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biphasic insulin aspart 30

Phase 3

Diabetes | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Nov 2, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials54
Total Enrollment8,362
FDA Designations
No designations recorded
Clinical Trials (54)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02762578Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart and BIAsp 30 in Subjects With Type 2 DiabetesPHASE3 COMPLETED 543 — — May 3, 2016Jun 19, 2017Apr 2, 201942 China
NCT02648217Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart Twice Daily and Biphasic Insulin Aspart Twice Daily in Subjects With Type 2 Diabetes Mellitus Before, During and After RamadanPHASE3 COMPLETED 263 — — Jan 4, 2016Sep 5, 2016Sep 11, 201832 Algeria, India +4
NCT01059812A Pan Asian Trial Comparing Efficacy and Safety of NN5401 and Biphasic Insulin Aspart 30 in Type 2 DiabetesPHASE3 COMPLETED 424 — — Feb 1, 2010Dec 23, 2010Dec 20, 201846 Hong Kong, Japan +3
NCT01009580Comparison of NN5401 With Biphasic Insulin Aspart 30 in Type 2 DiabetesPHASE3 COMPLETED 447 — — Nov 5, 2009Aug 23, 2010Dec 19, 201853 Australia, Denmark +8
NCT00627445Effect of Biphasic Insulin Aspart 50 on Blood Glucose Control in Subjects With Type 2 DiabetesPHASE3 COMPLETED 441 — — Feb 1, 2008Jan 1, 2009Oct 22, 20141 China
NCT00476437Safety and Effect of Biphasic Insulin Aspart 50 in Patients With Type 2 Diabetes Mellitus.PHASE3 COMPLETED 81 — — Apr 1, 2007Nov 1, 2007Nov 2, 20231 Japan
NCT00313001Effects of Biphasic Insulin Aspart 70/30 vs. Exenatide in Type 2 Diabetes Patients Not Reaching Blood Glucose Targets on Metformin and a Sulfonylurea.PHASE3 COMPLETED 373 — — Apr 1, 2006Jul 1, 2007Jan 6, 20171 United States
NCT00318786Efficacy and Safety of Three Times a Day BIAsp-70 Compared to Two Times a Day BIAsp-30 in Subjects With Type 2 DiabetesPHASE3 COMPLETED 289 — — Apr 1, 2006Jun 1, 2007Jan 6, 20171 Japan
NCT00184574Comparison of Biphasic Insulin Aspart 70/30, 50/50, and 30/70 in Subjects With Type 2 DiabetesPHASE3 COMPLETED 603 — — Apr 1, 2005Mar 1, 2006Jan 5, 2017108 Austria, Belgium +16
NCT00097877Comparison of Biphasic Insulin Aspart 70/30 Versus Insulin Glargine in Subjects With Type 2 DiabetesPHASE3 COMPLETED 293 — — Jan 1, 2005Nov 1, 2006Jan 11, 201773 United States, Puerto Rico
NCT00184600Comparison of Insulin Detemir, Insulin Aspart and Biphasic Insulin Aspart 30 With OAD Treatment in Type 2 DiabetesPHASE3 COMPLETED 708 — — Nov 1, 2004Aug 1, 2009Mar 9, 201763 Ireland, United Kingdom
NCT00097279Comparison of Biphasic Insulin Aspart 70/30 With Anti-Diabetic Drugs in Subjects With Type 2 DiabetesPHASE3 COMPLETED 230 — — Aug 1, 2004Aug 1, 2005Jan 11, 201773 United States
NCT00564668Comparison of Biphasic Insulin Aspart Produced by the NN2000 Process to Current Process to in Type 2 DiabetesPHASE3 COMPLETED 126 — — Jun 19, 2004Apr 12, 2005Mar 1, 20171 Japan
NCT00600626Basal Bolus of Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 DiabetesPHASE3 COMPLETED 394 — — Jan 1, 2004Jul 1, 2004Jan 6, 201755 Croatia, France +11
NCT00280046Effect of Biphasic Insulin Aspart 30 on Blood Glucose Control in Subjects With Type 2 DiabetesPHASE3 COMPLETED 307 — — Nov 1, 2003Jul 1, 2004Jan 6, 201711 Russia
NCT00612599Comparison of Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 50 to Biphasic Insulin Aspart 70 in Type 2 DiabetesPHASE3 COMPLETED 75 — — Sep 1, 2003Jun 1, 2004Jan 6, 20171 Denmark
NCT00617565Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or 2 DiabetesPHASE3 COMPLETED 219 — — Jul 8, 2003Nov 26, 2003Feb 24, 20176 China
NCT00598793Biphasic Insulin Aspart 30 in Type 2 Diabetes Failing OAD TherapyPHASE3 COMPLETED 242 — — Nov 1, 2002Mar 1, 2004Jan 9, 201727 United States
NCT01486381Long Term Safety of Biphasic Insulin Aspart 30 in Juveniles With Type 1 DiabetesPHASE3 COMPLETED 22 — — Mar 20, 2002May 30, 2003Feb 24, 20172 South Africa
NCT01527539Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 DiabetesPHASE3 COMPLETED 25 — — Nov 23, 2001Oct 12, 2004Feb 24, 20174 Canada
NCT01467375Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Type 2 DiabetesPHASE3 COMPLETED 89 — — Jan 8, 2001Oct 22, 2004Feb 24, 201712 Australia, Canada
NCT01650129Safety and Efficacy of Biphasic Insulin Aspart 50 in Subjects With Type 2 DiabetesPHASE3 COMPLETED 83 — — Dec 13, 2000Oct 18, 2001Feb 24, 20171 Japan
NCT01520818Comparison of Biphasic Human Insulin 30 With Biphasic Insulin Aspart in Subjects With DiabetesPHASE3 COMPLETED 666 — — Mar 1, 2000Apr 1, 2001Jan 4, 201777 Belgium, France +3
NCT01520753Comparison of Two Biphasic Insulin Aspart Treatments in Subjects With Type 2 DiabetesPHASE3 COMPLETED 16 — — Mar 1, 1999Jun 1, 1999Jan 4, 20171 Denmark
NCT01467323Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 1 or Type 2 DiabetesPHASE3 COMPLETED 303 — — Apr 1, 1998Sep 1, 1998Jan 4, 201737 Austria, Germany +3
NCT00842361Comparison of NN5401 Versus Biphasic Insulin Aspart 30 on a Twice Daily Regimen in Subjects With Type 2 Diabetes MellitusPHASE2 COMPLETED 66 — — Jan 1, 2009Jun 1, 2009Feb 9, 20178 Japan
NCT00613951Comparison of Two NN5401 Formulations Versus Biphasic Insulin Aspart 30, All in Combination With Metformin in Subjects With Type 2 DiabetesPHASE2 COMPLETED 182 — — Jan 1, 2008Aug 1, 2008Mar 20, 201731 Finland, France +3
NCT01526980Glycaemic Control of Biphasic Insulin Aspart 70 and 30 in Subjects With Type 2 DiabetesPHASE2 COMPLETED 31 — — May 1, 2002Nov 1, 2002Jan 5, 20171 United Kingdom
NCT01697618Pharmacokinetics, Pharmacodynamics and Safety of Biphasic Insulin Aspart 30 in Type 2 DiabetesPHASE2 COMPLETED 13 — — Apr 1, 1997Nov 1, 1998Jan 4, 20172 Netherlands, United Kingdom
NCT01242826Investigation of the Pharmacokinetic Properties of Biphasic Insulin Aspart 50 in Healthy Chinese SubjectsPHASE1 COMPLETED 24 — — Feb 1, 2011Mar 1, 2011May 29, 20151 China
NCT01174303A Trial Investigating the Exposure of NN5401 in Young Adults and Elderly Subjects With Type 1 DiabetesPHASE1 COMPLETED 28 — — Aug 1, 2010Nov 1, 2010Feb 10, 20171 Austria
NCT01134224A Trial Investigating the Effect of NN5401 in Subjects With Type 2 DiabetesPHASE1 COMPLETED 39 — — May 1, 2010Nov 1, 2010Nov 27, 20131 Germany
NCT01051102Effect of NN5401 in Japanese Subjects With Type 1 DiabetesPHASE1 COMPLETED 21 — — Jan 1, 2010Apr 1, 2010Feb 10, 20171 Japan
NCT00993096Investigation of the Response Relationship of NN5401 in Type 1 DiabeticsPHASE1 COMPLETED 33 — — Sep 1, 2009Dec 1, 2009Feb 10, 20171 Germany
NCT01868568Comparison of IDegAsp (Inclusive Three Explorative Formulations) With Insulin Degludec and Insulin Aspart Separately Injected in Subjects With Type 1 DiabetesPHASE1 COMPLETED 55 — — Apr 1, 2008Aug 1, 2008Oct 22, 20151 Germany
NCT00824668Comparison of Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30 and Insulin Glargine and Insulin Glulisine Therapy in Subjects With Type 2 DiabetesPHASE1 COMPLETED 24 — — Aug 1, 2007Oct 1, 2007Jan 6, 20171 Germany
