Trial · NCT01030952
Outcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Area Under Curve of 0-4 Hours Postprandial Glucose (AUCpp0-4hours) in Standardized Meal Test Using Continuous Glucose Monitoring System (CGMS) | 3 weeks (end of study) minus baseline | Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline. | millimoles hours per litre (mmol*hr/L) | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Incremental Glucose Peak (IGP) From Baseline | baseline, 3 weeks (end of study) | Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline. | millimoles per litre (mmol/L) | MEAN |
| SECONDARY | Change in Mean Blood Glucose (MBG) | baseline and at 3 weeks (end of study) | Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline | millimoles per litre (mmol/l) | MEAN |
| SECONDARY | Change in Standard Deviation (SD) From Baseline of Mean Blood Glucose (MBG) Over 24 Hours. | baseline, 3 weeks (end of study) | Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline | mmol/l | MEAN |
| SECONDARY | Change in Mean of Daily Difference of Paired Blood Glucose Value (MODD) | baseline, 3 weeks (end of study) | Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable. | millimoles per litre (mmol/l) | MEAN |
| SECONDARY | Changes in 24 Hour Glucose Area Under Curve (AUCpp) | baseline, end of study (3 weeks) | Intent-to treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable. | mmol*min/L | MEAN |
| SECONDARY | Change in Glycated Serum Albumin (GSA) Levels From Baseline After Treatment | baseline, 3 weeks (end of study) | Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline. During different time points, participants with observations at that time point were included in the analysis. | percent | MEAN |
| SECONDARY | Change in Insulin Levels (μU/ml) During Standardized Meal Test at Endpoint From Baseline | baseline, 3 weeks (end of study) | The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication. | (μU/ml) | MEAN |
| SECONDARY | Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) | baseline, 3 weeks (end of study) | Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline. During different time points, participants with observations at that time point were included in the analysis. | millimoles per litre (mmol/l) | MEAN |
| SECONDARY | Change of Total Cholesterol in Blood Lipids Levels During Standardized Meal Test at Endpoint From Baseline at Each Time Point | baseline, 3 weeks (end of study) | The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication. | millimoles per litre (mmol/l) | MEAN |
| SECONDARY | Change in Triglyceride (TG)Levels in Blood Lipid Levels During Standardized Meal Test at Endpoint | baseline, 3 weeks (end of study) | The Intent to Treat (ITT) population consists of all patients randomized and who have at least one dose of study medication. | millimoles per litre (mmol/l) | MEAN |
| SECONDARY | Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at the End of the Study | baseline, 3 weeks (end of study) | Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline. During different time points, participants with observations at that time point were included in the analysis. | millimoles per litre (mmol/l) | MEAN |
| SECONDARY | Change in Mean Amplitude of Glycaemic Excursion (MAGE) | baseline, 3 weeks (end of study) | Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline. During different time points, participants with observations at that time point were included in the analysis. | mmol/l | MEAN |
| SECONDARY | The Percent of 24 Hour Hypoglycemic Measurements | baseline, 3 weeks (end of study) | Intent-to-treat population (ITT): All randomized participants who received at least 1 dose of study drug, had valid baseline data, and at least 1 post-baseline assessment of the primary efficacy variable. During different time points, participants with observations at that time point were included in the analysis | percent of measurements | MEAN |
| SECONDARY | Change in Percent of 24 Hour Hyperglycemic Measurements | baseline, 3 weeks (end of study) | Intent to Treat population - All patients who received at least one dose of study drug after random allocation and had at least one primary or secondary efficacy evaluation after baseline. | percent of measurements | 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/NCT01030952/outcomes