Effect of Liraglutide on Absorption of Paracetamol in Subjects With Type 2 Diabetes
This study has been completed.
Sponsor:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01517555
First received: January 21, 2012
Last updated: October 29, 2014
Last verified: October 2014
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Diabetes Mellitus, Type 2 |
Drug: liraglutide Drug: placebo Drug: paracetamol |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk A/S:
Primary Outcome Measures:
- Area under the curve of paracetamol [ Designated as safety issue: No ]
- Area under the curve of post prandial plasma glucose [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Area under the curve of paracetamol [ Designated as safety issue: No ]
- Cmax, maximum concentration [ Designated as safety issue: No ]
- tmax, time to reach Cmax [ Designated as safety issue: No ]
- t½, terminal half-life [ Designated as safety issue: No ]
- Terminal elimination rate constant [ Designated as safety issue: No ]
- Adverse events [ Designated as safety issue: No ]
| Enrollment: | 18 |
| Study Start Date: | October 2006 |
| Study Completion Date: | May 2007 |
| Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Liraglutide |
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
Drug: placebo
Administered as a subcutaneous injection. Given as daily volume of 100 mcl, 200 mcl and 300 mcl respectively
Drug: paracetamol
One single dose of 1 g. Tablet
|
| Placebo Comparator: Placebo |
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
Drug: placebo
Administered as a subcutaneous injection. Given as daily volume of 100 mcl, 200 mcl and 300 mcl respectively
Drug: paracetamol
One single dose of 1 g. Tablet
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01517555
Please refer to this study by its ClinicalTrials.gov identifier: NCT01517555
Locations
| Germany | |
| Neuss, Germany, 41460 | |
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
| Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
More Information
Additional Information:
| Responsible Party: | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT01517555 History of Changes |
| Other Study ID Numbers: | NN2211-1698 2006-000561-10 |
| Study First Received: | January 21, 2012 |
| Last Updated: | October 29, 2014 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Acetaminophen Liraglutide Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antipyretics Hypoglycemic Agents Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on September 23, 2016