Renal Impairment, Type 2 Diabetes Mellitus
Conditions
Brief summary
The TRENT trial is designed to confirm the efficacy and safety of Gla-300 compared with IDeg-100 in insulin-naïve patient (participants who have not tried insulin) with Type 2 Diabetes Mellitus (T2DM) and renal impairment. It will test the hypothesis that Gla-300 is non-inferior to IDeg-100 with glucose control. If achieved, the trial will also test for the superiority of Gla-300 compared with IDeg-100 in Hemoglobin A1c (HbA1c) reduction, without an increased potential risk of hypoglycemia.
Detailed description
The trial will consist of the following periods: * A screening period of up to 2 weeks, * A 24-week, open-label treatment period, including a titration period and a maintenance period. * A 7-day, post-treatment, safety follow-up period after the last dose of the study drug or after premature/permanent discontinuation from study drug treatment. This will be a phone contact, but could be a site visit if ongoing or new AEs emerge during the post-treatment period, if necessary.
Interventions
Insulin glargine 300 U/mL in the SoloStar pen, self-administered once daily for 24 weeks.
DRUGInsulin degludec 100 U/mL
Insulin degludec 100 U/mL will be self- administered once daily for 24 weeks.
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Is an adult aged ≥18 years at screening. 2. Was diagnosed with Type 2 Diabetes Mellitus (T2DM) of \>1-year duration and had glycemic levels above target with OADs (Oral Antidiabetic Drug) with or without GLP-1 RA (glucagon-like peptide-1 receptor agonist) (oral or injectable) at stable doses for ≥3 months before the screening period. 3. Has an HbA1c ≥7.5% and ≤10.5% at screening. 4. Has renal impairment, as defined by an eGFR (estimated glomerular filtration rate) of \<60 mL/min/1.73m2 and ≥15 mL/min/1.73m2. 5. Has adequately controlled blood pressure with stable antihypertensive therapy at trial inclusion. 6. Is insulin-naïve, except for short use of insulin not exceeding 15 days during the last year before the screening period. 7. Is capable of understanding the written informed consent, and provides signed written informed consent. 8. Is willing and able to complete the electronic diary (eDiary) and agrees to comply with protocol requirements. 9. Is willing and able to fast without having administered study drug for scheduled site visits.
Exclusion criteria
1. Has initiated treatment with potential novel therapies like dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 RA. 2. Has a body mass index (BMI)\* \>45 kg/m² during the screening period. 3. Has a history of hypoglycemia unawareness (defined as the onset of neuroglycopenia before the appearance of autonomic warning symptoms \[eg, blurred vision, difficulty speaking, feeling faint, difficulty thinking, and confusion\] or as the failure to sense a significant fall in blood glucose below normal levels). 4. Has a history of 2 or more episodes of severe hypoglycemia and/or 2 or more episodes of diabetic ketoacidosis within the 6 months before the day of screening. 5. Has been exposed to other investigational drug(s) within 1 month or 5 half-lives from screening, whichever is longer. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the Mean Change From Baseline to Week 24 in HbA1c Level (Gla-300 vs IDeg-100) | Baseline to 24 weeks | Change in HbA1c was calculated by subtracting baseline value from Week 24 value and then mean values were calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fasting Self-Measured Plasma Glucose (SMPG) From Baseline to Week 24 | Baseline to 24 weeks | Change in SMPG was calculated by subtracting baseline value from the Week 24 value. |
| Change in 7-point SMPG Profiles From Baseline to Week 24, Per Time Point Within 24-hour Period | Baseline to 24 weeks | 7-point SMPG profiles were measured at the following 7 points: pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime. |
| Percentage of Participants Reaching HbA1c Target of <7.0% at Week 24 | At week 24 | If a patient has a missing HbA1c value at Week 24, it is assumed that they did not reach the HbA1c target of \<7.0%. HbA1c value of 7.0% is equivalent to 53.0 mmol/mol. |
| Percentage of Participants With ≥1 Episode(s) of Confirmed Hypoglycemia Event (Cut-off Value 70 mg/dL and 54 mg/dL) During the 24-week Treatment Period. | Baseline to end of study (25 weeks) | Any event recorded with Yes as response to the question, Was a glucose measurement obtained at the time of the event before countermeasure? and a measurable glucose level of \<70 mg/dL. ADA (American Diabetes Association), Level 1 was defined as a measurable glucose concentration of \<70 mg/dL (3.9 mmol/L) but ≥54 mg/dL (3.0 mmol/L). |
| Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24 | Baseline to 24 weeks | Change in FPG was calculated by subtracting baseline value from the Week 24 value. |
| Percentage of Participants and Event Rate of Hypoglycemia by Trial Period (for ≤12 Weeks, for >13 Weeks to ≤24 Weeks) | Baseline to end of study (25 weeks) | Hypoglycemic events measured at the following intervals: Weeks 1-12 and Weeks 13-24. |
| The 24-hour (All Time), Occurrence of Each Episode of Documented Hypoglycemia by Category, Presented by 2-hour Timeframe Over 24 Hours During the 24-week Treatment Period. | Baseline to end of study (25 weeks) | The time range for this outcome measure was 00:00 to 05:59, both inclusive. Hypoglycemia Categories \[(symptomatic, asymptomatic, severe) are defined per the American Diabetes Association/European Association for the Study of Diabetes hypoglycemia Classification\] |
| Number of Participants With Adverse Events (AEs)) and Serious Adverse Events (SAEs), Including Adverse Events of Special Interest (AESIs) | Baseline to end of study (25 weeks) | Adverse events (AEs) and serious adverse events (SAEs), including adverse events of special interest (AESIs), and other safety evaluations, including vital signs and body weight. |
| Rate of Hypoglycemia Per Participant-year | Baseline to end of study (25 weeks)] | Computed as: 365.25/12 × (number of episodes of hypoglycemia)/(number of days exposed in time window) |
Countries
Czechia, Hungary, Poland, Serbia, United States
Participant flow
Recruitment details
The study was conducted at 68 study centers across 5 countries. A total of 182 participants were screened between 05 December 2022 and 30 June 2023, of whom 120 were screen failures. The number of randomized participants remained significantly lower (\<10%) than was originally planned. Consequently, the estimated results would have been delayed by several years. Hence, the sponsor made the strategic decision to discontinue the trial due to this significant recruitment delay, not related safety.
Pre-assignment details
A total of 62 participants were randomized in 1:1 ratio to either Gla-300 group, or IDeg-100 group, stratified by screening glycated hemoglobin (HbA1c) values (\<8.5% or ≥ 8.5%); and use of sulfonylurea (SU) before the day of screening ('yes' versus 'no').There were no safety signals detected, and the study team remained blinded to the data collected for the randomized subjects at the time of the study termination decision.
Participants by arm
| Arm | Count |
|---|---|
| Gla-300 Arm Gla-300 will be administered once daily for 24 weeks
Insulin glargine 300 U/mL: Insulin glargine 300 U/mL in the SoloStar pen, self-administered once daily for 24 weeks. | 31 |
| IDeg-100 Arm Ideg-100 will be administered once daily for 24 weeks
Insulin degludec 100 U/mL: Insulin degludec 100 U/mL will be self- administered once daily for 24 weeks. | 31 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study was terminated by the Sponsor due to poor recruitment/severe recruitment delay | 30 | 30 |
Baseline characteristics
| Characteristic | IDeg-100 Arm | Gla-300 Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 25 Participants | 25 Participants | 50 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 6 Participants | 12 Participants |
| Age, Continuous | 71.0 years STANDARD_DEVIATION 7.7 | 71.9 years STANDARD_DEVIATION 7.5 | 71.5 years STANDARD_DEVIATION 7.5 |
| Age (years) at diagnosis of diabetes | 55.9 years STANDARD_DEVIATION 8.2 | 59.0 years STANDARD_DEVIATION 9.2 | 57.5 years STANDARD_DEVIATION 8.8 |
| Antihyperglycemic therapies Dipeptidyl peptidase IV inhibitors/gliptin | 6 Participants | 6 Participants | 12 Participants |
| Antihyperglycemic therapies GLP-1 RA (glucagon-like peptide-1 receptor agonist) | 2 Participants | 5 Participants | 7 Participants |
| Antihyperglycemic therapies Metformin | 21 Participants | 22 Participants | 43 Participants |
| Antihyperglycemic therapies SGLT-2i (sodium-glucose co-transporter-2 inhibitors) use | 12 Participants | 16 Participants | 28 Participants |
| Antihyperglycemic therapies SU (sulfonylurea) | 15 Participants | 17 Participants | 32 Participants |
| Antihyperglycemic therapies Thiazolidinediones/glitazones | 5 Participants | 2 Participants | 7 Participants |
| Baseline FPG (mg/dL) | 170.5 (mg/dL) STANDARD_DEVIATION 36.2 | 162.8 (mg/dL) STANDARD_DEVIATION 28.14 | 166.7 (mg/dL) STANDARD_DEVIATION 32.38 |
| Baseline HbA1c (%) | 8.4 Percentage of HbA1c STANDARD_DEVIATION 0.72 | 8.4 Percentage of HbA1c STANDARD_DEVIATION 0.74 | 8.4 Percentage of HbA1c STANDARD_DEVIATION 0.72 |
| Baseline HbA1c (%) group <8.5 | 19 Participants | 20 Participants | 39 Participants |
| Baseline HbA1c (%) group ≥8.5 | 12 Participants | 11 Participants | 23 Participants |
| Baseline SMPG (mg/dL) | 169.0 (mg/dL) STANDARD_DEVIATION 50.03 | 153.9 (mg/dL) STANDARD_DEVIATION 30.45 | 159.6 (mg/dL) STANDARD_DEVIATION 38.9 |
| BMI by category (kg/m²) <30 | 15 Participants | 13 Participants | 28 Participants |
| BMI by category (kg/m²) ≥30 | 16 Participants | 18 Participants | 34 Participants |
| BMI (kg//m²) | 32.2 (kg/m²) STANDARD_DEVIATION 6.56 | 31.6 (kg/m²) STANDARD_DEVIATION 5.54 | 31.9 (kg/m²) STANDARD_DEVIATION 6.03 |
| Duration of diabetes (time since diagnosis) (years) | 15.6 years STANDARD_DEVIATION 8.3 | 13.6 years STANDARD_DEVIATION 7.2 | 14.6 years STANDARD_DEVIATION 7.8 |
| eGFR (mL/min/1.73m²) <45 | 11 Participants | 13 Participants | 24 Participants |
| eGFR (mL/min/1.73m²) ≥45 | 20 Participants | 18 Participants | 38 Participants |
| eGFR (mL/min/1.73m²) | 47.8 (mL/min/1.73m²) STANDARD_DEVIATION 11.2 | 45.7 (mL/min/1.73m²) STANDARD_DEVIATION 9.6 | 46.7 (mL/min/1.73m²) STANDARD_DEVIATION 10.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 2 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 29 Participants | 54 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| History of gestational diabetes No | 31 Participants | 31 Participants | 62 Participants |
| History of gestational diabetes Yes | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 29 Participants | 27 Participants | 56 Participants |
| Region of Enrollment Czechia | 3 participants | 5 participants | 8 participants |
| Region of Enrollment Hungary | 6 participants | 3 participants | 9 participants |
| Region of Enrollment Poland | 9 participants | 12 participants | 21 participants |
| Region of Enrollment Serbia | 4 participants | 4 participants | 8 participants |
| Region of Enrollment United States | 9 participants | 7 participants | 16 participants |
| Sex: Female, Male Female | 15 Participants | 16 Participants | 31 Participants |
| Sex: Female, Male Male | 16 Participants | 15 Participants | 31 Participants |
| Weight (kg) | 89.5 kg STANDARD_DEVIATION 20.32 | 89.5 kg STANDARD_DEVIATION 25.3 | 89.5 kg STANDARD_DEVIATION 22.74 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 1 / 31 |
| other Total, other adverse events | 0 / 31 | 5 / 31 |
| serious Total, serious adverse events | 1 / 31 | 3 / 31 |
Outcome results
Primary
Difference in the Mean Change From Baseline to Week 24 in HbA1c Level (Gla-300 vs IDeg-100)
Change in HbA1c was calculated by subtracting baseline value from Week 24 value and then mean values were calculated.
Time frame: Baseline to 24 weeks
Population: In the Gla-300 arm, 8 participants were in the predefined Analysis Window for the 24 weeks assessment. In the IDeg-100 Arm, 9 participants were within the predefined Analysis Window for the 24 weeks assessment. These 8 and 9 participants did not complete the 24 weeks treatment period.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gla-300 U/mL Arm | Difference in the Mean Change From Baseline to Week 24 in HbA1c Level (Gla-300 vs IDeg-100) | -0.4 percentage of HbA1c | Standard Deviation 1.73 |
| IDeg-100 U/mL Arm | Difference in the Mean Change From Baseline to Week 24 in HbA1c Level (Gla-300 vs IDeg-100) | -1.0 percentage of HbA1c | Standard Deviation 0.98 |
Secondary
Change in 7-point SMPG Profiles From Baseline to Week 24, Per Time Point Within 24-hour Period
7-point SMPG profiles were measured at the following 7 points: pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime.
Time frame: Baseline to 24 weeks
Population: Due to early trial termination, a meaningful comparison of the mean (SD) change in 7-point SMPG profile (expressed in both mg/dL and mmol/L) at 7 time points within a 24-hour period was not possible because of the small sample size in both treatment groups, especially at Week 24.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Gla-300 U/mL Arm | Change in 7-point SMPG Profiles From Baseline to Week 24, Per Time Point Within 24-hour Period | 7-Point SMPG Profile (mmol/L), before breakfast (fasting) | -4.13 (mmol/L) |
| Gla-300 U/mL Arm | Change in 7-point SMPG Profiles From Baseline to Week 24, Per Time Point Within 24-hour Period | 7-Point SMPG Profile (mmol/L), 2 hours after breakfast | -1.30 (mmol/L) |
| Gla-300 U/mL Arm | Change in 7-point SMPG Profiles From Baseline to Week 24, Per Time Point Within 24-hour Period | 7-Point SMPG Profile (mmol/L), before lunch | 0.31 (mmol/L) |
| Gla-300 U/mL Arm | Change in 7-point SMPG Profiles From Baseline to Week 24, Per Time Point Within 24-hour Period | 7-Point SMPG Profile (mmol/L), 2 hours after lunch | 0.63 (mmol/L) |
| Gla-300 U/mL Arm | Change in 7-point SMPG Profiles From Baseline to Week 24, Per Time Point Within 24-hour Period | 7-Point SMPG Profile (mmol/L), before dinner | 2.18 (mmol/L) |
| Gla-300 U/mL Arm | Change in 7-point SMPG Profiles From Baseline to Week 24, Per Time Point Within 24-hour Period | 7-Point SMPG Profile (mmol/L), 2 hours after dinner | -5.36 (mmol/L) |
| Gla-300 U/mL Arm | Change in 7-point SMPG Profiles From Baseline to Week 24, Per Time Point Within 24-hour Period | 7-Point SMPG Profile (mmol/L), at bedtime | -6.20 (mmol/L) |
Secondary
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24
Change in FPG was calculated by subtracting baseline value from the Week 24 value.
Time frame: Baseline to 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gla-300 U/mL Arm | Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24 | -36.4 (mg/dL) | Standard Deviation 25.16 |
| IDeg-100 U/mL Arm | Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24 | -55.5 (mg/dL) | Standard Deviation 22.67 |
Secondary
Change in Fasting Self-Measured Plasma Glucose (SMPG) From Baseline to Week 24
Change in SMPG was calculated by subtracting baseline value from the Week 24 value.
Time frame: Baseline to 24 weeks
Population: Due to early trial termination, a meaningful comparison of the mean (SD) change in fasting SMPG (expressed in both mg/dL and mmol/L) was not possible because of the small sample size in both treatment groups, especially at Week 24.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Gla-300 U/mL Arm | Change in Fasting Self-Measured Plasma Glucose (SMPG) From Baseline to Week 24 | -4.00 (mmol/L) |
Secondary
Number of Participants With Adverse Events (AEs)) and Serious Adverse Events (SAEs), Including Adverse Events of Special Interest (AESIs)
Adverse events (AEs) and serious adverse events (SAEs), including adverse events of special interest (AESIs), and other safety evaluations, including vital signs and body weight.
Time frame: Baseline to end of study (25 weeks)
Population: Overall, 5 participants (16.1%) in the Gla-300 group reported 6 events, and 7 participants (22.6%) in the IDeg-100 group 16 events during the trial period. Note: in the Ideg group, 2 participants had both an AE and SAE.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gla-300 U/mL Arm | Number of Participants With Adverse Events (AEs)) and Serious Adverse Events (SAEs), Including Adverse Events of Special Interest (AESIs) | Adverse Event (AE) | 5 Participants |
| Gla-300 U/mL Arm | Number of Participants With Adverse Events (AEs)) and Serious Adverse Events (SAEs), Including Adverse Events of Special Interest (AESIs) | Serious Adverse Event | 1 Participants |
| Gla-300 U/mL Arm | Number of Participants With Adverse Events (AEs)) and Serious Adverse Events (SAEs), Including Adverse Events of Special Interest (AESIs) | Adverse Event of Special Interest (AESIs) | 0 Participants |
| Gla-300 U/mL Arm | Number of Participants With Adverse Events (AEs)) and Serious Adverse Events (SAEs), Including Adverse Events of Special Interest (AESIs) | Treatment-Emergent SAEs | 1 Participants |
| IDeg-100 U/mL Arm | Number of Participants With Adverse Events (AEs)) and Serious Adverse Events (SAEs), Including Adverse Events of Special Interest (AESIs) | Treatment-Emergent SAEs | 3 Participants |
| IDeg-100 U/mL Arm | Number of Participants With Adverse Events (AEs)) and Serious Adverse Events (SAEs), Including Adverse Events of Special Interest (AESIs) | Adverse Event (AE) | 7 Participants |
| IDeg-100 U/mL Arm | Number of Participants With Adverse Events (AEs)) and Serious Adverse Events (SAEs), Including Adverse Events of Special Interest (AESIs) | Adverse Event of Special Interest (AESIs) | 0 Participants |
| IDeg-100 U/mL Arm | Number of Participants With Adverse Events (AEs)) and Serious Adverse Events (SAEs), Including Adverse Events of Special Interest (AESIs) | Serious Adverse Event | 3 Participants |
Secondary
Percentage of Participants and Event Rate of Hypoglycemia by Trial Period (for ≤12 Weeks, for >13 Weeks to ≤24 Weeks)
Hypoglycemic events measured at the following intervals: Weeks 1-12 and Weeks 13-24.
Time frame: Baseline to end of study (25 weeks)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gla-300 U/mL Arm | Percentage of Participants and Event Rate of Hypoglycemia by Trial Period (for ≤12 Weeks, for >13 Weeks to ≤24 Weeks) | Titration period (Week 1 to Week 12) | 9 Participants |
| Gla-300 U/mL Arm | Percentage of Participants and Event Rate of Hypoglycemia by Trial Period (for ≤12 Weeks, for >13 Weeks to ≤24 Weeks) | Maintenance period (Week 13 to Week 24) | 5 Participants |
| IDeg-100 U/mL Arm | Percentage of Participants and Event Rate of Hypoglycemia by Trial Period (for ≤12 Weeks, for >13 Weeks to ≤24 Weeks) | Titration period (Week 1 to Week 12) | 7 Participants |
| IDeg-100 U/mL Arm | Percentage of Participants and Event Rate of Hypoglycemia by Trial Period (for ≤12 Weeks, for >13 Weeks to ≤24 Weeks) | Maintenance period (Week 13 to Week 24) | 5 Participants |
Secondary
Percentage of Participants Reaching HbA1c Target of <7.0% at Week 24
If a patient has a missing HbA1c value at Week 24, it is assumed that they did not reach the HbA1c target of \<7.0%. HbA1c value of 7.0% is equivalent to 53.0 mmol/mol.
Time frame: At week 24
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gla-300 U/mL Arm | Percentage of Participants Reaching HbA1c Target of <7.0% at Week 24 | 4 Participants |
| IDeg-100 U/mL Arm | Percentage of Participants Reaching HbA1c Target of <7.0% at Week 24 | 2 Participants |
Secondary
Percentage of Participants With ≥1 Episode(s) of Confirmed Hypoglycemia Event (Cut-off Value 70 mg/dL and 54 mg/dL) During the 24-week Treatment Period.
Any event recorded with Yes as response to the question, Was a glucose measurement obtained at the time of the event before countermeasure? and a measurable glucose level of \<70 mg/dL. ADA (American Diabetes Association), Level 1 was defined as a measurable glucose concentration of \<70 mg/dL (3.9 mmol/L) but ≥54 mg/dL (3.0 mmol/L).
Time frame: Baseline to end of study (25 weeks)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gla-300 U/mL Arm | Percentage of Participants With ≥1 Episode(s) of Confirmed Hypoglycemia Event (Cut-off Value 70 mg/dL and 54 mg/dL) During the 24-week Treatment Period. | 35.5 percentage of participants |
| IDeg-100 U/mL Arm | Percentage of Participants With ≥1 Episode(s) of Confirmed Hypoglycemia Event (Cut-off Value 70 mg/dL and 54 mg/dL) During the 24-week Treatment Period. | 29.0 percentage of participants |
Secondary
Rate of Hypoglycemia Per Participant-year
Computed as: 365.25/12 × (number of episodes of hypoglycemia)/(number of days exposed in time window)
Time frame: Baseline to end of study (25 weeks)]
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gla-300 U/mL Arm | Rate of Hypoglycemia Per Participant-year | 9.5 Rate of hypoglycemia per patient-year |
| IDeg-100 U/mL Arm | Rate of Hypoglycemia Per Participant-year | 5.6 Rate of hypoglycemia per patient-year |
Secondary
The 24-hour (All Time), Occurrence of Each Episode of Documented Hypoglycemia by Category, Presented by 2-hour Timeframe Over 24 Hours During the 24-week Treatment Period.
The time range for this outcome measure was 00:00 to 05:59, both inclusive. Hypoglycemia Categories \[(symptomatic, asymptomatic, severe) are defined per the American Diabetes Association/European Association for the Study of Diabetes hypoglycemia Classification\]
Time frame: Baseline to end of study (25 weeks)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gla-300 U/mL Arm | The 24-hour (All Time), Occurrence of Each Episode of Documented Hypoglycemia by Category, Presented by 2-hour Timeframe Over 24 Hours During the 24-week Treatment Period. | 11 Episodes |
| IDeg-100 U/mL Arm | The 24-hour (All Time), Occurrence of Each Episode of Documented Hypoglycemia by Category, Presented by 2-hour Timeframe Over 24 Hours During the 24-week Treatment Period. | 9 Episodes |