Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to determine the effect of NNC 90-1170 (liraglutide) on glucose and hormonal profiles, fasting gluconeogenesis and insulin secretion in subjects with type 2 diabetes.
Interventions
DRUGliraglutide
6 mcg/kg injected subcutaneously daily in each treatment period in random order. In total, subjects are treated 9-10 days
DRUGplacebo
6 mcg/kg injected subcutaneously daily in each treatment period in random order. In total, subjects are treated 9-10 days
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes mellitus * Diet treated and/or subjects in monotherapy with max. 50 % of maximal dose of sulphonylurea (SU). In addition, subjects in treatment with metformin and/or repaglinide could be included * Body Mass Index (BMI) maximum 35 kg/m\^2 * Fasting plasma glucose 7-15 mmol/l, both inclusive
Exclusion criteria
* Impaired liver function * Impaired renal function * Anaemia * Cardiac disease * Uncontrolled treated/untreated hypertension * Recurrent major hypoglycaemia as judged by the Investigator * Known or suspected allergy to trial product or related products * Females of child bearing potential who are pregnant, breast-feeding or have intention of becoming pregnant or are not using adequate contraceptive measures * Current treatment with thiazolidinediones or chronic daily use of insulin (more than 7 days) within three months in the absence of intercurrent illness * Loss of more than 400 ml blood during the three months prior to study start * Allergy to paracetamol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-hour glucose profiles after three fixed meals | — |
Secondary
| Measure | Time frame |
|---|---|
| First phase insulin and maximal insulin secretory capacity | — |
| EGR (endogenous glucose release) expressed in mg/kg/min | — |
| GNG (gluconeogenesis) expressed in mg/kg/min | — |
| 24-hour glucagon profiles after three fixed meals | — |
| 24-hour insulin profiles after three fixed meals | — |
| 4-hour paracetamol profiles after two fixed meals | — |
| 30-hour NNC 90-1170 profile | — |
| Adverse events | — |
| 24-hour FFA (free fatty acids) profiles after three fixed meals | — |
Countries
Denmark
Outcome results
None listed