Effect of Liraglutide on Absorption of Paracetamol in Subjects With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01517555
• Other study ID #: NN2211-1698
• Secondary ID: 2006-000561-10
• Status: Completed
• Phase: Phase 1
• First received: January 21, 2012
• Last updated: January 25, 2017
• Start date: October 2006
• Est. completion date: May 2007

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• liraglutide
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
• placebo
Administered as a subcutaneous injection. Given as daily volume of 100 mcl, 200 mcl and 300 mcl respectively
• paracetamol
One single dose of 1 g. Tablet

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & Publications (4)

Flint A, Kapitza C, Hindsberger C, Zdravkovic M. The once-daily human glucagon-like peptide-1 (GLP-1) analog liraglutide improves postprandial glucose levels in type 2 diabetes patients. Adv Ther. 2011 Mar;28(3):213-26. doi: 10.1007/s12325-010-0110-x. — View Citation

Flint A, Kapitza C, Zdravkovic M. The once-daily human GLP-1 analogue liraglutide impacts appetite and energy intake in patients with type 2 diabetes after short-term treatment. Diabetes Obes Metab. 2013 Oct;15(10):958-62. doi: 10.1111/dom.12108. — View Citation

Kapitza C, Zdravkovic M, Hindsberger C, Flint A. The effect of the once-daily human glucagon-like peptide 1 analog liraglutide on the pharmacokinetics of acetaminophen. Adv Ther. 2011 Aug;28(8):650-60. doi: 10.1007/s12325-011-0044-y. — View Citation

Røge RM, Klim S, Ingwersen SH, Kjellsson MC, Kristensen NR. The Effects of a GLP-1 Analog on Glucose Homeostasis in Type 2 Diabetes Mellitus Quantified by an Integrated Glucose Insulin Model. CPT Pharmacometrics Syst Pharmacol. 2015 Jan;4(1):e00011. doi: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve of paracetamol
Primary	Area under the curve of post prandial plasma glucose
Secondary	Area under the curve of paracetamol
Secondary	Cmax, maximum concentration
Secondary	tmax, time to reach Cmax
Secondary	t½, terminal half-life
Secondary	Terminal elimination rate constant
Secondary	Adverse events

External Links

•   Clinical Trials at Novo Nordisk