Effect of Liraglutide on Absorption of Paracetamol in Subjects With Type 2 Diabetes
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| ClinicalTrials.gov Identifier: NCT01517555 |
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Recruitment Status
:
Completed
First Posted
: January 25, 2012
Last Update Posted
: January 26, 2017
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Sponsor:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetes Diabetes Mellitus, Type 2 | Drug: liraglutide Drug: placebo Drug: paracetamol | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 18 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Double (Participant, 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 |
| Study Start Date : | October 2006 |
| Actual Primary Completion Date : | May 2007 |
| Actual Study Completion Date : | May 2007 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Type 2 diabetes
Drug Information available for:
Liraglutide
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
| 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
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| 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
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Primary Outcome Measures
:
- Area under the curve of paracetamol
- Area under the curve of post prandial plasma glucose
Secondary Outcome Measures
:
- Area under the curve of paracetamol
- Cmax, maximum concentration
- tmax, time to reach Cmax
- t½, terminal half-life
- Terminal elimination rate constant
- Adverse events
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01517555
Locations
| Germany | |
| Novo Nordisk Investigational Site | |
| Neuss, Germany, 41460 | |
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
| Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Additional Information:
Publications of Results:
| Responsible Party: | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT01517555 History of Changes |
| Other Study ID Numbers: |
NN2211-1698 2006-000561-10 ( EudraCT Number ) |
| First Posted: | January 25, 2012 Key Record Dates |
| Last Update Posted: | January 26, 2017 |
| Last Verified: | January 2017 |
Additional relevant MeSH terms:
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Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Liraglutide Acetaminophen Hypoglycemic Agents Physiological Effects of Drugs |
Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Antipyretics |