Type2 Diabetes MellitusPhase 4NCT03190798
Effects of Canagliflozin on Intravascular Volume and Hemodynamics
A Phase 4 study testing Canagliflozin 300mg in people with Type2 Diabetes Mellitus and Cardiovascular Diseases, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
RESEARCH HYPOTHESIS In subjects with T2DM and HF, effect of canagliflozin will be superior to placebo for the change from baseline in PCWP after a single dose (6 hours post-dose) and after 4 weeks. Treatment with canagliflozin will be well tolerated over 4 weeks. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type2 Diabetes Mellitus, Cardiovascular Diseases
- What is being tested?
- Canagliflozin 300mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 1 Aug 2018
- Phase
- Phase 4
- 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
- on stable doses (more than 3 months) of antihyperglycemic agents (except for an SGLT2 inhibitor and insulin)
- have an A1c ≥7% and ≤11%
- Estimated glomerular filtration rate (eGFR) must be ≥45 ml/min•1.73 m2
- have an NT-proBNP ≥500 pg/mL
- be on a stable dose of guideline-directed HF medication (i.e., angiotensin converting enzyme [ACE] inhibitor, angiotensin II receptor blocker [ARB], or angiotensin receptor neprilysin inhibitor [ARNI], β-blocker, diuretics, and/or mineralcorticoid receptor antagonist) for at least 4 weeks
- be on stable antihypertensive therapy for at least 2 months
Who cannot join
- T1DM
- repeated fasting plasma glucose (FPG) or fasting self-monitored blood glucose measurements ≥240 mg/dL or both
- during the pretreatment phase, NYHA Class IV HF status, uncontrolled hypertension as defined as systolic blood pressure (SBP) >160 or diastolic blood pressure (DBP) >100 mmHg
- liver disease (ALT or AST >3 x ULN)
- anemia Hb<10
- anticipated cardiac surgery or coronary intervention within the next 3 months
Show all 13Show fewer
- severe unremediated valvular heart disease
- major CV event (e.g., MI, cerebrovascular accident) within 3 months prior to screening visit
- hospitalization for HF within 2 months prior to screening visit
- documented atrial fibrillation
- history of atraumatic amputation within past 12 months of screening or critical ischemia of the lower extremity within 6 months of screening
- an active skin ulcer, osteomyelitis, or gangrene
- have an allergy to iodocyanine green and inulin
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single-Center, Mechanistic Study to Evaluate the Effects of Canagliflozin on Intravascular Volume and Hemodynamics in Subjects With Type 2 Diabetes Mellitus and Heart Failure
RESEARCH HYPOTHESIS
- In subjects with T2DM and HF, effect of canagliflozin will be superior to placebo for the change from baseline in PCWP after a single dose (6 hours post-dose) and after 4 weeks.
- Treatment with canagliflozin will be well tolerated over 4 weeks.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, parallel-group, single-center study (Figure 1). Thirty subjects will be randomized in a 3:2 randomization ratio to canagliflozin 300 mg once daily (QD) or placebo. The study will include a 3-week pretreatment screening phase and a 4-week double-blind treatment phase.
- Conditions
- Type2 Diabetes Mellitus, Cardiovascular Diseases
- Being tested
- Canagliflozin 300mg, Placebo
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canagliflozin 300mgDrug
Also called Invokana
Canagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. It works by decreasing the amount of sugar the body absorbs, and increasing the amount of sugar that leaves the body in the urine.
Administered in 300mg tablets.
PlaceboDrug
Also called Canagliflozin Placebo
Placebo for Canagliflozin
| Study group | Role | What they receive |
|---|---|---|
| Canagliflozin Group | Active comparator | Assuming a 25% dropout rate, 16 individuals in the canagliflozin group Receives: Drug: Canagliflozin 300mg |
| Placebo Group | Placebo comparator | Assuming a 25% dropout rate, 11 individuals in the placebo group Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pulmonary capillary wedge pressure (PCWP)
The primary efficacy endpoint will be change in PCWP from baseline to end of acute administration monitoring period (6 hours).
