Type 1 Diabetes Mellitus
Conditions
Keywords
Randomized, Double Blind, Parallel Group, Controlled Clinical Trial
Brief summary
The primary purpose of this protocol is to assess the efficacy, tolerability, and safety of MGA031 when administered according to 3 different MGA031 dosing regimens in children and adults with recent-onset (diagnosis within past 12 weeks) type 1 diabetes mellitus. All regimens will be administered as an addition to insulin and other standard of care treatments. Efficacy will be defined primarily by the capacity of MGA031 to markedly reduce typical insulin requirements while maintaining relatively normal blood sugar levels. Other studies involving the study drug use the name hOKT3γ1 (Ala-Ala). MGA031, a humanized monoclonal antibody, is the name used for hOKT3γ1 (Ala-Ala) that is produced by MacroGenics, Inc. The United States Adopted Name (USAN) for MGA031 is teplizumab.
Detailed description
The Protégé Study - A Multinational Clinical Trial of MGA031 for Preserving the Capability to Produce Insulin, Reducing Insulin Usage and Improving Blood Sugar Levels in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus
Interventions
BIOLOGICALTeplizumab
Daily IV dosing for 14 days, repeated at Week 26
DRUGPlacebo
Daily IV dosing for 14 days, repeated at Week 26
Sponsors
Eli Lilly and Company
MacroGenics
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
8 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
Subjects must meet all of the following criteria: 1. Enrollment (Segment #1) or randomization (Segment #2) on Study Day 0 within 12 weeks of first visit to any physician for symptoms or signs of diabetes. Study Day 0 is the first day of study drug dosing. 2. Diagnosis of type 1 diabetes mellitus, according to the American Diabetes Association (ADA) criteria 3. Requirement for injected insulin therapy 4. Have a detectable fasting or stimulated C-peptide level (above the lower limit of detection of the assay) 5. One positive result on testing for any of the following antibodies: 1. islet-cell autoantibodies (ICA512/IA-2), 2. glutamic acid decarboxylase autoantibodies, or 3. insulin autoantibodies (if present during first 2 weeks, but not beyond 2 weeks, of insulin treatment) 6. Male or female 7. Subject must be in one of the following age groups: * Age 18-35 years * Age 12-17 years pending approval by Data Monitoring Committee * Age 8-11 years pending approval by Data Monitoring Committee 8. Body weight ≥ 36 kg
Exclusion criteria
Subjects must have none of the following: 1. Prior administration of a monoclonal antibody -- within the 1 year before enrollment or randomization at Study Day 0 -- that could potentially prevent or confound a therapeutic response to MGA031 2. Participation in any type of therapeutic drug or vaccine clinical trial within the 12 weeks before enrollment or randomization 3. Any medical condition that, in the opinion of the investigator, would interfere with safe completion of the trial 4. Pregnant or lactating females 5. Prior murine OKT®3 treatment at any time before enrollment or randomization 6. Current or planned therapy with exenatide or any other agents that stimulate pancreatic beta cell regeneration or insulin secretion 7. Current or planned therapy with inhaled insulin 8. Uncompensated heart failure, fluid overload, myocardial infarction or evidence of ischemic heart disease, or other serious cardiac disease within the 12 weeks before enrollment or randomization 9. History of epilepsy, cancer, cystic fibrosis, sickle cell anemia, neuropathy, peripheral vascular disease or cerebrovascular disease 10. Newly diagnosed hypothyroidism (not currently being treated but which, in the opinion of the investigator, should be treated) or active Graves' disease 11. Eczema, asthma or severe atopic disease requiring treatment within the 12 weeks before enrollment or randomization 12. Evidence of active infection, such as fever ≥ 38.0 degrees Celsius (100.5 degrees Fahrenheit) 13. Known or suspected infection with human immunodeficiency virus (HIV) 14. Evidence of active hepatitis B (HBV) or hepatitis C virus (HCV) 15. Evidence of active or latent tuberculosis 16. Vaccination with a live virus within the 8 weeks before enrollment or randomization or planned live virus vaccination continuing through week 52 of the study. Vaccination with an antigen or killed organism must not be given within 8 weeks before or planned within 8 weeks after each dosing cycle. 17. Any infectious mononucleosis-like illness within the 6 months before enrollment or randomization 18. Serologic and clinical evidence of acute infection with Epstein-Barr virus (EBV) 19. Serologic evidence of acute infection with cytomegalovirus (CMV)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%. | 52 weeks after randomization | This is a composite endpoint is based on the proportion of subjects who have both a total daily insulin dose \<0.5 U/Kg/day and an HbAlc level 6.5% at 52 weeks after randomization. |
