Adjustment of the dose of long acting insulin (Degludec) to reduce low glucose after exercise in patients with type 1 diabetes

Phase 1

• Conditions: type 1 diabetes mellitus; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2019-004222-22-NL
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-10
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Adults with type 1 diabetes mellitus, 18-60 years
• Diabetes duration at least two years
• Treatment with long-acting insulin in combination with short-acting insulin analogue, according to basal-bolus regimen for at least one year
• Stable glycaemic control with HbA1c =75 mmol/mol (9%)
• At least one severe hypoglycaemia in the past year and/or =2 points on Dutch modified version of Clarke score or =3 points on Gold score
• Regularly engaging in exercise of moderate intensity or more (at least one hour per week)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Microvascular complications, except background retinopathy or microalbuminuria
• History of cardiovascular disease, including heart failure, symptomatic cardiac valve disease and treatment-requiring arrhythmia
• Use of drugs affecting glucose metabolism other than insulin or metformin
• BMI >30 kg/m2
• Blood pressure >160/90 mmHg or use of blood pressure lowering drugs
• Pregnancy or the wish to become pregnant
• MDRD-GFR <60 ml/min/1.73 m2

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified