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glucose clamp

Phase 1

Diabetes | Unknown | Metabolic |Novo Nordisk A/S|Last Updated: Jan 12, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials2
Total Enrollment55

FDA Designations

No designations recorded

Clinical trial landscape

glucose clamp · 2 trials · 3 indications

Phase 1 2
NCT01789593A Trial Investigating the Effect of Acute Hypoglycaemia on Cognitive Function and Brain Activation Patterns in Subjects With Type 1 DiabetesDiabetes
COMPLETED29 Analytics
NCT01780272A Trial to Investigate the Impact of Nocturnal Hypoglycaemia on Sleep in Subjects With Type 2 DiabetesDiabetes
COMPLETED26 Analytics
PHASE1COMPLETED
A Trial Investigating the Effect of Acute Hypoglycaemia on Cognitive Function and Brain Activation Patterns in Subjects With Type 1 Diabetes
DiabetesUnlock trial analytics
PHASE1COMPLETED
A Trial to Investigate the Impact of Nocturnal Hypoglycaemia on Sleep in Subjects With Type 2 Diabetes
DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

Digit Symbol Substitution Test (DSST) score
Average score during hypoglycaemia and/or euglycaemia measured 70-93 minutes after induction of hypoglycaemia and/or euglycaemia
The number of electroencephalogram (EEG) identified arousals
During the first four hours (0-4 hours) after reaching sleep stage N2

Secondary Endpoints

Regional cerebral blood flow (rCBF) score
Average score during hypoglycaemia and/or euglycaemia measured 70-93 minutes after induction of hypoglycaemia and/or euglycaemia
Paced Auditory Serial Addition Task (PASAT) score
During recovery from hypoglycaemia and/or euglycaemia measured 75-90 min after euglycaemia has been restored
Time spent in the different sleep stages (% of total sleep time): Sleep stage N1, Sleep stage N2, Sleep stage N3 and Rapid Eye Movement (REM) sleep
During the first four hours (0-4 hours) after reaching sleep stage N2
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
Hypoglycaemia / euglycaemia clampOTHER -
Euglycaemia clamp / hypoglycaemiaOTHER -
Normoglycaemia followed by hypoglycaemiaOTHER -
Hypoglycaemia followed by normoglycaemiaOTHER -

Interventions

NameTypeDescription
glucose clampOTHEREach subject will be randomly allocated to an experimental visit sequence consisting of a hypoglycaemic glucose clamp followed by euglycaemic glucose clamp (using i.v. infusion of human soluble insulin (Actrapid®)) or vice versa separated by at least 21 days. Each visit includes an overnight stay. For each of the two conditions (euglycaemia and hypoglycaemia) cognitive performance will be assessed by a validated cognitive test
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersNo
Study Sites1

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: * Subje...

Countries:Denmark
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Competitive Landscape -Diabetes Complications 6 trials (matched to "Diabetes")

Frequently asked questions about glucose clamp

What is glucose clamp used for?

Glucose clamp is an investigational tool being studied in diabetes. It is used in clinical trials to investigate the impact of hypoglycemia on sleep and cognitive function in people with type 1 and type 2 diabetes. It is currently in Phase 1 clinical development.

Who makes glucose clamp?

Glucose clamp is being developed by Novo Nordisk A/S, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVO. The company is conducting Phase 1 clinical trials to evaluate the effects of hypoglycemia in patients with diabetes.

What phase is glucose clamp in?

Glucose clamp is in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total of 55 participants enrolled. The drug is investigational and has not been approved by regulatory authorities for commercial use.

What clinical trials is glucose clamp in?

Glucose clamp has been studied in two completed Phase 1 trials. NCT01780272 investigated the impact of nocturnal hypoglycemia on sleep in 26 subjects with type 2 diabetes. NCT01789593 investigated the effect of acute hypoglycemia on cognitive function and brain activation in 29 subjects with type 1 diabetes.

Is glucose clamp the same as insulin?

Glucose clamp is not the same as insulin. It is an investigational tool used in clinical trials to study the effects of hypoglycemia in patients with diabetes. It is being developed by Novo Nordisk, a company known for insulin products, but glucose clamp itself is not an insulin product.