NCT00825253Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 in Type 2 DiabetesPHASE1 COMPLETED 24 — — Mar 1, 2007May 1, 2007Jan 6, 20171 Germany
NCT01865305Comparison of Explorative Formulation of Insulin Degludec and Insulin Aspart Co-formulation Versus Explorative Formulation of Insulin Degludec and Insulin Aspart Separately Compared With Biphasic Insulin Aspart 30 in Male Subjects With DiabetesPHASE1 COMPLETED 59 — — Sep 1, 2006Feb 1, 2007Oct 23, 20151 Germany
NCT01538511Insulin Profile of Biphasic Insulin Aspart 70 to That of Biphasic Insulin Aspart 30 in Healthy VolunteersPHASE1 COMPLETED 59 — — Jun 5, 2006Mar 13, 2007Oct 6, 20171 Japan
NCT01536028Comparison of the Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30, 50, 70 and Insulin Aspart in Subjects With Type 1 DiabetesPHASE1 COMPLETED 32 — — Apr 1, 2006Jul 1, 2006Jan 6, 20171 Germany
NCT01487811Comparison of Two Biphasic Insulin Aspart 30 Formulations (Current and New Formulation) in Healthy VolunteersPHASE1 COMPLETED 50 — — May 1, 2005Nov 1, 2005Jan 6, 20171 United States
NCT01527656Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 in Healthy SubjectsPHASE1 COMPLETED 40 — — Dec 1, 2003Feb 1, 2004Jan 6, 20171 Germany
NCT01620437Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Japanese SubjectsPHASE1 COMPLETED 30 — — Nov 29, 2003Dec 30, 2003Feb 24, 20171 Japan
NCT01527643Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy SubjectsPHASE1 COMPLETED 30 — — Nov 11, 2003Dec 17, 2003Feb 24, 20171 Germany
NCT01527565Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 in Healthy Male SubjectsPHASE1 COMPLETED 30 — — Jan 20, 2003Feb 26, 2003Feb 24, 20171 South Africa
NCT01527630Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Japanese SubjectsPHASE1 COMPLETED 30 — — Nov 16, 2002Jan 8, 2003Feb 24, 20171 Japan
NCT01527552Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Male SubjectsPHASE1 COMPLETED 30 — — Nov 5, 2002Dec 18, 2002Feb 24, 20171 South Africa
NCT01526941Comparison of Single Dose and Steady State Pharmacodynamics of Biphasic Insulin Aspart 30 and 70 in Subjects With Type 1 DiabetesPHASE1 COMPLETED 27 — — May 1, 2001Jul 1, 2001Jan 5, 20171 Germany
NCT01620424Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 and 50 in Subjects With Type 2 DiabetesPHASE1 COMPLETED 10 — — Feb 1, 2001Apr 1, 2001Jan 5, 20171 Japan
NCT01524809Pharmacokinetics of Biphasic Insulin Aspart 30 and 70 in Subjects With Type 1 DiabetesPHASE1 COMPLETED 26 — — Jan 1, 2001Jun 1, 2001Jan 5, 20171 Denmark
NCT01620333Pharmacokinetics of Biphasic Insulin Aspart 50 and 70 in Japanese Healthy VolunteersPHASE1 COMPLETED 24 — — Feb 1, 2000Apr 1, 2000Jan 5, 20171 Japan
NCT01523041Comparison of Two Formulations of Biphasic Insulin Aspart 70PHASE1 COMPLETED 24 — — Nov 3, 1999Nov 30, 1999Feb 24, 20171 United Kingdom
NCT01520831Comparison of Biphasic Insulin Aspart (30, 50 and 70) and Insulin Aspart in Healthy SubjectsPHASE1 COMPLETED 35 — — Apr 1, 1999May 1, 2000Jan 4, 20171 Germany
NCT01707160Pharmacokinetics and Pharmacodynamics of Biphasic Insulin Aspart 30 in Healthy VolunteersPHASE1 COMPLETED 24 — — Nov 1, 1995Dec 1, 1995Jan 4, 20171 United Kingdom
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Study Endpoints
Primary Endpoints
Change From Baseline in HbA1c (%) (Glycosylated Haemoglobin)
At 26 weeks

