Trial · NCT01717313
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Hemoglobin A1c (A1C) at Week 24 (Phase A, FAS Population) | Baseline and Week 24 | The Full Analysis Set (FAS) population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement for the analysis endpoint and a post-randomization measurement for the analysis endpoint after at least one dose of study treatment. | Percent | LEAST_SQUARES_MEAN |
| PRIMARY | Percentage of Participants Who Experienced at Least One Adverse Event in Phase A (Excluding Data After Glycemic Rescue, Safety Population) | Up to 27 weeks | The All-Participants-as-Treated (APaT) population included all participants who received at least one dose of study drug. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Discontinued From the Study Drug Due to an Adverse Event in Phase A (Excluding Data After Glycemic Rescue, Safety Population) | Up to 24 weeks | The APaT population included all participants who received at least one dose of study drug. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Experienced at Least One Adverse Event (Phase A + Phase B, Excluding Data After Glycemic Rescue, Safety Population) | Up to 57 weeks | The APaT population included all participants who received at least one dose of study drug. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Discontinued From the Study Drug Due to an Adverse Event (Phase A + Phase B, Excluding Data After Glycemic Rescue, Safety Population) | Up to 57 weeks | The APaT population included all participants who received at least one dose of study drug. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieve an A1C Goal of <7% (53 mmol/Mol) at Week 24 (Phase A, FAS Population) | Week 24 | The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement for the analysis endpoint and a post-randomization measurement for the analysis endpoint after at least one dose of study treatment, and estimated using standard multiple imputation techniques. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieve an A1C Goal of <6.5% (48 mmol/Mol) at Week 24 (Phase A, FAS Population) | Week 24 | The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement for the analysis endpoint and a post-randomization measurement for the analysis endpoint after at least one dose of study treatment, and estimated using standard multiple imputation techniques. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 (Phase A, FAS Population) | Baseline and Week 24 | The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint after at least one dose of study treatment. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 2-hour Post Meal Glucose (PMG) at Week 24 (Phase A, FAS Population) | Baseline and Week 24 | The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint after at least one dose of study treatment. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in A1C at Week 54 (Phase A + Phase B, FAS Population) | Baseline and Week 54 | The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint after at least one dose of study treatment. | Percent | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Achieve an A1C Goal of <7% (53 mmol/Mol) at Week 54 (Phase A + Phase B, FAS Population) | Week 54 | The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement for the analysis endpoint and a post-randomization measurement for the analysis endpoint after at least one dose of study treatment, and estimated using standard multiple imputation techniques. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieve an A1C Goal of <6.5% at Week 54 (Phase A + Phase B, FAS Population) | Week 54 | The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement for the analysis endpoint and a post-randomization measurement for the analysis endpoint after at least one dose of study treatment, and estimated using standard multiple imputation techniques. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in FPG at Week 54 (Phase A + Phase B, FAS Population) | Baseline and Week 54 | The FAS population was comprised of all participants who received at least one dose of study treatment and have a baseline measurement or a post-randomization measurement for the analysis endpoint after at least one dose of study treatment. | mg/dL | LEAST_SQUARES_MEAN |
| POST_HOC | Change From Baseline in A1C at Week 24 (Phase A, Per-Protocol Population) | Baseline and Week 24 | The Per-Protocol population excluded participants from the FAS population who either had \<75% drug compliance or used a prohibited medication (including metformin). | Percent | LEAST_SQUARES_MEAN |
| POST_HOC | Change From Baseline in FPG at Week 24 (Phase A, Per-Protocol Population) | Baseline and Week 24 | The Per-Protocol population excluded participants from the FAS population who either had \<75% drug compliance or used a prohibited medication (including metformin). | mg/dL | LEAST_SQUARES_MEAN |
| POST_HOC | Change From Baseline in 2-hour PMG at Week 24 (Phase A, Per-Protocol Population) | Baseline and Week 24 | The Per Protocol population excluded participants from the FAS population who either had \<75% drug compliance or used a prohibited medication (including metformin). | mg/dL | LEAST_SQUARES_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/NCT01717313/outcomes