country for insulin susp isophane recombinant human
Location Trials
Germany 3
Austria 1
Brazil 1
United States 1
Romania 1
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Trials by US State

Trials by US State for insulin susp isophane recombinant human
Location Trials
Virginia 1
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Clinical Trial Progress for insulin susp isophane recombinant human

Clinical Trial Phase

Clinical Trial Phase for insulin susp isophane recombinant human
Clinical Trial Phase Trials
Phase 4 2
Phase 3 2
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for insulin susp isophane recombinant human
Clinical Trial Phase Trials
Completed 5
Recruiting 1
Terminated 1
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Clinical Trial Sponsors for insulin susp isophane recombinant human

Sponsor Name

Sponsor Name for insulin susp isophane recombinant human
Sponsor Trials
Julphar Gulf Pharmaceutical Industries 2
Profil Institut für Stoffwechselforschung GmbH 2
Medical University of Vienna 2
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Sponsor Type

Sponsor Type for insulin susp isophane recombinant human
Sponsor Trials
Industry 7
Other 6
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