Comparison of Insulin Detemir With NPH Insulin in Type 1 Diabetes

NCT ID: NCT00184665

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

501 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2006-09-30

Brief Summary

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This trial is conducted in Africa, Asia, Europe, Oceania, and South America. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir compared to NPH insulin administered as basal insulin for the treatment of type 1 diabetes and to verify the safety of use (number and severity of episodes of hypoglycemia, body weight, and insulin antibodies and side effects).

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

Interventions

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insulin detemir

Intervention Type DRUG

insulin NPH

Intervention Type DRUG

insulin aspart

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Type 1 diabetes
* Currently on basal-bolus regimen
* BMI = 35.0 kg/m2
* HbA1c =11.0%

Exclusion Criteria

* Proliferative retinopathy or maculopathy
* Recurrent major hypoglycaemia
* Cardial problems
* Uncontrolled hypertension
* Impaired hepatic or renal function
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

Buenos Aires, , Argentina

Site Status

Novo Nordisk Investigational Site

Ciudad Autonoma de Bs As, , Argentina

Site Status

Novo Nordisk Investigational Site

Ciudad Autónoma de BsAs, , Argentina

Site Status

Novo Nordisk Investigational Site

Mar del Plata, , Argentina

Site Status

Novo Nordisk Investigational Site

St Leonards, New South Wales, Australia

Site Status

Novo Nordisk Investigational Site

Hobart, Tasmania, Australia

Site Status

Novo Nordisk Investigational Site

Melbourne, Victoria, Australia

Site Status

Novo Nordisk Investigational Site

Darlinghurst, , Australia

Site Status

Novo Nordisk Investigational Site

Melbourne, , Australia

Site Status

Novo Nordisk Investigational Site

Stones Corner, , Australia

Site Status

Novo Nordisk Investigational Site

Woodville, , Australia

Site Status

Novo Nordisk Investigational Site

Plovdiv, , Bulgaria

Site Status

Novo Nordisk Investigational Site

Sofia, , Bulgaria

Site Status

Novo Nordisk Investigational Site

Zagreb, , Croatia

Site Status

Novo Nordisk Investigational Site

Vellore, Tamil Nadu, India

Site Status

Novo Nordisk Investigational Site

Chennai, , India

Site Status

Novo Nordisk Investigational Site

Hyderabad, , India

Site Status

Novo Nordisk Investigational Site

Mumbai, , India

Site Status

Novo Nordisk Investigational Site

Cheras, , Malaysia

Site Status

Novo Nordisk Investigational Site

Kota Bharu, Kelantan, , Malaysia

Site Status

Novo Nordisk Investigational Site

Skopje, , North Macedonia

Site Status

Novo Nordisk Investigational Site

Bucharest, , Romania

Site Status

Novo Nordisk Investigational Site

Bucharest, , Romania

Site Status

Novo Nordisk Investigational Site

Johannesburg, Gauteng, South Africa

Site Status

Novo Nordisk Investigational Site

Johannesburg, Gauteng, South Africa

Site Status

Novo Nordisk Investigational Site

Cape Town, Western Cape, South Africa

Site Status

Novo Nordisk Investigational Site

Bloemfontein, , South Africa

Site Status

Novo Nordisk Investigational Site

Bornova-IZMIR, , Turkey (Türkiye)

Site Status

Novo Nordisk Investigational Site

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Argentina Australia Bulgaria Croatia India Malaysia North Macedonia Romania South Africa Turkey (Türkiye)

References

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Bartley PC, Bogoev M, Larsen J, Philotheou A. Long-term efficacy and safety of insulin detemir compared to Neutral Protamine Hagedorn insulin in patients with Type 1 diabetes using a treat-to-target basal-bolus regimen with insulin aspart at meals: a 2-year, randomized, controlled trial. Diabet Med. 2008 Apr;25(4):442-9. doi: 10.1111/j.1464-5491.2007.02407.x.

Reference Type RESULT
PMID: 18387078 (View on PubMed)

Gschwend MH, Aagren M, Valentine WJ. Cost-effectiveness of insulin detemir compared with neutral protamine Hagedorn insulin in patients with type 1 diabetes using a basal-bolus regimen in five European countries. J Med Econ. 2009 Jun;12(2):114-23. doi: 10.3111/13696990903080344.

Reference Type RESULT
PMID: 19545216 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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NN304-1595

Identifier Type: -

Identifier Source: org_study_id

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