NCT01542450CompletedPhase 1
A Randomised, Open-labelled, Single-centre, Two-period Crossover Trial Investigating the Pharmacodynamics and Pharmacokinetics of Single s.c. Doses of NN304 (Insulin Detemir) and NPH Human Insulin in Japanese Subjects With Type 1 Diabetes Mellitus
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- The ratio of area under the glucose infusion rate curve (AUCGIR) 0-5 hours to AUCGIR 0-24 hours
Study Overview
Brief Summary
This trial is conducted in Japan. The aim for this trial is to investigate the pharmacodynamics and pharmacokinetics of insulin detemir and insulin NPH in Japanese subjects with type 1 diabetes mellitus.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Type 1 diabetes mellitus
- •HbA1c (glycosylated haemoglobin) maximum 9.0%
- •Duration of diabetes at least 1 year
- •Body Mass Index (BMI) maximum 25.0 kg/m^2
Exclusion Criteria
- •Recurrent severe hypoglycaemia
- •Proliferative retinopathy or maculopathy requiring acute treatment as judged by the Investigator
- •Impaired hepatic function
- •Impaired renal function
- •Cardiac problems
- •Uncontrolled treated / untreated hypertension
- •Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies, positive
- •Known or suspected allergy against the trial products or related products including the components
- •Previous history of serious allergy or anaphylactic reaction
- •Any disease or condition which the Investigator feel would interfere with the trial participation or evaluation of the results
- •Severe late-phase diabetic complications including nephropathy
- •Blood donation of more than 400 mL (inclusive) in total within the last 12 weeks or more than 200 mL (inclusive) in total within the last 3 weeks
- •Known or suspected alcohol and illicit substance abuse or dependence
- •Pregnancy, breast-feeding (within a year after labour) or the intention to become pregnant
- •The receipt of any investigational drug within the last 12 weeks prior to this trial
- •Current or anticipated treatment with systemic corticosteroids
Arms & Interventions
Treatment period 1
Experimental
Intervention: insulin detemir (Drug)
Treatment period 1
Experimental
Intervention: insulin NPH (Drug)
Treatment period 2
Active Comparator
Intervention: insulin detemir (Drug)
Treatment period 2
Active Comparator
Intervention: insulin NPH (Drug)
Outcomes
Primary Outcomes
The ratio of area under the glucose infusion rate curve (AUCGIR) 0-5 hours to AUCGIR 0-24 hours
Secondary Outcomes
- MRT, mean residence time
- AUCGIR, area under the glucose infusion rate value curve
- GIRmax, the maximum GIR value
- tmax GIR, time to maximum GIR value
- Cmax, maximum concentration
- Area under the curve
- tmax, time to maximum concentration
- t½, terminal half-life
- Adverse events
Investigators
Study Sites (1)
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