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 administered as an individual tablets with repaglinide and metformin administered as a combination tablet.
Interventions
DRUGrepaglinide
Subjects will receive 850 mg metformin alone on a fasting state, 2 mg repaglinide alone on a fasting state, 2 mg repaglinide/850 mg metformin (NN4440 2/850) in the fasting state or 2 mg repaglinide/850 mg metformin (NN4440 2/850) immediately prior to a standardised high fat meal on 4 separate dosing visits in varying order
DRUGmetformin
Subjects will receive 850 mg metformin alone on a fasting state, 2 mg repaglinide alone on a fasting state, 2 mg repaglinide/850 mg metformin (NN4440 2/850) in the fasting state or 2 mg repaglinide/850 mg metformin (NN4440 2/850) immediately prior to a standardised high fat meal on 4 separate dosing visits in varying order
Subjects will receive 850 mg metformin alone on a fasting state, 2 mg repaglinide alone on a fasting state, 2 mg repaglinide/850 mg metformin (NN4440 2/850) in the fasting state or 2 mg repaglinide/850 mg metformin (NN4440 2/850) immediately prior to a standardised high fat meal on 4 separate dosing visits in varying order
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, health food or dietary supplement regimens, with the exception of contraceptives, that cannot be stopped at least 1 week prior to Visit 2 (trial product 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 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 |
|---|---|
| Fasting repaglinide and metformin Cmax (maximum drug concentration) following individual administration | — |
| Fasting repaglinide and metformin Area under the Curve (AUC) following NN4440 administration | — |
| Fasting repaglinide and metformin Area under the Curve (AUC) following individual administration | — |
| Fasting repaglinide and metformin Cmax (maximum drug concentration) following NN4440 administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Repaglinide and metformin tmax (time to maximum) following individual administration fasting state | — |
| Repaglinide and metformin tmax (time to maximum) following NN4440 administration fasting state | — |
| Physical examinations | — |
| Vital signs | — |
Countries
United States
Outcome results
None listed