Effect of Liraglutide on Glucose Profiles and Gastric Emptying in Subjects With Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Effect of NNC 90-1170 on 24-hour Glucose and Hormonal Profiles, Gastric Emptying, and Fasting Gluconeogenesis in Type 2 Diabetic Subjects. A Double-blind, Placebo-controlled, Randomised, Cross-over Trial

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: liraglutide
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment period 1<br> | Drug: liraglutide<br>* 6 mcg/kg injected subcutaneously daily in each treatment period in random order. In total, subjects are treated 9-10 days<br>* Other names: NNC 90-1170;Drug: placebo<br>* 6 mcg/kg injected subcutaneously daily in each treatment period in random order. In total, subjects are treated 9-10 days<br>|
| Placebo Comparator: Treatment period 2<br> | Drug: liraglutide<br>* 6 mcg/kg injected subcutaneously daily in each treatment period in random order. In total, subjects are treated 9-10 days<br>* Other names: NNC 90-1170;Drug: placebo<br>* 6 mcg/kg injected subcutaneously daily in each treatment period in random order. In total, subjects are treated 9-10 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour glucose profiles after three fixed meals |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour insulin profiles after three fixed meals |  |  | 
| 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 FFA (free fatty acids) profiles after three fixed meals |  |  | 
| 4-hour paracetamol profiles after two fixed meals |  |  | 
| 30-hour NNC 90-1170 profile |  |  | 
| Adverse events |  |  |