| Number of Subjects in Segment 1 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%. | 52 weeks after first dose | This is a composite endpoint based on the proportion of subjects who have both a total daily insulin dose \<0.5 U/Kg/day and an HbAlc level 6.5% |
| Mean HbA1c Change From Baseline in Segment 2 | 52 weeks after randomization | Comparison among study treatments of average change from baseline HbA1C. This endpoint will be assessed in a hierarchical manner only if the composite primary endpoint shows a statistically significant difference between arms |
| Mean HbA1c Change From Baseline in Segment 1 | 52 weeks after first dose | The average change in HbA1c levels after dosing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and HbA1c Level of Less Than 7.0%. | at 52 weeks after randomization | Comparison among study treatments of a composite endpoint based on the proportion of subjects who have both a total daily insulin dose \<0.5 U/Kg/day and an HbAlc level 7.0%. |
| Number of Subjects in Segment 1 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and HbA1c Level of Less Than 7.0%. | 52 weeks after first dose | Composite endpoint based on the proportion of subjects who have both a total daily insulin dose \<0.5 U/Kg/day and an HbAlc level 7.0%. |
| Change From Baseline in C-peptide Area Under the Curve (AUC) in Segment 2 | 104 weeks after randomization | Comparison among study treatments on the AUC of C-peptide secretory responses following a mixed meal eaten by the subject |
| Mean HbA1c Change From Baseline in Segment 1 | 104 weeks after first dose | Comparison among study treatments of the average change from baseline in HbA1c. |
| Mean HbA1c Change From Baseline in Segment 2 | at 104 weeks after randomization | Comparison among study treatments of the average change from baseline in HbA1c. |
| Change From Baseline in C-peptide AUC in Segment 1 | 104 weeks after first dose | AUC of C-peptide secretory responses following a mixed meal eaten by the subject |
| Number of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and HbA1c Level of Less Than 6.5% | 104 weeks after randomization | Comparison among study treatments of a composite endpoint based on the proportion of subjects who have both a total daily insulin dose \<0.5 U/Kg/day and an HbAlc level 6.5%. |
| Number of Subjects in Segment 1 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and HbA1c Level of Less Than 6.5% | 104 weeks after first dose | Comparison among study treatments of a composite endpoint based on the proportion of subjects who have both a total daily insulin dose \<0.5 U/Kg/day and an HbAlc level 6.5%. |
Countries
Canada, Czechia, Estonia, Germany, India, Israel, Latvia, Mexico, Netherlands, Poland, Romania, Spain, Sweden, Ukraine, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Open-label Herold Regimen Full dose of teplizumab IV for 14 days, repeated at Week 26 Teplizumab: Daily IV dosing for 14 days, repeated at Week 26 | 38 |
| Double-blind Herold Regimen Full dose of teplizumab IV for 14 days, repeated at Week 26
Teplizumab: Daily IV dosing for 14 days, repeated at Week 26 | 209 |
| Double-blind 33.3% Herold Regimen One third full dose of teplizumab IV for 14 days, repeated at Week 26
Teplizumab: Daily IV dosing for 14 days, repeated at Week 26 | 102 |
| Double-blind Curtailed Herold Regimen Full dose of teplizumab IV for 6 days followed by placebo for 8 days, repeated at Week 26
Teplizumab: Daily IV dosing for 14 days, repeated at Week 26 | 106 |
| Double-blind Placebo Placebo IV dosing daily for 14 days repeated at Week
Placebo: Daily IV dosing for 14 days, repeated at Week 26 | 99 |
| Total | 554 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Double-blind Segment 2 | Adverse Event | 0 | 3 | 1 | 0 | 0 |
| Double-blind Segment 2 | Lost to Follow-up | 0 | 11 | 5 | 2 | 5 |
| Double-blind Segment 2 | Other | 0 | 2 | 0 | 0 | 0 |
| Double-blind Segment 2 | Withdrawal by Subject | 0 | 10 | 6 | 7 | 2 |
| Open-label Segment 1 | Lost to Follow-up | 1 | 0 | 0 | 0 | 0 |
| Open-label Segment 1 | Withdrawal by Subject | 2 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Open-label Herold Regimen | Double-blind Herold Regimen | Double-blind 33.3% Herold Regimen | Double-blind Curtailed Herold Regimen | Double-blind Placebo | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 13.5 years | 17 years | 17 years | 16 years | 17 years | 17 years |
| Age, Customized age 12-17 years | 16 Participants | 81 Participants | 42 Participants | 44 Participants | 38 Participants | 221 Participants |
| Age, Customized age 18-35 years | 11 Participants | 95 Participants | 45 Participants | 46 Participants | 45 Participants | 242 Participants |
| Age, Customized age 8-11 years | 11 Participants | 31 Participants | 15 Participants | 16 Participants | 15 Participants | 88 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 14 Participants | 7 Participants | 12 Participants | 5 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants | 193 Participants | 95 Participants | 94 Participants | 93 Participants | 511 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 59 Participants | 28 Participants | 29 Participants | 27 Participants | 148 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 0 Participants | 1 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) White | 33 Participants | 145 Participants | 74 Participants | 75 Participants | 69 Participants | 396 Participants |
| Region of Enrollment Canada | 1 participants | 6 participants | 1 participants | 4 participants | 1 participants | 13 participants |
| Region of Enrollment Czechia | 8 participants | 12 participants | 7 participants | 5 participants | 6 participants | 38 participants |
| Region of Enrollment Estonia | 0 participants | 2 participants | 0 participants | 1 participants | 1 participants | 4 participants |
| Region of Enrollment Germany | 0 participants | 2 participants | 0 participants | 0 participants | 0 participants | 2 participants |
| Region of Enrollment India | 5 participants | 59 participants | 28 participants | 29 participants | 28 participants | 149 participants |
| Region of Enrollment Israel | 0 participants | 11 participants | 6 participants | 6 participants | 6 participants | 29 participants |
| Region of Enrollment Latvia | 0 participants | 3 participants | 1 participants | 2 participants | 1 participants | 7 participants |
| Region of Enrollment Mexico | 0 participants | 9 participants | 4 participants | 5 participants | 4 participants | 22 participants |
| Region of Enrollment Poland | 0 participants | 10 participants | 5 participants | 6 participants | 4 participants | 25 participants |
| Region of Enrollment Romania | 4 participants | 7 participants | 5 participants | 4 participants | 4 participants | 24 participants |
| Region of Enrollment Spain | 0 participants | 6 participants | 3 participants | 3 participants | 3 participants | 15 participants |
| Region of Enrollment Sweden | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants | 1 participants |
| Region of Enrollment Ukraine | 0 participants | 18 participants | 10 participants | 9 participants | 10 participants | 47 participants |
| Region of Enrollment United States | 20 participants | 64 participants | 32 participants | 31 participants | 31 participants | 178 participants |
| Sex: Female, Male Female | 8 Participants | 77 Participants | 40 Participants | 34 Participants | 37 Participants | 196 Participants |
| Sex: Female, Male Male | 30 Participants | 130 Participants | 62 Participants | 72 Participants | 61 Participants | 355 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 1 / 207 | 1 / 102 | 0 / 106 | 0 / 98 |
| other Total, other adverse events | 38 / 38 | 207 / 207 | 101 / 102 | 105 / 106 | 98 / 98 |
| serious Total, serious adverse events | 6 / 38 | 23 / 207 | 14 / 102 | 12 / 106 | 12 / 98 |
Outcome results
Primary
Mean HbA1c Change From Baseline in Segment 1
The average change in HbA1c levels after dosing.
Time frame: 52 weeks after first dose
Population: Open-label Segment 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open-label Herold Regimen | Mean HbA1c Change From Baseline in Segment 1 | 0.25 percent HbA1c | Standard Deviation 2.053 |
Primary
Mean HbA1c Change From Baseline in Segment 2
Comparison among study treatments of average change from baseline HbA1C. This endpoint will be assessed in a hierarchical manner only if the composite primary endpoint shows a statistically significant difference between arms
Time frame: 52 weeks after randomization
Population: Per the Analysis Plan, the change from baseline (CFB) analysis was performed on the FAS population in Double-blind Segment 2 only. The number of participants analyzed includes all participants with baseline HbA1c data at baseline and at 52 weeks after randomization. Eight participants did not have 52 week data. The analysis was not conducted for the open-label Herold Regimen because there was no placebo control.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Double-blind Herold Regimen | Mean HbA1c Change From Baseline in Segment 2 | -0.42 percentage of HbA1c | Standard Deviation 2.285 |
| Double-blind 33.3% Herold Regimen | Mean HbA1c Change From Baseline in Segment 2 | -0.34 percentage of HbA1c | Standard Deviation 2.196 |
| Double-blind Curtailed Herold Regimen | Mean HbA1c Change From Baseline in Segment 2 | -0.36 percentage of HbA1c | Standard Deviation 2.132 |
| Double-blind Placebo | Mean HbA1c Change From Baseline in Segment 2 | -0.43 percentage of HbA1c | Standard Deviation 2.668 |
p-value: 0.81495% CI: [-0.45, 0.572]ANCOVA
p-value: 0.59395% CI: [-0.433, 0.755]ANCOVA
p-value: 0.88695% CI: [-0.594, 0.513]ANCOVA
Primary
Number of Subjects in Segment 1 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%.