Change from baseline in HbA1c after 26 weeks of treatment. The response and change from baseline in response after 26 weeks are analysed using an analysis of covariance model with treatment, anti-diabetic therapy at screening and sex as fixed factors, age and baseline response as covariate. Missing values imputed using last observed value.

Change in HbA1c (%) (Glycosylated Haemoglobin)
From week 0 to end of Ramadan (day 29 of Ramadan)

Mean change in HbA1c was evaluated from baseline (week 0) to end of Ramadan (day 29 of Ramadan).

Change in HbA1c (Glycosylated Haemoglobin) After 26 Weeks of Treatment
Week 0, Week 26

Change from baseline in HbA1c after 26 weeks of treatment.

Change in Glycosylated Haemoglobin (HbA1c)
Week 0, Week 26

Change from baseline in HbA1c after 26 weeks of treatment.

Change in Glycosylated Haemoglobin A1c (HbA1c)
week 0, week 16

Change in glycosylated haemoglobin A1c (HbA1c) from week 0 (baseline) to end of treatment (week 16)

Incidence of hypoglycaemic episodes
During 16 weeks of treatment
Superiority as assessed by HbA1c reduction
at 24 weeks
Hemoglobin A1C (HbA1C)
After 16 weeks of treatment
HbA1c
after 36 weeks
HbA1c (Glycosylated Haemoglobin) at Month 12
Baseline, Month 12

HbA1c values offer evidence of the efficacy and durability of the insulin regimens.

HbA1c (Glycosylated Haemoglobin) at Month 36
Baseline, Month 36

HbA1c values offer evidence of the efficacy and durability of the insulin regimens.

Safety
During 24 weeks of treatment
Area under the serum glucose concentration profile during 24 hours
after 4 weeks of treatment
2-hr postprandial plasma glucose (PPPG) excursion
after 12 weeks of treatment
Number of hypoglycaemic episodes
Occurence of adverse events
Standard safety parameters: Haematology, biochemistry and vital signs
Occurrence of adverse events
Frequency of hypoglycaemic episodes
Glycosylated haemoglobin A1c (HbA1c)
HbA1c (glycosylated haemoglobin A1c)
Fasting serum glucose
Rate of Major and Minor Hypoglycaemic Episodes
Week 0 to Week 6 + 5 days follow up

Rate of major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL.

Rate of Nocturnal Major and Minor Hypoglycaemic Episodes
Week 0 to Week 6 + 5 days follow up

Rate of nocturnal major and minor hypoglycaemic episodes per patient year (1year=365.25days) of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose ≤ 55 mg/dL. Episodes were defined as nocturnal if the time of onset was between 23:00 and 05:59 (both inclusive).

