Trial · NCT01263496
Registered outcomes57
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 57
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events. | 52 Weeks. | A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug, which increases in intensity after the start of dosing. Adverse events data with onset occurring more than 30 days after last dose of study drug (AE start date - last dose date \>30) will be listed, but not included in the summary tables below. |
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 12). | Baseline and Week 12. | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 and glycosylated hemoglobin collected at baseline. |
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 16). | Baseline and Week 16. | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 16 and glycosylated hemoglobin collected at baseline. |
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 20). | Baseline and Week 20. | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 20 and glycosylated hemoglobin collected at baseline. |
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 24). | Baseline and Week 24. | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 and glycosylated hemoglobin collected at baseline. |
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 28). | Baseline and Week 28. | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 28 and glycosylated hemoglobin collected at baseline. |
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 32). | Baseline and Week 32. | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 32 and glycosylated hemoglobin collected at baseline. |
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 36). | Baseline and Week 36. | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 36 and glycosylated hemoglobin collected at baseline. |
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 40). | Baseline and Week 40. | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 40 and glycosylated hemoglobin collected at baseline. |
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 44). | Baseline and Week 44. | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 44 and glycosylated hemoglobin collected at baseline. |
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 48). | Baseline and Week 48. | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 48 and glycosylated hemoglobin collected at baseline. |
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 52). | Baseline and Week 52. | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 and glycosylated hemoglobin collected at baseline. |
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Final Visit). | Baseline and Final Visit (up to Week 52). | The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 52 or final visit and glycosylated hemoglobin collected at baseline. |
| Secondary | Change From Baseline in Fasting Plasma Glucose (Week 12). | Baseline and Week 12 | The change between the value of fasting plasma glucose collected at week 12 and fasting plasma glucose collected at baseline. |
| Secondary | Change From Baseline in Fasting Plasma Glucose (Week 16). | Baseline and Week 16. | The change between the value of fasting plasma glucose collected at week 16 and fasting plasma glucose collected at baseline. |
| Secondary | Change From Baseline in Fasting Plasma Glucose (Week 20). | Baseline and Week 20. | The change between the value of fasting plasma glucose collected at week 20 and fasting plasma glucose collected at baseline. |
| Secondary | Change From Baseline in Fasting Plasma Glucose (Week 24). | Baseline and Week 24. | The change between the value of fasting plasma glucose collected at week 24 and fasting plasma glucose collected at baseline. |
| Secondary | Change From Baseline in Fasting Plasma Glucose (Week 28). | Baseline and Week 28. | The change between the value of fasting plasma glucose collected at week 28 and fasting plasma glucose collected at baseline. |
| Secondary | Change From Baseline in Fasting Plasma Glucose (Week 32). | Baseline and Week 32. | The change between the value of fasting plasma glucose collected at week 32 and fasting plasma glucose collected at baseline. |
| Secondary | Change From Baseline in Fasting Plasma Glucose (Week 36). | Baseline and Week 36. | The change between the value of fasting plasma glucose collected at week 36 and fasting plasma glucose collected at baseline. |
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
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