Effect of Liraglutide on Absorption of Paracetamol 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 to investigate if there is a drug-drug interaction between liraglutide and paracetamol (Benuron®) and to investigate the effect of liraglutide on post prandial glucose.

Official Title
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A Single Centre, Randomised, Double-blind, Placebo Controlled Trial to Evaluate the Possible Drug-drug Interaction Between Liraglutide and Paracetamol and the Effects of Liraglutide on Postprandial Glucose and Insulin, Gastric Emptying, Appetite Sensations and Energy Intake in Subjects With Type 2 Diabetes

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: liraglutide
* Drug: placebo
* Drug: paracetamol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes mellitus Diet-treated subjects with type 2 diabetes with HbA1c 7.5-9.5 % Subjects with type 2 diabetes in oral anti-diabetic drug (OAD) monotherapy treated with metformin or alpha-glucosidase inhibitors with HbA1c 7.0-9.5% Body mass index (BMI) 18.5-40 kg/m^2 Subjects should have a stable body weight for at least 3 months prior to screening (as judged by the Investigator) Exclusion Criteria: Impaired liver function Impaired renal function Clinically significant active cardiovascular disease including history of myocardial infarction within the last 6 months and/or heart failure Any clinically significant abnormal ECG (electrocardiogram) Uncontrolled treated/untreated hypertension Recurrent severe hypoglycaemia as judged by the Investigator Active hepatitis B and/or active hepatitis C Positive human immunodeficiency virus (HIV) antibodies Known or suspected allergy to trial product(s) or related products

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Liraglutide<br> | Drug: liraglutide<br>* Administered as a subcutaneous injection. Initial dose 0.6 mg daily, adjusted to 1.2 mg daily in week 2 and escalated to 1.8 mg daily in week 3<br>Drug: placebo<br>* Administered as a subcutaneous injection. Given as daily volume of 100 mcl, 200 mcl and 300 mcl respectively<br>Drug: paracetamol<br>* One single dose of 1 g. Tablet<br>|
| Placebo Comparator: Placebo<br> | Drug: liraglutide<br>* Administered as a subcutaneous injection. Initial dose 0.6 mg daily, adjusted to 1.2 mg daily in week 2 and escalated to 1.8 mg daily in week 3<br>Drug: placebo<br>* Administered as a subcutaneous injection. Given as daily volume of 100 mcl, 200 mcl and 300 mcl respectively<br>Drug: paracetamol<br>* One single dose of 1 g. Tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve of paracetamol |  |  | 
| Area under the curve of post prandial plasma glucose |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve of paracetamol |  |  | 
| Cmax, maximum concentration |  |  | 
| tmax, time to reach Cmax |  |  | 
| t½, terminal half-life |  |  | 
| Terminal elimination rate constant |  |  | 
| Adverse events |  |  |