TriangleNCT04233034 · OUTCOME
C-peptide Area Under the Curve (AUC)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- (pmol/ml)*minutes
- Interval / dispersion
- Standard Deviation
- Time frame
- 52 weeks
What was measured
The primary outcome is the C-peptide in response to a 2-hour MMTT at 52 weeks. C-peptide was measured at 0, 15, 30, 45, 60, 90, and 120 minutes following the start of the mixed meal tolerance test (MMTT). This is summarized as the area under the stimulated C-peptide curve (AUC). AUC is computed using a trapezoidal rule, which is a weighted sum of the C-peptide values over the 120 min.
Analysis population: 1 participant randomized to Non-HCL and placebo dropped prior to baseline data being collected and was not analyzed. All other participants with at least one available measurement of C-Peptide AUC were included in the analysis model.
Groups in this outcome
HCL and Intensive Management
Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations. \[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\] HCL: Hybrid Closed Loop therapy verapamil
Non-HCL and Standard Care
Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider. \[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\] non-HCL: Usual diabetes care
Verapamil
Verapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets. Whether drug is active or placebo is blinded to both participant and site. \[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\] verapamil 120mg tablet: verapamil tablet
Placebo
Placebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets. Whether drug is active or placebo is blinded to both participant and site. \[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\] placebo: placebo pill manufactured to mimic verapamil 120mg tablet
| Group | Source count |
|---|---|
| HCL and Intensive Management | 61 |
| Non-HCL and Standard Care | 51 |
| Verapamil | 47 |
| Placebo | 40 |
Reported measurements
Randomization
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| HCL and Intensive Management | 0.57 | 0.22 | Not reported | Not reported | Not reported |
| Non-HCL and Standard Care | 0.60 | 0.18 | Not reported | Not reported | Not reported |
| Verapamil | 0.66 | 0.20 | Not reported | Not reported | Not reported |
| Placebo | 0.60 | 0.22 | Not reported | Not reported | Not reported |
52 Weeks
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| HCL and Intensive Management | 0.45 | 0.30 | Not reported | Not reported | Not reported |
| Non-HCL and Standard Care | 0.50 | 0.31 | Not reported | Not reported | Not reported |
| Verapamil | 0.65 | 0.31 | Not reported | Not reported | Not reported |
| Placebo | 0.44 | 0.30 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -0.11
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.10
- estimate Comment
- Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.89
- param Type
- Mean Difference (Final Values)
- param Value
- -0.01
- statistical Comment
- The model included age, days from T1D diagnosis to randomization, and drug group as fixed effects and clinical site as a random effect.
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- 0.01
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.27
- estimate Comment
- Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.04
- param Type
- Mean Difference (Final Values)
- param Value
- 0.14
- statistical Comment
- The model included age, days from T1D diagnosis to randomization, and Intensive group as fixed effects and clinical site as a random effect.
- statistical Method
- Mixed Models Analysis
Complete source fields
- analyses
- ci Lower Limit
- -0.11
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.10
- estimate Comment
- Mean difference (HCL - Non-HCL) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT drug group, and clinical site.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.89
- param Type
- Mean Difference (Final Values)
- param Value
- -0.01
- statistical Comment
- The model included age, days from T1D diagnosis to randomization, and drug group as fixed effects and clinical site as a random effect.
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- 0.01
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.27
- estimate Comment
- Mean difference (Verapamil - Placebo) at 52 weeks adjusted for age, days from T1D diagnosis to randomization, RCT intensive/standard care group, and clinical site.
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.04
- param Type
- Mean Difference (Final Values)
- param Value
- 0.14
- statistical Comment
- The model included age, days from T1D diagnosis to randomization, and Intensive group as fixed effects and clinical site as a random effect.
- statistical Method
- Mixed Models Analysis
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.22
- value
- 0.57
- group Id
- OG001
- spread
- 0.18
- value
- 0.60
- group Id
- OG002
- spread
- 0.20
- value
- 0.66
- group Id
- OG003
- spread
- 0.22
- value
- 0.60
- title
- Randomization
- categories
- measurements
- group Id
- OG000
- spread
- 0.30
- value
- 0.45
- group Id
- OG001
- spread
- 0.31
- value
- 0.50
- group Id
- OG002
- spread
- 0.31
- value
- 0.65
- group Id
- OG003
- spread
- 0.30
- value
- 0.44
- title
- 52 Weeks
- denoms
- counts
- group Id
- OG000
- value
- 61
- group Id
- OG001
- value
- 51
- group Id
- OG002
- value
- 47
- group Id
- OG003
- value
- 40
- units
- Participants
- description
- The primary outcome is the C-peptide in response to a 2-hour MMTT at 52 weeks. C-peptide was measured at 0, 15, 30, 45, 60, 90, and 120 minutes following the start of the mixed meal tolerance test (MMTT). This is summarized as the area under the stimulated C-peptide curve (AUC). AUC is computed using a trapezoidal rule, which is a weighted sum of the C-peptide values over the 120 min.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants assigned to HCL group will initially be randomly assigned 1:1 to use either the Tandem t:slim X2 with Control-IQ technology or a Medtronic HCL system (Medtronic 670G 4.0 AHCL (prior to protocol version 5.0) or Medtronic 780G (starting with protocol version 5.0)). This group will receive intensive diabetes management with frequent contacts by study staff with the goal of near-normalization of glucose concentrations. \[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\] HCL: Hybrid Closed Loop therapy verapamil
- id
- OG000
- title
- HCL and Intensive Management
- description
- Participants assigned to non-HCL will receive a Dexcom G6 CGM and diabetes management will follow usual care by their personal diabetes health care provider. \[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\] non-HCL: Usual diabetes care
- id
- OG001
- title
- Non-HCL and Standard Care
- description
- Verapamil will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets. Whether drug is active or placebo is blinded to both participant and site. \[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\] verapamil 120mg tablet: verapamil tablet
- id
- OG002
- title
- Verapamil
- description
- Placebo will be taken orally once per day by participants in Cohort A. A dosing scheme will be followed, using 120mg tablets or 60mg half tablets. Whether drug is active or placebo is blinded to both participant and site. \[Cohort B participants will not receive study drug. Instead, they will be randomized 2:1 to HCL or non-HCL.\] placebo: placebo pill manufactured to mimic verapamil 120mg tablet
- id
- OG003
- title
- Placebo
- param Type
- GEOMETRIC_MEAN
- population Description
- 1 participant randomized to Non-HCL and placebo dropped prior to baseline data being collected and was not analyzed. All other participants with at least one available measurement of C-Peptide AUC were included in the analysis model.
- reporting Status
- POSTED
- time Frame
- 52 weeks
- title
- C-peptide Area Under the Curve (AUC)
- type
- PRIMARY
- unit Of Measure
- (pmol/ml)*minutes
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice