Diabetes Mellitus, Type 2Phase 4COMETANCT03267576
An Efficacy Study of Canagliflozin or Sitagliptin to Determine Glucose Variability in Mexican Participants With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin
A Phase 4 study testing Canagliflozin 300 mg, Sitagliptin 100 mg and Metformin in people with Diabetes Mellitus, Type 2, run by Janssen Research & Development, LLC at 5 sites in Mexico.
Trial summary
The main purpose of this study is to assess the effects of 4 weeks each of daily treatment with canagliflozin 300 milligram (mg) versus sitagliptin 100 mg as treatment adjuncts to metformin (at stable dosages) on intrapatient glycemic coefficient of variation (CV), expressed as a ratio percentage of standard deviation… Read more about this study
- Who is it for?
- Ages 19 to 54 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Canagliflozin 300 mg, Sitagliptin 100 mg and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 5 sitesMexico
- Study dates
- 27 Oct 2017to 1 Oct 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 to 54 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Type 2 diabetes mellitus
- Inadequate glucose control while using metformin monotherapy (MET) for at least 8 weeks at stable daily doses of at least 1500 milligram (mg) before screening visit (Visit 1)
- Hemoglobin A1c (HbA1c) equal to (=) 7.5 percent (%) to 10.5% at Visit 1
- Adequate qualifying continuous glucose monitoring (CGM) reading during the pre-randomization (selection) phase
- Estimated glomerular filtration rate (eGFR) of at least 60 milliliter/minute (mL/min)/1.73 meter square (m^2) at Visit 1
- Body mass index of 22 through 45 kilogram per meter square (kg/m^2) at Visit 1
Who cannot join
- History of any of the following (at Visit 1):
- Diabetic ketoacidosis (DKA)
- Type 1 diabetes mellitus (T1DM)
- Pancreatic (for example, Beta-islet cell) transplantation
- Diabetes secondary to pancreatitis or pancreatectomy
- Personal history of, or ongoing, pancreatitis
Show all 12Show fewer
- One or more episodes of severe hypoglycemia (requiring assistance from others), as documented in the history obtained at Visit 1
- Hereditary glucose-galactose malabsorption or primary renal glucosuria
- Repeated fasting plasma glucose (FPG) or fasting self-monitored blood glucose (SMBG) greater than (>) 270 milligram per deciliter (mg/dL) during the pre-treatment phase
- Treatment with any other oral or parenteral antidiabetic medications different from metformin monotherapy, including but not limited to Dipeptidyl peptidase-4 (DPP-4) inhibitors, Sulphonylureas, thiazolidinediones, insulins and Glucagon-like peptide-1 receptor agonist (GLP-1RAs); Sodium-glucose co-transporter 2 (SGLT-2) inhibitors and investigational agents
- Received an investigational drug or vaccine or used an invasive investigational medical device within 30 days before the planned first dose of study drug
- Current use of "natural medicines" or natural medicinal products for diabetes (for example, cactus-derived nutrients, celery)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Mexico5 sites
Consultorio Privado
Guadalajara, 44150
Investigación Clínica Especializada
Guadalajara, 44600
Consultorio Privado en Unidad de Patología Clínica
Guadalajara, 44650
Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán
Mexico City, 14080
Hospital Universitario 'Dr. Jose Eleuterio Gonzalez'
Monterrey, 64460
About this study
Official title: Canagliflozin Continuous Glucose Monitoring (CANA CGM) Trial: A Pilot Randomized, Double-Blind, Controlled, Crossover Study on the Effects of the SGLT-2 Inhibitor Canagliflozin (vs. the DPP-4 Inhibitor Sitagliptin) on Glucose Variability in Mexican Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin
The main purpose of this study is to assess the effects of 4 weeks each of daily treatment with canagliflozin 300 milligram (mg) versus sitagliptin 100 mg as treatment adjuncts to metformin (at stable dosages) on intrapatient glycemic coefficient of variation (CV), expressed as a ratio percentage of standard deviation (SD) to mean glucose levels.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Canagliflozin 300 mg, Sitagliptin 100 mg, Metformin
- 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.
Canagliflozin 300 mgDrug
Also called JNJ-28431754
Participants will receive canagliflozin 300 mg oral tablet once-daily for 28 days.
Sitagliptin 100 mgDrug
Participants will receive sitagliptin 100 mg oral tablet once-daily for 28 days.
MetforminDrug
Participants will receive metformin at a stable dose of >= 1500 mg/day throughout the study including the washout period between each intervention.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence AB | Experimental | Participants will receive metformin monotherapy at stable doses (greater than or equal to [>=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin >=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition. A washout period of at least 16 days (from Days 28 to 43) of metformin monotherapy will be maintained between each treatment period. Receives: Drug: Canagliflozin 300 mg; Drug: Sitagliptin 100 mg; Drug: Metformin |
| Treatment Sequence BA | Experimental | Participants will receive treatment B from Day 0 to 27 (treatment Period 1), followed by treatment A from Day 44 to 71 (treatment period 2), under fasted condition. A washout period of at least 16 days (from days 28 to 43) of metformin monotherapy will be maintained between each treatment period. Receives: Drug: Canagliflozin 300 mg; Drug: Sitagliptin 100 mg; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 1
Continuous blood glucose monitoring was done in participants using continuous glucose monitoring (CGM) determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and after each active treatment. Glucose coefficient of variation (CV) was calculated based on CGM data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings. The participants were analyzed according to treatment received in treatment period 2 as per the sequence reported in this outcome measure.
Measured: Baseline up to End of Treatment Period 1 (Days 22 to 27)
Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 2
Continuous blood glucose monitoring was done in participants using CGM determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and after each active treatment. Glucose coefficient of variation was calculated based on CGM data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings. The participants were analyzed according to treatment received in treatment period 2 as per the sequence reported in this outcome measure.
Measured: Baseline up to End of Treatment Period 2 (Days 66 to 71)
Secondary outcomes (13)
Change From Baseline in Glycemic Standard Deviation (SD) for 24-hour Glucose Profile
Glycemic standard deviation for 24-hour glucose profile (glycemic variability), as measured by CGM was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants who received the study drug in the treatment period 1 and 2 as per the sequence were reported in this outcome measure.
Measured: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Change From Baseline in Mean 24-hour Glucose Profile
Mean 24-hour glucose profiles as measured by CGM was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.
Measured: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Change From Baseline in Fasting Plasma Glucose Levels
Fasting plasma glucose levels were determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.
Measured: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Change From Baseline in 2-hour Post-prandial Glucose (PPG) Levels
2-hour post-prandial glucose levels were determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.
Measured: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Percent Change From Baseline in Time During 24 Hours With Glucose 70 to 139 mg/dL
Percent change from baseline in time during 24 hours with glucose levels 70 to 139 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.
Measured: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Percent Change From Baseline in Time During 24 Hours With Glucose Greater Than (>) 140 mg/dL
Percent change from baseline in time during 24 hours within the glucose levels >140 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.
Measured: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Percent Change From Baseline in Time During 24 Hours With Glucose Level > 180 mg/dL
Percent change from baseline in time during 24 hours within the glucose levels >180 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 as per the sequence reported in this outcome measure.
Measured: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Percent Change From Baseline in Time During 24 Hours With Glucose Level Less Than (<) 70 mg/dL
Percent change from baseline in time during 24 hours within the glucose levels < 70 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.
Measured: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Change From Baseline in Time Spent With Glucose Level 70 to 139 mg/dL
Time spent with the glucose level 70 to 139 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.
Measured: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Change From Baseline in Time Spent With Glucose Level > 140 mg/dL
Time spent with the glucose level > 140 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.
Measured: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Change From Baseline in Time Spent With Glucose Level > 180 mg/dL
Time spent with the glucose level > 180 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 as per the sequence reported in this outcome measure.
Measured: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Change From Baseline in Time Spent With Glucose Level < 70 mg/dL
Time spent with the glucose level < 70 mg/dL was determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and at the end of each active treatment. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.
Measured: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Change From Baseline in Percentage of 2 Consecutive Glucose Readings With < 70 mg/dL
The percentage of 2 consecutive glucose readings with < 70 mg/dL were reported. The participants were analyzed according to treatment received in treatment period 1 and treatment period 2 as per the sequence reported in this outcome measure.
Measured: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start27 Oct 2017
- Primary completion1 Oct 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 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 Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267576
- Sponsor's protocol ID
- CR108346
- Other IDs
- 28431754DIA4026
- Acronym
- COMETA
- Status last verified
- Nov 2019
- First submitted
- 29 Aug 2017
- Last updated
- 29 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canagliflozin Continuous Glucose Monitoring (CANA CGM) Trial: A Pilot Randomized, Double-Blind, Controlled, Crossover Study on the Effects of the SGLT-2 Inhibitor Canagliflozin (vs. the DPP-4 Inhibitor Sitagliptin) on Glucose Variability in Mexican Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin
- ClinicalTrials.gov ID
- NCT03267576
- Acronym / sponsor ID
- COMETA / CR108346
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2017 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 30 Aug 2017 (actual)
- Results
- Posted 29 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to assess the effects of 4 weeks each of daily treatment with canagliflozin 300 milligram (mg) versus sitagliptin 100 mg as treatment adjuncts to metformin (at stable dosages) on intrapatient glycemic coefficient of variation (CV), expressed as a ratio percentage of standard deviation (SD) to mean glucose levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence AB | Experimental | Drug: Canagliflozin 300 mg, Drug: Sitagliptin 100 mg, Drug: MetforminParticipants will receive metformin monotherapy at stable doses (greater than or equal to [>=] 1500 milligram per day [mg/day]) orally once daily with canagliflozin 300 milligram (mg) tablet orally once daily (Treatment A) from Day 0 to 27 (treatment period 1), followed by sitagliptin 100 mg tablet orally once daily with metformin >=1500 mg/day (Treatment B) from Day 44 to 71 (treatment period 2), under fasted condition. A washout period of at least 16 days (from Days 28 to 43) of metformin monotherapy will be maintained between each treatment period. |
| Treatment Sequence BA | Experimental | Drug: Canagliflozin 300 mg, Drug: Sitagliptin 100 mg, Drug: MetforminParticipants will receive treatment B from Day 0 to 27 (treatment Period 1), followed by treatment A from Day 44 to 71 (treatment period 2), under fasted condition. A washout period of at least 16 days (from days 28 to 43) of metformin monotherapy will be maintained between each treatment period. |
Who may qualify
- Ages
- 19 to 54 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Type 2 diabetes mellitus
- Inadequate glucose control while using metformin monotherapy (MET) for at least 8 weeks at stable daily doses of at least 1500 milligram (mg) before screening visit (Visit 1)
- Adequate qualifying continuous glucose monitoring (CGM) reading during the pre-randomization (selection) phase
- Estimated glomerular filtration rate (eGFR) of at least 60 milliliter/minute (mL/min)/1.73 meter square (m^2) at Visit 1
- Body mass index of 22 through 45 kilogram per meter square (kg/m^2) at Visit 1
Key exclusion criteria (12 listed)
- History of any of the following (at Visit 1):
- Repeated fasting plasma glucose (FPG) or fasting self-monitored blood glucose (SMBG) greater than (>) 270 milligram per deciliter (mg/dL) during the pre-treatment phase
- Treatment with any other oral or parenteral antidiabetic medications different from metformin monotherapy, including but not limited to Dipeptidyl peptidase-4 (DPP-4) inhibitors, Sulphonylureas, thiazolidinediones, insulins and Glucagon-like peptide-1 receptor agonist (GLP-1RAs); Sodium-glucose co-transporter 2 (SGLT-2) inhibitors and investigational agents
- Received an investigational drug or vaccine or used an invasive investigational medical device within 30 days before the planned first dose of study drug
- Current use of "natural medicines" or natural medicinal products for diabetes (for example, cactus-derived nutrients, celery)
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 300 mgAlso: JNJ-28431754Participants will receive canagliflozin 300 mg oral tablet once-daily for 28 days. | Drug | Treatment Sequence AB, Treatment Sequence BA |
| Sitagliptin 100 mgParticipants will receive sitagliptin 100 mg oral tablet once-daily for 28 days. | Drug | Treatment Sequence AB, Treatment Sequence BA |
| MetforminParticipants will receive metformin at a stable dose of >= 1500 mg/day throughout the study including the washout period between each intervention. | Drug | Treatment Sequence AB, Treatment Sequence BA |
Primary outcome
Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 1
Time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27)
Continuous blood glucose monitoring was done in participants using continuous glucose monitoring (CGM) determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and after each active treatment. Glucose coefficient of variation (CV) was calculated based on CGM data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings. The participants were analyzed according to treatment received in treatment period 2 as per the sequence reported in this outcome measure.
Change From Baseline in Glycemic Coefficient of Variation (CV) in Treatment Period 2
Time frame: Baseline up to End of Treatment Period 2 (Days 66 to 71)
Continuous blood glucose monitoring was done in participants using CGM determined over a 6-day period (in order to obtain a continuous 72-hour reading) at baseline and after each active treatment. Glucose coefficient of variation was calculated based on CGM data dividing the standard deviation of blood glucose values by the mean of the corresponding glucose readings. The participants were analyzed according to treatment received in treatment period 2 as per the sequence reported in this outcome measure.
13 secondary outcomes
Change From Baseline in Glycemic Standard Deviation (SD) for 24-hour Glucose Profile
Time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Change From Baseline in Mean 24-hour Glucose Profile
Time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Change From Baseline in Fasting Plasma Glucose Levels
Time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Change From Baseline in 2-hour Post-prandial Glucose (PPG) Levels
Time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Percent Change From Baseline in Time During 24 Hours With Glucose 70 to 139 mg/dL
Time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Percent Change From Baseline in Time During 24 Hours With Glucose Greater Than (>) 140 mg/dL
Time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Percent Change From Baseline in Time During 24 Hours With Glucose Level > 180 mg/dL
Time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Percent Change From Baseline in Time During 24 Hours With Glucose Level Less Than (<) 70 mg/dL
Time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Change From Baseline in Time Spent With Glucose Level 70 to 139 mg/dL
Time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Change From Baseline in Time Spent With Glucose Level > 140 mg/dL
Time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Change From Baseline in Time Spent With Glucose Level > 180 mg/dL
Time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Change From Baseline in Time Spent With Glucose Level < 70 mg/dL
Time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Change From Baseline in Percentage of 2 Consecutive Glucose Readings With < 70 mg/dL
Time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27) and End of Treatment Period 2 (Days 66 to 71)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
5 sites 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 300 mg, Sitagliptin 100 mg and Metformin in people with Diabetes Mellitus, Type 2, run by Janssen Research & Development, LLC at 5 sites in Mexico.
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 12 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 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Mexico. 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 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?
Yes. Results are posted in the registry (first posted 29 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Glycemic Coefficient of Variation (CV) in Treatment Period 1 (time frame: Baseline up to End of Treatment Period 1 (Days 22 to 27)). The study lists 2 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 29 Nov 2019.