Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Brief summary
This study is conducted in Asia. The aim of this study is to investigate the safety and efficacy of NovoLet® human insulin delivery system in an outpatient setting.
Interventions
NovoLet® device delivering human insulin. Selection of drug and timing of dose for each patient was at the discretion of the investigator
NovoLet® device delivering human insulin. Selection of drug and timing of dose for each patient was at the discretion of the investigator
NovoLet® device delivering human insulin. Selection of drug and timing of dose for each patient was at the discretion of the investigator
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes mellitus * Type 2 diabetes mellitus * Other types of diabetes mellitus (gestational, drug induced \[thiazide\] or metabolic syndrome-related)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body weight | — |
Secondary
| Measure | Time frame |
|---|---|
| 2 hours postprandial blood glucose (2-hr PPBG) | — |
| HbA1c (glycosylated haemoglobin) | — |
| Adverse events (AEs) including hypoglycaemic episodes | — |
| Fasting blood glucose (FBG) | — |
Countries
Indonesia
Outcome results
None listed