Type 2 Diabetes MellitusPhase 1NCT01103622
Investigate the Effect of AZD1656 on the Pharmacokinetics of Digoxin in Type 2 Diabetes Mellitus Patients
A Phase 1 study testing AZD1656 and Digoxin in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 1 site in United States.
Trial summary
The purpose of this study is to determine whether AZD1656 will affect the pharmacokinetics (PK) of digoxin in type 2 diabetes mellitus (T2DM) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- AZD1656 and Digoxin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Dec 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with confirmed type 2 diabetes for at least 1 year and treated with metformin as a single treatment or in combination with one other oral anti diabetic for at least 2 months prior to screening.
- Body mass index between ≥19 and ≤42 kg/m2.
- Haemoglobin (Hb) A1c ≥6.5% and ≤9.5% at enrolment.
Who cannot join
- History of cardiovascular disease, eg, left ventricular hypertrophy, uncontrolled hypertension, paroxysmal or persistent cardiac arrhythmia or ischemic heart disease.
- Systolic blood pressure >160 mmHg or diastolic blood pressure >95 mmHg at screening
- Use of amiodarone within 3 months prior to screening and the use of potent CYP450 inhibitors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomised, Placebo Controlled, Two-Way Crossover, Phase I Single Centre Study in Type 2 Diabetes Mellitus Patients Treated With Metformin to Evaluate the Pharmacokinetics of Digoxin During Co-administration With AZD1656
The purpose of this study is to determine whether AZD1656 will affect the pharmacokinetics (PK) of digoxin in type 2 diabetes mellitus (T2DM) patients.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- AZD1656, Digoxin, Placebo
- Keywords
- Diabetes, Type 2, Digoxin, drug-drug interaction
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1656Drug
Oral tablet bd, step-wise increased dosage
DigoxinDrug
Also called Digacin
Oral tablet od on Day 4
PlaceboDrug
Oral tablet bd, step-wise increased dosage
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | twice daily Day 1 to Day 7; digoxin on day 4 Receives: Drug: AZD1656; Drug: Digoxin |
| 2 | Placebo comparator | twice daily Day 1 to Day 7; digoxin on day 4. Receives: Drug: Digoxin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the pharmacokinetics of digoxin after a single dose when administered alone and in combination with AZD1656 at steady state, by assessment of AUC and Cmax of digoxin
Measured: Serial PK blood samples will be taken on days 4-8 during the treatment periods
Secondary outcomes (3)
evaluate the safety of AZD1656 in combination with digoxin by assessment of electrocardiogram, weight, pulse, blood pressure, laboratory variables (including 7-point glucose), physical examination and adverse events.
Measured: Safety assessments will be monitored throughout the study, from screening visit until follow up visit.
describe the pharmacokinetics of AZD1656 and its metabolite during concomitant digoxin administration by assessment of AUC(0-24), Cmax, Ctrough, tmax, t1/2 and CL/F (AZD1656 only).
Measured: Serial PK blood samples will be taken on days 4-8 during the treatment periods
describe the pharmacokinetics of digoxin when administered alone or in combination with AZD1656 by assessment of tmax and t1/2.
Measured: Serial PK blood samples will be taken on days 4-8 during the treatment periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Stanko Skrtic, Study director, AstraZenecaChristoph Kapitza, Principal investigator, Profil Institut für Stoffwechselforschung GmbHMirjana Kujacic, Study chair, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103622
- Sponsor's protocol ID
- D1020C00031
- Status last verified
- Jan 2011
- First submitted
- 13 Apr 2010
- Last updated
- 5 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomised, Placebo Controlled, Two-Way Crossover, Phase I Single Centre Study in Type 2 Diabetes Mellitus Patients Treated With Metformin to Evaluate the Pharmacokinetics of Digoxin During Co-administration With AZD1656
- ClinicalTrials.gov ID
- NCT01103622
- Acronym / sponsor ID
- D1020C00031
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Diabetes, Type 2, Digoxin, drug-drug interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 14 Apr 2010 (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.
The purpose of this study is to determine whether AZD1656 will affect the pharmacokinetics (PK) of digoxin in type 2 diabetes mellitus (T2DM) patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD1656, Drug: Digoxintwice daily Day 1 to Day 7; digoxin on day 4 |
| 2 | Placebo comparator | Drug: Digoxin, Drug: Placebotwice daily Day 1 to Day 7; digoxin on day 4. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with confirmed type 2 diabetes for at least 1 year and treated with metformin as a single treatment or in combination with one other oral anti diabetic for at least 2 months prior to screening.
- Body mass index between ≥19 and ≤42 kg/m2.
- Haemoglobin (Hb) A1c ≥6.5% and ≤9.5% at enrolment.
Key exclusion criteria (3 listed)
- History of cardiovascular disease, eg, left ventricular hypertrophy, uncontrolled hypertension, paroxysmal or persistent cardiac arrhythmia or ischemic heart disease.
- Systolic blood pressure >160 mmHg or diastolic blood pressure >95 mmHg at screening
- Use of amiodarone within 3 months prior to screening and the use of potent CYP450 inhibitors
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 |
|---|---|---|
| AZD1656Oral tablet bd, step-wise increased dosage | Drug | 1 |
| DigoxinAlso: DigacinOral tablet od on Day 4 | Drug | 1, 2 |
| PlaceboOral tablet bd, step-wise increased dosage | Drug | 2 |
Primary outcome
evaluate the pharmacokinetics of digoxin after a single dose when administered alone and in combination with AZD1656 at steady state, by assessment of AUC and Cmax of digoxin
Time frame: Serial PK blood samples will be taken on days 4-8 during the treatment periods
3 secondary outcomes
evaluate the safety of AZD1656 in combination with digoxin by assessment of electrocardiogram, weight, pulse, blood pressure, laboratory variables (including 7-point glucose), physical examination and adverse events.
Time frame: Safety assessments will be monitored throughout the study, from screening visit until follow up visit.
describe the pharmacokinetics of AZD1656 and its metabolite during concomitant digoxin administration by assessment of AUC(0-24), Cmax, Ctrough, tmax, t1/2 and CL/F (AZD1656 only).
Time frame: Serial PK blood samples will be taken on days 4-8 during the treatment periods
describe the pharmacokinetics of digoxin when administered alone or in combination with AZD1656 by assessment of tmax and t1/2.
Time frame: Serial PK blood samples will be taken on days 4-8 during the treatment periods
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 5 Jan 2011.
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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.
Stanko Skrtic study director
AstraZeneca
Christoph Kapitza principal investigator
Profil Institut für Stoffwechselforschung GmbH
Mirjana Kujacic study chair
AstraZeneca
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 AZD1656 and Digoxin in people with Type 2 Diabetes Mellitus, run by AstraZeneca 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 3 inclusion and 3 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 5 Jan 2011. 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?
evaluate the pharmacokinetics of digoxin after a single dose when administered alone and in combination with AZD1656 at steady state, by assessment of AUC and Cmax of digoxin (time frame: Serial PK blood samples will be taken on days 4-8 during the treatment periods). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2011.