Diabetes MellitusPhase 4NCT04288778

A Study to Assess Safety of Canagliflozin and Metformin Hydrochloride Combination Given as a Supplement to Diet and Exercise to Improve Blood Sugar Level in Indian Adult Participants With Diabetes

A Phase 4 study testing Canagliflozin + Metformin hydrochloride (Fixed Dose Combination) in people with Diabetes Mellitus, run by Johnson & Johnson Private Limited at 10 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to assess safety of canagliflozin + metformin hydrochloride immediate Release (IR) fixed-dose combination. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Diabetes Mellitus
What is being tested?: Canagliflozin + Metformin hydrochloride (Fixed Dose Combination)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 276 participants
Where: 10 sitesIndia
Study dates: 25 Nov 2020to 26 Jul 2022
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participant willing to adhere to diet and exercise regimen as recommended by the investigator
Type 2 diabetes mellitus (T2DM) with inadequate glycemic control on diet and exercise, who in investigator's opinion are eligible to receive study drug as per prescribing information along with standard care for management of T2DM
Women must be postmenopausal, defined as greater than (>) 45 years of age with amenorrhea for at least 18 months, or > 45 years of age with amenorrhea for at least 6 months and less than (<) 18 months and a serum follicle stimulating hormone (FSH) level > 40 International Units Per Liter (IU/L), or surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal occlusion), or otherwise be incapable of pregnancy, or sexually active and practicing a highly effective method of birth control, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, tubal ligation, intrauterine device, double-barrier method (example, condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel), or male partner sterilization, and consistent with local regulations regarding use of birth control methods for participant participating in clinical studies, for the duration of their participation in the study, or not sexually active
Women of childbearing potential, regardless of age must have a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening and negative UPT at baseline (predose, Day 1)
Treatment naive participants or participants on stable antihyperglycemic agent (AHA) therapy (for at least 12 weeks before screening) and have a screening visit Glycosylated Haemoglobin (HbA1c) of greater than or equal to (>=) 7.0 percent (%) and less than or equal to (<=) 10.0 %

Who cannot join

History of liver or renal insufficiency (estimated creatinine clearance below 45 milliliter per minute [mL/min]); significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
Known allergies, hypersensitivity, or intolerance to Canagliflozin, Metformin or Canagliflozin + metformin hydrochloride immediate release (IR) Fixed Dose combination (FDC) or its excipients
Use of any other sodium glucose cotransporter 2 (SGLT2) inhibitor within 12 weeks before the screening visit
If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 30 days after last dose of study medication; or intending to donate ova during such time period
History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

India10 sites

Lifecare Hospital and Research Centre
Bengaluru, 560092
Post Graduate Institute of Medical Education And Research PGIMER
Chandigarh, 160012
Kovai Diabetes Specialty Centre & Hospital
Coimbatore, 641 009
Excelcare Hospitals (A unit of Asclepius Hospitals and Health Care Pvt. Ltd.)
Guwahati, 781033
Thumbay Hospital New life / Endocrinology
Hyderabad, 500024
Fortis Hospital
Mohali, 160062
Jehangir Clinical Development Center Pvt Ltd
Pune, 411001
Chellaram Diabetes Institute
Pune, 411021
Nirmal Hospital Pvt. Ltd.
Surat, 395002
Jothydev's Diabetes Research Centre
Trivandrum, 695032

Other trials in India

About this study

Official title: A Prospective, Multi-centric, Open-label, Single-arm, Phase 4 Study to Evaluate the Safety and Efficacy of Canagliflozin + Metformin Hydrochloride IR Fixed-dose Combination as an Adjunct to Diet and Exercise to Improve Glycemic Control in Indian Adult Patients With Type 2 Diabetes Mellitus When Treatment With Both Canagliflozin and Metformin is Appropriate

The purpose of this study is to assess safety of canagliflozin + metformin hydrochloride immediate Release (IR) fixed-dose combination.

Conditions: Diabetes Mellitus
Being tested: Canagliflozin + Metformin hydrochloride (Fixed Dose Combination)
Medical subject headings: Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Canagliflozin + Metformin hydrochloride (Fixed Dose Combination)Drug
Also called JNJ-28431754
Participants will receive canagliflozin + metformin hydrochloride IR fixed-dose combination, 50 milligram (mg) + 500 mg or 50 mg + 1000 mg, will be provided as tablets for oral administration. The study Treatment duration will be of 24 weeks.

