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biphasic insulin as

Phase 3

Diabetes | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Oct 6, 2017

Target and mechanism

ModalitySmall molecule

Also known as biphasic insulin aspart 30, biphasic insulin aspart 70, biphasic insulin aspart 50

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials27
Total Enrollment1,870

FDA Designations

No designations recorded

Clinical trial landscape

biphasic insulin as · 27 trials · 4 indications

Phase 3 6Phase 2 2Phase 1 19
NCT00627445Effect of Biphasic Insulin Aspart 50 on Blood Glucose Control in Subjects With Type 2 DiabetesDiabetes
COMPLETED441 Analytics
NCT01486381Long Term Safety of Biphasic Insulin Aspart 30 in Juveniles With Type 1 DiabetesDiabetes
COMPLETED22 Analytics
NCT01527539Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 DiabetesDiabetes
COMPLETED25 Analytics
NCT01650129Safety and Efficacy of Biphasic Insulin Aspart 50 in Subjects With Type 2 DiabetesDiabetes
COMPLETED83 Analytics
NCT01520818Comparison of Biphasic Human Insulin 30 With Biphasic Insulin Aspart in Subjects With DiabetesDiabetes
COMPLETED666 Analytics
NCT01520753Comparison of Two Biphasic Insulin Aspart Treatments in Subjects With Type 2 DiabetesDiabetes
COMPLETED16 Analytics
PHASE3COMPLETED
Effect of Biphasic Insulin Aspart 50 on Blood Glucose Control in Subjects With Type 2 Diabetes
Diabetes
NCT00627445441
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PHASE3COMPLETED
Long Term Safety of Biphasic Insulin Aspart 30 in Juveniles With Type 1 Diabetes
Diabetes
NCT0148638122
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PHASE3COMPLETED
Long Term Safety and Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes
Diabetes
NCT0152753925
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PHASE3COMPLETED
Safety and Efficacy of Biphasic Insulin Aspart 50 in Subjects With Type 2 Diabetes
Diabetes
NCT0165012983
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PHASE3COMPLETED
Comparison of Biphasic Human Insulin 30 With Biphasic Insulin Aspart in Subjects With Diabetes
Diabetes
NCT01520818666
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PHASE3COMPLETED
Comparison of Two Biphasic Insulin Aspart Treatments in Subjects With Type 2 Diabetes
Diabetes
NCT0152075316
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Study Endpoints

Primary Endpoints

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)

Number of hypoglycaemic episodes
Occurence of adverse events
Standard safety parameters: Haematology, biochemistry and vital signs
HbA1c
Glycosylated haemoglobin A1c (HbA1c)
HbA1c (glycosylated haemoglobin A1c)
Fasting serum glucose
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 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

The Percentage of Subjects Achieving HbA1c Treatment Targets
week 16
Change and Daily Average in 8-point Plasma Glucose
week 0, week 16
Change and Daily Average in Prandial Plasma Glucose Increment
week 0, week 16
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
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
BIAsp 30EXPERIMENTAL -
BIAspEXPERIMENTAL -
BHIEXPERIMENTAL -
BIAsp 50 or 70EXPERIMENTAL -
BHI 30ACTIVE_COMPARATOR -
BIAsp 70EXPERIMENTAL -
BIAsp 70 + BIAsp 50EXPERIMENTAL -
Treatment period 1EXPERIMENTAL -
Treatment period 2ACTIVE_COMPARATOR -
AEXPERIMENTAL -
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
biphasic insulin aspart 30DRUGTreat-to-target dose titration scheme (dose adjusted individually), s.c. (under the skin) injection before dinner
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 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 glargineDRUG -
insulin glulisineDRUG -
insulin aspartDRUGA single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Type 2 diabetes * Currently treated with premix human insulin twice daily with or without oral antidiabetic drugs for at least 3 months * HbA1c (Glycosylated Haemoglobin A1c) between 7.5% - 12.0% (both inclusive) * FPG (Fasting Plasma Glucose) higher than 7.0 mmol/L * BMI (Bod...

Countries:ChinaSouth AfricaCanadaJapanBelgiumFranceIrelandNetherlandsUnited KingdomDenmarkGermanyUnited States
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Competitive Landscape -Diabetes Complications 6 trials (matched to "Diabetes")

CompanyTickerTrialsLead PhaseDrugs
FibroBiologics, Inc.FBLG1PHASE1Undisclosed
MiMedx Group, Inc.MDXG2N/AUndisclosed
Integra LifeSciences Holdings CorporationIART1N/AUndisclosed
Organogenesis Holdings, Inc. Class AORGO1N/AUndisclosed
Healthcare Services Group, Inc.HCSG1N/AUndisclosed
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