Trial · NCT02730377
Outcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Inadequate Glycaemic Control | Weeks 26-104 | FAS included all randomised participants. Overall number of participants analyzed=participants with available data. | Weeks | MEDIAN |
| SECONDARY | Time to Premature Treatment Discontinuation (for Any Reason Including Inadequate Glycaemic Control) | Weeks 0-104 | FAS included all randomised participants. Overall number of participants analyzed=participants with available data. | Weeks | MEDIAN |
| SECONDARY | Change in HbA1c | Week 0, week 104/premature treatment discontinuation | Overall number of participants analyzed=FAS included all randomised participants. Number analyzed=participants with available data. | Percentage point of HbA1c | MEAN |
| SECONDARY | Participants Who Achieve HbA1c ≤6.5% (Yes/No) | Week 104/Premature treatment discontinuation | FAS included all randomised participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants Who Achieve HbA1c ≤7.0% Without Weight Gain | Week 104/Premature treatment discontinuation | FAS included all randomised participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants Who Achieve HbA1c ≤7.0% Without Treatment Emergent Severe Hypoglycaemic Episodes or BG Confirmed Symptomatic Hypoglycaemic Episodes | Week 104/Premature treatment discontinuation | FAS included all randomised participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants Who Achieve HbA1c ≤7.0% Without Weight Gain and no Treatment Emergent Severe Hypoglycaemic Episodes or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes | Week 104/Premature treatment discontinuation | FAS included all randomised participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Fasting Plasma Glucose (FPG) | Week 0, week 104/premature treatment discontinuation | Overall number of participants analyzed=FAS included all randomised participants. Number analyzed=participants with available data. | Millimoles per liter (mmol/L) | MEAN |
| SECONDARY | Change in Body Weight | Week 0, week 104/premature treatment discontinuation | Overall number of participants analyzed=FAS included all randomised participants. Number analyzed=participants with available data. | Kilogram (Kg) | MEAN |
| SECONDARY | Change in Body Mass Index (BMI) | Week 0, week 104/premature treatment discontinuation | Overall number of participants analyzed=FAS included all randomised participants. Number analyzed=participants with available data. | Kilograms per square meter (kg/m^2) | MEAN |
| SECONDARY | Change in Blood Pressure (Systolic and Diastolic Blood Pressure) | Week 0, week 104/premature treatment discontinuation | Overall number of participants analyzed=FAS included all randomised participants. Number analyzed=participants with available data. | Millimeters of mercury (mmHg) | MEAN |
| SECONDARY | Number of Severe Hypoglycaemic Episodes | Weeks 0-104 | Safety analysis set (SAS) included all participants exposed to at least one dose of trial product. | Episodes | NUMBER |
| SECONDARY | Number of Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | Weeks 0-104 | SAS included all participants exposed to at least one dose of trial product. | Episodes | NUMBER |
| SECONDARY | Number of Documented Symptomatic Hypoglycaemic Episodes (ADA) | Weeks 0-104 | SAS included all participants exposed to at least one dose of trial product. | Episodes | NUMBER |
| SECONDARY | Number of Serious Adverse Events (SAEs) | Weeks 0-105 | SAS included all participants exposed to at least one dose of trial product. | Events | NUMBER |
| SECONDARY | Number of AEs Leading to Permanent Discontinuation of Trial Product | Weeks 0-105 | SAS included all participants exposed to at least one dose of trial product. | Events | NUMBER |
| SECONDARY | Change in Lipids: HDL Cholesterol, LDL-cholesterol, Total Cholesterol, Triglycerides | Week 0, week 104/premature treatment discontinuation | Overall number of participants analyzed=SAS included all participants exposed to at least one dose of trial product. Number analyzed=participants with available data. | Millimoles per liter (mmol/L) | MEAN |
| SECONDARY | Change in Biochemistry- Alanine Aminotransferase (ALAT), Amylase, Aspartate Aminotransferase (ASAT), Lipase | Week 0, week 104/premature treatment discontinuation | Overall number of participants analyzed=SAS included all participants exposed to at least one dose of trial product. Number analyzed=participants with available data. | Units per liter (U/L) | MEAN |
| SECONDARY | Change in Biochemistry- Creatinine, Total Bilirubin | Week 0, week 104/premature treatment discontinuation | Overall number of participants analyzed=SAS included all participants exposed to at least one dose of trial product. Number analyzed=participants with available data. | Micromoles per liter (umol/L) | MEAN |
| SECONDARY | Change in Biochemistry- Estimated Glomerular Filtration Rate (eGFR) Serum | Week 0, week 104/premature treatment discontinuation | Overall number of participants analyzed=SAS included all participants exposed to at least one dose of trial product. Number analyzed=participants with available data. | mL/min/SSA | 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.
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