Diabetes Mellitus, Type 2Phase 1NCT01483781
A Study of the Effects of Canagliflozin on Plasma Volume in Patients With Type 2 Diabetes Mellitus
A Phase 1 study testing Canagliflozin in people with Diabetes Mellitus, Type 2 and Plasma Volume, run by Janssen Research & Development, LLC at 1 site in Germany.
Trial summary
The purpose of the study is to evaluate the effects of canagliflozin on plasma volume and renal parameters in patients with Type 2 Diabetes Mellitus who are currently taking metformin and being treated for high blood pressure. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Plasma Volume
- What is being tested?
- Canagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2011to Aug 2012
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients must have a diagnosis of T2DM with inadequate glycemic control (ie, HbA1c of >=7.0% and <=9.0% at Screening) on metformin monotherapy and be receiving therapy with an antihypertensive agent (an ACEI or ARB) for at least 4 weeks prior to Screening
Who cannot join
- -History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy; or a severe hypoglycemic episode within 6 months before screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Placebo-Controlled, Randomized, Parallel-Groups Study to Investigate the Effects of JNJ-28431754 (Canagliflozin) on Plasma Volume and Renal Function in Subjects With Type 2 Diabetes Mellitus
The purpose of the study is to evaluate the effects of canagliflozin on plasma volume and renal parameters in patients with Type 2 Diabetes Mellitus who are currently taking metformin and being treated for high blood pressure.
Read the detailed description
This is a double-blind (neither the patient or study staff will know the identity of the treatment assigned) in patients with Type 2 Diabetes Mellitus (T2DM) who have inadequate glycemic (blood sugar) control on metformin monotherapy (metformin taken alone for control of T2DM) and who are currently being treated for hypertension (high blood pressure) with agents called angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs). In the study, patients will be randomized (assigned by chance) to receive treatment with canagliflozin or a placebo (a treatment identical in appearance to canagliflozin but does not contain active drug) for 12 weeks. During the 12-week treatment period, patients will also take metformin at a dose of at least 1500 mg/day in addition to their prescribed ACEI or ARB for hypertension. Patients will participate in the study for up to approximately 22 weeks.
- Conditions
- Diabetes Mellitus, Type 2, Plasma Volume
- Being tested
- Canagliflozin, Placebo
- Keywords
- Diabetes Mellitus, Type 2, Plasma Volume, Canagliflozin, Metformin, Hemoglobin A1c, Hypertension, Angiotensin-Converting Enzyme Inhibitors (ACEIs), Angiotensin Receptor Blockers (ARBs), Pharmacodynamics, Pharmacokinetics
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CanagliflozinDrug
Type = exact number, unit = mg, number = 300, form = capsule, route = oral use. One encapsulated tablet once daily for up to approximately 85 days (approximately 12 weeks)
PlaceboDrug
Form = capsules, route = oral use. One capsule once daily for up to approximately 85 days (approximately 12 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Canagliflozin | Experimental | Not described Receives: Drug: Canagliflozin |
| 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 plasma volume (PV)
Baseline is defined as up to 3 days predose (Week -1)
Measured: Baseline to Week 12 of the double-blind treatment period
Number of patients who experience at least 1 occurrence of a treatment-related adverse event
Treatment-related adverse events are adverse events with onset during the treatment phase.
Measured: Day 1 to Day 85
Number of hypoglycemic events reported
Baseline is defined as up to 3 days predose (Week -1)
Measured: Baseline up to Day 98
Change in electrocardiogram (ECG) parameters
Baseline is defined as up to 3 days predose (Week -1)
Measured: Baseline up to Day 98
Change in blood pressure measurements
Baseline is defined as up to 3 days predose (Week -1)
Measured: Baseline up to Day 98
Number of patients with physical examination findings reported as adverse events
Baseline is defined as up to 3 days predose (Week -1)
Measured: Baseline up to Week 12
Change from baseline in pulse rate (beats/minute)
Baseline is defined as up to 3 days predose (Week -1)
Measured: Baseline up to Day 98
Change in chemistry laboratory analytes
Baseline is defined as up to 3 days predose (Week -1)
Measured: Baseline up to Day 98
Change from baseline in urinalysis laboratory analytes
Baseline is defined as up to 3 days predose (Week -1)
Measured: Baseline up to Day 98
Change in hematology laboratory analytes
Baseline is defined as up to 3 days predose (Week -1)
Measured: Baseline up to Day 98
Secondary outcomes (6)
Change in PV
Baseline is defined as up to 3 days predose (Week -1)
Measured: Baseline to Week 1 of the double-blind treatment period
Change in body weight
Baseline is defined as up to 3 days predose (Week -1)
Measured: Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase
Change in 24-hour urine volume
Baseline is defined as up to 3 days predose (Week -1)
Measured: Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase
Change in 24-hour fractional and total excretion of uric acid
Baseline is defined as up to 3 days predose (Week -1)
Measured: Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase
Change in urine pH
Baseline is defined as up to 3 days predose (Week -1)
Measured: Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase
Change in percent Hemoglobin A1c (HbA1c)
Baseline is defined as up to 3 days predose (Week -1)
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC L.L.C. Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483781
- Sponsor's protocol ID
- CR100685
- Other IDs
- 28431754DIA1047, 2011-004117-17
- Status last verified
- Aug 2014
- First submitted
- 30 Nov 2011
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Randomized, Parallel-Groups Study to Investigate the Effects of JNJ-28431754 (Canagliflozin) on Plasma Volume and Renal Function in Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01483781
- Acronym / sponsor ID
- CR100685
- Conditions
- Diabetes Mellitus, Type 2, Plasma Volume
- Keywords
- Diabetes Mellitus, Type 2, Plasma Volume, Canagliflozin, Metformin, Hemoglobin A1c, Hypertension, Angiotensin-Converting Enzyme Inhibitors (ACEIs), Angiotensin Receptor Blockers (ARBs)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 1 Dec 2011 (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 the study is to evaluate the effects of canagliflozin on plasma volume and renal parameters in patients with Type 2 Diabetes Mellitus who are currently taking metformin and being treated for high blood pressure.
