Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in the United States of America (USA). The aim of this trial is to compare repaglinide and metformin as co-administered tablets and as a combination tablet.
Interventions
DRUGrepaglinide
Single dose of 2 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with metformin as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
DRUGmetformin
Single dose of 500 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with repaglinide as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
Single dose of 2 mg repaglinide/500 mg metformin (NN4440 2/500) or 1 mg repaglinide/500 mg metformin (NN4440 1/500)administered immediately prior to a standard high fat breakfast. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Healthy male and female volunteers (female not pregnant, lactating or breastfeeding) * BMI (Body Mass Index) between 19-29 kg/m\^2, both inclusive * Fasting plasma glucose from 70-115 mg/dl * Subject is judged to be in good health on the basis of their medical history, physical examination, ECG (electrocardiogram), and routine laboratory data
Exclusion criteria
* Any clinically significant disease history, in the opinion of the Investigator, of systemic or organ disease * Clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening * Positive results on screening for Hepatitis B surface antigen, Hepatitis C antibody and HIV (human immunodeficiency virus) antibody * Positive results on the drug abuse/alcohol screen * Any regular use of prescription or nonprescription drugs, including mega-vitamin or herbal supplement regimens, other than contraceptives, that cannot be stopped at least 1 week prior to Visit 2 (trial product dose administration) and for the duration of the study * Subject is currently a smoker (more than one cigarette per day or equivalent) * Use of grapefruit or grapefruit juice within 7 days of trial product dose administration * Blood donation, surgery or trauma with significant blood loss (500 mL) within the last 2 months prior to dosing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NN4440 (2/500) Cmax (maximum plasma concentration) combination tablet | — |
| Repaglinide and metformin AUC (Area under the Curve) fed state concomitant tablet administration | — |
| Repaglinide and metformin AUC (Area under the Curve) NN4440 (2/500) combination tablet | — |
| Repaglinide and metformin Cmax (maximum plasma concentration) fed state concomitant tablet administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Repaglinide AUC after NN4440 (1/500) during fed state | — |
| Repaglinide Cmax after NN4440 ((1/500) during fed state | — |
| Change in physical examinations from screening | — |
| Vital signs | — |
Countries
United States
Outcome results
None listed