Measured: 6 hours
Secondary outcomes (1)
Change in Pulmonary capillary wedge pressure (PCWP)
The key secondary endpoint will be change in PCWP from baseline to 4 weeks.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start1 Sep 2017 (estimated)
- Primary completion1 Aug 2018 (estimated)
- Study completion1 Aug 2018 (estimated)
Why it stopped: Study has been withdrawn from IRB review pending IND revision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-Blind, Placebo-Controlled, Single-Center, Mechanistic Study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Responsible party
- Sponsor
- Investigators
- Devjit Tripathy, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190798
- Sponsor's protocol ID
- HSC20170151H
- Other IDs
- DIA4028
- Status last verified
- Jul 2017
- First submitted
- 15 Jun 2017
- Last updated
- 12 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single-Center, Mechanistic Study to Evaluate the Effects of Canagliflozin on Intravascular Volume and Hemodynamics in Subjects With Type 2 Diabetes Mellitus and Heart Failure
- ClinicalTrials.gov ID
- NCT03190798
- Acronym / sponsor ID
- HSC20170151H
- Conditions
- Type2 Diabetes Mellitus, Cardiovascular Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study has been withdrawn from IRB review pending IND revision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Janssen Scientific Affairs, LLC
- Study start
- 1 Sep 2017 (estimated)
- Primary completion
- 1 Aug 2018 (estimated)
- Study completion
- 1 Aug 2018 (estimated)
- First posted
- 19 Jun 2017 (actual)
- 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.
RESEARCH HYPOTHESIS
- In subjects with T2DM and HF, effect of canagliflozin will be superior to placebo for the change from baseline in PCWP after a single dose (6 hours post-dose) and after 4 weeks.
- Treatment with canagliflozin will be well tolerated over 4 weeks.
Detailed description
This is a randomized, double-blind, placebo-controlled, parallel-group, single-center study (Figure 1). Thirty subjects will be randomized in a 3:2 randomization ratio to canagliflozin 300 mg once daily (QD) or placebo. The study will include a 3-week pretreatment screening phase and a 4-week double-blind treatment phase.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomized, Double-Blind, Placebo-Controlled, Single-Center, Mechanistic Study
| Arm | Type | Receives |
|---|---|---|
| Canagliflozin Group | Active comparator | Drug: Canagliflozin 300mgAssuming a 25% dropout rate, 16 individuals in the canagliflozin group |
| Placebo Group | Placebo comparator | Drug: PlaceboAssuming a 25% dropout rate, 11 individuals in the placebo group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- on stable doses (more than 3 months) of antihyperglycemic agents (except for an SGLT2 inhibitor and insulin)
- have an A1c ≥7% and ≤11%
- Estimated glomerular filtration rate (eGFR) must be ≥45 ml/min•1.73 m2
- have an NT-proBNP ≥500 pg/mL
- be on a stable dose of guideline-directed HF medication (i.e., angiotensin converting enzyme [ACE] inhibitor, angiotensin II receptor blocker [ARB], or angiotensin receptor neprilysin inhibitor [ARNI], β-blocker, diuretics, and/or mineralcorticoid receptor antagonist) for at least 4 weeks
Key exclusion criteria (13 listed)
- T1DM
- repeated fasting plasma glucose (FPG) or fasting self-monitored blood glucose measurements ≥240 mg/dL or both
- during the pretreatment phase, NYHA Class IV HF status, uncontrolled hypertension as defined as systolic blood pressure (SBP) >160 or diastolic blood pressure (DBP) >100 mmHg
- liver disease (ALT or AST >3 x ULN)
- anemia Hb<10
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 |
|---|---|---|
| Canagliflozin 300mgAlso: InvokanaCanagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. It works by decreasing the amount of sugar the body absorbs, and increasing the amount of sugar that leaves the body in the urine. Administered in 300mg tablets. | Drug | Canagliflozin Group |
| PlaceboAlso: Canagliflozin PlaceboPlacebo for Canagliflozin | Drug | Placebo Group |
Primary outcome
Change in Pulmonary capillary wedge pressure (PCWP)
Time frame: 6 hours
The primary efficacy endpoint will be change in PCWP from baseline to end of acute administration monitoring period (6 hours).
1 secondary outcome
Change in Pulmonary capillary wedge pressure (PCWP)
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2017.
- Individual participant dataSharing planned: No
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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.
Devjit Tripathy, MD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Canagliflozin 300mg in people with Type2 Diabetes Mellitus and Cardiovascular Diseases, run by The University of Texas Health Science Center at San Antonio at 1 site 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 6 inclusion and 13 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: withdrawn, as of the sponsor's last update on 12 Oct 2017. 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 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 withdrawn before enrolling participants, so there are no results.
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 Pulmonary capillary wedge pressure (PCWP) (time frame: 6 hours). 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 12 Oct 2017.