TriangleNCT02804750 · OUTCOME
Percentage of Participants With IGT / T2DM Who Experienced Improvement in Glucose Control Following Treatment With CORT125134: Responder Definition Based on Response Criteria for Phase 3 Study NCT03697109
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Before and 0.5, 1, 1.5, and 2 hours after a glucose drink at Week 12 or last observation (Group 1) or Week 16 or last observation (Group 2)
What was measured
Improvement in glucose control was defined based on response criteria for Phase 3 study NCT03697109: a participant who experiences 1) a hemoglobin A1c (HbA1c) that is decreased by ≥ 0.5% from baseline, 2) a 2-hour oGTT plasma glucose that is normalized (\< 7.8 mmol/L) or decreased by ≥ 2.8 mmol/L from baseline, or 3) a total daily insulin dose that has decreased by ≥ 25% or total daily sulfonylurea dose that has decreased by ≥ 50% and an HbA1c that is unchanged or decreased from baseline.
Analysis population: All enrolled participants with IGT / T2DM at Baseline who received at least one dose of study drug and had non-missing post-baseline data collected, with exclusions based on clinical judgment and/or important protocol deviations applied on a visit and outcome level rather than a participant level.
Groups in this outcome
Group 1: Low-dose Group
100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. Period 3 was followed by a 4-week follow-up period. There was no washout between treatment periods. Per-protocol, Group 1 did not participate in Treatment Period 4.
Group 2: High-dose Group
250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. There was no washout between treatment periods. Period 4 was followed by a 4-week follow-up period.
| Group | Source count |
|---|---|
| Group 1: Low-dose Group | 13 |
| Group 2: High-dose Group | 12 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Group 1: Low-dose Group | 15.38 | Not reported | 1.92 | 45.45 | Not reported |
| Group 2: High-dose Group | 50.00 | Not reported | 21.09 | 78.91 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.92
- upper Limit
- 45.45
- value
- 15.38
- group Id
- OG001
- lower Limit
- 21.09
- upper Limit
- 78.91
- value
- 50.00
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 12
- units
- Participants
- description
- Improvement in glucose control was defined based on response criteria for Phase 3 study NCT03697109: a participant who experiences 1) a hemoglobin A1c (HbA1c) that is decreased by ≥ 0.5% from baseline, 2) a 2-hour oGTT plasma glucose that is normalized (\< 7.8 mmol/L) or decreased by ≥ 2.8 mmol/L from baseline, or 3) a total daily insulin dose that has decreased by ≥ 25% or total daily sulfonylurea dose that has decreased by ≥ 50% and an HbA1c that is unchanged or decreased from baseline.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 100 mg/day for 4 weeks in Period 1, then 150 mg/day for 4 weeks in Period 2, then 200 mg/day for 4 weeks in Period 3. Period 3 was followed by a 4-week follow-up period. There was no washout between treatment periods. Per-protocol, Group 1 did not participate in Treatment Period 4.
- id
- OG000
- title
- Group 1: Low-dose Group
- description
- 250 mg/day for 4 weeks in Period 1, then 300 mg/day for 4 weeks in Period 2, then 350 mg/day for 4 weeks in Period 3, then 400 mg/day for 4 weeks in Period 4. There was no washout between treatment periods. Period 4 was followed by a 4-week follow-up period.
- id
- OG001
- title
- Group 2: High-dose Group
- param Type
- NUMBER
- population Description
- All enrolled participants with IGT / T2DM at Baseline who received at least one dose of study drug and had non-missing post-baseline data collected, with exclusions based on clinical judgment and/or important protocol deviations applied on a visit and outcome level rather than a participant level.
- reporting Status
- POSTED
- time Frame
- Before and 0.5, 1, 1.5, and 2 hours after a glucose drink at Week 12 or last observation (Group 1) or Week 16 or last observation (Group 2)
- title
- Percentage of Participants With IGT / T2DM Who Experienced Improvement in Glucose Control Following Treatment With CORT125134: Responder Definition Based on Response Criteria for Phase 3 Study NCT03697109
- type
- POST_HOC
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice