A Trial Investigating the Effect of Acute Hypoglycaemia on Cognitive Function and Brain Activation Patterns in Subjects With Type 1 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Other: glucose clamp

Study type: Interventional

Funder types: Industry

Identifiers

NCT01789593

NN1250-4001

U1111-1131-8749 (Other Identifier)

Details and patient eligibility

About

This trial is conducted in Europe. The aim of the trial is to compare cognitive function and associated brain activation patterns during an acute hypoglycaemic episode and during euglycaemia (normal blood glucose concentration). Additionally, the purpose is to assess cognitive function in the recovery phase after hypoglycaemia or euglycaemia, respectively, in subjects with type 1 diabetes.

Enrollment: 29 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Right-handed subjects
• Type 1 diabetes mellitus for at least 12 months
• Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months
• Body mass index 18.0-28.0 kg/m^2 (both inclusive)

Exclusion criteria

• Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
• Current tobacco user (any smoking or use of nicotinic products within 3 months prior to screening)
• Visual impairment or auditory impairment

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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29 participants in 2 patient groups

Hypoglycaemia / euglycaemia clamp

Other group

Treatment:

Other: glucose clamp

Euglycaemia clamp / hypoglycaemia

Other group

Treatment:

Other: glucose clamp