Recent Updates
Recently added Catalysts

insulin NPH

Phase 3

Diabetes | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Feb 20, 2017

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials3
Total Enrollment642

FDA Designations

No designations recorded

Clinical trial landscape

insulin NPH · 3 trials · 3 indications

Phase 3 2Phase 2 1
NCT01562561Efficacy and Safety of Repaglinide Combined With Insulin NPH in Subjects With Type 2 DiabetesDiabetes
COMPLETED213 Analytics
NCT00065130Safety and Efficacy of Insulin Aspart vs. Regular Human Insulin in Gestational DiabetesDiabetes
COMPLETED27 Analytics
PHASE3COMPLETED
Efficacy and Safety of Repaglinide Combined With Insulin NPH in Subjects With Type 2 Diabetes
Diabetes
NCT01562561213
Unlock trial analytics
PHASE3COMPLETED
Safety and Efficacy of Insulin Aspart vs. Regular Human Insulin in Gestational Diabetes
Diabetes
NCT0006513027
Unlock trial analytics

Study Endpoints

Primary Endpoints

HbA1c (glycosylated haemoglobin)
Week 0 (visit 5); week 26
Postprandial glycemic control
HbA1c
For the duration of the trial

Secondary Endpoints

FPG (fasting plasma glucose)
Week 0 (visit 5); week 26
7-point blood glucose profile
Week 0 (visit 5); week 26
Hypoglycaemic episodes
Week 0 (visit 5); week 26
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Rep + NPHEXPERIMENTAL -
NPHACTIVE_COMPARATOR -
AACTIVE_COMPARATOR -
BEXPERIMENTAL -

Interventions

NameTypeDescription
repaglinideDRUG2 mg at each main meal
insulin NPHDRUGAdministrated subcutaneously (s.c., under the skin) either at bedtime or twice daily at breakfast and before dinner.
human insulinDRUG -
insulin aspartDRUG -
EX1000DRUG"Soft-treat-to-target" dose titration scheme, injection s.c.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Type 2 diabetes * HbA1c (glycosylated haemoglobin): 7-13% (both inclusive) * BMI (body mass index) maximum 35 kg/m\^2

Countries:Hong KongMalaysiaPhilippinesSouth AfricaTaiwanUnited StatesBrazil
Unlock Eligibility Criteria

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
Unlock Competitive Intelligence