Type 2 Diabetes MellitusPhase 2NCT01951235
A Study of the Efficacy and Safety of 4 Doses of Imeglimin After 24 Weeks of Treatment in Subjects With Type 2 Diabetes
A Phase 2 study testing Imeglimin in people with Type 2 Diabetes Mellitus, run by Poxel SA at 1 site in Latvia.
Trial summary
This study will assess the efficacy and safety/tolerability of 4 doses of Imeglimin versus placebo. The study will be performed in subjects with type 2 diabetes either naive of treatment or previously treated with an oral monotherapy excluding thiazolidinedione. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Imeglimin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 315 participants
- Where
- 1 siteLatvia
- Study dates
- Jan 2013to Jul 2014
- 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
Who may be able to join
- Subject has given written informed consent
- Male and female type 2 diabetic subjects, either naïve of antidiabetic agents or treated with an oral anti-diabetic monotherapy.
- Body mass index (BMI) : ≥ 24 to ≤ 40 kg/m²
- HbA1c criteria: ≥ 7% and ≤ 9.5%
- Creatinine clearance ≥ 50 mL/[min*1.73 m2] at Screening Visit
- Effective contraception for women of child bearing potential
Who cannot join
- Any disease which in the investigator's opinion would exclude the subject from the study
- Acute cardiovascular event within 3 months before randomization
- Uncontrolled high blood pressure
- Impairment of hepatic function
- History of drug-induced Torsades de Pointes or a marked baseline prolongation of the QTc interval
- Pregnancy or lactation
- Use of any non-permitted medication
- Positive screen for viral hepatitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Dose-ranging, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy and Safety of 4 Doses of Imeglimin After 24 Weeks of Treatment in Subjects With Type 2 Diabetes Mellitus.
This study will assess the efficacy and safety/tolerability of 4 doses of Imeglimin versus placebo. The study will be performed in subjects with type 2 diabetes either naive of treatment or previously treated with an oral monotherapy excluding thiazolidinedione.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Imeglimin, Placebo
- 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.
ImegliminDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Imeglimin (Dose 1) | Experimental | Not described Receives: Drug: Imeglimin |
| Imeglimin (Dose 2) | Experimental | Not described Receives: Drug: Imeglimin |
| Imeglimin (Dose 3) | Experimental | Not described Receives: Drug: Imeglimin |
| Imeglimin (Dose 4) | Experimental | Not described Receives: Drug: Imeglimin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Measured: Baseline and week 24
Secondary outcomes (1)
Safety will be assessed by the incidence of adverse events (AEs), physical examination, relevant changes on laboratory tests, vital signs, and 12-lead electrocardiograms (ECG)
Measured: Baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poxel SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Valdis Pirags, MD, Principal investigator, P. Stradins Clinical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01951235
- Sponsor's protocol ID
- PXL008-008
- Other IDs
- 2012-004045-33
- Status last verified
- Jul 2015
- First submitted
- 19 Sep 2013
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-ranging, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy and Safety of 4 Doses of Imeglimin After 24 Weeks of Treatment in Subjects With Type 2 Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT01951235
- Acronym / sponsor ID
- PXL008-008
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Poxel SAIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 26 Sep 2013 (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.
This study will assess the efficacy and safety/tolerability of 4 doses of Imeglimin versus placebo. The study will be performed in subjects with type 2 diabetes either naive of treatment or previously treated with an oral monotherapy excluding thiazolidinedione.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Imeglimin (Dose 1) | Experimental | Drug: Imeglimin |
| Imeglimin (Dose 2) | Experimental | Drug: Imeglimin |
| Imeglimin (Dose 3) | Experimental | Drug: Imeglimin |
| Imeglimin (Dose 4) | Experimental | Drug: Imeglimin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject has given written informed consent
- Male and female type 2 diabetic subjects, either naïve of antidiabetic agents or treated with an oral anti-diabetic monotherapy.
- Body mass index (BMI) : ≥ 24 to ≤ 40 kg/m²
- HbA1c criteria: ≥ 7% and ≤ 9.5%
- Creatinine clearance ≥ 50 mL/[min*1.73 m2] at Screening Visit
Key exclusion criteria (8 listed)
- Any disease which in the investigator's opinion would exclude the subject from the study
- Acute cardiovascular event within 3 months before randomization
- Uncontrolled high blood pressure
- Impairment of hepatic function
- History of drug-induced Torsades de Pointes or a marked baseline prolongation of the QTc interval
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 |
|---|---|---|
| Imeglimin | Drug | Imeglimin (Dose 1), Imeglimin (Dose 2), Imeglimin (Dose 3), Imeglimin (Dose 4) |
| Placebo | Drug | Placebo |
Primary outcome
Change in HbA1c
Time frame: Baseline and week 24
1 secondary outcome
Safety will be assessed by the incidence of adverse events (AEs), physical examination, relevant changes on laboratory tests, vital signs, and 12-lead electrocardiograms (ECG)
Time frame: Baseline to week 24
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 13 Aug 2015.
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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.
Valdis Pirags, MD principal investigator
P. Stradins Clinical 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 2 study testing Imeglimin in people with Type 2 Diabetes Mellitus, run by Poxel SA at 1 site in Latvia.
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 6 inclusion and 8 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 13 Aug 2015. 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 Latvia. 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 in HbA1c (time frame: Baseline and week 24). 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 13 Aug 2015.