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
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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 |
| 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
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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:
No publications provided
| 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 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Acetaminophen Liraglutide Analgesics Analgesics, Non-Narcotic Antipyretics |
Central Nervous System Agents Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Hypoglycemic Agents Incretins Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on February 26, 2015