A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency - Full Text View

Purpose

This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, availability and distribution in the body of once-weekly long-acting growth hormone (NNC0195-0092) compared to once daily Norditropin NordiFlex® in adults with growth hormone deficiency (GHD).

Condition	Intervention	Phase
Growth Hormone Disorder Adult Growth Hormone Deficiency	Drug: NNC0195-0092 Drug: Norditropin NordiFlex®	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomised, Open-labelled, Active-controlled, Multiple Dose, Dose Escalating, Sequential Dose Group Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Once-weekly Long-acting Growth Hormone (NNC0195-0092) Compared to Once-daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency

Resource links provided by NLM:

Genetics Home Reference related topics: combined pituitary hormone deficiency isolated growth hormone deficiency metatropic dysplasia pseudoachondroplasia

MedlinePlus related topics: Diabetes Medicines

Drug Information available for: Somatropin

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Incidence of adverse events (AEs) [ Time Frame: From first administration of trial product and up until Day 49 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

NNC0195-0092 only: Area under the curve, AUC (0-168h) [ Time Frame: From 0 to 168 hours ] [ Designated as safety issue: No ]
Norditropin NordiFlex® only: AUC (0-24h) [ Time Frame: From 0 to 24 hours ] [ Designated as safety issue: No ]
NNC0195-0092, first dose administration only: AUC (0-168h) [ Time Frame: From 0 to 168 hours ] [ Designated as safety issue: No ]
Norditropin NordiFlex®, first dose administration only: AUC (0-24h) [ Time Frame: From 0 to 24 hours ] [ Designated as safety issue: No ]
NNC0195-0092: Maximum serum concentration (Cmax) [ Time Frame: From 0 to 168 hours ] [ Designated as safety issue: No ]
Norditropin NordiFlex®: Cmax [ Time Frame: From 0 to 24 hours ] [ Designated as safety issue: No ]
Insulin-like growth factor I (IGF-I): AUC (0-168h) [ Time Frame: From 0 to 168 hours ] [ Designated as safety issue: No ]
IGF-I: Cmax [ Time Frame: From 0 to 168 hours ] [ Designated as safety issue: No ]
Insulin-like growth factor binding protein-3 (IGFBP-3): AUC IGFBP-3(0-168h) [ Time Frame: From 0 to 168 hours ] [ Designated as safety issue: No ]
IGFBP-3: Cmax [ Time Frame: From 0 to 168 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	32
Study Start Date:	October 2012
Estimated Study Completion Date:	October 2013
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: NNC0195-0092	Drug: NNC0195-0092 Subcutaneous (s.c., under the skin) administration once weekly (Days 1, 8, 15 and 22) of 4 different doses of NNC0195-0092 in an escalating order
Active Comparator: Norditropin NordiFlex®	Drug: Norditropin NordiFlex® Subcutaneous (s.c., under the skin) administration daily for 28 days. The daily dosing will be the same as the pre-trial daily dose of human growth hormone (hGH) taken by the adult with growth hormone deficiency

Eligibility

Ages Eligible for Study:	20 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adults with GHD as defined in the consensus guidelines for the diagnosis and treatment of adults with GHD
Stable human growth hormone (hGH) replacement therapy for at least 3 months

Exclusion Criteria:

Participation in another clinical trial within 3 months or receipt of any investigational medicinal product within 3 months prior to randomisation
Active malignant disease or malignant disease within the last 5 years with exception of fully treated local basal cell carcinoma or carcinoma in situ of cervix
Proliferative retinopathy judged by retina-photo within the last year - only with concomitant diabetes
Heart insufficiency, New York Heart Association (NYHA) class above 2
Adults with GHD with poorly controlled diabetes mellitus with a glycosylated haemoglobin (HbA1c) 64 mmol/mol (8.0%) and/or insulin treatment
Stable pituitary replacement therapy for less than 3 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01706783

Contacts

Contact: Novo Nordisk

clinicaltrials@novonordisk.com

Locations

Denmark
	Recruiting
København Ø, Denmark, 2100
Sweden
	Recruiting
Stockholm, Sweden, 141 86

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Lene Finnerup Nielsen

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT01706783 History of Changes
Other Study ID Numbers:	NN8640-3947, 2011-005484-24, U1111-1125-7331
Study First Received:	October 11, 2012
Last Updated:	May 8, 2013
Health Authority:	Denmark: Danish Medicines Agency Sweden: Medical Products Agency

Additional relevant MeSH terms:

Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases

Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013