Type 2 DiabetesPhase 2NCT00924534
A Safety PK/PD Study of SLV337 in Patients With Type 2 Diabetes
A Phase 2 study testing SLV337 in people with Type 2 Diabetes, run by Abbott Products at 12 sites in 3 countries.
Trial summary
The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamics of SLV337 in patients with type 2 diabetes Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- SLV337
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 12 sitesin 3 countries
- Study dates
- Dec 2009to Dec 2010
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria Type 2 diabetes ,stable dose of Metformin,HbA1c >= 7%, but < 9% Exclusion Criteria Type 1 diabetes mellitus, Body Mass Index (BMI) >40.0 kg/m2, evidence of unstable cardiovascular diseases, NYHA class I to IV, ALT > 1.5 times UNL, creatinine clearance <60 mL/min
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
Poland5 sites
Site Reference ID/Investigator# 44725
Lubin, 59-301
Site Reference ID/Investigator# 44724
Puławy, 24-100
Site Reference ID/Investigator# 54185
Radzymin, 05-250
Site Reference ID/Investigator# 44727
Ruda Śląska
Site Reference ID/Investigator# 54184
Wroclaw, 50-349
Bulgaria4 sites
Site Reference ID/Investigator# 54183
Dimitrovgrad, 6400
Site Reference ID/Investigator# 54182
Pleven, 5800
Site Reference ID/Investigator# 44722
Plovdiv, 4000
Site Reference ID/Investigator# 44723
Sofia, 1407
South Africa3 sites
Site Reference ID/Investigator# 44728
Cape Town, 7130
Site Reference ID/Investigator# 44730
Cape Town, 7937
Site Reference ID/Investigator# 44729
Johannesburg, 2198
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SLV337 in Patients With Type 2 Diabetes on Metformin Monotherapy
The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamics of SLV337 in patients with type 2 diabetes
- Conditions
- Type 2 Diabetes
- Being tested
- Placebo, SLV337
- Keywords
- type 2 diabetes, interventional, placebo, controlled, PK, PD, safety
- 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.
PlaceboDrug
Placebo
SLV337Drug
SLV337 400 mg/day
SLV337Drug
SLV337 800 mg/day
SLV337Drug
SLV337 1400 mg/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Drug: Placebo |
| 2 | Experimental | Not described Receives: Drug: SLV337 |
| 3 | Experimental | Not described Receives: Drug: SLV337 |
| 4 | Experimental | Not described Receives: Drug: SLV337 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in alanine amino transferase level to Day 35
Measured: 35 days
Change from baseline in Creatinine level to Day 35
Measured: 35 days
Change from baseline in the count of Red blood cells to Day 35
Measured: 35 days
Change from baseline in White blood cells count to Day 35
Measured: 35 days
Change from baseline in Creatinine kinase level to Day 35
Measured: 35 days
Secondary outcomes (4)
Change from baseline in Fasting plasma glucose level to Day 28
Measured: 28 days
Change from baseline in Adiponectin level to Day 28
Measured: 28 days
Change from baseline in Triglycerides level to Day 28
Measured: 28 days
Change from baseline in High density lipoprotein cholesterol level to Day 28
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2010
- Study completionDec 2010
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Responsible party
- Sponsor
- Investigators
- Francis Roy, MS, Study director, Abbott Products
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924534
- Sponsor's protocol ID
- S337.2.001
- Other IDs
- 2009-011589-27, 2009
- Status last verified
- Aug 2011
- First submitted
- 18 Jun 2009
- Last updated
- 4 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SLV337 in Patients With Type 2 Diabetes on Metformin Monotherapy
- ClinicalTrials.gov ID
- NCT00924534
- Acronym / sponsor ID
- S337.2.001
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes, interventional, placebo, controlled, PK, PD, safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Abbott ProductsIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- Dec 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 19 Jun 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, tolerability, pharmacokinetics and pharmacodynamics of SLV337 in patients with type 2 diabetes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Placebo |
| 2 | Experimental | Drug: SLV337 |
| 3 | Experimental | Drug: SLV337 |
| 4 | Experimental | Drug: SLV337 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| PlaceboPlacebo | Drug | 1 |
| SLV337SLV337 400 mg/day | Drug | 2 |
| SLV337SLV337 800 mg/day | Drug | 3 |
| SLV337SLV337 1400 mg/day | Drug | 4 |
Primary outcome
Change from Baseline in alanine amino transferase level to Day 35
Time frame: 35 days
Change from baseline in Creatinine level to Day 35
Time frame: 35 days
Change from baseline in the count of Red blood cells to Day 35
Time frame: 35 days
Change from baseline in White blood cells count to Day 35
Time frame: 35 days
Change from baseline in Creatinine kinase level to Day 35
Time frame: 35 days
4 secondary outcomes
Change from baseline in Fasting plasma glucose level to Day 28
Time frame: 28 days
Change from baseline in Adiponectin level to Day 28
Time frame: 28 days
Change from baseline in Triglycerides level to Day 28
Time frame: 28 days
Change from baseline in High density lipoprotein cholesterol level to Day 28
Time frame: 28 days
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 4 Jan 2012.
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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.
Francis Roy, MS study director
Abbott Products
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SLV337 in people with Type 2 Diabetes, run by Abbott Products at 12 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 4 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 12 sites in Poland, Bulgaria, South Africa. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change from Baseline in alanine amino transferase level to Day 35 (time frame: 35 days). The study lists 5 primary outcomes in all. 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 4 Jan 2012.