Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to compare NNC0123-0000-0338 (insulin-338) in a tablet formulation and insulin glargine in combination with metformin with or without DPP-4 inhibitor in subjects with type 2 diabetes currently treated with oral antidiabetic therapy
Interventions
Oral administered once daily in combination with metformin with or without DPP-4 inhibitor
DRUGinsulin glargine
Injected s.c./subcutaneously (under the skin) once daily in combination with metformin with or without DPP-4 inhibitor
DRUGplacebo
Administered once daily
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age of 18-70 years (both inclusive) at the time of signing informed consent * Body mass index of 25.0-40.0 kg/m\^2 (both inclusive) * Subject diagnosed (clinically) with type 2 diabetes mellitus for at least 180 days prior to the day of screening * Insulin naïve subject; however, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes
Exclusion criteria
* Known or suspected hypersensitivity to the trial products or related products * Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol * Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in fasting plasma glucose (FPG) | Week 0, Week 8 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in 10-points plasma glucose profile | Week 0, Week 8 |
| Number of treatment emergent hypoglycaemic episodes | From start of treatment until Visit 14 (Day 68) |
| area under the serum insulin concentration-time curve | During one dosing interval (0 to 24 hours) at steady state (Day 56) |
Countries
Germany
Outcome results
None listed