NCT04233034 · OUTCOME
Number of Participants With a Peak C-peptide >= 0.2 Pmol/ml
Hybrid Closed Loop Therapy and Verapamil for Beta Cell Preservation in New Onset Type 1 Diabetes · Source last updated 2024-11-27
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- 13, 26, 39 weeks and 52 weeks
What was measured
Percentage where maximum of all C-peptide values during the MMTT \>= 0.2 pmol/ml
Analysis population: 1 participant in Non-HCL+Placebo group dropped at baseline and was not analyzed. N missing in each group are as follows; HCL (N=1 at baseline, N=3 at 13 weeks, N=4 at 26 weeks, N=4 at 39 weeks, N=2 at 52 weeks); Non-HCL (N=0 at baseline, N=0 at 13 weeks, N=2 at 26 weeks , N=6 at 39 weeks, N=5 at 52 weeks); Verapamil (N=1 at baseline, N=1 at 13 weeks, N=2 at 26 weeks, N=4 at 39 Weeks, N=4 at 52 weeks); Placebo (N=0 at baseline, N=1 at 13 weeks, N=3 at 26 weeks, N=3 at 39 weeks, N=2 at 52 weeks).
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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| HCL and Intensive Management | 61 |
|---|
| Non-HCL and Standard Care | 51 |
|---|
| Verapamil | 47 |
|---|
| Placebo | 40 |
|---|
Reported measurements
Randomization
Analysis denominator · Participants
| Group | Source count |
|---|
| HCL and Intensive Management | 60 |
|---|
| Non-HCL and Standard Care | 51 |
|---|
| Verapamil | 46 |
|---|
| Placebo | 40 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| HCL and Intensive Management | 60 | Not reported | Not reported | Not reported | Not reported |
|---|
| Non-HCL and Standard Care | 51 | Not reported | Not reported | Not reported | Not reported |
|---|
| Verapamil | 46 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 40 | Not reported | Not reported | Not reported | Not reported |
|---|
13 Weeks
Analysis denominator · Participants
| Group | Source count |
|---|
| HCL and Intensive Management | 58 |
|---|
| Non-HCL and Standard Care | 51 |
|---|
| Verapamil | 46 |
|---|
| Placebo | 39 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| HCL and Intensive Management | 58 | Not reported | Not reported | Not reported | Not reported |
|---|
| Non-HCL and Standard Care | 50 | Not reported | Not reported | Not reported | Not reported |
|---|
| Verapamil | 45 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 39 | Not reported | Not reported | Not reported | Not reported |
|---|
26 Weeks
Analysis denominator · Participants
| Group | Source count |
|---|
| HCL and Intensive Management | 57 |
|---|
| Non-HCL and Standard Care | 49 |
|---|
| Verapamil | 45 |
|---|
| Placebo | 37 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| HCL and Intensive Management | 56 | Not reported | Not reported | Not reported | Not reported |
|---|
| Non-HCL and Standard Care | 47 | Not reported | Not reported | Not reported | Not reported |
|---|
| Verapamil | 44 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 37 | Not reported | Not reported | Not reported | Not reported |
|---|
39 Weeks
Analysis denominator · Participants
| Group | Source count |
|---|
| HCL and Intensive Management | 57 |
|---|
| Non-HCL and Standard Care | 45 |
|---|
| Verapamil | 43 |
|---|
| Placebo | 37 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| HCL and Intensive Management | 49 | Not reported | Not reported | Not reported | Not reported |
|---|
| Non-HCL and Standard Care | 38 | Not reported | Not reported | Not reported | Not reported |
|---|
| Verapamil | 41 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 31 | Not reported | Not reported | Not reported | Not reported |
|---|
52 Weeks
Analysis denominator · Participants
| Group | Source count |
|---|
| HCL and Intensive Management | 59 |
|---|
| Non-HCL and Standard Care | 46 |
|---|
| Verapamil | 43 |
|---|
| Placebo | 38 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| HCL and Intensive Management | 45 | Not reported | Not reported | Not reported | Not reported |
|---|
| Non-HCL and Standard Care | 36 | Not reported | Not reported | Not reported | Not reported |
|---|
| Verapamil | 41 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo | 27 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 60
- group Id
- OG001
- value
- 51
- group Id
- OG002
- value
- 46
- group Id
- OG003
- value
- 40
- denoms
- counts
- group Id
- OG000
- value
- 60
- group Id
- OG001
- value
- 51
- group Id
- OG002
- value
- 46
- group Id
- OG003
- value
- 40
- units
- Participants
- title
- Randomization
- categories
- measurements
- group Id
- OG000
- value
- 58
- group Id
- OG001
- value
- 50
- group Id
- OG002
- value
- 45
- group Id
- OG003
- value
- 39
- denoms
- counts
- group Id
- OG000
- value
- 58
- group Id
- OG001
- value
- 51
- group Id
- OG002
- value
- 46
- group Id
- OG003
- value
- 39
- units
- Participants
- title
- 13 Weeks
- categories
- measurements
- group Id
- OG000
- value
- 56
- group Id
- OG001
- value
- 47
- group Id
- OG002
- value
- 44
- group Id
- OG003
- value
- 37
- denoms
- counts
- group Id
- OG000
- value
- 57
- group Id
- OG001
- value
- 49
- group Id
- OG002
- value
- 45
- group Id
- OG003
- value
- 37
- units
- Participants
- title
- 26 Weeks
- categories
- measurements
- group Id
- OG000
- value
- 49
- group Id
- OG001
- value
- 38
- group Id
- OG002
- value
- 41
- group Id
- OG003
- value
- 31
- denoms
- counts
- group Id
- OG000
- value
- 57
- group Id
- OG001
- value
- 45
- group Id
- OG002
- value
- 43
- group Id
- OG003
- value
- 37
- units
- Participants
- title
- 39 Weeks
- categories
- measurements
- group Id
- OG000
- value
- 45
- group Id
- OG001
- value
- 36
- group Id
- OG002
- value
- 41
- group Id
- OG003
- value
- 27
- denoms
- counts
- group Id
- OG000
- value
- 59
- group Id
- OG001
- value
- 46
- group Id
- OG002
- value
- 43
- group Id
- OG003
- value
- 38
- units
- Participants
- 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
- Percentage where maximum of all C-peptide values during the MMTT \>= 0.2 pmol/ml
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- 1 participant in Non-HCL+Placebo group dropped at baseline and was not analyzed. N missing in each group are as follows; HCL (N=1 at baseline, N=3 at 13 weeks, N=4 at 26 weeks, N=4 at 39 weeks, N=2 at 52 weeks); Non-HCL (N=0 at baseline, N=0 at 13 weeks, N=2 at 26 weeks , N=6 at 39 weeks, N=5 at 52 weeks); Verapamil (N=1 at baseline, N=1 at 13 weeks, N=2 at 26 weeks, N=4 at 39 Weeks, N=4 at 52 weeks); Placebo (N=0 at baseline, N=1 at 13 weeks, N=3 at 26 weeks, N=3 at 39 weeks, N=2 at 52 weeks).
- reporting Status
- POSTED
- time Frame
- 13, 26, 39 weeks and 52 weeks
- title
- Number of Participants With a Peak C-peptide >= 0.2 Pmol/ml
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle