Trial Outcomes & Findings for Gla-300 and IDeg-100 in Insulin-Naïve People With Type 2 Diabetes Mellitus and Renal Impairment (NCT NCT05552859)
NCT ID: NCT05552859
Last Updated: 2025-09-08
Results Overview
Change in HbA1c was calculated by subtracting baseline value from Week 24 value and then mean values were calculated.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
62 participants
Primary outcome timeframe
Baseline to 24 weeks
Results posted on
2025-09-08
Participant Flow
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.
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.
Participant milestones
| Measure |
Gla-300 U/mL 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.
|
IDeg-100 U/mL 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.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
30
|
30
|
Reasons for withdrawal
| Measure |
Gla-300 U/mL 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.
|
IDeg-100 U/mL 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.
|
|---|---|---|
|
Overall Study
Study was terminated by the Sponsor due to poor recruitment/severe recruitment delay
|
30
|
30
|
Baseline Characteristics
Baseline FPG was missing 2 participants (1 participant in the Gla-300 and 1 in the IDeg-100 Arm).
Baseline characteristics by cohort
| Measure |
Gla-300 Arm
n=31 Participants
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.
|
IDeg-100 Arm
n=31 Participants
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.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=31 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=62 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=31 Participants
|
6 Participants
n=31 Participants
|
12 Participants
n=62 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=31 Participants
|
25 Participants
n=31 Participants
|
50 Participants
n=62 Participants
|
|
Age, Continuous
|
71.9 years
STANDARD_DEVIATION 7.5 • n=31 Participants
|
71.0 years
STANDARD_DEVIATION 7.7 • n=31 Participants
|
71.5 years
STANDARD_DEVIATION 7.5 • n=62 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=31 Participants
|
15 Participants
n=31 Participants
|
31 Participants
n=62 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=31 Participants
|
16 Participants
n=31 Participants
|
31 Participants
n=62 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=31 Participants
|
6 Participants
n=31 Participants
|
8 Participants
n=62 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=31 Participants
|
25 Participants
n=31 Participants
|
54 Participants
n=62 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=31 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=62 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=31 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=62 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=31 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=62 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=31 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=62 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=31 Participants
|
1 Participants
n=31 Participants
|
4 Participants
n=62 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=31 Participants
|
29 Participants
n=31 Participants
|
56 Participants
n=62 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=31 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=62 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=31 Participants
|
1 Participants
n=31 Participants
|
2 Participants
n=62 Participants
|
|
Region of Enrollment
Hungary
|
3 participants
n=31 Participants
|
6 participants
n=31 Participants
|
9 participants
n=62 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=31 Participants
|
9 participants
n=31 Participants
|
16 participants
n=62 Participants
|
|
Region of Enrollment
Czechia
|
5 participants
n=31 Participants
|
3 participants
n=31 Participants
|
8 participants
n=62 Participants
|
|
Region of Enrollment
Poland
|
12 participants
n=31 Participants
|
9 participants
n=31 Participants
|
21 participants
n=62 Participants
|
|
Region of Enrollment
Serbia
|
4 participants
n=31 Participants
|
4 participants
n=31 Participants
|
8 participants
n=62 Participants
|
|
Weight (kg)
|
89.5 kg
STANDARD_DEVIATION 25.30 • n=31 Participants
|
89.5 kg
STANDARD_DEVIATION 20.32 • n=31 Participants
|
89.5 kg
STANDARD_DEVIATION 22.74 • n=62 Participants
|
|
BMI (kg//m²)
|
31.6 (kg/m²)
STANDARD_DEVIATION 5.54 • n=31 Participants
|
32.2 (kg/m²)
STANDARD_DEVIATION 6.56 • n=31 Participants
|
31.9 (kg/m²)
STANDARD_DEVIATION 6.03 • n=62 Participants
|
|
BMI by category (kg/m²)
<30
|
13 Participants
n=31 Participants
|
15 Participants
n=31 Participants
|
28 Participants
n=62 Participants
|
|
BMI by category (kg/m²)
≥30
|
18 Participants
n=31 Participants
|
16 Participants
n=31 Participants
|
34 Participants
n=62 Participants
|
|
Baseline HbA1c (%)
|
8.4 Percentage of HbA1c
STANDARD_DEVIATION 0.74 • n=31 Participants
|
8.4 Percentage of HbA1c
STANDARD_DEVIATION 0.72 • n=31 Participants
|
8.4 Percentage of HbA1c
STANDARD_DEVIATION 0.72 • n=62 Participants
|
|
Baseline HbA1c (%) group
<8.5
|
20 Participants
n=31 Participants
|
19 Participants
n=31 Participants
|
39 Participants
n=62 Participants
|
|
Baseline HbA1c (%) group
≥8.5
|
11 Participants
n=31 Participants
|
12 Participants
n=31 Participants
|
23 Participants
n=62 Participants
|
|
Baseline FPG (mg/dL)
|
162.8 (mg/dL)
STANDARD_DEVIATION 28.14 • n=30 Participants • Baseline FPG was missing 2 participants (1 participant in the Gla-300 and 1 in the IDeg-100 Arm).
