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NCT00184665 Clinical Trial

Comparison of Insulin Detemir With NPH Insulin in Type 1 Diabetes

Diabetes Clinical Trial

Official title:
2 Year Efficiency and Safety Comparison of Insulin Detemir and NPH Insulin in Type 1 Diabetes.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00184665
Other study ID # NN304-1595
Secondary ID
Status Completed
Phase Phase 3
First received September 13, 2005
Last updated January 26, 2017
Start date June 2004
Est. completion date September 2006

Study information
Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Completed
Enrollment 501
Est. completion date September 2006
Est. primary completion date September 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• insulin detemir

• insulin NPH

• insulin aspart

Locations
Country Name City State
Argentina Novo Nordisk Investigational Site Buenos Aires
Argentina Novo Nordisk Investigational Site Ciudad Autonoma de Bs As
Argentina Novo Nordisk Investigational Site Ciudad Autónoma de BsAs
Argentina Novo Nordisk Investigational Site Mar del Plata
Australia Novo Nordisk Investigational Site Darlinghurst
Australia Novo Nordisk Investigational Site Hobart Tasmania
Australia Novo Nordisk Investigational Site Melbourne Victoria
Australia Novo Nordisk Investigational Site Melbourne
Australia Novo Nordisk Investigational Site St Leonards New South Wales
Australia Novo Nordisk Investigational Site Stones Corner
Australia Novo Nordisk Investigational Site Woodville
Bulgaria Novo Nordisk Investigational Site Plovdiv
Bulgaria Novo Nordisk Investigational Site Sofia
Croatia Novo Nordisk Investigational Site Zagreb
India Novo Nordisk Investigational Site Chennai
India Novo Nordisk Investigational Site Hyderabad
India Novo Nordisk Investigational Site Mumbai
India Novo Nordisk Investigational Site Vellore Tamil Nadu
Macedonia, The Former Yugoslav Republic of Novo Nordisk Investigational Site Skopje
Malaysia Novo Nordisk Investigational Site Cheras
Malaysia Novo Nordisk Investigational Site Kota Bharu, Kelantan
Romania Novo Nordisk Investigational Site Bucharest
Romania Novo Nordisk Investigational Site Bucharest
South Africa Novo Nordisk Investigational Site Bloemfontein
South Africa Novo Nordisk Investigational Site Cape Town Western Cape
South Africa Novo Nordisk Investigational Site Johannesburg Gauteng
South Africa Novo Nordisk Investigational Site Johannesburg Gauteng
Turkey Novo Nordisk Investigational Site Bornova-IZMIR
Turkey Novo Nordisk Investigational Site Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Argentina,  Australia,  Bulgaria,  Croatia,  India,  Macedonia, The Former Yugoslav Republic of,  Malaysia,  Romania,  South Africa,  Turkey, 

References & Publications (2)

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-ye — View Citation

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 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c after a two-year trial period
Secondary Adverse events
Secondary Body weight
Secondary Antibodies
Secondary Body composition
Secondary Blood glucose
Secondary Hypoglycaemia
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