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NCT01707134

CompletedPhase 3

Safety and Efficacy of Insulin Aspart in Subjects With Type ...

Novo Nordisk A/S Source

NCT01707134|CompletedPhase 3

Safety and Efficacy of Insulin Aspart in Subjects With Type 1 Diabetes

An Open-labelled, Controlled, Multicentre, Multinational, Extension Study Assessing Safety and Efficacy of the Human Insulin Analogue Insulin Aspart (X14) and Human Soluble Insulin as Meal Related Insulin in a Multiple Injection Regimen in Type 1 Diabetic Subjects

Novo Nordisk A/S ClinicalTrials.gov

1 other identifier

ANA/DCD/050

Study Type

interventional

Target

753

Locations

8 countries

Sites

80

Timeline

RegisteredOct 2012

StartedSep 1997

CompletionMay 2000

Brief Summary

This trial is conducted in Europe. The aim of this trial is to evaluate the safety profile of insulin aspart in subjects with type 1 diabetes having participated in trial ANA/DCD/035.

Trial Health

93

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

753

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Sep 1997

Longer than P75 for phase_3 diabetes

Geographic Reach

8 countries

80 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.7 years study duration

Study Start

First participant enrolled

September 1, 1997

Completed

2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2000

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2000

Completed

12.5 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2012

Completed

6 days until next milestone

First Posted

Study publicly available on registry

October 16, 2012

Completed

Last Updated

January 4, 2017

Status Verified

January 1, 2017

Enrollment Period

2.7 years

First QC Date

October 10, 2012

Last Update Submit

January 3, 2017

Conditions

Diabetes Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

Number of hypoglycaemic events

Secondary Outcomes (4)

Occurrence of adverse events
Incidence of hypoglycaemic episodes
Standard safety parameters: Haematology and biochemistry
HbA1c (glycosylated haemoglobin)

Study Arms (2)

insulin aspart

EXPERIMENTAL

Drug: insulin aspartDrug: insulin NPH

human insulin

ACTIVE COMPARATOR

Drug: human soluble insulinDrug: insulin NPH

Interventions

insulin aspartDRUG

Injected subcutaneously (s.c, under the skin) as meal time insulin

insulin aspart

human soluble insulinDRUG

Injected subcutaneously (s.c, under the skin) as meal time insulin

human insulin

insulin NPHDRUG

Will be administrated subcutaneously (s.c, under the skin) once or twice daily as basal insulin

human insulininsulin aspart

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

The subject must have completed the six month controlled treatment period in trial ANA/DCD/035

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Novo Nordisk A/Slead

Study Sites (80)

Novo Nordisk Investigational Site

Graz, 8036, Austria

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Novo Nordisk Investigational Site

Vienna, 1030, Austria

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Novo Nordisk Investigational Site

Vienna, 1090, Austria

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Novo Nordisk Investigational Site

Copenhagen, 2400, Denmark

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Novo Nordisk Investigational Site

Frederiksberg, 2000, Denmark

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Novo Nordisk Investigational Site

Gentofte Municipality, 2820, Denmark

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Novo Nordisk Investigational Site

Kolding, 6000, Denmark

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Novo Nordisk Investigational Site

Køge, 4600, Denmark

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Novo Nordisk Investigational Site

Helsinki, 00029, Finland

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Novo Nordisk Investigational Site

Kotka, 48210, Finland

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Novo Nordisk Investigational Site

Kuopio, 70210, Finland

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Novo Nordisk Investigational Site

Vantaa, 01400, Finland

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Novo Nordisk Investigational Site

Bad Neuenahr-Ahrweiler, 53474, Germany

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Novo Nordisk Investigational Site

Bad Oeynhausen, 32454, Germany

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Novo Nordisk Investigational Site

Bochum, 44789, Germany

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Novo Nordisk Investigational Site

Essen, 45131, Germany

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Novo Nordisk Investigational Site

Essen, 45138, Germany

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Novo Nordisk Investigational Site

Flensburg, 24939, Germany

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Novo Nordisk Investigational Site

Frankfurt, 60590, Germany

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Freiburg im Breisgau, 79106, Germany

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Novo Nordisk Investigational Site

Friedrichsthal, 66299, Germany

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Novo Nordisk Investigational Site

Giessen, 35385, Germany

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Novo Nordisk Investigational Site

Haan, 42781, Germany

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Novo Nordisk Investigational Site

Hamburg, 20251, Germany

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Kiel, 24103, Germany

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Novo Nordisk Investigational Site

Magdeburg, 39120, Germany

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Novo Nordisk Investigational Site

Magdeburg, 39124, Germany

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Novo Nordisk Investigational Site

Mainz, 55116, Germany

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Novo Nordisk Investigational Site

Mainz, 55131, Germany

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Novo Nordisk Investigational Site

Mönchengladbach, 41061, Germany

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Novo Nordisk Investigational Site

München, 81925, Germany

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Novo Nordisk Investigational Site

Oberhausen, 46145, Germany

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Novo Nordisk Investigational Site

Ostercappeln, 49179, Germany

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Novo Nordisk Investigational Site

Saarlouis, 66740, Germany

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Novo Nordisk Investigational Site

Schwerin, 19049, Germany

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Novo Nordisk Investigational Site

Stuttgart, 70184, Germany

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Novo Nordisk Investigational Site

Stuttgart, 70191, Germany

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Novo Nordisk Investigational Site

Wiesbaden, 65191, Germany

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Novo Nordisk Investigational Site

Wuppertal, 42117, Germany

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Novo Nordisk Investigational Site

Würzburg, 97070, Germany

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Novo Nordisk Investigational Site

Bergen, 5021, Norway

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Novo Nordisk Investigational Site

Haugesund, 5500, Norway

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Novo Nordisk Investigational Site

Oslo, 0407, Norway

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Novo Nordisk Investigational Site

Stavanger, 4011, Norway

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Novo Nordisk Investigational Site

Trondheim, 7006, Norway

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Novo Nordisk Investigational Site

Falun, 791 82, Sweden

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Novo Nordisk Investigational Site

Karlstad, 651 85, Sweden

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Novo Nordisk Investigational Site

Zurich, 8032, Switzerland

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Novo Nordisk Investigational Site

Airdrie, ML6 0JS, United Kingdom

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Novo Nordisk Investigational Site

Bath, BA1 3NG, United Kingdom

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Novo Nordisk Investigational Site

Blackburn, BB3 3LR, United Kingdom

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Novo Nordisk Investigational Site

Bolton, BL1 4QS, United Kingdom

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Novo Nordisk Investigational Site

Church Village, CF38 1AB, United Kingdom

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Novo Nordisk Investigational Site

Cosham, PO6 3LY, United Kingdom

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Novo Nordisk Investigational Site

Coventry, CV1 4FH, United Kingdom

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Novo Nordisk Investigational Site

Edinburgh, EH16 4SA, United Kingdom

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Edinburgh, EH4 2XU, United Kingdom

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Exeter, EX2 5AX, United Kingdom

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Novo Nordisk Investigational Site

Gillingham, ME7 5NY, United Kingdom

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Novo Nordisk Investigational Site

Hull, HU3 2JZ, United Kingdom

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Novo Nordisk Investigational Site

Inverness, IV2 3UJ, United Kingdom

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Leicester, LE1 5WW, United Kingdom

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Novo Nordisk Investigational Site

London, E1 1BB, United Kingdom

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Novo Nordisk Investigational Site

Middlesbrough, TS5 5AZ, United Kingdom

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Novo Nordisk Investigational Site

Newcastle, NE7 7DN, United Kingdom

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Northampton, NN1 5BD, United Kingdom

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Nottingham, NG7 2UH, United Kingdom

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Novo Nordisk Investigational Site

Penarth, CF64 2XX, United Kingdom

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Novo Nordisk Investigational Site

Plymouth, PL8 8DQ, United Kingdom

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Novo Nordisk Investigational Site

Reading, RG51 5BS, United Kingdom

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Novo Nordisk Investigational Site

Rugby, CV22 5PX, United Kingdom

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Novo Nordisk Investigational Site

Salisbury, SP2 8BJ, United Kingdom

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Sheffield, S5 7AU, United Kingdom

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Southampton, SO14 OYG, United Kingdom

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Novo Nordisk Investigational Site

Stevenage, SG1 4AB, United Kingdom

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Novo Nordisk Investigational Site

Stirling, FK8 2AU, United Kingdom

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Novo Nordisk Investigational Site

Swansea, SA6 6NL, United Kingdom

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Novo Nordisk Investigational Site

Watford, WD18 0HB, United Kingdom

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Novo Nordisk Investigational Site

Whiston, L35 5DR, United Kingdom

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Novo Nordisk Investigational Site

York, YO3 7HE, United Kingdom

Location

Related Publications (1)

Home PD, Hallgren P, Usadel KH, Sane T, Faber J, Grill V, Friberg HH. Pre-meal insulin aspart compared with pre-meal soluble human insulin in type 1 diabetes. Diabetes Res Clin Pract. 2006 Feb;71(2):131-9. doi: 10.1016/j.diabres.2005.05.015. Epub 2005 Jul 27.
PMID: 16054266RESULT

Related Links

Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1

Interventions

Insulin AspartInsulin, Isophane

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInsulin, Long-Acting

Study Officials

Global Clinical Registry (GCR,1452)
Novo Nordisk A/S
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 10, 2012

First Posted

October 16, 2012

Study Start

September 1, 1997

Primary Completion

May 1, 2000

Study Completion

May 1, 2000

Last Updated

January 4, 2017

Record last verified: 2017-01

Locations

GB(32)FI(4)DE(28)CH(1)DK(5)NO(5)SE(2)AU(3)