Study groups in NCT04288778
Study group	Role	What they receive
Canagliflozin + Metformin Hydrochloride Immediate Release (IR)	Experimental	Participants will receive canagliflozin + metformin hydrochloride IR fixed-dose combination, 50 milligram (mg) + 500 mg or 50 mg + 1000 mg, will be provided as tablets for oral administration. Receives: Drug: Canagliflozin + Metformin hydrochloride (Fixed Dose Combination)

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product. TEAEs were defined as events that started on or after the study medication start date and time.
Measured: Baseline (Day 1) up to 24 weeks
Percentage of Participants With Unexpected Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An adverse event was considered unexpected if the nature or severity was not consistent with the applicable product reference safety information.
Measured: Baseline (Day 1) up to 24 weeks
Percentage of Participants With Adverse Drug Reactions (ADRs)
ADRs were defined as the treatment related TEAEs. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAEs were defined as events that started on or after the study medication start date and time.
Measured: Baseline (Day 1) up to 24 weeks

Secondary outcomes (1)

Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24
Percent change from baseline in HbA1c at Weeks 12 and 24 was reported.
Measured: Baseline, Weeks 12 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Nov 202026 Jul 2022

First posted28 Feb 2020
Study start25 Nov 2020
Primary completion26 Jul 2022
Study completion26 Jul 2022

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for 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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 276 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04288778
Sponsor's protocol ID: CR108749
Other IDs: 28431754DIA4032
Status last verified: Mar 2025
First submitted: 26 Feb 2020
Last updated: 30 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Publications

LaRoche JK, Lanier J, Alvarenga R, Collins M, Costelloe T, Chiau A, Whetherly H, De Soete W, Faludi J, Rens K. Climate footprint of industry-sponsored in-human clinical trials: life cycle assessments of clinical trials spanning multiple phases and disease areas. BMJ Open. 2025 Feb 19;15(2):e085364. doi: 10.1136/bmjopen-2024-085364.
PubMed 39971605

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

All Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multi-centric, Open-label, Single-arm, Phase 4 Study to Evaluate the Safety and Efficacy of Canagliflozin + Metformin Hydrochloride IR Fixed-dose Combination as an Adjunct to Diet and Exercise to Improve Glycemic Control in Indian Adult Patients With Type 2 Diabetes Mellitus When Treatment With Both Canagliflozin and Metformin is Appropriate
ClinicalTrials.gov ID: NCT04288778
Acronym / sponsor ID: CR108749
Conditions: Diabetes Mellitus
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 276 participants (actual)
Lead sponsor: Johnson & Johnson Private LimitedIndustry (pharma, biotech, devices)
Study start: 25 Nov 2020 (actual)
Primary completion: 26 Jul 2022 (actual)
Study completion: 26 Jul 2022 (actual)
First posted: 28 Feb 2020 (actual)
Results: Posted 18 Aug 2023

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 this study is to assess safety of canagliflozin + metformin hydrochloride immediate Release (IR) fixed-dose combination.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Canagliflozin + Metformin Hydrochloride Immediate Release (IR)	Experimental	Drug: Canagliflozin + Metformin hydrochloride (Fixed Dose Combination)Participants will receive canagliflozin + metformin hydrochloride IR fixed-dose combination, 50 milligram (mg) + 500 mg or 50 mg + 1000 mg, will be provided as tablets for oral administration.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Participant willing to adhere to diet and exercise regimen as recommended by the investigator
Type 2 diabetes mellitus (T2DM) with inadequate glycemic control on diet and exercise, who in investigator's opinion are eligible to receive study drug as per prescribing information along with standard care for management of T2DM
Women must be postmenopausal, defined as greater than (>) 45 years of age with amenorrhea for at least 18 months, or > 45 years of age with amenorrhea for at least 6 months and less than (<) 18 months and a serum follicle stimulating hormone (FSH) level > 40 International Units Per Liter (IU/L), or surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal occlusion), or otherwise be incapable of pregnancy, or sexually active and practicing a highly effective method of birth control, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, tubal ligation, intrauterine device, double-barrier method (example, condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel), or male partner sterilization, and consistent with local regulations regarding use of birth control methods for participant participating in clinical studies, for the duration of their participation in the study, or not sexually active
Women of childbearing potential, regardless of age must have a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening and negative UPT at baseline (predose, Day 1)
Treatment naive participants or participants on stable antihyperglycemic agent (AHA) therapy (for at least 12 weeks before screening) and have a screening visit Glycosylated Haemoglobin (HbA1c) of greater than or equal to (>=) 7.0 percent (%) and less than or equal to (<=) 10.0 %

