DiabetesPhase 1NCT01516255
Effect of Liraglutide on Heart Frequency in Healthy Volunteers
A Phase 1 study testing liraglutide, moxifloxacin and electrocardiogram (ECG) in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- liraglutide, moxifloxacin and electrocardiogram (ECG)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Nov 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Novo Nordisk Investigational Site
Fargo, North Dakota, 58104
About this study
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
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.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- liraglutide, placebo, moxifloxacin, electrocardiogram (ECG)
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liraglutideDrug
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
placeboDrug
Injected subcutaneously. Subjects are randomly allocated to two treatment sequences
moxifloxacinDrug
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
placeboDrug
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
electrocardiogram (ECG)Procedure or surgery
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
electrocardiogram (ECG)Procedure or surgery
Six hours after moxifloxacin or placebo single dose, 1 hour serial ECG is collected
| Study group | Role | What they receive |
|---|---|---|
| Double-blind / liraglutide | Experimental | Not described Receives: Drug: liraglutide; Drug: placebo; Procedure: electrocardiogram (ECG) |
| Double-blind / placebo | Placebo comparator | Not described Receives: Drug: liraglutide; Drug: placebo; Procedure: electrocardiogram (ECG) |
| Open-label / moxifloxacin | Active comparator | Not described Receives: Drug: moxifloxacin; Procedure: electrocardiogram (ECG) |
| Open-label / placebo | Placebo comparator | Not described Receives: Drug: placebo; Procedure: electrocardiogram (ECG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum time-matched mean difference between the baseline subtracted QTci intervals
Secondary outcomes (8)
QTc at liraglutide tmax (time to reach maximum concentration)
Percentage subjects with QTc at least 450, 480 and 500 milliseconds
Moxifloxacin maximum time-matched mean change QTc and QTci
Cmax, maximum concentration of liraglutide
tmax, time to reach Cmax of liraglutide
Vitals signs: Blood pressure
Vital signs: Pulse
Serial electrocardiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startJul 2006
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01516255
- Sponsor's protocol ID
- NN2211-1644
- Status last verified
- Jan 2017
- First submitted
- 19 Jan 2012
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Chatterjee DJ, Khutoryansky N, Zdravkovic M, Sprenger CR, Litwin JS. Absence of QTc prolongation in a thorough QT study with subcutaneous liraglutide, a once-daily human GLP-1 analog for treatment of type 2 diabetes. J Clin Pharmacol. 2009 Nov;49(11):1353-62. doi: 10.1177/0091270009339189. Epub 2009 Sep 8.
PubMed 19737980
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01516255
- Acronym / sponsor ID
- NN2211-1644
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 24 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Double-blind / liraglutide | Experimental | Drug: liraglutide, Drug: placebo, Procedure: electrocardiogram (ECG) |
| Double-blind / placebo | Placebo comparator | Drug: liraglutide, Drug: placebo, Procedure: electrocardiogram (ECG) |
| Open-label / moxifloxacin | Active comparator | Drug: moxifloxacin, Procedure: electrocardiogram (ECG) |
| Open-label / placebo | Placebo comparator | Drug: placebo, Procedure: electrocardiogram (ECG) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liraglutide0.6 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 | Double-blind / liraglutide, Double-blind / placebo |
| placeboInjected subcutaneously. Subjects are randomly allocated to two treatment sequences | Drug | Double-blind / liraglutide, Double-blind / placebo |
| moxifloxacinFollowing 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 | Drug | Open-label / moxifloxacin |
| placeboFollowing 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 | Drug | Open-label / placebo |
| 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 | Procedure or surgery | Double-blind / liraglutide, Double-blind / placebo |
| electrocardiogram (ECG)Six hours after moxifloxacin or placebo single dose, 1 hour serial ECG is collected | Procedure or surgery | Open-label / moxifloxacin, Open-label / placebo |
Primary outcome
Maximum time-matched mean difference between the baseline subtracted QTci intervals
8 secondary outcomes
QTc at liraglutide tmax (time to reach maximum concentration)
Percentage subjects with QTc at least 450, 480 and 500 milliseconds
Moxifloxacin maximum time-matched mean change QTc and QTci
Cmax, maximum concentration of liraglutide
tmax, time to reach Cmax of liraglutide
Vitals signs: Blood pressure
Vital signs: Pulse
Serial electrocardiography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
- Results publication: PubMed 19737980Chatterjee DJ, Khutoryansky N, Zdravkovic M, Sprenger CR, Litwin JS. Absence of QTc prolongation in a thorough QT study with subcutaneous liraglutide, a once-daily human GLP-1 analog for treatment of type 2 diabetes. J Clin Pharmacol. 2009 Nov;49(11):1353-62. doi: 10.1177/0091270009339189. Epub 2009 Sep 8.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing liraglutide, moxifloxacin and electrocardiogram (ECG) in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum time-matched mean difference between the baseline subtracted QTci intervals. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01516255, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2017.