Type 2 Diabetes MellitusPhase 1NCT01221519

A Relative Bioavailability Study Measuring the Extent and Rate of Absorption of Different Tablet Formulations of AZD1656 in Type 2 Diabetes Mellitus (T2DM) Patients

A Phase 1 study testing AZD1656 in people with Type 2 Diabetes Mellitus and High Blood Sugar, 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.

Official record

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Trial summary

The purpose of this study is to assess the relative bioavailability by measuring the extent and rate of absorption of different tablet formulations of AZD1656 in 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, High Blood Sugar
What is being tested?: AZD1656
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Sep 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provision of signed and dated, written informed consent prior to any study specific procedures.
Males or females of non-childbearing potential (post-menopausal, and/or have undergone hysterectomy and/or bilateral oophorectomy or salpingectomy/ tubal ligation) aged ≥18 years. Females will be defined as post-menopausal if last menstruation period was >1 year ago and serum follicle stimulating hormone (FSH) is within the post-menopausal range, or if age >50 years and with last menstruation period >2 years ago.
A confirmed clinical diagnosis of T2DM for at least 1 year, treated with metformin as a single treatment or in combination with one other oral anti-diabetic (ie, DPPIV inhibitor or SU) for at least 2 months prior to screening. Doses of anti-diabetic treatment should have been stable for at least 1 month prior to screening.
Treatment with at least 1000mg of Metformin for 2 months and being stable on the Metformin Therapy for 1 month
Hb A1c >6.5% (international standard) at enrolment.
Body mass index (BMI) between ≥19 and ≤42 kg/m2.

Who cannot join

Clinically significant illness or clinically relevant trauma, as judged by the Investigator, within 2 weeks prior to the first administration of AZD1656
Participation in another clinical study during the 30 days prior to screening or intake of another investigational drug within 30 days (or at least 5 x t1/2 of the drug) prior to the first administration of AZD1656.
History of, or ongoing, ischemic heart disease or heart failure. Stroke, transitory ischemic attack, or symptomatic peripheral arterial disease within the last 6 months.
Clinically significant abnormalities in ECG, clinical chemistry, hematology or urinalysis results.
Positive test for Hepatitis B surface antigen (HBsAg) or antibodies to human immunodeficiency virus (HIV) or Hepatitis C virus.

Trial locations and contacts

1 site in 1 country.

United States1 site

Research Site
Saint Paul, Minnesota

Other trials in United States

About this study

Official title: Randomized, Open, 4-way Crossover, Single Center, Phase I Relative Bioavailability Study in Type 2 Diabetes Mellitus Patients to Measure the Extent and Rate of Absorption of AZD1656 From Different Tablet Formulations

The purpose of this study is to assess the relative bioavailability by measuring the extent and rate of absorption of different tablet formulations of AZD1656 in T2DM patients.

Conditions: Type 2 Diabetes Mellitus, High Blood Sugar
Being tested: AZD1656
Keywords: Phase I, Bioavailability, Type 2 Diabetes Mellitus, Diabetic treatment, Metformin, High blood sugar
Medical subject headings: Diabetes Mellitus, Type 2, Hyperglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD1656Drug
3 different formulations, A, B and C of AZD1656 assessed before food intake and formulation B also after food intake

Study groups in NCT01221519
Study group	Role	What they receive
1	Experimental	AZD1656 Receives: Drug: AZD1656
2	Experimental	AZD1656 Receives: Drug: AZD1656
3	Experimental	AZD1656 Receives: Drug: AZD1656

What is being measured

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

Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of AUC of AZD1656.
Measured: Blood samples will be collected from predose to 48 hrs at each treatment period 1
Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of Cmax of AZD1656.
Measured: Blood samples will be collected from predose to 48 hrs at each treatment period 1
Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of tmax of AZD1656.
Measured: Blood samples will be collected from predose to 48 hrs at each treatment period 1
Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of AUC of AZD1656.
Measured: Blood samples will be collected from predose to 48 hrs at each treatment period 2
Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of Cmax of AZD1656.
Measured: Blood samples will be collected from predose to 48 hrs at each treatment period 2
Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of tmax of AZD1656.
Measured: Blood samples will be collected from predose to 48 hrs at each treatment period 2
Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of AUC of AZD1656.
Measured: Blood samples will be collected from predose to 48 hrs at each treatment period 3
Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of Cmax of AZD1656.
Measured: Blood samples will be collected from predose to 48 hrs at each treatment period 3
Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of tmax of AZD1656.
Measured: Blood samples will be collected from predose to 48 hrs at each treatment period 3
Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of AUC of AZD1656.
Measured: Blood samples will be collected from predose to 48 hrs at each treatment period 4
Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of Cmax of AZD1656.
Measured: Blood samples will be collected from predose to 48 hrs at each treatment period 4
Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of tmax of AZD1656.
Measured: Blood samples will be collected from predose to 48 hrs at each treatment period 4

Secondary outcomes (23)

To evaluate the safety of AZD1656 by assessing a panel of adverse events measures: physical examination, electrocardiogram, pulse and blood pressure, weight and laboratory, variables including plasma glucose.
Measured: start of treatment until follow up
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC
Measured: PK blood samples will be collected from predose to 48 hrs after each treatment period 1
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC(0-t).
Measured: PK blood samples will be collected from predose to 48 hrs after each treatment period 1
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of Cmax.
Measured: PK blood samples will be collected from predose to 48 hrs after each treatment period 1
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of tmax.
Measured: PK blood samples will be collected from predose to 48 hrs after each treatment period 1
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of t½.
Measured: PK blood samples will be collected from predose to 48 hrs after each treatment period 1
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC.
Measured: PK blood samples will be collected from predose to 48 hrs after each treatment period 2
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC(0-t).
Measured: PK blood samples will be collected from predose to 48 hrs after each treatment period 2
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of Cmax.
Measured: PK blood samples will be collected from predose to 48 hrs after each treatment period 2
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of tmax.
Measured: PK blood samples will be collected from predose to 48 hrs after each treatment period 2
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of t½.
Measured: PK blood samples will be collected from predose to 48 hrs after each treatment period 2
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC.
Measured: PK blood samples will be collected from predose to 48 hrs after each treatment period 3
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC(0-t).
Measured: PK blood samples will be collected from predose to 48 hrs after each treatment period 3
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of Cmax.
Measured: PK blood samples will be collected from predose to 48 hrs after each treatment period 3
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of tmax.
Measured: PK blood samples will be collected from predose to 48 hrs after each treatment period 3
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of t½.
Measured: PK blood samples will be collected from predose to 48 hrs after each treatment period 3
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC.
Measured: PK blood samples will be collected from predose to 48 hrs after each treatment period 4
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC(0-t).
Measured: PK blood samples will be collected from predose to 48 hrs after each treatment period 4
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of Cmax.
Measured: PK blood samples will be collected from predose to 48 hrs after each treatment period 4
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of tmax.
Measured: PK blood samples will be collected from predose to 48 hrs after each treatment period 4
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of t½.
Measured: PK blood samples will be collected from predose to 48 hrs after each treatment period 4
pharmacodynamics of AZD1656 following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC(0-4) and AUC(0-24) for glucose
Measured: PK blood samples will be collected from predose to 48 hrs after treatment period and P-glucose on Day 1 of each treatment period
pharmacodynamics of AZD1656 following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC(0-4) for insulin
Measured: PK blood samples will be collected from predose to 48 hrs after treatment period and P-glucose on Day 1 of each treatment period

Timeline

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

Sep 2010Jan 2011

First posted15 Oct 2010 (estimated)
Study startSep 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: Crossover
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01221519
Sponsor's protocol ID: D1020C00033
Status last verified: Jan 2012
First submitted: 12 Oct 2010
Last updated: 19 Jan 2012
Results posted: No
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 Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Open, 4-way Crossover, Single Center, Phase I Relative Bioavailability Study in Type 2 Diabetes Mellitus Patients to Measure the Extent and Rate of Absorption of AZD1656 From Different Tablet Formulations
ClinicalTrials.gov ID: NCT01221519
Acronym / sponsor ID: D1020C00033
Conditions: Type 2 Diabetes Mellitus, High Blood Sugar
Keywords: Phase I, Bioavailability, Type 2 Diabetes Mellitus, Diabetic treatment, Metformin, High blood sugar
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Sep 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 assess the relative bioavailability by measuring the extent and rate of absorption of different tablet formulations of AZD1656 in T2DM patients.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Drug: AZD1656AZD1656
2	Experimental	Drug: AZD1656AZD1656
3	Experimental	Drug: AZD1656AZD1656

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Provision of signed and dated, written informed consent prior to any study specific procedures.
Males or females of non-childbearing potential (post-menopausal, and/or have undergone hysterectomy and/or bilateral oophorectomy or salpingectomy/ tubal ligation) aged ≥18 years. Females will be defined as post-menopausal if last menstruation period was >1 year ago and serum follicle stimulating hormone (FSH) is within the post-menopausal range, or if age >50 years and with last menstruation period >2 years ago.
A confirmed clinical diagnosis of T2DM for at least 1 year, treated with metformin as a single treatment or in combination with one other oral anti-diabetic (ie, DPPIV inhibitor or SU) for at least 2 months prior to screening. Doses of anti-diabetic treatment should have been stable for at least 1 month prior to screening.
Treatment with at least 1000mg of Metformin for 2 months and being stable on the Metformin Therapy for 1 month
Hb A1c >6.5% (international standard) at enrolment.