|
170.5 (mg/dL)
STANDARD_DEVIATION 36.20 • n=30 Participants • Baseline FPG was missing 2 participants (1 participant in the Gla-300 and 1 in the IDeg-100 Arm).
|
166.7 (mg/dL)
STANDARD_DEVIATION 32.38 • n=60 Participants • Baseline FPG was missing 2 participants (1 participant in the Gla-300 and 1 in the IDeg-100 Arm).
|
|
Baseline SMPG (mg/dL)
|
153.9 (mg/dL)
STANDARD_DEVIATION 30.45 • n=18 Participants • Baseline SMPG was missing from 13 participants (Gla-300 Arm) and from 20 participants (IDeg-100 arm).
|
169.0 (mg/dL)
STANDARD_DEVIATION 50.03 • n=11 Participants • Baseline SMPG was missing from 13 participants (Gla-300 Arm) and from 20 participants (IDeg-100 arm).
|
159.6 (mg/dL)
STANDARD_DEVIATION 38.90 • n=29 Participants • Baseline SMPG was missing from 13 participants (Gla-300 Arm) and from 20 participants (IDeg-100 arm).
|
|
eGFR (mL/min/1.73m²)
|
45.7 (mL/min/1.73m²)
STANDARD_DEVIATION 9.6 • n=31 Participants
|
47.8 (mL/min/1.73m²)
STANDARD_DEVIATION 11.2 • n=31 Participants
|
46.7 (mL/min/1.73m²)
STANDARD_DEVIATION 10.4 • n=62 Participants
|
|
eGFR (mL/min/1.73m²)
<45
|
13 Participants
n=31 Participants
|
11 Participants
n=31 Participants
|
24 Participants
n=62 Participants
|
|
eGFR (mL/min/1.73m²)
≥45
|
18 Participants
n=31 Participants
|
20 Participants
n=31 Participants
|
38 Participants
n=62 Participants
|
|
Antihyperglycemic therapies
SU (sulfonylurea)
|
17 Participants
n=31 Participants
|
15 Participants
n=31 Participants
|
32 Participants
n=62 Participants
|
|
Antihyperglycemic therapies
Metformin
|
22 Participants
n=31 Participants
|
21 Participants
n=31 Participants
|
43 Participants
n=62 Participants
|
|
Antihyperglycemic therapies
GLP-1 RA (glucagon-like peptide-1 receptor agonist)
|
5 Participants
n=31 Participants
|
2 Participants
n=31 Participants
|
7 Participants
n=62 Participants
|
|
Antihyperglycemic therapies
Dipeptidyl peptidase IV inhibitors/gliptin
|
6 Participants
n=31 Participants
|
6 Participants
n=31 Participants
|
12 Participants
n=62 Participants
|
|
Antihyperglycemic therapies
SGLT-2i (sodium-glucose co-transporter-2 inhibitors) use
|
16 Participants
n=31 Participants
|
12 Participants
n=31 Participants
|
28 Participants
n=62 Participants
|
|
Antihyperglycemic therapies
Thiazolidinediones/glitazones
|
2 Participants
n=31 Participants
|
5 Participants
n=31 Participants
|
7 Participants
n=62 Participants
|
|
Age (years) at diagnosis of diabetes
|
59.0 years
STANDARD_DEVIATION 9.2 • n=31 Participants
|
55.9 years
STANDARD_DEVIATION 8.2 • n=31 Participants
|
57.5 years
STANDARD_DEVIATION 8.8 • n=62 Participants
|
|
Duration of diabetes (time since diagnosis) (years)
|
13.6 years
STANDARD_DEVIATION 7.2 • n=31 Participants
|
15.6 years
STANDARD_DEVIATION 8.3 • n=31 Participants
|
14.6 years
STANDARD_DEVIATION 7.8 • n=62 Participants
|
|
History of gestational diabetes
Yes
|
0 Participants
n=31 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=62 Participants
|
|
History of gestational diabetes
No
|
31 Participants
n=31 Participants
|
31 Participants
n=31 Participants
|
62 Participants
n=62 Participants
|
PRIMARY outcome
Timeframe: Baseline to 24 weeksPopulation: 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.
Change in HbA1c was calculated by subtracting baseline value from Week 24 value and then mean values were calculated.
Outcome measures
| Measure |
Gla-300 U/mL Arm
n=8 Participants
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.
|
IDeg-100 U/mL Arm
n=9 Participants
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.
|
|---|---|---|
|
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
|
-1.0 percentage of HbA1c
Standard Deviation 0.98
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksChange in FPG was calculated by subtracting baseline value from the Week 24 value.
Outcome measures
| Measure |
Gla-300 U/mL Arm
n=7 Participants
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.
|
IDeg-100 U/mL Arm
n=9 Participants
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.
|
|---|---|---|
|
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24
|
-36.4 (mg/dL)
Standard Deviation 25.16
|
-55.5 (mg/dL)
Standard Deviation 22.67
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksPopulation: 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.
Change in SMPG was calculated by subtracting baseline value from the Week 24 value.
Outcome measures
| Measure |
Gla-300 U/mL Arm
n=1 Participants
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.
|
IDeg-100 U/mL 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.
|
|---|---|---|
|
Change in Fasting Self-Measured Plasma Glucose (SMPG) From Baseline to Week 24
|
-4.00 (mmol/L)
|
—
|
SECONDARY outcome
Timeframe: Baseline to 24 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Gla-300 U/mL Arm
n=1 Participants
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.
|
IDeg-100 U/mL 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.
|
|---|---|---|
|
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)
|
—
|
|
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)
|
—
|
|
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)
|
—
|
|
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)
|
—
|
|
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)
|
—
|
|
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)
|
—
|
|
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 outcome
Timeframe: At week 24If 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.
Outcome measures
| Measure |
Gla-300 U/mL Arm
n=31 Participants
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.
|
IDeg-100 U/mL Arm
n=31 Participants
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.
|
|---|---|---|
|
Percentage of Participants Reaching HbA1c Target of <7.0% at Week 24
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Gla-300 U/mL Arm
n=11 Participants
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.
|
IDeg-100 U/mL Arm
n=9 Participants
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.
|
|---|---|---|
|
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
|
29.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to end of study (25 weeks)]Computed as: 365.25/12 × (number of episodes of hypoglycemia)/(number of days exposed in time window)
Outcome measures
| Measure |
Gla-300 U/mL Arm
n=31 Participants
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.
|
IDeg-100 U/mL Arm
n=31 Participants
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.
|
|---|---|---|
|
Rate of Hypoglycemia Per Participant-year
|
9.5 Rate of hypoglycemia per patient-year
|
5.6 Rate of hypoglycemia per patient-year
|
SECONDARY outcome
Timeframe: Baseline to end of study (25 weeks)Hypoglycemic events measured at the following intervals: Weeks 1-12 and Weeks 13-24.
Outcome measures
| Measure |
Gla-300 U/mL Arm
n=31 Participants
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.
|
IDeg-100 U/mL Arm
n=31 Participants
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.
|
|---|---|---|
|
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
|
7 Participants
|
|
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
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline to end of study (25 weeks)The time range for this outcome measure was 00:00 to 05:59, both inclusive. Hypoglycemia Categories \[(symptomatic, asymptomatic, severe) are defined per the American Diabetes Association/European Association for the Study of Diabetes hypoglycemia Classification\]
Outcome measures
| Measure |
Gla-300 U/mL Arm
n=31 Participants
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.
|
IDeg-100 U/mL Arm
n=31 Participants
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.
|
|---|---|---|
|
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
|
9 Episodes
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Gla-300 U/mL Arm
n=31 Participants
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.
