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NPH insulin

Phase 3

Diabetes | Small molecule | Metabolic |Novo Nordisk A/S|Last Updated: Jul 18, 2017

Success Probability

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment470

FDA Designations

No designations recorded

Clinical trial landscape

NPH insulin · 2 trials · 2 indications

Phase 3 2
NCT00474045Efficacy and Safety of Insulin Detemir Versus Neutral Protamine Hagedorn (NPH) Insulin in Pregnant Women With Type 1 DiabetesDiabetes
COMPLETED470 Analytics
NCT03220425Evaluation of the Efficacy and Safety of Insulin Detemir Compared With That of NPH Insulin in Subjects With Type 1 Diabetes.Diabetes Mellitus, Type 1
COMPLETED752 Analytics
PHASE3COMPLETED
Efficacy and Safety of Insulin Detemir Versus Neutral Protamine Hagedorn (NPH) Insulin in Pregnant Women With Type 1 Diabetes
DiabetesUnlock trial analytics
PHASE3COMPLETED
Evaluation of the Efficacy and Safety of Insulin Detemir Compared With That of NPH Insulin in Subjects With Type 1 Diabetes.
Diabetes Mellitus, Type 1Unlock trial analytics

Study Endpoints

Primary Endpoints

Glycosylated Haemoglobin (HbA1c) for Full Analysis Set (Pregnant Subjects) at GW 36
At gestational week (GW) 36
Glycosylated Haemoglobin (HbA1c) for Per Protocol Analysis Set (Pregnant Subjects) at GW 36
At gestational week (GW) 36
The change in the level of glycosylated haemoglobin(HbA1c)
From start of treatment visit 2 (week 0) until end of treatment visit 8 (week 26)

Secondary Endpoints

Glycosylated Haemoglobin (HbA1c) During Pregnancy
During the pregnancy period [Visit P1 (GW 8-12), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36), Delivery Visit (end of pregnancy)] and Follow-Up Visit ( 6 weeks after delivery)
Subjects Reaching HbA1c at or Below 6.0% Both at GW 24 and GW 36
At both Visit P3 (GW 24) and Visit P4 (GW 36)
Fasting Plasma Glucose (FPG)
During the pregnancy period [Visit P1 (GW 8-12), Visit P2 (GW 14), Visit P3 (GW 24), Visit P4 (GW 36)]
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Insulin detemirEXPERIMENTALIndividually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
Neutral Protamine Hagedorn (NPH) insulinACTIVE_COMPARATORIndividually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
NPH insulinACTIVE_COMPARATOR -

Interventions

NameTypeDescription
insulin detemirDRUGTreat-to-target, dose titration, s.c. (under the skin) injection
NPH insulinDRUGTreat-to-target, dose titration, s.c. (under the skin) injection
insulin aspartDRUGTreat-to-target, dose titration, s.c. (under the skin) injection
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites98

Inclusion Criteria: * Type 1 diabetes treated with insulin for at least 12 months * Planning to become pregnant and have a screening HbA1c (glycosylated haemoglobin) lesser than or equal to 9.0%, or * Pregnant with an intrauterine singleton living foetus, 8-12 weeks pregnant when joining the trial ...

Countries:ArgentinaAustraliaAustriaBrazilCanadaCroatiaDenmarkFinlandFranceIrelandIsraelNorwayPolandRussiaSouth AfricaSpainUnited KingdomBelgiumNetherlandsSweden
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Competitive Landscape -Diabetes Complications 6 trials (matched to "Diabetes")

Frequently asked questions about NPH insulin

What is NPH insulin used for?

NPH insulin is an intermediate-acting insulin used for the treatment of diabetes mellitus, including type 1 diabetes. It is administered to help control blood glucose levels in patients who require insulin therapy.

Who makes NPH insulin?

NPH insulin is developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker symbol NVO.

What phase is NPH insulin in?

NPH insulin is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. Clinical trials are ongoing to evaluate its efficacy and safety.

What clinical trials is NPH insulin in?

NPH insulin has been studied in two Phase 3 clinical trials. One trial (NCT00474045) evaluated its efficacy and safety in pregnant women with type 1 diabetes, enrolling 470 participants. Another trial (NCT03220425) compared NPH insulin with insulin detemir in subjects with type 1 diabetes, enrolling 752 participants. Both trials have been completed.

Is NPH insulin the same as insulin detemir?

No, NPH insulin is not the same as insulin detemir. They are different insulin formulations. In clinical trials, insulin detemir has been compared with NPH insulin to evaluate their relative efficacy and safety in managing type 1 diabetes.