Glucose average in 24-hour blood glucose profiles
Area under the serum insulin curve
Area under the serum insulin aspart concentration-time curve from 0 to 24hours
24 hours profile after single dose of trial drug
Area under the Glucose Infusion Rate curve (only for NN5401)
from 0 to 24 hours after single-dose administration
Area under the glucose infusion rate curve (only for IDegAsp)
From 0 to 24 hours after single-dose
Area under the Glucose Infusion Rate curve after a single dose
From 4-12 hours
Area (AUC) under the glucose infusion rate curve
From 0 to 24 hours after single-dose administration
Area under the insulin aspart concentration curve
0-2 hours after dosing
Area under the insulin aspart concentration curve from 0-2 hours (for subjects with type 1 diabetes)
0-2 hours after dosing
Maximum glucose infusion rate divided by the average glucose infusion rate (for subjects with type 2 diabetes)
0-24 hours after dosing
Area under the plasma insulin concentration curve from 0 to 24 hours
Area under the GIR (glucose infusion rate)-curves in the first two hours post-dosing
Area under the concentration curve (AUC) of the two formulations from time 0 hours to infinity
Maximum drug concentration of the two formulations (Cmax)
Area under the insulin aspart curve in the interval from 0-16 hours
Cmax, maximum insulin aspart concentration
Area under the insulin aspart concentration-time curve in the interval from 0 to 16 hours
Steady state area under the glucose infusion rate profile, 6-12 hours
The maximum insulin aspart concentration
Area under the serum insulin curve 6-14 hours after dinner at day 15
Area under the insulin aspart curve in the interval from 0 to 24 hours (BIAsp 70)
Area under the insulin aspart curve in the interval from 0-24 hours
Area under the GIR (Glucose Infusion Rate) profile (AUC GIR) in the interval 0-120 minutes
Area under the Curve
Secondary Endpoints
Change From Baseline in FPG (Fasting Plasma Glucose)
At 26 weeks
Number of Treatment Emergent Nocturnal Confirmed Hypoglycaemic Episodes
Weeks 0-26
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes
Weeks 0-26
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IDegAsp BIDEXPERIMENTAL -
BIAsp 30 BIDACTIVE_COMPARATOR -
IDegAsp U100 BIDEXPERIMENTAL -
BIAsp U100 BIDACTIVE_COMPARATOR -
BIAsp 50-50-30EXPERIMENTALBiphasic insulin aspart 50 administered before breakfast and lunch + biphasic insulin aspart 30 at dinner combined with metformin
BIAsp 30-30ACTIVE_COMPARATORBiphasic insulin aspart 30 administered before breakfast and dinner combined with metformin
Insulin detemir (basal insulin)EXPERIMENTALIndividually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a second insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen.
Insulin aspart (prandial insulin)ACTIVE_COMPARATORIndividually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. In the second and third years, a second insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen.
Biphasic insulin aspart 30 (biphasic insulin)ACTIVE_COMPARATORIndividually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. In the second and third years, a second insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen.
BIAsp 30EXPERIMENTAL -
AEXPERIMENTAL -
BIAspEXPERIMENTAL -
BHIEXPERIMENTAL -
BIAsp 50 or 70EXPERIMENTAL -
BHI 30ACTIVE_COMPARATOR -
BIAsp 70EXPERIMENTAL -
BIAsp 70 + BIAsp 50EXPERIMENTAL -
BACTIVE_COMPARATOR -
Mix30ACTIVE_COMPARATOR -
SIACEXPERIMENTAL -
SIAC 30 (B)EXPERIMENTAL -
SIAC 45 (B)EXPERIMENTAL -
Treatment period 1EXPERIMENTAL -
Treatment period 2ACTIVE_COMPARATOR -
IDegAsp - BIAspEXPERIMENTAL -
BIAsp - IDegAspEXPERIMENTAL -
NN5401 - low doseEXPERIMENTAL -
NN5401 - medium doseEXPERIMENTAL -
NN5401 - high doseEXPERIMENTAL -
biphasic insulin aspart 30 - low doseACTIVE_COMPARATOR -
biphasic insulin aspart 30 - medium doseACTIVE_COMPARATOR -
biphasic insulin aspart 30 - high doseACTIVE_COMPARATOR -
IDegAspEXPERIMENTAL -
IDegAsp lowEXPERIMENTAL -
IDegAsp middleEXPERIMENTAL -
