Effect of Liraglutide on Heart Frequency in Healthy Volunteers
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01516255
First received: January 19, 2012
Last updated: August 30, 2012
Last verified: January 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This trial is conducted in the United States of America (USA). The aim of this trial is to investigate if liraglutide effects the QTc interval. Moxifloxacin (Avelox®) is administered as positive control.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Diabetes Mellitus, Type 2 |
Drug: liraglutide Drug: placebo Drug: moxifloxacin Procedure: electrocardiogram (ECG) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Thorough QTc Evaluation of the Effect of Liraglutide on Cardiac Repolarization in Healthy Volunteers: A Randomized, Double-blind, Placebo-controlled, Two Period Crossover Study Followed by Open-label Moxifloxacin (Positive Control) Administration |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Maximum time-matched mean difference between the baseline subtracted QTci intervals [ Designated as safety issue: No ]
Secondary Outcome Measures:
- QTc at liraglutide tmax (time to reach maximum concentration) [ Designated as safety issue: No ]
- Percentage subjects with QTc at least 450, 480 and 500 milliseconds [ Designated as safety issue: No ]
- Moxifloxacin maximum time-matched mean change QTc and QTci [ Designated as safety issue: No ]
- Cmax, maximum concentration of liraglutide [ Designated as safety issue: No ]
- tmax, time to reach Cmax of liraglutide [ Designated as safety issue: No ]
- Vitals signs: Blood pressure [ Designated as safety issue: No ]
- Vital signs: Pulse [ Designated as safety issue: No ]
- Serial electrocardiography [ Designated as safety issue: No ]
| Enrollment: | 64 |
| Study Start Date: | July 2006 |
| Study Completion Date: | November 2006 |
| Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Double-blind / liraglutide |
Drug: liraglutide
0.6 mg daily for 7 days followed by 1.2 mg daily for 7 days followed by 1.8 mg daily for 7 days. Injected subcutaneously. Subjects are randomly allocated to two treatment sequences
Drug: placebo
Injected subcutaneously. Subjects are randomly allocated to two treatment sequences
Procedure: electrocardiogram (ECG)
24 hours serial ECG is collected before initial dose of 0.6 mg liraglutide, on the last dosing day of 1.2 mg liraglutide and on the last dosing day of 1.8 mg liraglutide
|
| Placebo Comparator: Double-blind / placebo |
Drug: liraglutide
0.6 mg daily for 7 days followed by 1.2 mg daily for 7 days followed by 1.8 mg daily for 7 days. Injected subcutaneously. Subjects are randomly allocated to two treatment sequences
Drug: placebo
Injected subcutaneously. Subjects are randomly allocated to two treatment sequences
Procedure: electrocardiogram (ECG)
24 hours serial ECG is collected before initial dose of 0.6 mg liraglutide, on the last dosing day of 1.2 mg liraglutide and on the last dosing day of 1.8 mg liraglutide
|
| Active Comparator: Open-label / moxifloxacin |
Drug: moxifloxacin
Following the double-blinded period and a wash-out period of 7 days, subjects are re-randomised to an open-label, parallel period where a single dose of 400 mg moxifloxacin (tablets) is administered as positive control
Procedure: electrocardiogram (ECG)
Six hours after moxifloxacin or placebo single dose, 1 hour serial ECG is collected
|
| Placebo Comparator: Open-label / placebo |
Drug: placebo
Following the double-blinded period and a wash-out period of 7 days, subjects are re-randomised to an open-label, parallel period where single dose of oral placebo is administered
Procedure: electrocardiogram (ECG)
Six hours after moxifloxacin or placebo single dose, 1 hour serial ECG is collected
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy
- Fasting plasma glucose within normal limits (80-100 mg/dl)
- BMI (Body Mass Index): 20.0-29.0 kg/m^2 (inclusive)
- Heart rate within the range of 50-90 beats per minute (inclusive)
- Subject is judged to be in good health on the basis of their medical history, physical examination, ECG (electrocardiogram), and routine laboratory data
Exclusion Criteria:
- Any clinically significant disease history, in the opinion of the investigator, of systemic or organ disease
- Any clinically significant disease history, in the opinion of the investigator, of cardiovascular disease
- Clinically significant abnormalities on any pre-study clinical examination or any abnormal laboratory measurements during screening
- A family history of sudden cardiac death at age less than 50 years old
- T-wave abnormalities
- Individual or familial history of long QT Syndrome
- Positive results on Screening for Hepatitis B surface antigen, Hepatitis C antibody or HIV (human immunodeficiency virus) antibody
- Positive results on the urine drug and alcohol screen
- Any regular use of prescription or nonprescription drugs or vitamins and herbal/nutritional supplements that cannot be stopped at screening
- Any strenuous exercise (as judged by the investigator) from 4 days prior to randomisation and during the entire trial period
- Blood donation, trauma or surgery with blood loss exceeding 500 ml within the last 2 months prior to dosing
- Subject is a smoker, occasional smoker or has a history of smoking (or use of any tobacco) within the last 3 months
- Excessive use of methylxanthine-containing beverages (more than 8 cups/day of coffee, tea, soda or chocolate)
- Females who are pregnant, breastfeeding, intend to become pregnant within the next 3 months, or who are judged to be using inadequate contraceptive measures
- A history (within the last 2 years) of drug or alcohol abuse
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01516255
Locations
| United States, North Dakota | |
| Novo Nordisk Clinical Trial Call Center | |
| Fargo, North Dakota, United States, 58104 | |
Sponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Milan Zdravkovic, MD, PhD | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT01516255 History of Changes |
| Other Study ID Numbers: | NN2211-1644 |
| Study First Received: | January 19, 2012 |
| Last Updated: | August 30, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Moxifloxacin Norgestimate, ethinyl estradiol drug combination Glucagon-Like Peptide 1 Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions Contraceptives, Oral, Combined Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on May 23, 2013