Trial · NCT02500706
Outcomes49
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 49
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in HbA1c 26 Weeks After Randomisation | Week 0, week 26 | Analysis was based on FAS. Number of subjects analysed=subject with data available for HbA1c. | percentage of HbA1c | MEAN |
| SECONDARY | Change From Baseline in 1-hour Post Prandial Glucose (PPG) Increment 26 Weeks After Randomisation (Meal Test) | Week 0, week 26 | Analysis was based on FAS. Number of subjects analysed=subject with data available for 1-hour PPG and pre-prandial PG. | mmol/L | MEAN |
| SECONDARY | Change From Baseline in 1,5-anhydroglucitol 26 Weeks After Randomisation | Week 0, week 26 | Analysis was based on FAS. Number of subjects analysed=subject with data available for 1,5-anhydroglucitol. | ug/mL | MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (FPG) 26 Weeks After Randomisation | Week 0, week 26 | Analysis was based on FAS. Number of subjects analysed=subject with data available for HbA1c. | mmol/L | MEAN |
| SECONDARY | Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0%) 26 Weeks After Randomisation | 26 weeks after randomisation | Analysis was based on FAS. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia) 26 Weeks After Randomisation | 26 weeks after randomisation | Analysis was based on FAS. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia and Minimal Weight Gain [<3.0%]) 26 Weeks After Randomisation | 26 weeks after randomisation | Analysis was based on FAS. | percentage of subjects | NUMBER |
| SECONDARY | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation | Week 0, week 26 | Analysis was based on FAS. Number of analysed=subject with data available for PPG at individual timepoints. | mmol/L | MEAN |
| SECONDARY | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation | Week 0, week 26 | Analysis was based on FAS. Number of analysed=subject with data available for PPG and pre-prandial PG at individual timepoints. | mmol/L | MEAN |
| SECONDARY | Change From Baseline in 7-9-7-point Self-measured Plasma Glucose (SMPG) 26 Weeks After Randomisation: Mean of the 7-9-7-point Profile | Week 0, week 26 | Analysis was based on FAS. Number of analysed=subject with data available for 7-9-7 point profile. | mmol/L | MEAN |
| SECONDARY | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG (Mean, Breakfast, Lunch, Main Evening Meal) | Week 0, week 26 | Analysis was based on FAS. Number of analysed=subject with data available data at three profiles: post-breakfast, post-lunch, post-main evening meal. | mmol/L | MEAN |
| SECONDARY | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) | Week 0, week 26 | Analysis was based on FAS. Number of analysed=subject with data available data for PPG values and the PG value before the meal (breakfast, lunch, main evening meal). | mmol/L | MEAN |
| SECONDARY | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Fluctuation in 7-9-7-point Profile | Week 0, week 26 | Analysis was based on FAS. Number of analysed=subjects who contributed to this analysis. | ratio | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Change in the Nocturnal Self-measured Plasma Glucose Measurements | Week 0, week 26 | Analysis was based on FAS. Number of analysed=subjects with available data for nocturnal SMPG measurements. | mmol/L | MEAN |
| SECONDARY | Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L | 26 weeks after randomisation | Analysis was based on FAS. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L Without Severe Hypoglycaemia | 26 weeks after randomisation | Analysis was based on FAS. | percentage of subjects | NUMBER |
| SECONDARY | Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L and HbA1c <7.0% and Minimal Weight Gain (<3.0%) Without Severe Hypoglycaemia | 26 weeks after randomisation | Analysis was based on FAS. | percentage of subjects | NUMBER |
| SECONDARY | Change From Baseline in Lipids-lipoproteins Profile 26 Weeks After Randomisation (Total Cholesterol, High Density Lipoproteins [HDL] Cholesterol, Low Density Lipoproteins [LDL] Cholesterol) | Week 0, week 26 | Analysis was based on FAS. Number analysed=number of subjects with available data for individual lipid parameter. | ratio | GEOMETRIC_MEAN |
| SECONDARY | Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose) | Week 0, week 26 | Analysis was based on safety analysis set (all subjects receiving at least one dose of the investigational product or its comparator). Number of subjects analysed=subjects with available data for specified categories. | Units | MEAN |
| SECONDARY | Number of Treatment Emergent Adverse Events During 26 Weeks After Randomisation | Week 0 to week 26 (+7 days) | Analysis was based on SAS. | events | NUMBER |
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/NCT02500706/outcomes