This is a composite endpoint based on the proportion of subjects who have both a total daily insulin dose \<0.5 U/Kg/day and an HbAlc level 6.5%
Time frame: 52 weeks after first dose
Population: Open-label Segment 1. Participants with missing data were considered non-responders.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Open-label Herold Regimen | Number of Subjects in Segment 1 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%. | 11 Participants |
Primary
Number of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%.
This is a composite endpoint is based on the proportion of subjects who have both a total daily insulin dose \<0.5 U/Kg/day and an HbAlc level 6.5% at 52 weeks after randomization.
Time frame: 52 weeks after randomization
Population: Efficacy analysis was performed on the FAS population from the double-blind Segment 2. No efficacy analysis was performed on the Open-label Segment 1.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Double-blind Herold Regimen | Number of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%. | 41 Participants |
| Double-blind 33.3% Herold Regimen | Number of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%. | 14 Participants |
| Double-blind Curtailed Herold Regimen | Number of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%. | 22 Participants |
| Double-blind Placebo | Number of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and Hemoglobin A1c (HbA1c) Level of Less Than 6.5%. | 20 Participants |
p-value: 0.90495% CI: [0.521, 1.779]Mantel Haenszel
p-value: 0.22295% CI: [0.297, 1.33]Mantel Haenszel
p-value: 0.88595% CI: [0.521, 2.129]Mantel Haenszel
Secondary
Change From Baseline in C-peptide Area Under the Curve (AUC) in Segment 2
Comparison among study treatments on the AUC of C-peptide secretory responses following a mixed meal eaten by the subject
Time frame: 104 weeks after randomization
Population: Per the Analysis Plan, the change from baseline (CFB) analysis was performed on the FAS population in Double-blind Segment 2 only. The number of participants analyzed includes all participants with baseline C-peptide data at baseline and at 52 weeks after randomization. Eight participants did not have 52 week data. The analysis was not conducted for the open-label Herold Regimen because there was no placebo control.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Double-blind Herold Regimen | Change From Baseline in C-peptide Area Under the Curve (AUC) in Segment 2 | -0.18 min*nmol/L | Standard Deviation 0.355 |
| Double-blind 33.3% Herold Regimen | Change From Baseline in C-peptide Area Under the Curve (AUC) in Segment 2 | -0.27 min*nmol/L | Standard Deviation 0.318 |
| Double-blind Curtailed Herold Regimen | Change From Baseline in C-peptide Area Under the Curve (AUC) in Segment 2 | -0.20 min*nmol/L | Standard Deviation 0.354 |
| Double-blind Placebo | Change From Baseline in C-peptide Area Under the Curve (AUC) in Segment 2 | -0.22 min*nmol/L | Standard Deviation 0.428 |
p-value: 0.04995% CI: [0, 0.093]ANCOVA
p-value: 0.93795% CI: [-0.061, 0.056]ANCOVA
p-value: 0.38295% CI: [-0.032, 0.084]ANCOVA
Secondary
Change From Baseline in C-peptide AUC in Segment 1
AUC of C-peptide secretory responses following a mixed meal eaten by the subject
Time frame: 104 weeks after first dose
Population: Open-label Segment 1.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open-label Herold Regimen | Change From Baseline in C-peptide AUC in Segment 1 | -0.45 min*nmol/L | Standard Deviation 0.451 |
Secondary
Mean HbA1c Change From Baseline in Segment 1
Comparison among study treatments of the average change from baseline in HbA1c.
Time frame: 104 weeks after first dose
Population: Analysis performed on the FAS population in Double-blind Segment 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Open-label Herold Regimen | Mean HbA1c Change From Baseline in Segment 1 | 0.73 percentage of HbA1c | Standard Deviation 2.091 |
Secondary
Mean HbA1c Change From Baseline in Segment 2
Comparison among study treatments of the average change from baseline in HbA1c.