Key exclusion criteria (5 listed)

History of liver or renal insufficiency (estimated creatinine clearance below 45 milliliter per minute [mL/min]); significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
Known allergies, hypersensitivity, or intolerance to Canagliflozin, Metformin or Canagliflozin + metformin hydrochloride immediate release (IR) Fixed Dose combination (FDC) or its excipients
Use of any other sodium glucose cotransporter 2 (SGLT2) inhibitor within 12 weeks before the screening visit
If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 30 days after last dose of study medication; or intending to donate ova during such time period
History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy

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 + Metformin hydrochloride (Fixed Dose Combination)Also: JNJ-28431754Participants will receive canagliflozin + metformin hydrochloride IR fixed-dose combination, 50 milligram (mg) + 500 mg or 50 mg + 1000 mg, will be provided as tablets for oral administration. The study Treatment duration will be of 24 weeks.	Drug	Canagliflozin + Metformin Hydrochloride Immediate Release (IR)

Primary outcome

Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Time frame: Baseline (Day 1) up to 24 weeks
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product. TEAEs were defined as events that started on or after the study medication start date and time.
Percentage of Participants With Unexpected Adverse Events (AEs)
Time frame: Baseline (Day 1) up to 24 weeks
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An adverse event was considered unexpected if the nature or severity was not consistent with the applicable product reference safety information.
Percentage of Participants With Adverse Drug Reactions (ADRs)
Time frame: Baseline (Day 1) up to 24 weeks
ADRs were defined as the treatment related TEAEs. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAEs were defined as events that started on or after the study medication start date and time.

1 secondary outcome

Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24
Time frame: Baseline, Weeks 12 and 24

Results and safety

Results posted to the registry on 18 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Canagliflozin + Metformin Hydrochloride FDC	276	265

Primary outcome: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

Time frame: Baseline (Day 1) up to 24 weeks. Number. Unit: Percentage of participants

Measure	Canagliflozin + Metformin Hydrochloride FDC n = 274
TEAEs	41.6
TESAEs	1.1

Population analysed: Safety analysis set included all participants who had taken at least 1 dose of study treatment.

Primary outcome: Percentage of Participants With Unexpected Adverse Events (AEs)

Time frame: Baseline (Day 1) up to 24 weeks. Number. Unit: Percentage of participants

Measure	Canagliflozin + Metformin Hydrochloride FDC n = 274
Value	0

Population analysed: Safety analysis set included all participants who had taken at least 1 dose of study treatment.

Primary outcome: Percentage of Participants With Adverse Drug Reactions (ADRs)

Time frame: Baseline (Day 1) up to 24 weeks. Number. Unit: Percentage of participants

Measure	Canagliflozin + Metformin Hydrochloride FDC n = 274
Value	10.6

Population analysed: Safety analysis set included all participants who had taken at least 1 dose of study treatment.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Baseline (Day 1) up to end of study (28 weeks). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Canagliflozin + Metformin Hydrochloride FDC	3 of 274 (1.1%)	114 of 274 (41.6%)	0 of 274

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39971605LaRoche JK, Lanier J, Alvarenga R, Collins M, Costelloe T, Chiau A, Whetherly H, De Soete W, Faludi J, Rens K. Climate footprint of industry-sponsored in-human clinical trials: life cycle assessments of clinical trials spanning multiple phases and disease areas. BMJ Open. 2025 Feb 19;15(2):e085364. doi: 10.1136/bmjopen-2024-085364.
Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Related trials for Diabetes Mellitus

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
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

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.

Johnson & Johnson Private Limited Clinical Trial study director

Johnson & Johnson Private Limited

10 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 + Metformin hydrochloride (Fixed Dose Combination) in people with Diabetes Mellitus, run by Johnson & Johnson Private Limited at 10 sites in India.

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 5 inclusion and 5 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 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in India. 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 18 Aug 2023). 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?

Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) (time frame: Baseline (Day 1) up to 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04288778, which also lists 1 linked publication.

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 30 Mar 2025.