Detailed description
This is a double-blind (neither the patient or study staff will know the identity of the treatment assigned) in patients with Type 2 Diabetes Mellitus (T2DM) who have inadequate glycemic (blood sugar) control on metformin monotherapy (metformin taken alone for control of T2DM) and who are currently being treated for hypertension (high blood pressure) with agents called angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs). In the study, patients will be randomized (assigned by chance) to receive treatment with canagliflozin or a placebo (a treatment identical in appearance to canagliflozin but does not contain active drug) for 12 weeks. During the 12-week treatment period, patients will also take metformin at a dose of at least 1500 mg/day in addition to their prescribed ACEI or ARB for hypertension. Patients will participate in the study for up to approximately 22 weeks.
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 |
|---|---|---|
| Canagliflozin | Experimental | Drug: Canagliflozin |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients must have a diagnosis of T2DM with inadequate glycemic control (ie, HbA1c of >=7.0% and <=9.0% at Screening) on metformin monotherapy and be receiving therapy with an antihypertensive agent (an ACEI or ARB) for at least 4 weeks prior to Screening
Key exclusion criteria (1 listed)
- -History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy; or a severe hypoglycemic episode within 6 months before screening
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 |
|---|---|---|
| CanagliflozinType = exact number, unit = mg, number = 300, form = capsule, route = oral use. One encapsulated tablet once daily for up to approximately 85 days (approximately 12 weeks) | Drug | Canagliflozin |
| PlaceboForm = capsules, route = oral use. One capsule once daily for up to approximately 85 days (approximately 12 weeks) | Drug | Placebo |
Primary outcome
Change in plasma volume (PV)
Time frame: Baseline to Week 12 of the double-blind treatment period
Baseline is defined as up to 3 days predose (Week -1)
Number of patients who experience at least 1 occurrence of a treatment-related adverse event
Time frame: Day 1 to Day 85
Treatment-related adverse events are adverse events with onset during the treatment phase.
Number of hypoglycemic events reported
Time frame: Baseline up to Day 98
Baseline is defined as up to 3 days predose (Week -1)
Change in electrocardiogram (ECG) parameters
Time frame: Baseline up to Day 98
Baseline is defined as up to 3 days predose (Week -1)
Change in blood pressure measurements
Time frame: Baseline up to Day 98
Baseline is defined as up to 3 days predose (Week -1)
Number of patients with physical examination findings reported as adverse events
Time frame: Baseline up to Week 12
Baseline is defined as up to 3 days predose (Week -1)
Change from baseline in pulse rate (beats/minute)
Time frame: Baseline up to Day 98
Baseline is defined as up to 3 days predose (Week -1)
Change in chemistry laboratory analytes
Time frame: Baseline up to Day 98
Baseline is defined as up to 3 days predose (Week -1)
Change from baseline in urinalysis laboratory analytes
Time frame: Baseline up to Day 98
Baseline is defined as up to 3 days predose (Week -1)
Change in hematology laboratory analytes
Time frame: Baseline up to Day 98
Baseline is defined as up to 3 days predose (Week -1)
6 secondary outcomes
Change in PV
Time frame: Baseline to Week 1 of the double-blind treatment period
Change in body weight
Time frame: Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase
Change in 24-hour urine volume
Time frame: Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase
Change in 24-hour fractional and total excretion of uric acid
Time frame: Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase
Change in urine pH
Time frame: Baseline to approximately Week 1 and Week 12 of Double-Blind Treatment Phase
Change in percent Hemoglobin A1c (HbA1c)
Time frame: Baseline to Week 12
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 20 Aug 2014.
- A Double-Blind, Placebo-Controlled, Randomized, Parallel-Groups Study to Investigate the Effects of JNJ-28431754 (Canagliflozin) on Plasma Volume and Renal Function in Subjects With Type 2 Diabetes MellitusLink provided by the sponsor.
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Janssen Research & Development, LLC L.L.C. Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Canagliflozin in people with Diabetes Mellitus, Type 2 and Plasma Volume, run by Janssen Research & Development, LLC at 1 site in Germany.
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 1 inclusion and 1 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 20 Aug 2014. 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 Germany. 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 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?
Change in plasma volume (PV) (time frame: Baseline to Week 12 of the double-blind treatment period). The study lists 10 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 20 Aug 2014.