Type II DiabetesPhase 1NCT00819884

To Evaluate 24-hr Glucose After OD vs BD AZD1656

A Phase 1 study testing AZD1656 in people with Type II 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 compare the 24-hour glucose profiles in diabetic patients treated with metformin following once daily and twice daily oral dosing Read more about this study

Who is it for?: Ages 30 to 75 years
Conditions the study is for: Type II Diabetes
What is being tested?: AZD1656
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteUnited States
Study dates: Jan 2009to May 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

type II diabetes patients, female with non child-bearing potential
Type 2 Diabetes Mellitus (T2DM) diagnosis confirmed by C-peptide >0.3nmol/L and no Glutamic acid decarboxylase (GAD) antibodies at enrolment (screening)
Treatment with metformin as single therapy for T2DM for at least 30 days prior to enrolment and the metformin dose must have been unchanged during this period

Who cannot join

History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease
Any clinically significant abnormality identified on physical examination, laboratory test or ECG, which in the judgement of investigator would compromise the subject's safety or successful participation in the clinical study

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, Two Way Cross-Over, Single-Blind, Phase I Study to Evaluate 24-hr Glucose Profiles in Patients With T2DM When Dosed OD and BD on Top of Metformin for Four Days With AZD1656

The purpose of this study is to compare the 24-hour glucose profiles in diabetic patients treated with metformin following once daily and twice daily oral dosing

Conditions: Type II Diabetes
Being tested: AZD1656
Keywords: Type II Diabetes, 24 hour glucose profile
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
Oral suspension

Study groups in NCT00819884
Study group	Role	What they receive
1	Experimental	twice daily during 4 days Receives: Drug: AZD1656
2	Experimental	once daily during 4 days Receives: Drug: AZD1656

What is being measured

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

24-hr glucose (Calculated plasma glucose AUC0-24, change in fasting plasma glucose)
Measured: Repeated sampling during the 24 hour period on day -1, 4 and 8

Secondary outcomes (3)

Safety and tolerability (Adverse events (AEs) during the study, blood pressure (BP), pulse rate, safety laboratory variables (incl. glucose) and investigator's interpretation of electrocardiogram (ECG)
Measured: Frequent measurements during the study period
Pharmacokinetic variables (Area under the plasma conc vs. time curve (AUC0-24), maximum plasma conc (Cmax), time to reach maximum plasma conc(tmax), terminal elimination half-life and apparent oral clearance
Measured: Repeated sampling at pre-specified timepoints on day 4 and 8
Pharmacodynamics (S-Insulin AUC0-24 and C-peptide AUC0-24)
Measured: Repeated sampling during the 24 hour period on day -1, 4 and 8

Timeline

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

Jan 2009May 2009

First posted9 Jan 2009 (estimated)
Study startJan 2009
Primary completionMay 2009
Study completionMay 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type II 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: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 36 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00819884
Sponsor's protocol ID: D1020C00017
Status last verified: May 2009
First submitted: 8 Jan 2009
Last updated: 7 May 2009
Results posted: 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 II Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 7 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Two Way Cross-Over, Single-Blind, Phase I Study to Evaluate 24-hr Glucose Profiles in Patients With T2DM When Dosed OD and BD on Top of Metformin for Four Days With AZD1656
ClinicalTrials.gov ID: NCT00819884
Acronym / sponsor ID: D1020C00017
Conditions: Type II Diabetes
Keywords: Type II Diabetes, 24 hour glucose profile
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: May 2009 (actual)
Study completion: May 2009 (actual)
First posted: 9 Jan 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 compare the 24-hour glucose profiles in diabetic patients treated with metformin following once daily and twice daily oral dosing

Study design

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

Arm	Type	Receives
1	Experimental	Drug: AZD1656twice daily during 4 days
2	Experimental	Drug: AZD1656once daily during 4 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)

type II diabetes patients, female with non child-bearing potential
Type 2 Diabetes Mellitus (T2DM) diagnosis confirmed by C-peptide >0.3nmol/L and no Glutamic acid decarboxylase (GAD) antibodies at enrolment (screening)
Treatment with metformin as single therapy for T2DM for at least 30 days prior to enrolment and the metformin dose must have been unchanged during this period

Key exclusion criteria (2 listed)

History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease
Any clinically significant abnormality identified on physical examination, laboratory test or ECG, which in the judgement of investigator would compromise the subject's safety or successful participation in the clinical study

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 suspension	Drug	1, 2

Primary outcome

24-hr glucose (Calculated plasma glucose AUC0-24, change in fasting plasma glucose)
Time frame: Repeated sampling during the 24 hour period on day -1, 4 and 8

3 secondary outcomes

Safety and tolerability (Adverse events (AEs) during the study, blood pressure (BP), pulse rate, safety laboratory variables (incl. glucose) and investigator's interpretation of electrocardiogram (ECG)
Time frame: Frequent measurements during the study period
Pharmacokinetic variables (Area under the plasma conc vs. time curve (AUC0-24), maximum plasma conc (Cmax), time to reach maximum plasma conc(tmax), terminal elimination half-life and apparent oral clearance
Time frame: Repeated sampling at pre-specified timepoints on day 4 and 8
Pharmacodynamics (S-Insulin AUC0-24 and C-peptide AUC0-24)
Time frame: Repeated sampling during the 24 hour period on day -1, 4 and 8

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 7 May 2009.

Related trials for Type II Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
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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 1 study testing AZD1656 in people with Type II 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 7 May 2009. 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?

24-hr glucose (Calculated plasma glucose AUC0-24, change in fasting plasma glucose) (time frame: Repeated sampling during the 24 hour period on day -1, 4 and 8). 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 NCT00819884.

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 7 May 2009.