Study to Assess the Safety and Tolerability After Multiple Oral Doses of AZD1656 in Patients With Type 2 Diabetes Mellitus Treated With Metformin

A Phase 2 study testing AZD1656 in people with Type 2 Diabetes, run by AstraZeneca at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to assess the 1 month safety and tolerability after multiple oral doses of AZD1656 in patients with Type 2 Diabetes Mellitus Treated with Metformin 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: 27 participants
Where: 1 siteUnited States
Study dates: Jan 2009to Jul 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 women of non-childbearing potential (postmenopausal, and/or have undergone hysterectomy and/or bilateral oophorectomy or salpingectomy/ tubal ligation)
Ongoing treatment with metformin on a stable dose of ≥ 1500 mg/day for at least 8 weeks prior to randomisation
HbA1c ≤ 10% at enrolment (HbA1c value according to international Diabetes Control and Complications Trial [DCCT] standard)

Who cannot join

History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease
Clinically significant abnormalities in ECG, clinical chemistry, haematology, or urine analysis results. Positive test for Hepatitis B surface antigen or antibodies to human immunodeficiency virus (HIV) or antibodies to Hepatitis C virus

Trial locations and contacts

1 site in 1 country.

United States1 site

Research Site
San Antonio, Texas

Other trials in United States

About this study

Official title: A Randomised, Single-Blind, Placebo-Controlled, Phase IIA Study to Assess the Safety and Tolerability After Multiple Oral Doses of AZD1656 in Patients With Type 2 Diabetes Mellitus Treated With Metformin

The purpose of this study is to assess the 1 month safety and tolerability after multiple oral doses of AZD1656 in patients with Type 2 Diabetes Mellitus Treated with Metformin

Conditions: Type 2 Diabetes
Being tested: AZD1656, Placebo
Keywords: Type II Diabetes
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
Subjects will be treated with tolerable dose twice daily for another 24 days.
PlaceboDrug
Subjects will be treated with tolerable dose twice daily for another 24 days.

Study groups in NCT00817778
Study group	Role	What they receive
AZD1656	Experimental	Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days Receives: Drug: AZD1656
Placebo	Placebo comparator	Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Systolic Blood Pressure, Change From Baseline to End of Treatment
Measured: Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period
Diastolic Blood Pressure, Change From Baseline to End of Treatment
Measured: Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period
Pulse, Change From Baseline to End of Treatment
Measured: Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period
Weight, Change From Baseline to End of Treatment
Measured: Baseline is the day before first dose, end of treatment is last day of treatment
Clinically Relevant Change of Laboratory Variables
Number of participants with clinically relevant change of laboratory variables (clinical chemistry, haematology and urinalysis parameters
Measured: Measured regularly from day before first dose to day after last dose

Secondary outcomes (8)

Area Under the Plasma Concentration vs Time Curve (AUC0-24) of AZD1656
Dose-adjusted to a total daily dose of 100 mg due to titrated doses
Measured: Measured last day of treatment
Maximum Plasma Concentration of AZD1656
Dose-adjusted to a morning dose of 50 mg due to titrated doses
Measured: Measured last day of treatment
Time to Reach Maximum Plasma Concentration of AZD1656
Measured: Measured last day of treatment
Terminal Elimination Half-life of AZD1656
Measured: Measured following the afternoon dose last day of treatment
Apparent Oral Clearance of AZD1656
Measured: Measured last day of treatment
P-Glucose (AUC0-24)/24, Change From Baseline to End of Treatment
Log ratio (End of treatment/Baseline) has been analysed in a mixed-effect ANOVA model, using treatment as fixed effect and log(Baseline) as covariate. Resulting estimates have been back-transformed from the log-scale and then multiplied by 100 to obtain the relative ratio (end of treatment/placebo) in percent.
Measured: Baseline is the day before first dose, end of treatment is last day of treatment
S-Insulin (AUC0-24)/24, Change From Baseline to End of Treatment
Log ratio (End of treatment/Baseline) has been analysed in a mixed-effect ANOVA model, using treatment as fixed effect and log(Baseline) as covariate. Resulting estimates have been back-transformed from the log-scale and then multiplied by 100 to obtain the relative ratio (end of treatment/placebo) in percent.
Measured: Baseline is the day before first dose, end of treatment is last day of treatment
S-C-Peptide (AUC0-24)/24, Change From Baseline to End of Treatment
Log ratio (End of treatment/Baseline) has been analysed in a mixed-effect ANOVA model, using treatment as fixed effect and log(Baseline) as covariate. Resulting estimates have been back-transformed from the log-scale and then multiplied by 100 to obtain the relative ratio (end of treatment/placebo) in percent.
Measured: Baseline is the day before first dose, end of treatment is last day of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2009Jul 2009

First posted6 Jan 2009 (estimated)
Study startJan 2009
Primary completionJul 2009
Study completionJul 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00817778
Sponsor's protocol ID: D1020C00019
Status last verified: Oct 2012
First submitted: 5 Jan 2009
Last updated: 16 Nov 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Single-Blind, Placebo-Controlled, Phase IIA Study to Assess the Safety and Tolerability After Multiple Oral Doses of AZD1656 in Patients With Type 2 Diabetes Mellitus Treated With Metformin
ClinicalTrials.gov ID: NCT00817778
Acronym / sponsor ID: D1020C00019
Conditions: Type 2 Diabetes
Keywords: Type II Diabetes
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: Jul 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 6 Jan 2009 (estimated)
Results: Posted 16 Nov 2012