Key exclusion criteria (5 listed)

Clinically significant illness or clinically relevant trauma, as judged by the Investigator, within 2 weeks prior to the first administration of AZD1656
Participation in another clinical study during the 30 days prior to screening or intake of another investigational drug within 30 days (or at least 5 x t1/2 of the drug) prior to the first administration of AZD1656.
History of, or ongoing, ischemic heart disease or heart failure. Stroke, transitory ischemic attack, or symptomatic peripheral arterial disease within the last 6 months.
Clinically significant abnormalities in ECG, clinical chemistry, hematology or urinalysis results.
Positive test for Hepatitis B surface antigen (HBsAg) or antibodies to human immunodeficiency virus (HIV) or 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
AZD16563 different formulations, A, B and C of AZD1656 assessed before food intake and formulation B also after food intake	Drug	1, 2, 3

Primary outcome

Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of AUC of AZD1656.
Time frame: Blood samples will be collected from predose to 48 hrs at each treatment period 1
Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of Cmax of AZD1656.
Time frame: Blood samples will be collected from predose to 48 hrs at each treatment period 1
Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of tmax of AZD1656.
Time frame: Blood samples will be collected from predose to 48 hrs at each treatment period 1
Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of AUC of AZD1656.
Time frame: Blood samples will be collected from predose to 48 hrs at each treatment period 2
Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of Cmax of AZD1656.
Time frame: Blood samples will be collected from predose to 48 hrs at each treatment period 2
Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of tmax of AZD1656.
Time frame: Blood samples will be collected from predose to 48 hrs at each treatment period 2
Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of AUC of AZD1656.
Time frame: Blood samples will be collected from predose to 48 hrs at each treatment period 3
Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of Cmax of AZD1656.
Time frame: Blood samples will be collected from predose to 48 hrs at each treatment period 3
Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of tmax of AZD1656.
Time frame: Blood samples will be collected from predose to 48 hrs at each treatment period 3
Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of AUC of AZD1656.
Time frame: Blood samples will be collected from predose to 48 hrs at each treatment period 4
Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of Cmax of AZD1656.
Time frame: Blood samples will be collected from predose to 48 hrs at each treatment period 4
Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of tmax of AZD1656.
Time frame: Blood samples will be collected from predose to 48 hrs at each treatment period 4

23 secondary outcomes

To evaluate the safety of AZD1656 by assessing a panel of adverse events measures: physical examination, electrocardiogram, pulse and blood pressure, weight and laboratory, variables including plasma glucose.
Time frame: start of treatment until follow up
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC
Time frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 1
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC(0-t).
Time frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 1
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of Cmax.
Time frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 1
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of tmax.
Time frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 1
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of t½.
Time frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 1
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC.
Time frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 2
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC(0-t).
Time frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 2
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of Cmax.
Time frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 2
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of tmax.
Time frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 2
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of t½.
Time frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 2
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC.
Time frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 3
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC(0-t).
Time frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 3
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of Cmax.
Time frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 3
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of tmax.
Time frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 3
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of t½.
Time frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 3
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC.
Time frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 4
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC(0-t).
Time frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 4
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of Cmax.
Time frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 4
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of tmax.
Time frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 4
Evaluate: pharmacokinetics of the AZD1656 metabolite, following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of t½.
Time frame: PK blood samples will be collected from predose to 48 hrs after each treatment period 4
pharmacodynamics of AZD1656 following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC(0-4) and AUC(0-24) for glucose
Time frame: PK blood samples will be collected from predose to 48 hrs after treatment period and P-glucose on Day 1 of each treatment period
pharmacodynamics of AZD1656 following single-dose administration of Tablets A, B, and C, given before food intake and following administration of Tablet B after food intake, by assessment of AUC(0-4) for insulin
Time frame: PK blood samples will be collected from predose to 48 hrs after treatment period and P-glucose on Day 1 of each treatment period

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 19 Jan 2012.

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Type 2 Diabetes
RecruitingObservational study
Investigating the Link Between Advanced Glycation End Products (AGEs) and Muscle Wasting in Sarcobesity
Sarcopenia, Obesity

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.

Eva Johnsson, MD, PhD study director

AstraZeneca Sweden

Mark Matson, MD principal investigator

Prism Research

Mirjana Kujacic Kujacic, MD, PhD study chair

AstraZeneca R&D Mölndal

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 and High Blood Sugar, 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 6 inclusion and 5 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 19 Jan 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. 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?

Measure: rate and extent of absorption of AZD1656 following single-dose administration of Tablets A, B, and C, administered before food intake and following administration of Tablet B after food intake, by assessment of AUC of AZD1656. (time frame: Blood samples will be collected from predose to 48 hrs at each treatment period 1). The study lists 12 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 NCT01221519.

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 19 Jan 2012.