The Effect of Exercise on Blood Glucose Levels in Patients With Type 1 Diabetes: A Comparison of 3 Long-acting Insulins

Diabetes Clinical Trial

Official title:

An Assessment of the Impact of Performing Physical Exercise on the Maximum Plasma Glucose Decline in Subjects With Type 1 Diabetes Managed on a Basal Bolus Insulin Regimen: A Comparison of 3 Basal Insulin Treatments - Insulin Detemir, Insulin Glargine and NPH Insulin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00313742
• Other study ID #: NN304-1724
• Status: Completed
• Phase: Phase 4
• Start date: April 2006
• Est. completion date: November 2006

Study information

• Verified date: October 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Europe. The aim of this research is to assess the impact of three basal (long-acting) insulin treatments on blood glucose levels in people with type 1 diabetes when performing physical exercise.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Type 1 Diabetes

• Current basal-bolus insulin therapy

• HbA1c < 10%

• BMI < 32 kg/m2

Exclusion Criteria:

• Proliferative Retinopathy / Maculopathy

• Recurrent major hypoglycaemias

• Impaired hepatic or renal function

• Cardiac Problems

• Uncontrolled hypertension

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• insulin detemir

• insulin glargine

• insulin NPH

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference between plasma glucose concentrations immediately pre-exercise and the minimum plasma glucose concentrations (nadir) in the period 0-150 min following exercise		following 4 weeks of treatment
Secondary	Plasma glucose pre-exercise & post-exercise
Secondary	Hypoglycaemia episodes (major and minor episodes) during exercise, afterwards & from end of study until 07:30 the following morning
Secondary	Plasma glucose profile post-exercise
Secondary	Incidence of adverse events during the trial

External Links

•   Clinical Trials at Novo Nordisk