Trial · NCT03689374
Outcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Glycated Haemoglobin (HbA1c) | Baseline (week 0), week 52 | Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Percentage of HbA1c | MEAN |
| SECONDARY | Time to First Event Adjudication Committee (EAC)-Confirmed Severe Hypoglycaemic Episode American Diabetes Association (ADA) From Randomization up to Week 52 | From randomization (week 0) up to week 52 | Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | First event per 100 years of exposure | NUMBER |
| SECONDARY | Time to First Event Adjudication Committee-confirmed Severe Hypoglycaemic Episode (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening Randomization up to Week 52 | From randomization (week 0) up to week 52 | Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | First event per 100 years of exposure | NUMBER |
| SECONDARY | Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) From Randomization to Week 52 | From randomization (week 0) to week 52 | Full analysis set included all randomized participants. | Episodes | NUMBER |
| SECONDARY | Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose (BG) Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose Less Than (<) 3.1 mmol/L (56 mg/dL)) From Randomization to Week 52 | From randomization (week 0) to week 52 | Full analysis set included all randomized participants. | Episodes | NUMBER |
| SECONDARY | Number of Event Adjudication Committee-confirmed Severe (ADA) or Blood Glucose Confirmed, Symptomatic Hypoglycaemic Episodes (Plasma Glucose <= 3.9 mmol/L (70 mg/dL)) From Randomization to Week 52 | From randomization (week 0) to week 52 | Full analysis set included all randomized participants. | Episodes | NUMBER |
| SECONDARY | Number of Event Adjudication Committee-confirmed Severe Hypoglycaemic Episodes (ADA) Requiring Hospitalization, Documented Medical Help, or is Life-threatening From Randomization to Week 52 | From randomization (week 0) to week 52 | Full analysis set included all randomized participants. | Episodes | NUMBER |
| SECONDARY | Number of Event Adjudication Committee-confirmed Severe (ADA) or Clinically Significant Hypoglycaemic Episodes (Plasma Glucose < 3.0 mmol/L (54 mg/dL)) From Randomization to Week 52 | From randomization (week 0) to week 52 | Full analysis set included all randomized participants. | Episodes | NUMBER |
| SECONDARY | Daily Basal Insulin Dose at Week 52 | At week 52 | Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Units of insulin | MEAN |
| SECONDARY | Total Daily Insulin Dose at Week 52 | At week 52 | Safety analysis set included all participants exposed to at least one dose of trial product. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Units of insulin | MEAN |
| SECONDARY | Change From Baseline to Week 52 in Body Weight (Kilogram (kg)) | Baseline (week 0), week 52 | Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | kilograms | MEAN |
| SECONDARY | Change From Baseline to Week 52 in Fasting Plasma Glucose (FPG) | Baseline (week 0), week 52 | Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | millimoles per liter (mmol/L) | MEAN |
| SECONDARY | Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile (SMPG ): Mean 7-point Profile (7-PP) | Baseline (week 0), week 52 | Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | mmol/L | MEAN |
| SECONDARY | Change From Baseline to Week 52 in 7-point Self-measured Plasma Glucose Profile: Mean Post-prandial Increment (Over All Meals) | Baseline (week 0), week 52 | Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure . | mmol/L | MEAN |
| SECONDARY | Change From Baseline to Week 52 in Body Mass Index (BMI) | Baseline (week 0), week 52 | Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | kilograms per meter square (kg/m^2) | MEAN |
| SECONDARY | Change From Baseline to Week 52 in Waist Circumference | Baseline (week 0), week 52 | Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | centimeters (cm) | MEAN |
| SECONDARY | Change From Baseline to Week 52 in Body Weight (Percentage): Ratio to Baseline | Baseline (week 0), week 52 | Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Ratio of body weight | MEAN |
| SECONDARY | Change From Baseline to Week 52 in Fasting Blood Lipids: Total Cholesterol (Ratio to Baseline) | Baseline (week 0), week 52 | Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Ratio of total cholesterol | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline to Week 52 in Fasting Blood Lipids: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline) | Baseline (week 0), week 52 | Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Ratio of LDL cholesterol | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline to Week 52 in Fasting Blood Lipids: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline) | Baseline (week 0), week 52 | Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Ratio of HDL cholesterol | GEOMETRIC_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.
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GET https://conductscience.org/api/trials/v1/NCT03689374/outcomes