Type 2 DiabetesPhase 1JMADNCT00916604
To Study Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD1656 in Japanese Type 2 Diabetes Mellitus (T2DM) Patients
A Phase 1 study testing AZD1656 in people with Type 2 Diabetes, run by AstraZeneca at 2 sites in Japan.
Trial summary
The purpose of this study is to assess the safety and tolerability of AZD1656 after multiple repeated oral doses in Japanese patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- AZD1656
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesJapan
- Study dates
- May 2009to Oct 2009
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female non-childbearing potential Japanese T2DM patients, 30-75 years.
- A body mass index (BMI) of 19 to 27 kg/m2.
- Diagnosed Diabetes Mellitus patients treated with diet and exercise or with up to two oral anti-diabetic drugs. Stable glycemic control indicated by no changed treatment within 3 months prior to enrollment.
Who cannot join
- Renal dysfunction GFR < 60 mL/min.
- Systolic pressure (SBP) > 160 mmHg or diastolic pressure (DBP) > 95 mmHg
- Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP.
- History of ischemic heart disease, stroke, transient ischemic attack or symptomatic peripheral vascular disease.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Randomized, Single-blind, Placebo-Controlled, Multi-centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Ascending Oral Doses of AZD1656 in Japanese T2DM Patients
The purpose of this study is to assess the safety and tolerability of AZD1656 after multiple repeated oral doses in Japanese patients with type 2 diabetes.
- Conditions
- Type 2 Diabetes
- Being tested
- AZD1656, Placebo
- Keywords
- AZD1656, Safety, Pharmacokinetics, Pharmacodynamic, Multiple ascending doses, Japanese, T2DM
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1656Drug
Three increasing dose-steps with oral suspension, 8 days treatment
PlaceboDrug
Placebo oral suspension, 8 days treatment
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 3 gradually increasing repeated oral doses of AZD1656 given to 3 groups (6 on active substance in each group) Receives: Drug: AZD1656 |
| B | Placebo comparator | Placebo oral suspension given to 3 groups (2 on placebo in each group) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety by assessment of adverse events, BP, pulse rate, plasma glucose, safety laboratory variables and ECG
Measured: Blood samples taken repeatedly during 24 hours on study day sessions
Secondary outcomes (2)
Pharmacokinetic variables (AUC, Cmax, tmax, t½, CL/F, Ae and CLR).
Measured: Blood samples taken repeatedly during 24 hours on study day sessions
Pharmacodynamic variables (P-Glucose, S-Insulin and S-C-peptide).
Measured: Blood samples taken repeatedly during 24 hours on study day sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2009 (estimated)
- Study startMay 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Klas Malmberg, MD, Study director, AstraZeneca R&D MölndalTakashi Eto, MD, PhD, Principal investigator, PS Clinic, Fukuoka, JapanMitsuyasu Hokamura, MD, Principal investigator, HONJO CLINIC II, Tokyo, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916604
- Sponsor's protocol ID
- D1020C00004
- Acronym
- JMAD
- Status last verified
- Nov 2009
- First submitted
- 8 Jun 2009
- Last updated
- 3 Nov 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-blind, Placebo-Controlled, Multi-centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Ascending Oral Doses of AZD1656 in Japanese T2DM Patients
- ClinicalTrials.gov ID
- NCT00916604
- Acronym / sponsor ID
- JMAD / D1020C00004
- Conditions
- Type 2 Diabetes
- Keywords
- AZD1656, Safety, Pharmacokinetics, Pharmacodynamic, Multiple ascending doses, Japanese, T2DM
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Study completion
- Oct 2009 (actual)
- First posted
- 9 Jun 2009 (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 assess the safety and tolerability of AZD1656 after multiple repeated oral doses in Japanese patients with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: AZD16563 gradually increasing repeated oral doses of AZD1656 given to 3 groups (6 on active substance in each group) |
| B | Placebo comparator | Drug: PlaceboPlacebo oral suspension given to 3 groups (2 on placebo in each group) |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female non-childbearing potential Japanese T2DM patients, 30-75 years.
- A body mass index (BMI) of 19 to 27 kg/m2.
- Diagnosed Diabetes Mellitus patients treated with diet and exercise or with up to two oral anti-diabetic drugs. Stable glycemic control indicated by no changed treatment within 3 months prior to enrollment.
Key exclusion criteria (4 listed)
- Renal dysfunction GFR < 60 mL/min.
- Systolic pressure (SBP) > 160 mmHg or diastolic pressure (DBP) > 95 mmHg
- Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the IP.
- History of ischemic heart disease, stroke, transient ischemic attack or symptomatic peripheral vascular disease.
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 |
|---|---|---|
| AZD1656Three increasing dose-steps with oral suspension, 8 days treatment | Drug | A |
| PlaceboPlacebo oral suspension, 8 days treatment | Drug | B |
Primary outcome
Safety by assessment of adverse events, BP, pulse rate, plasma glucose, safety laboratory variables and ECG
Time frame: Blood samples taken repeatedly during 24 hours on study day sessions
2 secondary outcomes
Pharmacokinetic variables (AUC, Cmax, tmax, t½, CL/F, Ae and CLR).
Time frame: Blood samples taken repeatedly during 24 hours on study day sessions
Pharmacodynamic variables (P-Glucose, S-Insulin and S-C-peptide).
Time frame: Blood samples taken repeatedly during 24 hours on study day sessions
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 3 Nov 2009.
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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.
Klas Malmberg, MD study director
AstraZeneca R&D Mölndal
Takashi Eto, MD, PhD principal investigator
PS Clinic, Fukuoka, Japan
Mitsuyasu Hokamura, MD principal investigator
HONJO CLINIC II, Tokyo, Japan
2 sites 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, run by AstraZeneca at 2 sites in Japan.
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 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 3 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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?
Safety by assessment of adverse events, BP, pulse rate, plasma glucose, safety laboratory variables and ECG (time frame: Blood samples taken repeatedly during 24 hours on study day sessions). 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 3 Nov 2009.