Trial · NCT04159415
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute Change From Baseline in Participants With Elevated Baseline Hemoglobin A1c (HbA1c ≥7%) at Week 8 | Baseline, Week 8 | Absolute change from baseline in HbA1c for subgroup of participants with baseline HbA1c ≥7% reported |
| Primary | Absolute Change From Baseline in Fasting Glucose at Week 8 | Baseline, Week 8 | Absolute change from baseline in fasting glucose for subgroup of participants with baseline HbA1c ≥7% reported |
| Primary | Absolute Change From Baseline in Weighted Mean Glucose (WMG) at Week 8 | Baseline, Week 8 | Absolute change from baseline in WMG for subgroup of participants with baseline HbA1c ≥7% reported |
| Primary | Percent Change From Baseline in Fasting Triglycerides (TG) at Week 8 | Baseline, Week 8 | Percent change from baseline in participants with elevated baseline fasting TG (fasting TG ≥250 mg/dL) reported |
| Secondary | Absolute Change From Baseline in HbA1c and Fasting TG Composite Endpoint at Week 8 | Baseline, Week 8 | The composite score is calculated for each individual participant using baseline and Week 8 measurements of HbA1c and fasting TG. For each participant, a Z-score is calculated separately for HbA1c and fasting TG, rescaling the change from baseline based on the standard deviation of the baseline value for all participants, as a way of standardizing the change value. The composite score uses one or both of the calculated Z-scores depending on which parameters were abnormal at baseline. If both, then the participant's composite is the average of the two parameter Z-scores. At the participant level, a Z-score of zero for either parameter indicates no change in that metabolic parameter, but a composite Z-score of zero can also reflect offsetting changes in metabolic parameters. A negative Z-score would be interpreted as an overall improvement in metabolic function, but a negative Z-score can also result from a decrease in one parameter not being canceled by an increase in the other. |
| Secondary | Absolute Change From Baseline in Fasting Glucose | Baseline, Weeks 16, 24, 36, 52; OLTP 5 Weeks 4, 12, 24, 52 | |
| Secondary | Absolute Change From Baseline in Fasting Glucose for Participants With Baseline HbA1c ≥7% | Baseline, Weeks 16, 24, 36, 52; OLTP 5 Weeks 4, 12, 24, 52 | |
| Secondary | Percent Change From Baseline in Fasting TG | Baseline, Weeks 16, 24, 36, 52; OLTP 5 Weeks 4, 12, 24, 52 | |
| Secondary | Percent Change From Baseline in Fasting TG for Participants With Baseline Fasting TG ≥250 mg/dL | Baseline, Weeks 16, 24, 36, 52; OLTP 5 Weeks 4, 12, 24, 52 | |
| Secondary | Absolute Change From Baseline in HbA1c | Baseline, Weeks 16, 24, 36, 52; OLTP 5 Weeks 12, 24, 52 | |
| Secondary | Absolute Change From Baseline in HbA1c for Participants With Baseline HbA1c ≥7% | Baseline, Weeks 16, 24, 36, 52; OLTP 5 Weeks 12, 24, 52 | |
| Secondary | Absolute Change From Baseline in Weighted Mean Glucose (WMG) | Baseline, Weeks 16 and 24 | |
| Secondary | Absolute Change From Baseline in WMG for Participants With Baseline Fasting HbA1c ≥7% | Baseline, Weeks 16 and 24 | |
| Secondary | Change From Baseline in Glucose Area Under the Concentration-time Curve (AUC0-4) During a Mixed Meal Tolerance Test (MMTT) | Baseline, Weeks 8, 16, 24 | |
| Secondary | Change From Baseline in Glucose AUC0-4 During a MMTT for Participants With Baseline HbA1c ≥7% | Baseline, Weeks 8, 16, 24 | |
| Secondary | Change From Baseline in Glucose Infusion Rate Per Kilogram (kg) Body Mass During Hyperinsulinemia-euglycemic Clamp | Baseline, Weeks 8 and 52 | |
| Secondary | Change From Baseline in Glucose Infusion Rate Per kg Body Mass During Hyperinsulinemia-euglycemic Clamp for Participants With Baseline HbA1c ≥7% | Baseline, Weeks 8 and 52 | |
| Secondary | Change From Baseline in Glucose Clearance Rate (kITT) During Insulin-tolerance Test (ITT) | Baseline, Weeks 8 and 52 | |
| Secondary | Change From Baseline in Glucose kITT During ITT for Participants With Baseline HbA1c ≥7% | Baseline, Weeks 8 and 52 | |
| Secondary | Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE) | From first dose of DBTP study treatment through last dose of OLTP 5 study treatment plus 16 weeks (approximately 120 weeks) |
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/NCT04159415/registered