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NNC 0148-0000-0362

Phase 1

Diabetes | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: May 29, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment83

FDA Designations

No designations recorded

Clinical trial landscape

NNC 0148-0000-0362 · 1 trial · 3 indications

Phase 1 1
NCT01597713A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0362 in Healthy SubjectsDiabetes
COMPLETED83 Analytics
PHASE1COMPLETED
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0362 in Healthy Subjects
DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of adverse events
Recorded from trial product administration and until completion of Sub-visit G (i.e. Day 13) of the dosing visit

Secondary Endpoints

Area under the serum insulin concentration-time curve (with Trial part 1)
From 0 to 288 hours after a single oral dose of NNC 0148-0000-0362 or a single subcutaneous (s.c.) dose of insulin glargine, respectively
Area under the glucose infusion rate (GIR)-time curve (Trial part 1)
From 0 to 24 hours after a single oral dose of NNC 0148-0000-0362 or a single s.c. dose of insulin glargine, respectively
Area under the serum insulin concentration-time curve (Trial part 2)
From 0 hours to infinity after a single dose of NNC 0148-0000-0362 administered orally as 1 and 3 tablets and intravenously, respectively
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1, level 1-7 escalating dosesEXPERIMENTAL -
Part 2, cross-overEXPERIMENTAL -

Interventions

NameTypeDescription
NNC 0148-0000-0362DRUGSubjects will be randomised to receive a single dose of NNC 0148-0000-0362 orally within each dose group
insulin glargineDRUGAs an active comparator, one standard dose will be given subcutaneously (s.c., under the skin) within each dose group
placeboDRUGSubjects will receive a single dose of oral placebo within each dose group
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Body mass index 18-28 kg/m\^2 (both inclusive) * Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by...

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

Frequently asked questions about NNC 0148-0000-0362

What is NNC 0148-0000-0362 used for?

NNC 0148-0000-0362 is an investigational small molecule being developed for the treatment of diabetes, including type 2 diabetes. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes NNC 0148-0000-0362?

NNC 0148-0000-0362 is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO.

What phase is NNC 0148-0000-0362 in?

NNC 0148-0000-0362 is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. One Phase 1 trial has been completed.

What clinical trials is NNC 0148-0000-0362 in?

NNC 0148-0000-0362 has been studied in one completed Phase 1 trial, NCT01597713, which investigated its safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy subjects. The trial enrolled 83 participants and was conducted in Germany.

Is NNC 0148-0000-0362 the same as NNC0148-0000-0362?

NNC 0148-0000-0362 is the same compound as NNC0148-0000-0362, with the hyphenation being a formatting variation. Both names refer to the same investigational drug developed by Novo Nordisk.