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 1 month safety and tolerability after multiple oral doses of AZD1656 in patients with Type 2 Diabetes Mellitus Treated with Metformin

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
AZD1656	Experimental	Drug: AZD1656Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
Placebo	Placebo comparator	Drug: PlaceboDose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days

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 women of non-childbearing potential (postmenopausal, and/or have undergone hysterectomy and/or bilateral oophorectomy or salpingectomy/ tubal ligation)
Ongoing treatment with metformin on a stable dose of ≥ 1500 mg/day for at least 8 weeks prior to randomisation
HbA1c ≤ 10% at enrolment (HbA1c value according to international Diabetes Control and Complications Trial [DCCT] standard)

Key exclusion criteria (2 listed)

History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease
Clinically significant abnormalities in ECG, clinical chemistry, haematology, or urine analysis results. Positive test for Hepatitis B surface antigen or antibodies to human immunodeficiency virus (HIV) or antibodies to Hepatitis C virus

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
AZD1656Subjects will be treated with tolerable dose twice daily for another 24 days.	Drug	AZD1656
PlaceboSubjects will be treated with tolerable dose twice daily for another 24 days.	Drug	Placebo

Primary outcome

Systolic Blood Pressure, Change From Baseline to End of Treatment
Time frame: Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period
Diastolic Blood Pressure, Change From Baseline to End of Treatment
Time frame: Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period
Pulse, Change From Baseline to End of Treatment
Time frame: Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period
Weight, Change From Baseline to End of Treatment
Time frame: Baseline is the day before first dose, end of treatment is last day of treatment
Clinically Relevant Change of Laboratory Variables
Time frame: Measured regularly from day before first dose to day after last dose
Number of participants with clinically relevant change of laboratory variables (clinical chemistry, haematology and urinalysis parameters

8 secondary outcomes

Area Under the Plasma Concentration vs Time Curve (AUC0-24) of AZD1656
Time frame: Measured last day of treatment
Maximum Plasma Concentration of AZD1656
Time frame: Measured last day of treatment
Time to Reach Maximum Plasma Concentration of AZD1656
Time frame: Measured last day of treatment
Terminal Elimination Half-life of AZD1656
Time frame: Measured following the afternoon dose last day of treatment
Apparent Oral Clearance of AZD1656
Time frame: Measured last day of treatment
P-Glucose (AUC0-24)/24, Change From Baseline to End of Treatment
Time frame: Baseline is the day before first dose, end of treatment is last day of treatment
S-Insulin (AUC0-24)/24, Change From Baseline to End of Treatment
Time frame: Baseline is the day before first dose, end of treatment is last day of treatment
S-C-Peptide (AUC0-24)/24, Change From Baseline to End of Treatment
Time frame: Baseline is the day before first dose, end of treatment is last day of treatment

Results and safety

Results posted to the registry on 16 Nov 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental	19	16
Placebo Comparator	8	5

Primary outcome: Systolic Blood Pressure, Change From Baseline to End of Treatment

Time frame: Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period. Mean (Standard Deviation). Unit: mmHg

Measure	Experimental n = 16	Placebo Comparator n = 5
Value	-0.5 (11.48)	9.2 (10.43)

Primary outcome: Diastolic Blood Pressure, Change From Baseline to End of Treatment

Time frame: Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period. Mean (Standard Deviation). Unit: mmHg

Measure	Experimental n = 16	Placebo Comparator n = 5
Value	-0.2 (6.20)	2.0 (10.32)

Primary outcome: Pulse, Change From Baseline to End of Treatment

Time frame: Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period. Mean (Standard Deviation). Unit: beats/min

Measure	Experimental n = 16	Placebo Comparator n = 5
Value	2.7 (5.69)	-1.6 (6.23)

Primary outcome: Weight, Change From Baseline to End of Treatment

Time frame: Baseline is the day before first dose, end of treatment is last day of treatment. Mean (Standard Deviation). Unit: kg

Measure	Experimental n = 16	Placebo Comparator n = 5
Value	0.2 (1.00)	0.0 (3.81)

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental	1 of 19 (5.3%)	15 of 19 (78.9%)	Not reported
Placebo Comparator	0 of 8 (0%)	7 of 8 (87.5%)	Not reported

Limitations and caveats (from the sponsor): The primary objective of the study was to assess safety and tolerability and hence the study was not sized based on statistical considerations. The most import outcome, "no safety or tolerability concerns were identified", is not a numerical variable

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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, PhD, Prof study director

AstraZeneca R&D Mölndal

Emanuel P DeNoia, M.D principal investigator

Healthcare Discoveries LLC Icon Development Solutions

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD1656 in people with Type 2 Diabetes, 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 2 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 16 Nov 2012. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Systolic Blood Pressure, Change From Baseline to End of Treatment (time frame: Baseline is pre-dose first day of dosing, end of treatment is the morning following the treatment period). The study lists 5 primary outcomes in all. 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 NCT00817778.

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 16 Nov 2012.