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Actrapid HM

Phase 2

Diabetes, Type I | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Apr 7, 2008

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment112

FDA Designations

No designations recorded

Clinical trial landscape

Actrapid HM · 1 trial · 1 indication

Phase 2 1
NCT00654121Prevention of Clinical Onset of Type 1 Diabetes in High Risk First Degree RelativesDiabetes, Type I
COMPLETED112 Analytics
PHASE2COMPLETED
Prevention of Clinical Onset of Type 1 Diabetes in High Risk First Degree Relatives
Diabetes, Type IUnlock trial analytics

Study Endpoints

Primary Endpoints

Fasting glycemia;
2004
fasting and stimulated plasma C-peptide and proinsulin values;
2004
islet cell autoantibodies;
2004
body weight gain.
2004
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Study Design & Arms

MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATOR56 subjects will receive metabolically active insulin by subcutaneous injections for 36 months (twice daily)
2NO_INTERVENTION -

Interventions

NameTypeDescription
Actrapid HMDRUG56 subjects will receive metabolically active insulin by subcutaneous injections for 36 months (twice daily)
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Eligibility Criteria

Age Range5 Years to 39 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Sibling/offspring of a Type 1 diabetic patient * in good general condition * age 5-39 years * fasting plasma glucose \<126 mg/dL AND an OGTT that is non-diabetic by 1997 ADA criteria (33): 1. Normal glycemia: * fasting plasma glucose \< 110 mg/dL and * 2 hour pla...

Countries:Belgium
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Competitive Landscape -Diabetes Complications 6 trials (matched to "Diabetes, Type I")

Frequently asked questions about Actrapid HM

What is Actrapid HM used for in Type I diabetes?

Actrapid HM is an investigational small molecule being studied for the prevention of clinical onset of Type 1 diabetes in high-risk first-degree relatives. It is being developed by Novo Nordisk A/S (NVO) and is currently in Phase 2 clinical development.

Who makes Actrapid HM?

Actrapid HM is being developed by Novo Nordisk A/S, a biopharmaceutical company listed on the stock exchange under the ticker NVO. The drug is currently in Phase 2 clinical development for Type 1 diabetes.

What phase is Actrapid HM in?

Actrapid HM is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 clinical trial has been completed for the prevention of Type 1 diabetes.

What clinical trials is Actrapid HM in?

Actrapid HM has been studied in one completed Phase 2 clinical trial with the identifier NCT00654121. The trial, titled 'Prevention of Clinical Onset of Type 1 Diabetes in High Risk First Degree Relatives', enrolled 112 participants in Belgium and included healthy volunteers.

Is Actrapid HM the same as insulin?

Actrapid HM is a small molecule being investigated for the prevention of Type 1 diabetes. The available information does not indicate that it is the same as insulin. Its mechanism of action has not been disclosed in the clinical trial data.