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Faster Aspart 200 U/mL

Phase 1

Diabetes Mellitus, Type 1 | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Mar 18, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

Faster Aspart 200 U/mL · 1 trial · 1 indication

Phase 1 1
NCT03723759A Research Study Looking at How Faster Aspart Injected in Double Concentration Works in the Body of People With Type 1 Diabetes MellitusDiabetes Mellitus, Type 1
COMPLETED56 Analytics
PHASE1COMPLETED
A Research Study Looking at How Faster Aspart Injected in Double Concentration Works in the Body of People With Type 1 Diabetes Mellitus
Diabetes Mellitus, Type 1Unlock trial analytics

Study Endpoints

Primary Endpoints

AUCIAsp,0h-t - Area under the serum insulin aspart concentration-time curve from 0 to t hours after investigational medicinal product (IMP) administration, where t is end of exposure
0 to 10 hours after IMP administration

Measured in pmol\*h/L

Secondary Endpoints

AUCIAsp,0-1h - Area under the serum insulin aspart concentration-time curve from 0 to 1 hour after IMP administration
0 to 1 hour after IMP administration
AUCIAsp,0-2h - Area under the serum insulin aspart concentration-time curve from 0 to 2 hours after IMP administration
0 to 2 hours after IMP administration
AUCIAsp,0-inf - Area under the serum insulin aspart concentration-time curve from 0 hours after IMP administration to infinity
0 to 10 hours after IMP administration
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTALParticipants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: formulation D, faster aspart 100 U/mL, formulation B, formulation A, formulation C, formulation E. The dosing visits will be separated by wash-out periods (2-21 days).
Group BEXPERIMENTALParticipants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: formulation C, formulation B, formulation D, formulation E, formulation A, faster aspart 100 U/mL. The dosing visits will be separated by wash-out periods (2-21 days).
Group CEXPERIMENTALParticipants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: formulation E, formulation C, formulation A, formulation B, faster aspart 100 U/mL, formulation D. The dosing visits will be separated by wash-out periods (2-21 days).
Group DEXPERIMENTALParticipants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: formulation A, formulation D, formulation C, faster aspart 100 U/mL, formulation E, formulation B. The dosing visits will be separated by wash-out periods (2-21 days).
Group EEXPERIMENTALParticipants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: faster aspart 100 U/mL, formulation A, formulation E, formulation D, formulation B, formulation C. The dosing visits will be separated by wash-out periods (2-21 days).
Group FEXPERIMENTALParticipants will be allocated to a treatment sequence consisting of 5 formulations of faster aspart 200 U/mL and faster aspart 100 U/mL in following sequence: formulation B, formulation E, faster aspart 100 U/mL, formulation C, formulation D, formulation A. The dosing visits will be separated by wash-out periods (2-21 days).

Interventions

NameTypeDescription
Faster Aspart 200 U/mLDRUGA single dose (0.15 U/kg) of five formulations of fast-acting insulin aspart 200 U/mL (formulations A, B, C, D, E) in a sequential manner via subcutaneous injection.
Faster aspart 100 U/mLDRUGA single dose (0.15 U/kg) of fast-acting insulin aspart 100 U/mL via subcutaneous injection.
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent * Diagnosed with type 1 diabetes mellitus greater than or equal to 1 year prior to the day of screening * Treated with multiple daily insulin injections or continuous subcutaneous insulin...

Countries:Germany
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Frequently asked questions about Faster Aspart 200 U/mL

What is Faster Aspart 200 U/mL used for?

Faster Aspart 200 U/mL is an investigational drug being studied for the treatment of Type 1 Diabetes Mellitus. It is a small molecule developed by Novo Nordisk A/S and is currently in Phase 1 clinical development. The drug is not yet approved and remains under investigation.

Who makes Faster Aspart 200 U/mL?

Faster Aspart 200 U/mL is developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting clinical trials to evaluate the drug's effects in people with Type 1 Diabetes Mellitus.

What phase is Faster Aspart 200 U/mL in?

Faster Aspart 200 U/mL is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing.

What clinical trials is Faster Aspart 200 U/mL in?

Faster Aspart 200 U/mL has one completed clinical trial, identified as NCT03723759. This Phase 1 study, titled 'A Research Study Looking at How Faster Aspart Injected in Double Concentration Works in the Body of People With Type 1 Diabetes Mellitus,' enrolled 56 participants in Germany.

Is Faster Aspart 200 U/mL FDA approved?

Faster Aspart 200 U/mL is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial, NCT03723759, was a controlled, double-blind, randomized study involving 56 participants with Type 1 Diabetes Mellitus.