Trial · NCT04288778
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
NCT04288778, Phase 4, Completed, Johnson & Johnson Private Limited; results first posted 2023-08-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT04288778. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04288778
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT04288778
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 276 participants, actual
- Lead sponsor
- Johnson & Johnson Private Limited
- Conditions
- Diabetes Mellitus
- Interventions
- Canagliflozin + Metformin hydrochloride (Fixed Dose Combination)
- First posted
- 2020-02-28
- Last updated
- 2025-03-30
- Results first posted
- 2023-08-18
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | 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. |
| Primary | Percentage of Participants With Unexpected Adverse Events (AEs) | 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. |
| Primary | Percentage of Participants With Adverse Drug Reactions (ADRs) | 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. |
| Secondary | Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24 | Baseline, Weeks 12 and 24 | Percent change from baseline in HbA1c at Weeks 12 and 24 was reported. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Baseline (Day 1) up to 24 weeks | Safety analysis set included all participants who had taken at least 1 dose of study treatment. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Unexpected Adverse Events (AEs) | Baseline (Day 1) up to 24 weeks | Safety analysis set included all participants who had taken at least 1 dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24 | Baseline, Weeks 12 and 24 | Efficacy analysis set included all participants who had taken at least 1 dose of study treatment and had both baseline and at least 1 post-baseline efficacy assessment. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure and 'n' (number analyzed) represents number of participants evaluable at the specified timepoints. | Percent change | MEAN |
| PRIMARY | Percentage of Participants With Adverse Drug Reactions (ADRs) | Baseline (Day 1) up to 24 weeks | Safety analysis set included all participants who had taken at least 1 dose of study treatment. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Canagliflozin + Metformin Hydrochloride FDC | TEAEs | 41.6 | Percentage of participants | |
| Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Canagliflozin + Metformin Hydrochloride FDC | TESAEs | 1.1 | Percentage of participants | |
| Percentage of Participants With Unexpected Adverse Events (AEs) | Canagliflozin + Metformin Hydrochloride FDC | 0 | Percentage of participants | ||
| Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24 | Canagliflozin + Metformin Hydrochloride FDC | Percent change at Week 12 | -0.918 | Standard Deviation 1.1348 | Percent change |
| Percent Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Weeks 12 and 24 | Canagliflozin + Metformin Hydrochloride FDC | Percent change at Week 24 | -0.926 | Standard Deviation 1.3054 | Percent change |
| Percentage of Participants With Adverse Drug Reactions (ADRs) | Canagliflozin + Metformin Hydrochloride FDC | 10.6 | Percentage of participants |
Source ClinicalTrials.gov
Participant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Canagliflozin + Metformin Hydrochloride FDC | 276 | |
| Overall Study | Treated | Canagliflozin + Metformin Hydrochloride FDC | 274 | |
| Overall Study | COMPLETED | Canagliflozin + Metformin Hydrochloride FDC | 265 | |
| Overall Study | NOT COMPLETED | Canagliflozin + Metformin Hydrochloride FDC | 11 |
Source ClinicalTrials.gov
Adverse events91
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Canagliflozin + Metformin Hydrochloride FDC | 1 | 274 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Canagliflozin + Metformin Hydrochloride FDC | 1 | 274 | |
| other | Palpitations | Cardiac disorders | Canagliflozin + Metformin Hydrochloride FDC | 1 | 274 | |
| other | Sinus Bradycardia | Cardiac disorders | Canagliflozin + Metformin Hydrochloride FDC | 1 | 274 | |
| other | Sinus Tachycardia | Cardiac disorders | Canagliflozin + Metformin Hydrochloride FDC | 1 | 274 | |
| other | Hydrocele | Congenital, familial and genetic disorders | Canagliflozin + Metformin Hydrochloride FDC | 1 | 274 | |
| other | Cataract | Eye disorders | Canagliflozin + Metformin Hydrochloride FDC | 1 | 274 | |
| other | Diabetic Retinal Oedema | Eye disorders | Canagliflozin + Metformin Hydrochloride FDC | 1 | 274 | |
| other | Constipation | Gastrointestinal disorders | Canagliflozin + Metformin Hydrochloride FDC | 3 | 274 | |
| other | Diarrhoea | Gastrointestinal disorders | Canagliflozin + Metformin Hydrochloride FDC | 2 | 274 |
1 to 10 of 91Source ClinicalTrials.gov
See all 91 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Canagliflozin + Metformin Hydrochloride FDC | 0 | 274 |
| Total, other adverse events | Canagliflozin + Metformin Hydrochloride FDC | 114 | 274 |
| Total, serious adverse events | Canagliflozin + Metformin Hydrochloride FDC | 3 | 274 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39971605 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04288778
GET https://conductscience.org/api/trials/v1/NCT04288778/events?page=2