Type 2 DiabetesPhase 1NCT00790153
To Evaluate the Hormonal Response to Low Blood Sugar After a Single Oral Dose of AZD1656 Suspension
A Phase 1 study testing Insulin and AZD1656 in people with Type 2 Diabetes, run by AstraZeneca at 1 site in United States.
Trial summary
To evaluate the hormonal response to low blood sugar after a single oral dose of AZD1656 suspension. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Insulin and AZD1656
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Feb 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers.
- Clinically normal physical findings (incl. Electrocardiogram (ECG)) and laboratory values as judged by the investigator.
- Have a body mass index (BMI) ≥19 and ≤30
Who cannot join
- Clinically significant illness or clinically relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the investigational product
- Intake of any prescribed medicine and OTC drugs (including herbals, vitamins and minerals), except for occasional paracetamol or nasal spray for nasal congestion, within two weeks before the first administration of the investigational product.
- Daily use of nicotine containing substances.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open, Two-Way Cross-Over, Single-Centre, Phase I Study to Assess the Counter Regulatory Response During Hypoglycaemia in Healthy Male Volunteers After a Single Oral Dose of AZD1656 Suspension in Comparison With Insulin Infusion
To evaluate the hormonal response to low blood sugar after a single oral dose of AZD1656 suspension.
- Conditions
- Type 2 Diabetes
- Being tested
- Insulin, AZD1656
- Keywords
- Type 2 diabetes, hormonal response
- 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.
InsulinDrug
Insulin infusion given during 3 hours at one occasion.
AZD1656Drug
Single dose oral suspension given at one occasion.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | AZD1656 Receives: Drug: AZD1656 |
| 2 | Active comparator | Insulin Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamic variables
Measured: Blood samples taken repeatedly up to 6 hours during study days
Secondary outcomes (2)
Pharmacokinetic variables
Measured: Blood samples taken repeatedly during 24 hours on study day sessions
Safety Variables (AEs, BP, pulse, electrocardiogram (ECG), hypoglycaemic symptoms and laboratory variables)
Measured: Taken repeatedly during treatment periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study startNov 2008
- Study completionFeb 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Klas Malmberg, MD, PhD, Prof, Study director, AstraZeneca R&D MölndalLinda Morrow, MD, Principal investigator, Profil Institute for Clinical Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00790153
- Sponsor's protocol ID
- D1020C00012
- Status last verified
- Apr 2009
- First submitted
- 11 Nov 2008
- Last updated
- 10 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open, Two-Way Cross-Over, Single-Centre, Phase I Study to Assess the Counter Regulatory Response During Hypoglycaemia in Healthy Male Volunteers After a Single Oral Dose of AZD1656 Suspension in Comparison With Insulin Infusion
- ClinicalTrials.gov ID
- NCT00790153
- Acronym / sponsor ID
- D1020C00012
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, hormonal response
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Study completion
- Feb 2009 (actual)
- First posted
- 13 Nov 2008 (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.
To evaluate the hormonal response to low blood sugar after a single oral dose of AZD1656 suspension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: AZD1656AZD1656 |
| 2 | Active comparator | Drug: InsulinInsulin |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male volunteers.
- Clinically normal physical findings (incl. Electrocardiogram (ECG)) and laboratory values as judged by the investigator.
- Have a body mass index (BMI) ≥19 and ≤30
Key exclusion criteria (3 listed)
- Clinically significant illness or clinically relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the investigational product
- Intake of any prescribed medicine and OTC drugs (including herbals, vitamins and minerals), except for occasional paracetamol or nasal spray for nasal congestion, within two weeks before the first administration of the investigational product.
- Daily use of nicotine containing substances.
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 |
|---|---|---|
| InsulinInsulin infusion given during 3 hours at one occasion. | Drug | 2 |
| AZD1656Single dose oral suspension given at one occasion. | Drug | 1 |
Primary outcome
Pharmacodynamic variables
Time frame: Blood samples taken repeatedly up to 6 hours during study days
2 secondary outcomes
Pharmacokinetic variables
Time frame: Blood samples taken repeatedly during 24 hours on study day sessions
Safety Variables (AEs, BP, pulse, electrocardiogram (ECG), hypoglycaemic symptoms and laboratory variables)
Time frame: Taken repeatedly during treatment periods
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 10 Apr 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, PhD, Prof study director
AstraZeneca R&D Mölndal
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 Insulin and 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 3 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 10 Apr 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?
Pharmacodynamic variables (time frame: Blood samples taken repeatedly up to 6 hours during study days). 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 10 Apr 2009.