Effect of Liraglutide on Glucose Profiles and Gastric Emptying in Subjects With Type 2 Diabetes
Phase 2
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 2
- Interventions
- Drug: placebo
- Registration Number
- NCT01508923
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Treatment period 1 placebo - Treatment period 2 placebo - Treatment period 1 liraglutide - Treatment period 2 liraglutide -
- Primary Outcome Measures
Name Time Method 24-hour glucose profiles after three fixed meals
- Secondary Outcome Measures
Name Time Method EGR (endogenous glucose release) expressed in mg/kg/min 24-hour glucagon profiles after three fixed meals 24-hour FFA (free fatty acids) profiles after three fixed meals 24-hour insulin profiles after three fixed meals First phase insulin and maximal insulin secretory capacity GNG (gluconeogenesis) expressed in mg/kg/min 4-hour paracetamol profiles after two fixed meals 30-hour NNC 90-1170 profile Adverse events
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇩🇰Århus C, Denmark