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148-0287-A-4.2mM-cartridge

Phase 1

Diabetes | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Jul 31, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment70

FDA Designations

No designations recorded

Clinical trial landscape

148-0287-A-4.2mM-cartridge · 1 trial · 3 indications

Phase 1 1
NCT01730014A Trial Investigating the Safety, Tolerability, and Distribution and Activity in the Body of NNC0148-0000-0287 Injected Under the Skin in Healthy Subjects and in Subjects With Type 1 DiabetesDiabetes
COMPLETED70 Analytics
PHASE1COMPLETED
A Trial Investigating the Safety, Tolerability, and Distribution and Activity in the Body of NNC0148-0000-0287 Injected Under the Skin in Healthy Subjects and in Subjects With Type 1 Diabetes
DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of adverse events (AE)
From trial product administration until completion of the post-treatment follow-up visit at Day 37

Secondary Endpoints

Incidence of hypoglycaemic episodes
From trial product administration until completion of the post-treatment follow-up visit at Day 37
AUC, the area under the serum insulin 287 concentration-time curve
From dosing visit to infinity calculated from a 0-36 days NNC0148-0287 serum concentration-time-curve based on 43 sampling time points
Cmax, the maximum serum insulin 287 concentration
Observed (within 0-36 days)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Trial part 1EXPERIMENTAL -
Trial part 2, treatment AEXPERIMENTAL -
Trial part 2, treatment BEXPERIMENTAL -

Interventions

NameTypeDescription
148-0287-A-4.2mM-cartridgeDRUGIn a dose-escalating design, healthy subjects will receive a single dose, injected subcutaneously.
placeboDRUGIn a dose-escalating design, healthy subjects will receive 148-0287-A-placebo-cartridge, injected subcutaneously.
insulin glargineDRUGIn a dose-escalating design, subjects with type 1 diabetes will receive insulin glargine once daily, injected subcutaneously. Subjects will only be randomised to receive either treatment A or B.
sodium chloride 0.9% w/vDRUGIn a dose-escalating design, subjects with type 1 diabetes will receive sodium chloride 0.9% w/v, injected subcutaneously daily. Subjects will only be randomised to receive either treatment A or B.
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Eligibility Criteria

Age Range18 Years to 64 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * TRIAL PART 1 (HEALTHY SUBJECTS): * Healthy male subject * Age 18-55 years (both inclusive) * Body mass index 18.0-28.0 kg/m\^2 (both inclusive) * TRIAL PART 2 (SUBJECTS WITH TYPE 1 DIABETES): * Healthy male subject (with the exception of conditions associated with diabetes mel...

Countries:Germany
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Competitive Landscape -Diabetes Complications 6 trials (matched to "Diabetes")

Frequently asked questions about 148-0287-A-4.2mM-cartridge

What is 148-0287-A-4.2mM-cartridge used for?

148-0287-A-4.2mM-cartridge is an investigational small molecule being developed for diabetes. It is currently in Phase 1 clinical development, meaning it has not been approved and is still being studied for safety and tolerability in humans.

Who makes 148-0287-A-4.2mM-cartridge?

148-0287-A-4.2mM-cartridge is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO.

What phase is 148-0287-A-4.2mM-cartridge in?

148-0287-A-4.2mM-cartridge 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.

What clinical trials is 148-0287-A-4.2mM-cartridge in?

148-0287-A-4.2mM-cartridge has one completed Phase 1 trial, registered as NCT01730014. The trial investigated safety, tolerability, distribution, and activity in healthy subjects and subjects with type 1 diabetes. It enrolled 70 male participants in Germany.

Is 148-0287-A-4.2mM-cartridge the same as NNC0148-0000-0287?

Yes, 148-0287-A-4.2mM-cartridge is the same as NNC0148-0000-0287. The clinical trial NCT01730014 refers to the drug as NNC0148-0000-0287, which is the active ingredient or compound name, while 148-0287-A-4.2mM-cartridge is the formulation name.