Trial · NCT01318135
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 31
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events. | 52 Weeks. | Treatment-emergent adverse events (TEAE) are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug. A TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing. |
| Secondary | Change From Baseline in Glycosylated Hemoglobin (Week 8). | Baseline and Week 8. | 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 8 and glycosylated hemoglobin collected at baseline. |
| 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 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 final visit and glycosylated hemoglobin collected at baseline. |
| Secondary | Change From Baseline in Fasting Blood Glucose (Week 8). | Baseline and Week 8. | The change between the value of fasting blood glucose collected at week 8 and baseline. |
| Secondary | Change From Baseline in Fasting Blood Glucose (Week 12). | Baseline and Week 12. | The change between the value of fasting blood glucose collected at week 12 and baseline. |
| Secondary | Change From Baseline in Fasting Blood Glucose (Week 16). | Baseline and Week 16. | The change between the value of fasting blood glucose collected at week 6 and baseline. |
| Secondary | Change From Baseline in Fasting Blood Glucose (Week 20). | Baseline and Week 20. | The change between the value of fasting blood glucose collected at week 20 and baseline. |
| Secondary | Change From Baseline in Fasting Blood Glucose (Week 24). | Baseline and Week 24. | The change between the value of fasting blood glucose collected at week 24 and baseline. |
| Secondary | Change From Baseline in Fasting Blood Glucose (Week 28). | Baseline and Week 28. | The change between the value of fasting blood glucose collected at week 28 and 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.
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