TriangleNCT04233034 · OUTCOME
Peak C-peptide
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- pmol/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- 13, 26, 39 weeks and 52 weeks
What was measured
Maximum of all C-peptide values during the MMTT
Analysis population: 1 participant randomized to Non-HCL and placebo dropped prior to baseline data being collected and was excluded from the analyses.
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 | 0.72 | 0.25 | Not reported | Not reported | Not reported |
| Non-HCL and Standard Care | 0.78 | 0.23 | Not reported | Not reported | Not reported |
| Verapamil | 0.96 | 0.30 | Not reported | Not reported | Not reported |
| Placebo | 0.89 | 0.27 | Not reported | Not reported | Not reported |
13 Weeks
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| HCL and Intensive Management | 0.81 | 0.27 | Not reported | Not reported | Not reported |
| Non-HCL and Standard Care | 0.87 | 0.29 | Not reported | Not reported | Not reported |
| Verapamil | 0.84 | 0.24 | Not reported | Not reported | Not reported |
| Placebo | 0.78 | 0.27 | Not reported | Not reported | Not reported |
26 Weeks
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| HCL and Intensive Management | 0.78 | 0.34 | Not reported | Not reported | Not reported |
| Non-HCL and Standard Care | 0.76 | 0.33 | Not reported | Not reported | Not reported |
| Verapamil | 0.97 | 0.35 | Not reported | Not reported | Not reported |
| Placebo | 0.76 | 0.30 | Not reported | Not reported | Not reported |
39 Weeks
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| HCL and Intensive Management | 0.65 | 0.35 | Not reported | Not reported | Not reported |
| Non-HCL and Standard Care | 0.69 | 0.35 | Not reported | Not reported | Not reported |
| Verapamil | 0.89 | 0.36 | Not reported | Not reported | Not reported |
| Placebo | 0.63 | 0.32 | Not reported | Not reported | Not reported |
52 Weeks
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| HCL and Intensive Management | 0.56 | 0.36 | Not reported | Not reported | Not reported |
| Non-HCL and Standard Care | 0.62 | 0.37 | Not reported | Not reported | Not reported |
| Verapamil | 0.83 | 0.37 | Not reported | Not reported | Not reported |
| Placebo | 0.55 | 0.34 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.25
- value
- 0.72
- group Id
- OG001
- spread
- 0.23
- value
- 0.78
- group Id
- OG002
- spread
- 0.30
- value
- 0.96
- group Id
- OG003
- spread
- 0.27
- value
- 0.89
- title
- Randomization
- categories
- measurements
- group Id
- OG000
- spread
- 0.27
- value
- 0.81
- group Id
- OG001
- spread
- 0.29
- value
- 0.87
- group Id
- OG002
- spread
- 0.24
- value
- 0.84
- group Id
- OG003
- spread
- 0.27
- value
- 0.78
- title
- 13 Weeks
- categories
- measurements
- group Id
- OG000
- spread
- 0.34
- value
- 0.78
- group Id
- OG001
- spread
- 0.33
- value
- 0.76
- group Id
- OG002
- spread
- 0.35
- value
- 0.97
- group Id
- OG003
- spread
- 0.30
- value
- 0.76
- title
- 26 Weeks
- categories
- measurements
- group Id
- OG000
- spread
- 0.35
- value
- 0.65
- group Id
- OG001
- spread
- 0.35
- value
- 0.69
- group Id
- OG002
- spread
- 0.36
- value
- 0.89
- group Id
- OG003
- spread
- 0.32
- value
- 0.63
- title
- 39 Weeks
- categories
- measurements
- group Id
- OG000
- spread
- 0.36
- value
- 0.56
- group Id
- OG001
- spread
- 0.37
- value
- 0.62
- group Id
- OG002
- spread
- 0.37
- value
- 0.83
- group Id
- OG003
- spread
- 0.34
- value
- 0.55
- 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
- Maximum of all C-peptide values during the MMTT
- 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
- MEAN
- population Description
- 1 participant randomized to Non-HCL and placebo dropped prior to baseline data being collected and was excluded from the analyses.
- reporting Status
- POSTED
- time Frame
- 13, 26, 39 weeks and 52 weeks
- title
- Peak C-peptide
- type
- SECONDARY
- unit Of Measure
- pmol/mL
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Preserved source evidence · Not medical advice