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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003971-12 | EudraCT Number |
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The purpose of this study is to compare the safety and efficacy of MK-1293 to Lantusâ„¢ in participants with T1DM. The primary hypothesis is that after 24 weeks, the mean change in hemoglobin A1c (A1C) from baseline is non-inferior in participants treated with MK-1293 compared with participants treated with Lantusâ„¢.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-1293 | Experimental | MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L). |
|
| Lantus | Active Comparator | Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-1293 | Drug | MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Initial dose will be determined based on the participant's previous insulin therapy. Thereafter, the dose will be titrated to the suggested target for fasting fingerstick glucose levels. MK-1293 dosing once daily at times other than bedtime will be permitted for participants with a previously established dosing time. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary: Change From Baseline in Hemoglobin A1c (A1C) at Week 24 | A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 24 A1C minus the Week 0 A1C. | Baseline and Week 24 |
| Percentage of Participants With Any Confirmed Positive Anti-insulin Antibody (AIA) at Any Time Up Through Week 24 | Percentage of participants with confirmed positive AIA at any time up through Week 24 including baseline. | Up to Week 24 |
| Percentage of Participants With Negative AIA at Baseline Who Develop Confirmed Positive AIA at Any Time Up Through Week 24 | Percentage of participants who became positive to AIA at or before Week 24, among participants who were AIA negative at baseline. | Up to Week 24 |
| Change From Baseline in AIA Titer After 24 Weeks of Treatment | This immunogenicity analysis will assess the effect of treatment with MK-1293 compared with Lantus on anti-insulin antibody development after 24 weeks of treatment. This change from baseline reflects the Week 24 AIA titer minus the Week 0 AIA titer. | Baseline and Week 24 |
| Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 24 | Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 24. This immunogenicity analysis assessed the effect of treatment with MK-1293 and with Lantus on insulin-neutralizing antibody (INab) development up through 24 weeks of treatment. | Up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in A1C at Week 52 | A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 52 A1C minus the Week 0 A1C. | Baseline and Week 52 |
| Total Insulin Dose at Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29766635 | Derived | Home PD, Lam RLH, Carofano WL, Golm GT, Eldor R, Crutchlow MF, Marcos MC, Rosenstock J, Hollander PA, Gallwitz B. Efficacy and safety of MK-1293 insulin glargine compared with originator insulin glargine (Lantus) in type 1 diabetes: A randomized, open-label clinical trial. Diabetes Obes Metab. 2018 Sep;20(9):2220-2228. doi: 10.1111/dom.13354. Epub 2018 Jun 5. |
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Participants at least 18 years of age who have had Type 1 diabetes mellitus (T1DM) for at least one year prior to study start.
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| ID | Title | Description |
|---|---|---|
| FG000 | MK-1293 | MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L). |
| FG001 | Lantus | Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The analysis population included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | MK-1293 | MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L). |
| BG001 | Lantus |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Primary: Change From Baseline in Hemoglobin A1c (A1C) at Week 24 | A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 24 A1C minus the Week 0 A1C. | The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | Percent | Baseline and Week 24 |
|
Up to 54 weeks
The safety population consisted of all randomized participants who received at least one dose of study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MK-1293 | MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000629534 | MK-1293 |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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|
| Lantusâ„¢ | Drug | Lantusâ„¢ dosed subcutaneously once daily at bedtime for 52 weeks. Initial dose will be determined based on the participant's previous insulin therapy. Thereafter, the dose will be titrated to the suggested target for fasting fingerstick glucose levels. Lantusâ„¢ dosing once daily at times other than bedtime will be permitted for participants with a previously established dosing time. |
|
|
| Prandial Insulin | Drug | Participants will continue their prandial insulin during the study. |
|
Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication). |
| Week 24 |
| Total Insulin Dose Per Kilogram (kg) of Body Weight (Unit/kg) at Week 24 | Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication). | Week 24 |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Blood glucose was measured on a fasting basis (collected after a 10-hour fast). FPG is expressed as mg/dL. This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0. | Baseline and Week 24 |
| Percentage of Participants With Confirmed Positive AIA Up Through Week 52 | Percentage of participants with confirmed positive AIA at any time up through Week 52 including baseline. | Up to Week 52 including baseline |
| Percentage of Participants With Negative AIA at Baseline Who Develop Confirmed Positive AIA at Any Time Up Through Week 52 | Percentage of participants who became positive to AIA at or before Week 52, among participants who were AIA negative at baseline. | Up to Week 52 |
| Change From Baseline in AIA Titer After 52 Weeks of Treatment | This immunogenicity analysis assessed the effect of treatment with MK-1293 compared with Lantus on anti-insulin antibody development after 52 weeks of treatment. This change from baseline reflects the AIA titers at Week 52 minus the AIA titers at Week 0. | Baseline and Week 52 |
| Total Insulin Dose at Week 52 | Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication). | Week 52 |
| Total Insulin Dose Per Kilogram (kg) of Body Weight (Unit/kg) at Week 52 | Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication). | Week 52 |
| Change From Baseline in FPG at Week 52 | Blood glucose was measured on a fasting basis (collected after a 10-hour fast). This change from baseline reflects the FPG level at Week 52 minus the FPG level at Week 0. | Baseline and Week 52 |
| Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 52 | Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Thought Week 52. This immunogenicity analysis assessed the effect of treatment with MK-1293 and with Lantus on insulin-neutralizing antibody (INAb) development up through 52 weeks of treatment. | Up to Week 52 |
| Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) at Week 24 | The 7-point SMBG profile consisted of the following measurements by glucose meter: morning pre-meal (fasting), 2 hours after morning meal, midday pre-meal, 2 hours after midday meal, evening pre meal, pre-bedtime (pre-dose and at least 2 hours after evening meal), between 2:00 AM and 4:00 AM in the morning. | Baseline and Week 24 |
| Change From Baseline in 7-point SMBG at Week 52 | The 7-point SMBG profile consisted of the following measurements by glucose meter: morning pre-meal (fasting), 2 hours after morning meal, midday pre-meal, 2 hours after midday meal, evening pre meal, pre-bedtime (pre-dose and at least 2 hours after evening meal), between 2:00 AM and 4:00 AM in the morning. | Baseline and Week 52 |
| Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% After 24 Weeks of Treatment. | Percentage of participants attaining A1C glycemic goals of <7.0% and <6.5% after 24 weeks of treatment. | 24 weeks |
| Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% After 52 Weeks of Treatment. | Percentage of participants attaining A1C glycemic goals of <7.0% and <6.5% after 52 weeks of treatment. | 52 weeks |
| Basal Insulin Dose at Week 52 | Basal Insulin Dose at Week 52. | Week 52 |
| Basal Insulin Dose Per kg of Body Weight at Week 52 | Basal Insulin Dose per kg of Body Weight at Week 52. | Week 52 |
| Bolus Insulin Dose at Week 52 | Bolus Insulin Dose at Week 52. | Week 52 |
| Bolus Insulin Dose Per kg of Body Weight at Week 52 | Bolus Insulin Dose per kg of Body Weight at Week 52. | Week 52 |
| Basal Insulin Dose at Week 24 | Basal Insulin Dose at Week 24. | Week 24 |
| Basal Insulin Dose Per kg of Body Weight at Week 24 | Basal Insulin Dose per kg of Body Weight at Week 24. | Week 24 |
| Bolus Insulin Dose at Week 24 | Bolus Insulin Dose at Week 24. | Week 24 |
| Bolus Insulin Dose Per kg of Body Weight at Week 24 | Bolus Insulin Dose per kg of Body Weight at Week 24. | Week 24 |
| Lost to Follow-up |
|
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Randomized in error, no study drug |
|
| Non-compliance with study drug |
|
Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L). |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Lantus |
Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L). |
|
|
|
| Primary | Percentage of Participants With Any Confirmed Positive Anti-insulin Antibody (AIA) at Any Time Up Through Week 24 | Percentage of participants with confirmed positive AIA at any time up through Week 24 including baseline. | The analysis population included all randomized, treated participants who had data for AIA at or before Week 24. | Posted | Number | Percentage of participants | Up to Week 24 |
|
|
|
|
| Primary | Percentage of Participants With Negative AIA at Baseline Who Develop Confirmed Positive AIA at Any Time Up Through Week 24 | Percentage of participants who became positive to AIA at or before Week 24, among participants who were AIA negative at baseline. | The analysis population included all randomized, treated participants who were AIA negative at baseline and had data for AIA at or before Week 24. | Posted | Number | Percentage of participants | Up to Week 24 |
|
|
|
|
| Primary | Change From Baseline in AIA Titer After 24 Weeks of Treatment | This immunogenicity analysis will assess the effect of treatment with MK-1293 compared with Lantus on anti-insulin antibody development after 24 weeks of treatment. This change from baseline reflects the Week 24 AIA titer minus the Week 0 AIA titer. | The analysis population included all randomized, treated participants who had AIA data at baseline and Week 24. | Posted | Mean | Standard Deviation | AIA Titers | Baseline and Week 24 |
|
|
|
| Primary | Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 24 | Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 24. This immunogenicity analysis assessed the effect of treatment with MK-1293 and with Lantus on insulin-neutralizing antibody (INab) development up through 24 weeks of treatment. | The analysis population included all randomized, treated participants who were INAb negative at baseline and who had data for INAb at or before Week 24. | Posted | Number | Percentage of participants | Up to Week 24 |
|
|
|
| Secondary | Change From Baseline in A1C at Week 52 | A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 52 A1C minus the Week 0 A1C. | The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | Percent | Baseline and Week 52 |
|
|
|
|
| Secondary | Total Insulin Dose at Week 24 | Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication). | The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | Insulin units | Week 24 |
|
|
|
|
| Secondary | Total Insulin Dose Per Kilogram (kg) of Body Weight (Unit/kg) at Week 24 | Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication). | The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | Insulin units/kg. | Week 24 |
|
|
|
|
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Blood glucose was measured on a fasting basis (collected after a 10-hour fast). FPG is expressed as mg/dL. This change from baseline reflects the FPG level at Week 24 minus the FPG level at Week 0. | The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 24 |
|
|
|
|
| Secondary | Percentage of Participants With Confirmed Positive AIA Up Through Week 52 | Percentage of participants with confirmed positive AIA at any time up through Week 52 including baseline. | The analysis population included all randomized, treated participants who had data for AIA at or before Week 52. | Posted | Number | Percentage of participants | Up to Week 52 including baseline |
|
|
|
|
| Secondary | Percentage of Participants With Negative AIA at Baseline Who Develop Confirmed Positive AIA at Any Time Up Through Week 52 | Percentage of participants who became positive to AIA at or before Week 52, among participants who were AIA negative at baseline. | The analysis population included all randomized, treated participants who had data for AIA at baseline and Week 52. | Posted | Number | Percentage of participants | Up to Week 52 |
|
|
|
|
| Secondary | Change From Baseline in AIA Titer After 52 Weeks of Treatment | This immunogenicity analysis assessed the effect of treatment with MK-1293 compared with Lantus on anti-insulin antibody development after 52 weeks of treatment. This change from baseline reflects the AIA titers at Week 52 minus the AIA titers at Week 0. | The analysis population included all randomized, treated participants who had AIA data at baseline and Week 52. | Posted | Mean | Standard Deviation | AIA Titers | Baseline and Week 52 |
|
|
|
| Secondary | Total Insulin Dose at Week 52 | Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication). | The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | Insulin units | Week 52 |
|
|
|
|
| Secondary | Total Insulin Dose Per Kilogram (kg) of Body Weight (Unit/kg) at Week 52 | Total insulin dose = basal insulin (MK-1293 or Lantus) + bolus (prandial) insulin (non-study medication). | The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | Insulin units/kg. | Week 52 |
|
|
|
|
| Secondary | Change From Baseline in FPG at Week 52 | Blood glucose was measured on a fasting basis (collected after a 10-hour fast). This change from baseline reflects the FPG level at Week 52 minus the FPG level at Week 0. | The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 52 |
|
|
|
|
| Secondary | Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Through Week 52 | Percentage of Participants Who Develop Insulin Neutralizing Antibodies Up Thought Week 52. This immunogenicity analysis assessed the effect of treatment with MK-1293 and with Lantus on insulin-neutralizing antibody (INAb) development up through 52 weeks of treatment. | The analysis population included all randomized, treated participants who were INAb negative at baseline and who had data for INAb at or before Week 52. | Posted | Number | Percentage of participants | Up to Week 52 |
|
|
|
| Secondary | Change From Baseline in 7-point Self-monitored Blood Glucose (SMBG) at Week 24 | The 7-point SMBG profile consisted of the following measurements by glucose meter: morning pre-meal (fasting), 2 hours after morning meal, midday pre-meal, 2 hours after midday meal, evening pre meal, pre-bedtime (pre-dose and at least 2 hours after evening meal), between 2:00 AM and 4:00 AM in the morning. | The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 24 |
|
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|
|
| Secondary | Change From Baseline in 7-point SMBG at Week 52 | The 7-point SMBG profile consisted of the following measurements by glucose meter: morning pre-meal (fasting), 2 hours after morning meal, midday pre-meal, 2 hours after midday meal, evening pre meal, pre-bedtime (pre-dose and at least 2 hours after evening meal), between 2:00 AM and 4:00 AM in the morning. | The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Baseline and Week 52 |
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| Secondary | Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% After 24 Weeks of Treatment. | Percentage of participants attaining A1C glycemic goals of <7.0% and <6.5% after 24 weeks of treatment. | The analysis population included all randomized, treated participants with a Week 24 A1C measurement. | Posted | Number | Percentage of participants | 24 weeks |
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| Secondary | Percentage of Participants Attaining A1C Glycemic Goals of <7% and <6.5% After 52 Weeks of Treatment. | Percentage of participants attaining A1C glycemic goals of <7.0% and <6.5% after 52 weeks of treatment. | The analysis population included all randomized, treated participants with a Week 52 A1C measurement. | Posted | Number | Percentage of participants | 52 weeks |
|
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| Secondary | Basal Insulin Dose at Week 52 | Basal Insulin Dose at Week 52. | The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | Units | Week 52 |
|
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| Secondary | Basal Insulin Dose Per kg of Body Weight at Week 52 | Basal Insulin Dose per kg of Body Weight at Week 52. | The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | Units/kg | Week 52 |
|
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| Secondary | Bolus Insulin Dose at Week 52 | Bolus Insulin Dose at Week 52. | The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | Units | Week 52 |
|
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| Secondary | Bolus Insulin Dose Per kg of Body Weight at Week 52 | Bolus Insulin Dose per kg of Body Weight at Week 52. | The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | Units/kg | Week 52 |
|
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| Secondary | Basal Insulin Dose at Week 24 | Basal Insulin Dose at Week 24. | The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | Units | Week 24 |
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| Secondary | Basal Insulin Dose Per kg of Body Weight at Week 24 | Basal Insulin Dose per kg of Body Weight at Week 24. | The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | Units/kg | Week 24 |
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| Secondary | Bolus Insulin Dose at Week 24 | Bolus Insulin Dose at Week 24. | The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | Units | Week 24 |
|
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| Secondary | Bolus Insulin Dose Per kg of Body Weight at Week 24 | Bolus Insulin Dose per kg of Body Weight at Week 24. | The analysis population included all randomized, treated participants who had at least one observation for the analysis endpoint. | Posted | Least Squares Mean | 95% Confidence Interval | Units/kg | Week 24 |
|
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|
|
| 23 |
| 241 |
| 190 |
| 241 |
| EG001 | Lantus | Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L). | 30 | 258 | 216 | 258 |
| Cardiac failure congestive | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
|
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| bile duct stone | Hepatobiliary disorders | MedDRA 18.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 18.0 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 18.0 | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Oseomyelitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
|
| Ovarian adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypoglycaemic seizure | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hypoglycaemic unconsciousness | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| VIth nerve paresis | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| Peripheral vascular disorder | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
|
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
|
The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/ presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Adjusted Difference in %s (A1C <6.5%) |
| -1.1 |
| 2-Sided |
| 95 |
| -8.6 |
| 6.5 |
Miettinen and Nurminen, stratified by prior insulin status. |
| Superiority or Other |
| Adjusted Difference (A1C < 6.5%) |
| -4.4 |
| 2-Sided |
| 95 |
| -11.5 |
| 2.8 |
Miettinen and Nurminen |
| Superiority or Other |