Trial Outcomes & Findings for A Research Study in People With Type 2 Diabetes to Compare Two Types of Insulin: Insulin 287 and Insulin Glargine (NCT NCT03922750)
NCT ID: NCT03922750
Last Updated: 2022-01-18
Results Overview
The percentage of time spent in glycaemic target range was calculated as 100 times the number of recorded measurements in glycaemic target range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive divided by the total number of recorded measurements. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
154 participants
Primary outcome timeframe
During the last 2 weeks of treatment (week 15 and 16)
Results posted on
2022-01-18
Participant Flow
The trial was conducted at 34 sites in 5 countries as follows: Canada (10), Italy (5), Czech Republic (4), Germany (5) and the United States (10). In addition, 3 sites in the United states and 1 site in Germany screened, but didn't randomise any subjects.
Participants were randomised to receive once weekly insulin 287 using any of 2 different switch approaches or once daily insulin glargine; as an add-on to background therapy with basal insulin analogue with metformin, with or without dipeptidyl peptidase-4 inhibitors (DPP4i) and with or without sodium-glucose cotransporter 2 inhibitors (SGLT2i) at stable, pre-trial dose and at same frequency during the entire treatment period unless due to safety concerns related to the background medication.
Participant milestones
| Measure |
Insulin 287 (Without Loading Dose)
Participants were to receive once weekly subcutaneous (s.c.) injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
Insulin 287 (With 100% Loading Dose)
Participants were to receive once weekly s.c. injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants with additional loading dose ('unit to unit switch with an additional 100% loading dose' approach: current daily dose x 7 x 2). Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: insulin dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
Insulin Glargine U100
Participants were to receive once daily s.c. injection of insulin glargine U100 for 16 weeks, using SoloSTAR prefilled pen-injector at a starting dose same as the pre-trial basal insulin. Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 4 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: insulin dose increased by 4 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
54
|
50
|
|
Overall Study
Full Analysis Set (FAS)
|
50
|
54
|
50
|
|
Overall Study
Safety Analysis Set (SAS)
|
50
|
54
|
50
|
|
Overall Study
COMPLETED
|
50
|
53
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Insulin 287 (Without Loading Dose)
Participants were to receive once weekly subcutaneous (s.c.) injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
Insulin 287 (With 100% Loading Dose)
Participants were to receive once weekly s.c. injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants with additional loading dose ('unit to unit switch with an additional 100% loading dose' approach: current daily dose x 7 x 2). Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: insulin dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
Insulin Glargine U100
Participants were to receive once daily s.c. injection of insulin glargine U100 for 16 weeks, using SoloSTAR prefilled pen-injector at a starting dose same as the pre-trial basal insulin. Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 4 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: insulin dose increased by 4 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
|---|---|---|---|
|
Overall Study
Unclassified
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
Baseline Characteristics
A Research Study in People With Type 2 Diabetes to Compare Two Types of Insulin: Insulin 287 and Insulin Glargine
Baseline characteristics by cohort
| Measure |
Insulin 287 (Without Loading Dose)
n=50 Participants
Participants were to receive once weekly subcutaneous (s.c.) injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
Insulin 287 (With 100% Loading Dose)
n=54 Participants
Participants were to receive once weekly s.c. injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants with additional loading dose ('unit to unit switch with an additional 100% loading dose' approach: current daily dose x 7 x 2). Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: insulin dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
Insulin Glargine U100
n=50 Participants
Participants were to receive once daily s.c. injection of insulin glargine U100 for 16 weeks, using SoloSTAR prefilled pen-injector at a starting dose same as the pre-trial basal insulin. Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 4 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: insulin dose increased by 4 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
Total
n=154 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
62.4 years
STANDARD_DEVIATION 7.2 • n=7 Participants
|
60.5 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
61.7 years
STANDARD_DEVIATION 7.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
141 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
129 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: During the last 2 weeks of treatment (week 15 and 16)Population: Full analysis set included all randomised participants. Overall number of participants analyzed = participants with available data.
The percentage of time spent in glycaemic target range was calculated as 100 times the number of recorded measurements in glycaemic target range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive divided by the total number of recorded measurements. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication).