|
IDeg-100 U/mL Arm
n=31 Participants
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.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)) and Serious Adverse Events (SAEs), Including Adverse Events of Special Interest (AESIs)
Treatment-Emergent SAEs
|
1 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events (AEs)) and Serious Adverse Events (SAEs), Including Adverse Events of Special Interest (AESIs)
Adverse Event (AE)
|
5 Participants
|
7 Participants
|
|
Number of Participants With Adverse Events (AEs)) and Serious Adverse Events (SAEs), Including Adverse Events of Special Interest (AESIs)
Serious Adverse Event
|
1 Participants
|
3 Participants
|
|
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
|
0 Participants
|
Adverse Events
Gla-300 U/mL Arm
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
IDeg-100 U/mL Arm
Serious events: 3 serious events
Other events: 5 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Gla-300 U/mL Arm
n=31 participants at risk
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.
|
IDeg-100 U/mL Arm
n=31 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Hypertensive Heart Disease
|
0.00%
0/31 • All AEs (serious or nonserious) will be recorded from the signing of the ICF until the safety follow-up visit, patient's permanent discontinuation from the trial, or loss to follow-up, up to 25 weeks.
|
3.2%
1/31 • Number of events 1 • All AEs (serious or nonserious) will be recorded from the signing of the ICF until the safety follow-up visit, patient's permanent discontinuation from the trial, or loss to follow-up, up to 25 weeks.
|
|
Metabolism and nutrition disorders
Hypoglycemic Event
|
0.00%
0/31 • All AEs (serious or nonserious) will be recorded from the signing of the ICF until the safety follow-up visit, patient's permanent discontinuation from the trial, or loss to follow-up, up to 25 weeks.
|
3.2%
1/31 • Number of events 1 • All AEs (serious or nonserious) will be recorded from the signing of the ICF until the safety follow-up visit, patient's permanent discontinuation from the trial, or loss to follow-up, up to 25 weeks.
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/31 • All AEs (serious or nonserious) will be recorded from the signing of the ICF until the safety follow-up visit, patient's permanent discontinuation from the trial, or loss to follow-up, up to 25 weeks.
|
3.2%
1/31 • Number of events 1 • All AEs (serious or nonserious) will be recorded from the signing of the ICF until the safety follow-up visit, patient's permanent discontinuation from the trial, or loss to follow-up, up to 25 weeks.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/31 • All AEs (serious or nonserious) will be recorded from the signing of the ICF until the safety follow-up visit, patient's permanent discontinuation from the trial, or loss to follow-up, up to 25 weeks.
|
3.2%
1/31 • Number of events 1 • All AEs (serious or nonserious) will be recorded from the signing of the ICF until the safety follow-up visit, patient's permanent discontinuation from the trial, or loss to follow-up, up to 25 weeks.
|
|
Vascular disorders
Circulatory collapse
|
3.2%
1/31 • Number of events 1 • All AEs (serious or nonserious) will be recorded from the signing of the ICF until the safety follow-up visit, patient's permanent discontinuation from the trial, or loss to follow-up, up to 25 weeks.
|
0.00%
0/31 • All AEs (serious or nonserious) will be recorded from the signing of the ICF until the safety follow-up visit, patient's permanent discontinuation from the trial, or loss to follow-up, up to 25 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/31 • All AEs (serious or nonserious) will be recorded from the signing of the ICF until the safety follow-up visit, patient's permanent discontinuation from the trial, or loss to follow-up, up to 25 weeks.
|
3.2%
1/31 • Number of events 1 • All AEs (serious or nonserious) will be recorded from the signing of the ICF until the safety follow-up visit, patient's permanent discontinuation from the trial, or loss to follow-up, up to 25 weeks.
|
Other adverse events
| Measure |
Gla-300 U/mL Arm
n=31 participants at risk
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.
|
IDeg-100 U/mL Arm
n=31 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/31 • All AEs (serious or nonserious) will be recorded from the signing of the ICF until the safety follow-up visit, patient's permanent discontinuation from the trial, or loss to follow-up, up to 25 weeks.
|
6.5%
2/31 • Number of events 2 • All AEs (serious or nonserious) will be recorded from the signing of the ICF until the safety follow-up visit, patient's permanent discontinuation from the trial, or loss to follow-up, up to 25 weeks.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/31 • All AEs (serious or nonserious) will be recorded from the signing of the ICF until the safety follow-up visit, patient's permanent discontinuation from the trial, or loss to follow-up, up to 25 weeks.
|
9.7%
3/31 • Number of events 3 • All AEs (serious or nonserious) will be recorded from the signing of the ICF until the safety follow-up visit, patient's permanent discontinuation from the trial, or loss to follow-up, up to 25 weeks.
|
Additional Information
Trial Transparency email recommended (Toll free for US & Canada)
Sanofi
Phone: 800-633-1610
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER