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Comparison of Insulin Detemir Plus Insulin Aspart With Insulin NPH Plus Human Soluble Insulin in Subjects With Type 1 Diabetes

NCT ID: NCT01486940

Last Updated: 2017-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

598 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2002-10-31

Brief Summary

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This trial is conducted in Europe and South America. The aim of this trial is to compare the glycaemic control of insulin detemir plus insulin aspart with that of insulin NPH plus human soluble insulin in subjects with type 1 diabetes on a basal/bolus regimen.

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Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Basal/bolus regimen 1

Group Type EXPERIMENTAL

insulin detemir

Intervention Type DRUG

Individually adjusted dose administered subcutaneously (s.c., under the skin) twice daily

insulin aspart

Intervention Type DRUG

Individually adjusted dose administered subcutaneously (s.c., under the skin) prior to meals

Basal/bolus regimen 2

Group Type ACTIVE_COMPARATOR

insulin NPH

Intervention Type DRUG

Individually adjusted dose administered subcutaneously (s.c., under the skin) twice daily

human soluble insulin

Intervention Type DRUG

Individually adjusted dose administered subcutaneously (s.c., under the skin) prior to meals

Interventions

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insulin detemir

Individually adjusted dose administered subcutaneously (s.c., under the skin) twice daily

Intervention Type DRUG

insulin aspart

Individually adjusted dose administered subcutaneously (s.c., under the skin) prior to meals

Intervention Type DRUG

insulin NPH

Individually adjusted dose administered subcutaneously (s.c., under the skin) twice daily

Intervention Type DRUG

human soluble insulin

Individually adjusted dose administered subcutaneously (s.c., under the skin) prior to meals

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 1 diabetes for at least 12 months
* Current treatment with any basal/bolus regimen or any biphasic insulin treatment for at least 6 months
* BMI below or equal to 35 kg/m\^2
* HbA1c below or equal to 12%

Exclusion Criteria

* Proliferative retinopathy or maculopathy requiring acute treatment
* Recurrent major hypoglycaemia that may interfere with trial participation (as judged by the Investigator)
* Subjects with known hypoglycaemic unawareness as judged by the Investigator
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Junín, , Argentina

Site Status

Novo Nordisk Investigational Site

Morón, , Argentina

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Novo Nordisk Investigational Site

Varaždin, , Croatia

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Novo Nordisk Investigational Site

Hradec Králové, , Czechia

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Novo Nordisk Investigational Site

Liberec, , Czechia

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Novo Nordisk Investigational Site

Plzen - Lochotin, , Czechia

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Novo Nordisk Investigational Site

Prague, , Czechia

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Novo Nordisk Investigational Site

Prague, , Czechia

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Novo Nordisk Investigational Site

Prague, , Czechia

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Novo Nordisk Investigational Site

Prague, , Czechia

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Novo Nordisk Investigational Site

Århus C, , Denmark

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Novo Nordisk Investigational Site

Copenhagen, , Denmark

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Novo Nordisk Investigational Site

Hillerød, , Denmark

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Novo Nordisk Investigational Site

Hjørring, , Denmark

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Novo Nordisk Investigational Site

Holbæk, , Denmark

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Køge, , Denmark

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Silkeborg, , Denmark

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Slagelse, , Denmark

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Svendborg, , Denmark

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Kemi, , Finland

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Kokkola, , Finland

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Kuopio, , Finland

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Oulu, , Finland

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Pärnu, , Finland

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Rovaniemi, , Finland

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Viljandi, , Finland

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Angers, , France

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Grenoble, , France

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Lille, , France

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Lorient, , France

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Montpellier, , France

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Mougins, , France

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Narbonne, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Poitiers, , France

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Athens, , Greece

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Athens, , Greece

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Athens, , Greece

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Alessandria, , Italy

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Asti, , Italy

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Bari, , Italy

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Bergamo, , Italy

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Catania, , Italy

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Catania, , Italy

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Genova, , Italy

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Lucca, , Italy

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Milan, , Italy

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Padua, , Italy

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Prato, , Italy

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Ravenna, , Italy

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Roma, , Italy

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Torino, , Italy

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Novo Nordisk Investigational Site

Skopje, , North Macedonia

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Novo Nordisk Investigational Site

Arendal, , Norway

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Novo Nordisk Investigational Site

Gjettum, , Norway

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Novo Nordisk Investigational Site

Gjøvik, , Norway

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Kongsberg, , Norway

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Novo Nordisk Investigational Site

Kongsvinger, , Norway

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Novo Nordisk Investigational Site

Kristiansand, , Norway

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Novo Nordisk Investigational Site

Rådal, , Norway

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Bydgoszcz, , Poland

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Novo Nordisk Investigational Site

Bydgoszcz, , Poland

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Gdansk, , Poland

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Krakow, , Poland

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Lodz, , Poland

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Lublin, , Poland

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Novo Nordisk Investigational Site

Szczecin, , Poland

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Novo Nordisk Investigational Site

Timișoara, , Romania

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Novo Nordisk Investigational Site

Moscow, , Russia

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Novo Nordisk Investigational Site

Moscow, , Russia

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Novo Nordisk Investigational Site

Košice, , Slovakia

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Novo Nordisk Investigational Site

Moldava nad Bodvou, , Slovakia

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Novo Nordisk Investigational Site

Falun, , Sweden

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Countries

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Argentina Croatia Czechia Denmark Finland France Greece Italy North Macedonia Norway Poland Romania Russia Slovakia Sweden

References

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Hermansen K, Fontaine P, Kukolja KK, Peterkova V, Leth G, Gall MA. Insulin analogues (insulin detemir and insulin aspart) versus traditional human insulins (NPH insulin and regular human insulin) in basal-bolus therapy for patients with type 1 diabetes. Diabetologia. 2004 Apr;47(4):622-9. doi: 10.1007/s00125-004-1365-z.

Reference Type RESULT
PMID: 15298338 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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NN304-1374

Identifier Type: -

Identifier Source: org_study_id

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