Type 2 Diabetes MellitusPhase 2BRIDNCT02537470
Safety and Efficacy of Biphasic Remogliflozin Etabonate in the Treatment of Type 2 Diabetes
A Phase 2 study testing Biphasic Remogliflozin Etabonate in people with Type 2 Diabetes Mellitus and Diabetes Mellitus, Type 2, run by BHV Pharma at 19 sites in United States.
Trial summary
This is a dose-ranging study to evaluate the efficacy, safety and tolerability of a range of doses of a biphasic formulation of remogliflozin etabonate compared to placebo, administered over 12 weeks in subjects with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Diabetes Mellitus, Type 2
- What is being tested?
- Biphasic Remogliflozin Etabonate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 191 participants
- Where
- 19 sitesUnited States
- Study dates
- Jul 2015to Aug 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent
- Subject with clinical diagnosis of type 2 diabetes
- HbA1c 7.0 - 10.5% inclusive at Visit 1.
Who cannot join
- History of metabolic acidosis or ketoacidosis.
- Current active renal disease that is not related to hypertension or type 2 diabetes (e.g. non-diabetic glomerulonephritis, interstitial nephritis, symptomatic nephrolithiasis, etc.)
- Use of an investigational device or investigational drug within 30 days or 5 half-lives (whichever is longer) prior to Visit 1.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Albuquerque Clinical Trials, Inc
Albuquerque, New Mexico, 87102
Austin Center for Clinical Research
Austin, Texas, 78756
Comprehensive Clinical Research
Berlin, New Jersey, 08009
Padre Coast Clinical Research
Corpus Christi, Texas, 78404
Mountain View Clinical Research
Greer, South Carolina, 29651
Medical Research Unlimited
Hialeah, Florida, 33012
Juno Research, LLC
Houston, Texas, 77074
New Phase Research & Development
Knoxville, Tennessee, 37909
eStudySite, Las Vegas
Las Vegas, Nevada, 89109
Long Beach Clinical Trials
Long Beach, California, 90806
Long Beach Center for Clinical Research
Long Beach, California, 90807
National Research Institute
Los Angeles, California, 90057
Progressive Medical Research
Port Orange, Florida, 32127
Wasatch Clinical Research
Salt Lake City, Utah, 84107
Meridien Research
Tampa, Florida, 33634
Advanced Arizona Clinical Research
Tucson, Arizona, 85712
Orange County Research Center
Tustin, California, 92780
Diablo Clinical Research
Walnut Creek, California, 94598
Chase Medical Research
Waterbury, Connecticut, 06708
About this study
Official title: A 12-week Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Determine the Efficacy and Safety of Biphasic Remogliflozin Etabonate When Administered to Subjects With Type 2 Diabetes Mellitus
This is a dose-ranging study to evaluate the efficacy, safety and tolerability of a range of doses of a biphasic formulation of remogliflozin etabonate compared to placebo, administered over 12 weeks in subjects with type 2 diabetes mellitus.
- Being tested
- Biphasic Remogliflozin Etabonate, 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.
Biphasic Remogliflozin EtabonateDrug
Experimental Drug
PlaceboOther
Placebo Comparator
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Placebo Receives: Other: Placebo |
| Arm 2 | Experimental | Biphasic remogliflozin etabonate Receives: Drug: Biphasic Remogliflozin Etabonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycosylated haemoglobin A1c (HbA1c) at Week 12
Measured: 12 weeks
Secondary outcomes (12)
HbA1c
Measured: at weeks 4, 8 and 12
Fasting plasma glucose (FPG)
Measured: at Weeks 4, 8 and 12
Insulin
Measured: at Weeks 4, 8 and 12
C-peptide
Measured: at Weeks 4, 8 and 12
Total Cholesterol
Measured: at Weeks 4, 8 and 12
LDL-c
Measured: at Weeks 4, 8 and 12
HDL-c
Measured: at Weeks 4, 8 and 12
Serum Triglycerides
Measured: at Weeks 4, 8 and 12
Body Weight
Measured: at Weeks 4, 8 and 12
Waist Circumference
Measured: at Weeks 4, 8 and 12
Adverse Events (AE)
Measured: Over 12 weeks
Safety endpoints include AEs, incidence of urinary tract infections, incidence of genital fungal infections, vital signs, ECGs and standard laboratory tests
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startJul 2015
- Primary completionAug 2016
- Study completionAug 2016
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
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- BHV Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Integrium
- Responsible party
- Sponsor
- Investigators
- Joel M Neutel, MD, Principal investigator, Orange County Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02537470
- Sponsor's protocol ID
- BHV20200
- Acronym
- BRID
- Status last verified
- Jan 2018
- First submitted
- 25 Aug 2015
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Determine the Efficacy and Safety of Biphasic Remogliflozin Etabonate When Administered to Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02537470
- Acronym / sponsor ID
- BRID / BHV20200
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- BHV PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Integrium
- Study start
- Jul 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 1 Sep 2015 (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 is a dose-ranging study to evaluate the efficacy, safety and tolerability of a range of doses of a biphasic formulation of remogliflozin etabonate compared to placebo, administered over 12 weeks in subjects with type 2 diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Other: PlaceboPlacebo |
| Arm 2 | Experimental | Drug: Biphasic Remogliflozin EtabonateBiphasic remogliflozin etabonate |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to provide written informed consent
- Subject with clinical diagnosis of type 2 diabetes
- HbA1c 7.0 - 10.5% inclusive at Visit 1.
Key exclusion criteria (3 listed)
- History of metabolic acidosis or ketoacidosis.
- Current active renal disease that is not related to hypertension or type 2 diabetes (e.g. non-diabetic glomerulonephritis, interstitial nephritis, symptomatic nephrolithiasis, etc.)
- Use of an investigational device or investigational drug within 30 days or 5 half-lives (whichever is longer) prior to Visit 1.
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 |
|---|---|---|
| Biphasic Remogliflozin EtabonateExperimental Drug | Drug | Arm 2 |
| PlaceboPlacebo Comparator | Other | Arm 1 |
Primary outcome
Glycosylated haemoglobin A1c (HbA1c) at Week 12
Time frame: 12 weeks
12 secondary outcomes
HbA1c
Time frame: at weeks 4, 8 and 12
Fasting plasma glucose (FPG)
Time frame: at Weeks 4, 8 and 12
Insulin
Time frame: at Weeks 4, 8 and 12
C-peptide
Time frame: at Weeks 4, 8 and 12
Total Cholesterol
Time frame: at Weeks 4, 8 and 12
LDL-c
Time frame: at Weeks 4, 8 and 12
HDL-c
Time frame: at Weeks 4, 8 and 12
Serum Triglycerides
Time frame: at Weeks 4, 8 and 12
Body Weight
Time frame: at Weeks 4, 8 and 12
Waist Circumference
Time frame: at Weeks 4, 8 and 12
Adverse Events (AE)
Time frame: Over 12 weeks
Safety endpoints include AEs, incidence of urinary tract infections, incidence of genital fungal infections, vital signs, ECGs and standard laboratory tests
Time frame: 12 weeks
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 18 Jan 2018.
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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.
Joel M Neutel, MD principal investigator
Orange County Research Center
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biphasic Remogliflozin Etabonate in people with Type 2 Diabetes Mellitus and Diabetes Mellitus, Type 2, run by BHV Pharma at 19 sites 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 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites 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 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?
Glycosylated haemoglobin A1c (HbA1c) at Week 12 (time frame: 12 weeks). 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 18 Jan 2018; AzTrials last refreshed its copy on 8 Nov 2026.