Type 2 DiabetesPhase 1NCT00886366
Single Ascending Dose Study With Healthy Male Volunteers and Type II Diabetic Patients
A Phase 1 study testing AZD6714 in people with Type 2 Diabetes, run by AstraZeneca at 1 site in Sweden.
Trial summary
The purpose of this study is to assess safety and tolerability of AZD6714 after single ascending oral doses in healthy male subjects and type 2 diabetic patients. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- AZD6714
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2009to Sep 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Part A,Healthy male subjects, aged between ≥20 and ≤40 years.
- Part B,Male T2DM patients, aged between ≥20 and ≤65 years. Treatment with metformin as single therapy for T2DM for at least 30 days prior to enrollment
Who cannot join
- Part A,Clin sign illness or clin relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the IP.
- Part A Clin sign abnormalities in clinical chemistry, haematology, or urinalysis results as judged by the investigator
- Part B, 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 tests or ECG, which in the judgment of the investigator would compromise the patient's safety or successful participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Single-Blind, Placebo-Controlled, Single-Centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Interaction After Single Ascending Oral Doses of AZD6714 in Healthy Male Volunteers and Male Type II Diabetic Patients
The purpose of this study is to assess safety and tolerability of AZD6714 after single ascending oral doses in healthy male subjects and type 2 diabetic patients.
- Conditions
- Type 2 Diabetes
- Being tested
- AZD6714, 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.
AZD6714Drug
Oral single doses a-h suspension
PlaceboDrug
Oral single doses suspension
AZD6714Drug
Oral single doses a-d suspension
AZD6714Drug
Oral single doses d and g suspension
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AZD6714 in 8 increasing oral single doses a-h given to 8 groups (3 on active and 1 on placebo in each group) Receives: Drug: AZD6714; Drug: Placebo |
| 2 | Experimental | 2 oral single doses d and g suspensions of AZD6714 given to 2 groups (3+1) together with food Receives: Drug: Placebo; Drug: AZD6714 |
| 3 | Experimental | Two increasing oral doses of AZD6714 and one placebo given to 2 groups with 3 type 2 diabetic patients. Receives: Drug: Placebo; Drug: AZD6714 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety variables (AE, BP, pulse, plasma glucose, laboratory variables and ECG)
Measured: AEs will be collected during the whole study period (1-3 months). The other variables will be measured repeatedly during 24 hours on the study day sessions
Secondary outcomes (2)
Pharmacokinetic variables
Measured: Blood samples taken repeatedly during 24 hours on study day sessions.
Pharmacodynamic variables (P-Glucose, S-Insulin and 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 posted22 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionSep 2009
- Study completionSep 2009
Why it stopped: Part A reached a predefined stopping criteria. Relevant doses for part B could not be established based on A and subsequently study was stopped.
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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Klas Malmberg, MD, PhD, Study director, AstraZeneca R&D MölndalMarianne Hartford, Principal investigator, CPU Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886366
- Sponsor's protocol ID
- D1920C00001
- Status last verified
- Dec 2010
- First submitted
- 17 Apr 2009
- Last updated
- 7 Dec 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Single-Blind, Placebo-Controlled, Single-Centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Interaction After Single Ascending Oral Doses of AZD6714 in Healthy Male Volunteers and Male Type II Diabetic Patients
- ClinicalTrials.gov ID
- NCT00886366
- Acronym / sponsor ID
- D1920C00001
- Conditions
- Type 2 Diabetes
- Keywords
- Type II Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Part A reached a predefined stopping criteria. Relevant doses for part B could not be established based on A and subsequently study was stopped.
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 22 Apr 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 safety and tolerability of AZD6714 after single ascending oral doses in healthy male subjects and type 2 diabetic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD6714, Drug: PlaceboAZD6714 in 8 increasing oral single doses a-h given to 8 groups (3 on active and 1 on placebo in each group) |
| 2 | Experimental | Drug: Placebo, Drug: AZD67142 oral single doses d and g suspensions of AZD6714 given to 2 groups (3+1) together with food |
| 3 | Experimental | Drug: Placebo, Drug: AZD6714Two increasing oral doses of AZD6714 and one placebo given to 2 groups with 3 type 2 diabetic patients. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Part A,Healthy male subjects, aged between ≥20 and ≤40 years.
- Part B,Male T2DM patients, aged between ≥20 and ≤65 years. Treatment with metformin as single therapy for T2DM for at least 30 days prior to enrollment
Key exclusion criteria (4 listed)
- Part A,Clin sign illness or clin relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the IP.
- Part A Clin sign abnormalities in clinical chemistry, haematology, or urinalysis results as judged by the investigator
- Part B, 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 tests or ECG, which in the judgment of the investigator would compromise the patient's safety or successful participation.
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 |
|---|---|---|
| AZD6714Oral single doses a-h suspension | Drug | 1 |
| PlaceboOral single doses suspension | Drug | 1, 2, 3 |
| AZD6714Oral single doses a-d suspension | Drug | 3 |
| AZD6714Oral single doses d and g suspension | Drug | 2 |
Primary outcome
Safety variables (AE, BP, pulse, plasma glucose, laboratory variables and ECG)
Time frame: AEs will be collected during the whole study period (1-3 months). The other variables will be measured repeatedly during 24 hours on the study day sessions
2 secondary outcomes
Pharmacokinetic variables
Time frame: Blood samples taken repeatedly during 24 hours on study day sessions.
Pharmacodynamic variables (P-Glucose, S-Insulin and C-peptide)
Time frame: Blood samples taken repeatedly during 24 hours on study day sessions.
Results and safety
The study was stopped early (reason given: Part A reached a predefined stopping criteria. Relevant doses for part B could not be established based on A and subsequently study was stopped.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2010.
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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 study director
AstraZeneca R&D Mölndal
Marianne Hartford principal investigator
CPU Sahlgrenska University Hospital
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 AZD6714 in people with Type 2 Diabetes, run by AstraZeneca at 1 site in Sweden.
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 2 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: stopped early, as of the sponsor's last update on 7 Dec 2010. 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 Sweden. 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 was stopped early (reason given: Part A reached a predefined stopping criteria. Relevant doses for part B could not be established based on A and subsequently study was stopped.). Results are not available in the source record.
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 variables (AE, BP, pulse, plasma glucose, laboratory variables and ECG) (time frame: AEs will be collected during the whole study period (1-3 months). The other variables will be measured repeatedly during 24 hours on the 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 7 Dec 2010.