Type 2 Diabetes MellitusPhase 1NCT01221545
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics After High Single Ascending Oral Doses of AZD1656 in T2DM Patients
A Phase 1 study testing AZD1656 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 investigate safety and tolerability after high Single Ascending Oral Doses of AZD1656. Read more about this study
- Who is it for?
- Ages 20 to 60 years, men only
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- AZD1656
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jan 2011
- 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 20 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Male, T2DM patients aged 20-60 years
- Treatment with 1 to 2 OADs as Therapy for T2DM for at least 30 days prior to enrollment
- Patients should not have been treated with glitazones within 6 months prior to enrollment
- Male T2DM patients without known cardiovascular disease, with the exception of Grade 1 hypertension without secondary organ involvement (eg. grade 1 HT is allowed if no eye, kidney disease or LVH has been documented).
Who cannot join
- History of ischemic heart disease , heart failure, stroke, transitory ischemic attack or peripheral vascular disease.
- Prolonged QTcF>450 msec or shortened QTcF<350 msec or family history of long QT syndrome.
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.
- Systolic BP>159 mmHg or diastolic BP>99 mmHg at screening and on Day-1
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Single-Blind, Placebo-Controlled, Single-Centre Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After High Single Ascending Oral Supratherapeutic Doses of AZD1656 in Male Type 2 Diabetes Mellitus (T2DM) Patients
The purpose of this study is to investigate safety and tolerability after high Single Ascending Oral Doses of AZD1656.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- AZD1656, Placebo
- Keywords
- Diabetes Mellitus
- 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
3 escalating dose levels are planned. Administration of the escalating doses of AZD1656 will be based on review of available safety from the previous dose.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| A - AZD1656 | Experimental | AZD1656 Receives: Drug: AZD1656 |
| B - Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective to assess the safety and tolerability of AZD1656, following oral administration of single ascending supratherapeutic doses of AZD1656 to patients with type 2 diabetes mellitus in a fasted state.
Measured: From screening until Follow up
Secondary outcomes (3)
Secondary objective to evaluate the pharmacokinetics (AUC, Cmax, t1/2, CL/F) of AZD1656 and its metabolite following oral administration of single ascending supratherapeutic doses of AZD1656
Measured: From pre-dose Day 1 to 48 hours after dose
Secondary objective to evaluate glucose levels and insulin secretion in type 2 diabetes mellitus patients following oral administration of single ascending supratherapeutic doses of AZD1656
Measured: Glucose levels from Day -1 to day 3
Secondary objective to evaluate glucose levels and insulin secretion in type 2 diabetes mellitus patients following oral administration of single ascending supratherapeutic doses of AZD1656
Measured: Insuline secretion from Day -1 to 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionJan 2011
- Study completionJan 2011
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Linda Morrow, MD, Principal investigator, Profil Institute for Clinical Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01221545
- Sponsor's protocol ID
- D1020C00044
- Status last verified
- Feb 2011
- First submitted
- 14 Oct 2010
- Last updated
- 17 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Single-Blind, Placebo-Controlled, Single-Centre Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After High Single Ascending Oral Supratherapeutic Doses of AZD1656 in Male Type 2 Diabetes Mellitus (T2DM) Patients
- ClinicalTrials.gov ID
- NCT01221545
- Acronym / sponsor ID
- D1020C00044
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 15 Oct 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 investigate safety and tolerability after high Single Ascending Oral Doses of AZD1656.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A - AZD1656 | Experimental | Drug: AZD1656AZD1656 |
| B - Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Male, T2DM patients aged 20-60 years
- Treatment with 1 to 2 OADs as Therapy for T2DM for at least 30 days prior to enrollment
- Patients should not have been treated with glitazones within 6 months prior to enrollment
- Male T2DM patients without known cardiovascular disease, with the exception of Grade 1 hypertension without secondary organ involvement (eg. grade 1 HT is allowed if no eye, kidney disease or LVH has been documented).
Key exclusion criteria (4 listed)
- History of ischemic heart disease , heart failure, stroke, transitory ischemic attack or peripheral vascular disease.
- Prolonged QTcF>450 msec or shortened QTcF<350 msec or family history of long QT syndrome.
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.
- Systolic BP>159 mmHg or diastolic BP>99 mmHg at screening and on Day-1
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 |
|---|---|---|
| AZD16563 escalating dose levels are planned. Administration of the escalating doses of AZD1656 will be based on review of available safety from the previous dose. | Drug | A - AZD1656 |
| PlaceboPlacebo | Drug | B - Placebo |
Primary outcome
Primary Objective to assess the safety and tolerability of AZD1656, following oral administration of single ascending supratherapeutic doses of AZD1656 to patients with type 2 diabetes mellitus in a fasted state.
Time frame: From screening until Follow up
3 secondary outcomes
Secondary objective to evaluate the pharmacokinetics (AUC, Cmax, t1/2, CL/F) of AZD1656 and its metabolite following oral administration of single ascending supratherapeutic doses of AZD1656
Time frame: From pre-dose Day 1 to 48 hours after dose
Secondary objective to evaluate glucose levels and insulin secretion in type 2 diabetes mellitus patients following oral administration of single ascending supratherapeutic doses of AZD1656
Time frame: Glucose levels from Day -1 to day 3
Secondary objective to evaluate glucose levels and insulin secretion in type 2 diabetes mellitus patients following oral administration of single ascending supratherapeutic doses of AZD1656
Time frame: Insuline secretion from Day -1 to 2.
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 17 Feb 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.
Linda Morrow, MD principal investigator
Profil Institute for Clinical Research, Inc.
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 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 5 inclusion and 4 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 17 Feb 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?
Primary Objective to assess the safety and tolerability of AZD1656, following oral administration of single ascending supratherapeutic doses of AZD1656 to patients with type 2 diabetes mellitus in a fasted state. (time frame: From screening until Follow up). 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 17 Feb 2011.