Comparison of Insulin Detemir With NPH Insulin in Type 1 Diabetes

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).

Official Title

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

Conditions

Diabetes Mellitus, Type 1

Study Type

Interventional

Study Design

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• HbA1c [Time Frame: after a two-year trial period]

Secondary Outcome Measures:

• Adverse events
• body weight
• Antibodies
• Body-composition
• Blood glucose
• Hypoglycaemia

Study Start

June 2004

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

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

Total Enrolment

500

Contact Details

Australian Locations:

• Brisbane, Australia

For more information, refer to the Novo Nordisk Clinical Trials Registry

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