Time frame: at 104 weeks after randomization
Population: Per the Analysis Plan, the change from baseline (CFB) analysis was performed on data available for the FAS population in Double-blind Segment 2 only. The analysis was not conducted for the open-label Herold Regimen because there was no placebo control.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Double-blind Herold Regimen | Mean HbA1c Change From Baseline in Segment 2 | 0.14 percent of HbA1c | Standard Deviation 2.411 |
| Double-blind 33.3% Herold Regimen | Mean HbA1c Change From Baseline in Segment 2 | 0.08 percent of HbA1c | Standard Deviation 2.261 |
| Double-blind Curtailed Herold Regimen | Mean HbA1c Change From Baseline in Segment 2 | 0.04 percent of HbA1c | Standard Deviation 2.208 |
| Double-blind Placebo | Mean HbA1c Change From Baseline in Segment 2 | 0.16 percent of HbA1c | Standard Deviation 2.51 |
p-value: 0.87295% CI: [-0.455, 0.536]ANCOVA
p-value: 0.97995% CI: [-0.581, 0.556]ANCOVA
p-value: 0.495% CI: [-0.75, 0.301]ANCOVA
Secondary
Number of Subjects in Segment 1 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and HbA1c Level of Less Than 6.5%
Comparison among study treatments of a composite endpoint based on the proportion of subjects who have both a total daily insulin dose \<0.5 U/Kg/day and an HbAlc level 6.5%.
Time frame: 104 weeks after first dose
Population: Open-label Segment 1. Participants with missing values were counted as non-responders
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Open-label Herold Regimen | Number of Subjects in Segment 1 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and HbA1c Level of Less Than 6.5% | 5 Participants |
Secondary
Number of Subjects in Segment 1 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and HbA1c Level of Less Than 7.0%.
Composite endpoint based on the proportion of subjects who have both a total daily insulin dose \<0.5 U/Kg/day and an HbAlc level 7.0%.
Time frame: 52 weeks after first dose
Population: Open-label Segment 1. Missing values counted as non-responders.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Open-label Herold Regimen | Number of Subjects in Segment 1 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and HbA1c Level of Less Than 7.0%. | 14 Participants |
Secondary
Number of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and HbA1c Level of Less Than 6.5%
Comparison among study treatments of a composite endpoint based on the proportion of subjects who have both a total daily insulin dose \<0.5 U/Kg/day and an HbAlc level 6.5%.
Time frame: 104 weeks after randomization
Population: Analysis performed on the FAS population in Double-blind Segment 2. Missing values were counted as non-responders.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Double-blind Herold Regimen | Number of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and HbA1c Level of Less Than 6.5% | 17 Participants |
| Double-blind 33.3% Herold Regimen | Number of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and HbA1c Level of Less Than 6.5% | 6 Participants |
| Double-blind Curtailed Herold Regimen | Number of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and HbA1c Level of Less Than 6.5% | 10 Participants |
| Double-blind Placebo | Number of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and HbA1c Level of Less Than 6.5% | 9 Participants |
p-value: 0.77595% CI: [0.372, 2.089]Mantel Haenszel
p-value: 0.40295% CI: [0.212, 1.861]Mantel Haenszel
p-value: 0.85995% CI: [0.41, 2.912]Mantel Haenszel
Secondary
Number of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and HbA1c Level of Less Than 7.0%.
Comparison among study treatments of a composite endpoint based on the proportion of subjects who have both a total daily insulin dose \<0.5 U/Kg/day and an HbAlc level 7.0%.
Time frame: at 52 weeks after randomization
Population: Analysis performed on the FAS population in Double-blind Segment 2.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Double-blind Herold Regimen | Number of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and HbA1c Level of Less Than 7.0%. | 60 Participants |
| Double-blind 33.3% Herold Regimen | Number of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and HbA1c Level of Less Than 7.0%. | 21 Participants |
| Double-blind Curtailed Herold Regimen | Number of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and HbA1c Level of Less Than 7.0%. | 28 Participants |
| Double-blind Placebo | Number of Subjects in Segment 2 With Both a Total Daily Insulin Dose of Less Than 0.5 U/kg/Day and HbA1c Level of Less Than 7.0%. | 24 Participants |
p-value: 0.40495% CI: [0.727, 2.2]Mantel Haenszel
p-value: 0.52895% CI: [0.412, 1.576]Mantel Haenszel
p-value: 0.70695% CI: [0.594, 2.164]Mantel Haenszel