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Serving leading biopharmaceutical companies globally:

McKesson
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Harvard Business School
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UBS

Generated: December 13, 2017

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR
APIDRA SOLOSTAR

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Clinical Trial Listing

Trial ID Title Status Sponsor Phase Summary
NCT00115570 Comparison of the Ability of Glulisine With Lispro to Control Type 1 Diabetes Mellitus in Children and AdolescentsCompletedSanofiPhase 3 The purpose of this study is to determine if insulin glulisine (Apidra) is as safe and effective a rapid acting insulin as insulin lispro (Humalog) in children and adolescents with type 1 diabetes mellitus.
NCT00135083 Variable Bolus Regimen 1-2-3 for Type 2 Diabetes MellitusCompletedSanofiPhase 3 The purpose of this study is to show the non-inferiority of insulin glulisine administered with 1 meal versus 2 meals versus 3 daily meals, as measured by the change in hemoglobin A1c (HbA1c), from baseline to study week 24.
NCT00135096 Insulin Glulisine Administered Pre-meal Versus Post-meal in Adult Subjects With Type 2 Diabetes Mellitus Receiving Insulin Glargine as Basal InsulinCompletedSanofiPhase 3 The purpose of this study is to compare the change in weight from baseline to study week 52 in the per-protocol population of pre-meal insulin glulisine (Apidra) versus post-meal Apidra, in patients receiving insulin glargine (Lantus) as basal insulin.
NCT00311077 Insulin Glulisine in Healthy Lean and Obese SubjectsCompletedSanofiPhase 1 Primary objective - To investigate pharmacodynamic and pharmacokinetic parameters after s.c. administration of two different doses (low dose, 0.2 IU/kg and high dose, 0.4 IU/kg) of insulin glulisine across healthy subjects in 4 different BMI-classes (lean, overweight, moderately obese, severely obese), using the euglycemic clamp technique with the Biostator™. Secondary objective - To investigate the pharmacodynamic and pharmacokinetic properties after subcutaneous administration of insulin glulisine in comparison to insulin lispro and to investigate the safety and tolerability after subcutaneous administration of insulin glulisine in comparison to insulin lispro.
NCT00384085 Insulin Glargine "All to Target" TrialCompletedSanofiPhase 4 The primary objectives were: - To demonstrate the superiority of Lantus plus stepwise addition of mealtime Apidra® (Lantus/Apidra-3) versus twice-daily Premixed insulin based on the proportion of patients achieving target glycemic control (as measured by hemoglobin A1c [HbA1c] <7.0%) at Week 60 - To demonstrate the noninferiority of Lantus plus addition of 1 mealtime Apidra injection (Lantus/Apidra-1) versus twice-daily Premixed insulin based on the reduction from Baseline to Week 60 in HbA1c
NCT00394407 Basal/Bolus Versus Sliding Scale Insulin In Hospitalized Patients With Type 2 DiabetesCompletedSanofiPhase 4 High blood glucose levels in hospitalized patients with diabetes are associated with increased risk of medical complications. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. It is not known; however, what is the best insulin regimen in hospitalized patients. The use of repeated injections of regular insulin (known as sliding scale regimen) is one of the most commonly used insulin regimen for glucose control in hospitalized patients with diabetes. Recently, the combination of basal and rapid acting insulins has been shown to improve glucose control with lower rate of hypoglycemia (low blood sugar).
NCT00394407 Basal/Bolus Versus Sliding Scale Insulin In Hospitalized Patients With Type 2 DiabetesCompletedUniversity of MiamiPhase 4 High blood glucose levels in hospitalized patients with diabetes are associated with increased risk of medical complications. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. It is not known; however, what is the best insulin regimen in hospitalized patients. The use of repeated injections of regular insulin (known as sliding scale regimen) is one of the most commonly used insulin regimen for glucose control in hospitalized patients with diabetes. Recently, the combination of basal and rapid acting insulins has been shown to improve glucose control with lower rate of hypoglycemia (low blood sugar).
NCT00394407 Basal/Bolus Versus Sliding Scale Insulin In Hospitalized Patients With Type 2 DiabetesCompletedEmory UniversityPhase 4 High blood glucose levels in hospitalized patients with diabetes are associated with increased risk of medical complications. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. It is not known; however, what is the best insulin regimen in hospitalized patients. The use of repeated injections of regular insulin (known as sliding scale regimen) is one of the most commonly used insulin regimen for glucose control in hospitalized patients with diabetes. Recently, the combination of basal and rapid acting insulins has been shown to improve glucose control with lower rate of hypoglycemia (low blood sugar).
NCT00489190 APIDRA Registration StudyCompletedSanofiPhase 4 To collect effectiveness and safety data during the treatment with Apidra glulisine (HMR1964) by means of subcutaneous injections to patients with Diabetes Mellitus 1st type during 12 weeks-active phase.
NCT00526513 Study of Safety and Effectiveness of Apidra® in Combination With Basal Insulin in Patients With Type 1 & 2 Diabetes MellitusCompletedSanofiPhase 4 Primary Objectives: To determine the effect of insulin glulisine on glycemic control (HbA1c, FBG & PPBG) from baseline to the end of the study. Secondary Objectives: To evaluate the safety of insulin glulisine in basal/bolus regimen by monitoring the incidence of hypoglycemia and other adverse events.
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Conditions

Condition Name

Condition Name for APIDRA SOLOSTAR
Intervention Trials
Diabetes Mellitus, Type 2 8
Diabetes Mellitus, Type 1 4
Type 2 Diabetes 3
Hyperglycemia 3
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Condition MeSH

Condition MeSH for APIDRA SOLOSTAR
Intervention Trials
Diabetes Mellitus 24
Diabetes Mellitus, Type 2 14
Diabetes Mellitus, Type 1 7
Hyperglycemia 5
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Trial Locations

Trials by Country

Trials by Country for APIDRA SOLOSTAR
Location Trials
United States 14
Brazil 3
Mexico 3
Canada 3
Kuwait 2
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Trials by US State

Trials by US State for APIDRA SOLOSTAR
Location Trials
New Jersey 5
Georgia 2
Florida 2
Pennsylvania 1
Colorado 1
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Clinical Trial Progress

Clinical Trial Phase

Clinical Trial Phase for APIDRA SOLOSTAR
Clinical Trial Phase Trials
Phase 4 17
Phase 3 5
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for APIDRA SOLOSTAR
Clinical Trial Phase Trials
Completed 22
Terminated 4
Not yet recruiting 1
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Clinical Trial Sponsors

Sponsor Name

Sponsor Name for APIDRA SOLOSTAR
Sponsor Trials
Sanofi 27
Emory University 2
Guillermo Umpierrez 1
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Sponsor Type

Sponsor Type for APIDRA SOLOSTAR
Sponsor Trials
Industry 28
Other 16
NIH 1
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Serving leading biopharmaceutical companies globally:

Healthtrust
Dow
Medtronic
AstraZeneca
Colorcon
Deloitte
Julphar
McKinsey
Moodys
Boehringer Ingelheim

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