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NCT02804750 · OUTCOME

Percentage of Participants With IGT / T2DM Who Experienced a ≥25% Reduction in AUCglucose Following Treatment With CORT125134

Study to Evaluate CORT125134 in Participants With Cushing's Syndrome · Source last updated 2019-10-15

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 as a participant who experiences at least a 25% decrease from baseline in area under the concentration-time curve for blood glucose (AUCglucose) who has not taken an additional diabetes medication during the treatment period or increased the dosage of a concurrent diabetes medication.

Analysis population: All enrolled participants with IGT / T2DM at Baseline who received at least one dose of study drug and had at least one post-baseline assessment.

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.

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. Period 4 was followed by a 4-week follow-up period.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Group 1: Low-dose Group13
Group 2: High-dose Group14

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Group 1: Low-dose Group23.08Not reported5.0453.81Not reported
Group 2: High-dose Group0Not reported023.16Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.04
        upper Limit
        53.81
        value
        23.08
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        23.16
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    2. group Id
      OG001
      value
      14
    units
    Participants
description
Improvement in glucose control was defined as a participant who experiences at least a 25% decrease from baseline in area under the concentration-time curve for blood glucose (AUCglucose) who has not taken an additional diabetes medication during the treatment period or increased the dosage of a concurrent diabetes medication.
dispersion Type
95% Confidence Interval
groups
  1. 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.
    id
    OG000
    title
    Group 1: Low-dose Group
  2. 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. 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 at least one post-baseline assessment.
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 a ≥25% Reduction in AUCglucose Following Treatment With CORT125134
type
SECONDARY
unit Of Measure
Percentage of participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice