Trial · NCT03078478
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) | 36 Weeks | The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator. | Episodes/(PYE*100) | NUMBER |
| SECONDARY | Basal Insulin Dose (U) at End of Treatment (up to 88 Weeks) | 88 weeks | The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator. Number Analyzed = number of participants with available data. | Units | MEAN |
| SECONDARY | Number of Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) | 36 weeks | The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator. Number Analyzed = number of participants with available data. | Episodes/(PYE*100) | NUMBER |
| SECONDARY | Number of Severe Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) | 36 weeks (maintenance 2) | The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator. Number Analyzed = number of participants with available data. | Episodes/(PYE*100) | NUMBER |
| SECONDARY | Change in HbA1c From Baseline to End of Treatment (up to 88 Weeks) | Week 0, week 88 | The full analysis set (FAS) comprised all randomised subjects. Number Analyzed = number of participants with available data. | Percentage of HbA1c | MEAN |
| SECONDARY | Change in Fasting Plasma Glucose (FPG) From Baseline to End of Treatment (up to 88 Weeks) | Week 0, week 88 | Full analysis set (FAS) included all randomised subjects. Number Analyzed = number of participants with available data. | mg/dL | MEAN |
| SECONDARY | Percentage of Participants With FPG ≤ 7.2 mmol/L (130 mg/dL) at End of Treatment (up to 88 Weeks) (Yes/no) | At 88 weeks | Full analysis set (FAS) included all randomised subjects. Number Analyzed = number of participants with available data. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With FPG ≤ 5.0 mmol/L (90 mg/dL) at End of Treatment (up to 88 Weeks) (Yes/no) | At 88 weeks | Full analysis set (FAS) included all randomised subjects. Number Analyzed = number of participants with available data. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HbA1c < 7.0% (53 mmol/Mol) at End of Treatment (up to 88 Weeks) and no Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) (Yes/no) | End of Treatment (up to 88 Weeks) | Full analysis set (FAS) included all randomised subjects. Number Analyzed = number of participants with available data. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HbA1c < 7.0% (53 mmol/Mol) at End of Treatment (up to 88 Weeks) and no Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) (Yes/no) | At 88 weeks | Full analysis set (FAS) included all randomised subjects. Number Analyzed = number of participants with available data. | Percentage of participants | NUMBER |
| SECONDARY | Change in Mean Pre-breakfast Self-measured Plasma Glucose Used for Titration From Baseline to End of Treatment (up to 88 Weeks) | Week 0, week 88 | Full analysis set (FAS) included all randomised subjects. Number Analyzed = number of participants with available data. | mmol/L | MEAN |
| SECONDARY | Number of Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Treatment (up to 88 Weeks) | 88 weeks | The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator. | Episodes/(PYE*100) | NUMBER |
| SECONDARY | Number of Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Treatment (up to 88 Weeks) | 88 weeks | The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator. | Episodes/(PYE*100) | NUMBER |
| SECONDARY | Number of Severe Hypoglycaemic Episodes During Treatment (up to 88 Weeks) | 88 weeks | The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator. | Episodes/(PYE*100) | NUMBER |
| SECONDARY | Number of Adverse Events From Randomisation to End of Maintenance Period 2 (up to 88 Weeks) | 88 weeks | The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator. | Episodes/(PYE*100) | NUMBER |
| SECONDARY | Change in Body Weight From Baseline to End of Treatment (up to 88 Weeks) | Week 0, week 88 | The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator. Number Analyzed = number of participants with available data. | kg | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03078478/outcomes