Type 2 DiabetesPhase 1NCT00690287
A Study to Evaluate P-Glucose, Safety and Tolerability After Oral Single Dosing of AZD6370 in Type 2 Diabetic Patients
A Phase 1 study testing AZD6370 in people with Type 2 Diabetes, run by AstraZeneca at 3 sites in Sweden.
Trial summary
The purpose of this study is to assess the effect of AZD6370 on blood sugar and to study safety and tolerability in patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- AZD6370
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 3 sitesSweden
- Study dates
- Feb 2008to Jun 2008
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treated with diet or metformin. Stable glycemic control indicated by no changed treatment within 3 months
- Diabetes Mellitus diagnosis <5 years
Who cannot join
- Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the investigational product
- Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: A Dose-Ranging Study to Evaluate Fasting and Postprandial P-Glucose, Safety and Tolerability After Oral Single, B.I.D and Q.I.D Dosing of AZD6370 in Patients With Diabetes Mellitus: a Randomized, Single-Blind, Placebo-Controlled, Phase I Study
The purpose of this study is to assess the effect of AZD6370 on blood sugar and to study safety and tolerability in patients with type 2 diabetes.
- Conditions
- Type 2 Diabetes
- Being tested
- AZD6370, Placebo
- Keywords
- Type 2 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.
AZD6370Drug
Oral single doses a+b+c, o.d., suspension
AZD6370Drug
Oral single dose, o.d., b.i.d. and q.i.d., suspension
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Part A, arm 1 | Experimental | 1) 8 pats: AZD6370 increasing oral single doses a+b+c+placebo together with food Receives: Drug: AZD6370 |
| Part A, arm 2 | Experimental | 1) 8 pats: AZD6370 increasing oral single doses a+b+c+placebo without food Receives: Drug: AZD6370 |
| Part B, arm1, 2, and 3 | Experimental | 1. AZD6370 dose x mg o.d.
2. dose x/2 mg b.i.d.
3. dose x/4 mg q.i.d. Receives: Drug: AZD6370 |
| Part B, arm 4 | Experimental | 4) Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamic variables
Measured: Blood samples taken repeatedly during 24 hours on study day sessions
Secondary outcomes (2)
Safety variables
Measured: Blood samples taken repeatedly during 24 hours on study day sessions
Pharmacokinetic variables
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 posted4 Jun 2008 (estimated)
- Study startFeb 2008
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Klas Malmberg, MD, PhD, Prof., Study director, AstraZeneca R&D Mölndal, SE-431 83 Mölndal, SwedenWolfgang Kühn, MD, Principal investigator, Quintiles AB, Phase I Services, Strandbodgatan 1, SE-753 23 Uppsala, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690287
- Sponsor's protocol ID
- D0280C00014
- Status last verified
- Jan 2012
- First submitted
- 2 Jun 2008
- Last updated
- 11 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Ericsson H, Sjoberg F, Heijer M, Dorani H, Johansson P, Wollbratt M, Norjavaara E. The glucokinase activator AZD6370 decreases fasting and postprandial glucose in type 2 diabetes mellitus patients with effects influenced by dosing regimen and food. Diabetes Res Clin Pract. 2012 Dec;98(3):436-44. doi: 10.1016/j.diabres.2012.09.025. Epub 2012 Sep 23.
PubMed 23010558
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Ranging Study to Evaluate Fasting and Postprandial P-Glucose, Safety and Tolerability After Oral Single, B.I.D and Q.I.D Dosing of AZD6370 in Patients With Diabetes Mellitus: a Randomized, Single-Blind, Placebo-Controlled, Phase I Study
- ClinicalTrials.gov ID
- NCT00690287
- Acronym / sponsor ID
- D0280C00014
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 4 Jun 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.
The purpose of this study is to assess the effect of AZD6370 on blood sugar and to study safety and tolerability in patients with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A, arm 1 | Experimental | Drug: AZD63701) 8 pats: AZD6370 increasing oral single doses a+b+c+placebo together with food |
| Part A, arm 2 | Experimental | Drug: AZD63701) 8 pats: AZD6370 increasing oral single doses a+b+c+placebo without food |
| Part B, arm1, 2, and 3 | Experimental | Drug: AZD63701. AZD6370 dose x mg o.d. 2. dose x/2 mg b.i.d. 3. dose x/4 mg q.i.d. |
| Part B, arm 4 | Experimental | Drug: Placebo4) Placebo |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Treated with diet or metformin. Stable glycemic control indicated by no changed treatment within 3 months
- Diabetes Mellitus diagnosis <5 years
Key exclusion criteria (2 listed)
- Clinically significant illness or clinically relevant trauma, as judged by the investigator, within two weeks before the first administration of the investigational product
- Clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results
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 |
|---|---|---|
| AZD6370Oral single doses a+b+c, o.d., suspension | Drug | Part A, arm 1, Part A, arm 2 |
| AZD6370Oral single dose, o.d., b.i.d. and q.i.d., suspension | Drug | Part B, arm1, 2, and 3 |
| PlaceboPlacebo | Drug | Part B, arm 4 |
Primary outcome
Pharmacodynamic variables
Time frame: Blood samples taken repeatedly during 24 hours on study day sessions
2 secondary outcomes
Safety variables
Time frame: Blood samples taken repeatedly during 24 hours on study day sessions
Pharmacokinetic variables
Time frame: Blood samples taken repeatedly during 24 hours on study day sessions
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 11 Jan 2012.
- Derived from this study: PubMed 23010558Ericsson H, Sjoberg F, Heijer M, Dorani H, Johansson P, Wollbratt M, Norjavaara E. The glucokinase activator AZD6370 decreases fasting and postprandial glucose in type 2 diabetes mellitus patients with effects influenced by dosing regimen and food. Diabetes Res Clin Pract. 2012 Dec;98(3):436-44. doi: 10.1016/j.diabres.2012.09.025. Epub 2012 Sep 23.
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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, SE-431 83 Mölndal, Sweden
Wolfgang Kühn, MD principal investigator
Quintiles AB, Phase I Services, Strandbodgatan 1, SE-753 23 Uppsala, Sweden
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD6370 in people with Type 2 Diabetes, run by AstraZeneca at 3 sites 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 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 11 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 3 sites 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 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 during 24 hours on study day sessions). 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 NCT00690287, which also lists 1 linked publication.
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 11 Jan 2012.