Trial · NCT01517373
Outcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 12 | Baseline (Day 1), Week 12 | Full analysis set (FAS) included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure and 'n' signifies participants evaluable at given time points for each group. | percentage of hemoglobin | MEAN |
| SECONDARY | Change From Baseline in Glycosylated Hemoglobin (HbA1C) at Week 2, 4, 6 and 8 | Baseline (Day 1), Week 2, 4, 6, 8 | FAS: All randomized participants who received at least 1 dose of study treatment. Here, 'N' signifies participants for whom data was summarized for this measure and 'n' signifies participants who were evaluable at given time points for each group. Data for Week 2 had not been reported because as per protocol it was not intended to be collected. | percentage of hemoglobin | MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose at Week 2, 4, 6, 8 and 12 | Baseline (Day 1), Week 2, 4, 6, 8, 12 | FAS included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure and 'n' signifies participants evaluable at given time points for each group. | milligram per deciliter (mg/dL) | MEAN |
| SECONDARY | Percentage of Participants Achieving Less Than 6.5 Percent and Less Than 7 Percent Glycosylated Hemoglobin (HbA1c) Levels at Week 12 | Week 12 | FAS included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Increase From Baseline Electrocardiogram (ECG) Data | Baseline (Day 1) up to Week 14 | Safety analysis set included all randomized participants who received at least 1 dose of study treatment. N(number of participants analyzed)= participants who were evaluable for this measure. | participants | NUMBER |
| SECONDARY | Number of Participants With Increase/Decrease From Baseline Vital Signs Data | Baseline (Day 1) up to Week 14 | Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure | participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Baseline (Day 1) up to 14 days after last dose of study treatment (up to 101 days) | Safety analysis set included all randomized participants who received at least 1 dose of study treatment. | participants | NUMBER |
| SECONDARY | Percentage of Participants With at Least 1 Hypoglycemic Events (HAE) Episode | Baseline (Day 1) up to Week 14 | Safety analysis set included all randomized participants who received at least 1 dose of study treatment. | percentage of participants | NUMBER |
| SECONDARY | Number of Hypoglycemic Events (HAE) Episodes Per Participant | Baseline (Day 1) up to Week 14 | Safety analysis set included all randomized participants who received at least 1 dose of study treatment. | events per participant | MEDIAN |
| SECONDARY | Time to Each Recurrent Hypoglycemic Events (HAE) Episode Per Participant | Baseline (Day 1) up to Week 14 | Data was not collected since this outcome measure was not analyzed due to infrequency of the occurrence of HAEs among the participants. | ||
| SECONDARY | Change From Baseline in Body Weight at Week 2, 4, 6, 8, 12 and 14 | Baseline (Day 1), Week 2, 4, 6, 8, 12, 14 (follow-up) | Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure and 'n' signifies participants evaluable at given time points for each group. | kilogram (kg) | MEAN |
| SECONDARY | Number of Participants With Abnormal Laboratory Values | Baseline (Day 1) up to Week 14 | Safety analysis set included all randomized participants who received at least 1 dose of study treatment. Here, 'N' (number of participants analyzed) signifies participants for whom data was summarized for this measure | participants | 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.
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GET https://conductscience.org/api/trials/v1/NCT01517373/outcomes