IDegAsp highEXPERIMENTAL -
BIAsp 30 lowEXPERIMENTAL -
BIAsp 30 middleEXPERIMENTAL -
BIAsp 30 highEXPERIMENTAL -
IDegAsp 30 + placeboEXPERIMENTAL -
Insulin aspart + insulin degludec - low concentration 1EXPERIMENTAL -
IDegAsp 40 + placeboEXPERIMENTAL -
Insulin aspart + insulin degludec - high concentration 1EXPERIMENTAL -
IDegAsp 45 + placeboEXPERIMENTAL -
Insulin aspart + insulin degludecEXPERIMENTAL -
IDegAsp 55 + placeboEXPERIMENTAL -
Insulin aspart + insulin degludec - high concentrationEXPERIMENTAL -
BIAsp 30 + placeboACTIVE_COMPARATOR -
Trial part 1EXPERIMENTAL -
Trial part 2EXPERIMENTAL -
BIAsp 50EXPERIMENTAL -
IAspACTIVE_COMPARATOR -
Formulation 1EXPERIMENTAL -
Formulation 2ACTIVE_COMPARATOR -
Formulation AEXPERIMENTAL -
Formulation BEXPERIMENTAL -
Dosing visit 1EXPERIMENTAL -
Dosing visit 2EXPERIMENTAL -
BIAsp 70 clinical trial formulationEXPERIMENTAL -
BIAsp 70 final formulationEXPERIMENTAL -
BIAsp 50 final formulationEXPERIMENTAL -
Insulin aspartACTIVE_COMPARATOR -
Interventions
NameTypeDescription
insulin degludec/insulin aspartDRUGTwice daily subcutaneous (sc, under the skin) injection.
biphasic insulin aspartDRUGTwice daily subcutaneous (sc, under the skin) injection.
biphasic insulin aspart 30DRUGInjected subcutaneously twice daily. Dose was individually adjusted.
metforminDRUGTablets, 500 - 2000 mg, once, twice or three times daily
biphasic insulin aspart 50DRUGTreat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before breakfast and lunch
biphasic human insulinDRUG -
exenatideDRUG -
insulin glargineDRUG -
insulin detemirDRUGTreat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, once or twice daily plus option for insulin aspart
insulin aspartDRUGTreat-to-target (individually adjusted dose), subcutaneously (under the skin) injection, twice daily plus option for insulin detemir
pioglitazoneDRUG -
insulin NPHDRUG -
biphasic human insulin 50DRUGAdministered subcutaneously (s.c., under the skin) twice daily for 24 weeks. Injected 30 minutes before breakfast and dinner
biphasic insulin aspart 70DRUGAdministered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner. Randomised subjects being lean and overweight with a body mass index (BMI) of maximum 30 kg/m\^2 will receive BIAsp 70
biphasic human insulin 30DRUGAdministered subcutaneously (s.c., under the skin), twice a day
insulin degludecDRUGAdministered subcutaneously (s.c., under the skin).
insulin degludec/insulin aspart 30DRUGA single dose administered subcutaneously (s.c., under the skin).
insulin degludec/insulin aspart 40DRUGA single dose administered subcutaneously (s.c., under the skin).
insulin degludec/insulin aspart 45DRUGA single dose administered subcutaneously (s.c., under the skin).
insulin degludec/insulin aspart 55DRUGA single dose administered subcutaneously (s.c., under the skin).
placeboDRUGA single dose administered subcutaneously (s.c., under the skin).
insulin glulisineDRUG -
insulin degludec/insulin aspart 50DRUGSingle dose administrated subcutaneously (s.c., under the skin).
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites42

Inclusion Criteria: * Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * Male or female at least 18 years of age * Type 2 diabetes mellitu...

Countries:ChinaAlgeriaIndiaLebanonMalaysiaSouth AfricaUnited Arab EmiratesHong KongJapanSouth KoreaTaiwanAustraliaDenmarkFinlandPolandSwedenThailandTurkey (Türkiye)United StatesAustriaBelgiumBulgariaCzechiaFranceGermanyHungaryItalyNetherlandsRomaniaRussiaSloveniaSpainSwitzerlandUnited KingdomPuerto RicoIrelandCroatiaSingaporeCanada
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Competitive Landscape -Diabetes Complications 6 trials
CompanyTickerTrialsLead PhaseDrugs
FibroBiologics, Inc.FBLG1PHASE1Undisclosed
MiMedx Group, Inc.MDXG2NAUndisclosed
Integra LifeSciences Holdings CorporationIART1NAUndisclosed
Organogenesis Holdings, Inc. Class AORGO1NAUndisclosed
Healthcare Services Group, Inc.HCSG1NAUndisclosed
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