Outcome measures
| Measure |
Insulin 287 (Without Loading Dose)
n=49 Participants
Participants were to receive once weekly subcutaneous (s.c.) injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
Insulin 287 (With 100% Loading Dose)
n=53 Participants
Participants were to receive once weekly s.c. injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants with additional loading dose ('unit to unit switch with an additional 100% loading dose' approach: current daily dose x 7 x 2). Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: insulin dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
Insulin Glargine U100
n=50 Participants
Participants were to receive once daily s.c. injection of insulin glargine U100 for 16 weeks, using SoloSTAR prefilled pen-injector at a starting dose same as the pre-trial basal insulin. Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 4 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: insulin dose increased by 4 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
|---|---|---|---|
|
Percentage of Time in Target Range 3.9-10.0 mmol/L (70-180 Milligrams Per Deciliter (mg/dL)) Measured Using CGM (Continuous Glucose Monitoring)
|
65.99 Percentage of time
Standard Error 2.34
|
72.86 Percentage of time
Standard Error 2.13
|
64.98 Percentage of time
Standard Error 2.23
|
SECONDARY outcome
Timeframe: From baseline week 0 (V2) to week 16 (V18)Population: Full analysis set included all randomised participants. Overall number of participants analyzed = participants with available data.
Estimated mean change from baseline (week 0) in HbA1c at week 16 is presented. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication).
Outcome measures
| Measure |
Insulin 287 (Without Loading Dose)
n=50 Participants
Participants were to receive once weekly subcutaneous (s.c.) injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
Insulin 287 (With 100% Loading Dose)
n=54 Participants
Participants were to receive once weekly s.c. injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants with additional loading dose ('unit to unit switch with an additional 100% loading dose' approach: current daily dose x 7 x 2). Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: insulin dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
Insulin Glargine U100
n=50 Participants
Participants were to receive once daily s.c. injection of insulin glargine U100 for 16 weeks, using SoloSTAR prefilled pen-injector at a starting dose same as the pre-trial basal insulin. Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 4 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: insulin dose increased by 4 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
|---|---|---|---|
|
Change in Glycosylated Haemoglobin (HbA1c)
|
-0.47 Percentage point of HbA1c
Standard Error 0.09
|
-0.77 Percentage point of HbA1c
Standard Error 0.09
|
-0.54 Percentage point of HbA1c
Standard Error 0.09
|
SECONDARY outcome
Timeframe: From baseline week 0 (V2) to week 16 (V18)Population: Full analysis set included all randomised participants. Overall number analyzed = participants with available data.
Estimated mean change from baseline (week 0) in FPG at week 16 is presented. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication).
Outcome measures
| Measure |
Insulin 287 (Without Loading Dose)
n=50 Participants
Participants were to receive once weekly subcutaneous (s.c.) injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
Insulin 287 (With 100% Loading Dose)
n=52 Participants
Participants were to receive once weekly s.c. injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants with additional loading dose ('unit to unit switch with an additional 100% loading dose' approach: current daily dose x 7 x 2). Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: insulin dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
Insulin Glargine U100
n=49 Participants
Participants were to receive once daily s.c. injection of insulin glargine U100 for 16 weeks, using SoloSTAR prefilled pen-injector at a starting dose same as the pre-trial basal insulin. Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 4 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: insulin dose increased by 4 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
|---|---|---|---|
|
Change in Fasting Plasma Glucose (FPG)
|
-0.83 Millimoles per liter (mmol/L)
Standard Error 0.23
|
-0.69 Millimoles per liter (mmol/L)
Standard Error 0.22
|
-0.57 Millimoles per liter (mmol/L)
Standard Error 0.23
|
SECONDARY outcome
Timeframe: From baseline week 0 (V2) to week 16 (V18)Population: Full analysis set included all randomised participants. Overall number analyzed = participants with available data.
Estimated mean change from baseline (week 0) in body weight at week 16 is presented. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication).
Outcome measures
| Measure |
Insulin 287 (Without Loading Dose)
n=50 Participants
Participants were to receive once weekly subcutaneous (s.c.) injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
Insulin 287 (With 100% Loading Dose)
n=54 Participants
Participants were to receive once weekly s.c. injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants with additional loading dose ('unit to unit switch with an additional 100% loading dose' approach: current daily dose x 7 x 2). Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: insulin dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
Insulin Glargine U100
n=50 Participants
Participants were to receive once daily s.c. injection of insulin glargine U100 for 16 weeks, using SoloSTAR prefilled pen-injector at a starting dose same as the pre-trial basal insulin. Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 4 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: insulin dose increased by 4 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
|---|---|---|---|
|
Change in Body Weight
|
1.32 Kilogram (Kg)
Standard Error 0.36
|
0.61 Kilogram (Kg)
Standard Error 0.34
|
0.10 Kilogram (Kg)
Standard Error 0.35
|
SECONDARY outcome
Timeframe: During the last 2 weeks of treatment (week 15 and 16)Population: Full analysis set included all randomised participants. Overall Number analyzed = participants with available data.
Estimated mean average weekly insulin dose during the last 2 weeks of treatment is presented. The endpoint was evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of a non-randomised insulin treatment (rescue medication).
Outcome measures
| Measure |
Insulin 287 (Without Loading Dose)
n=50 Participants
Participants were to receive once weekly subcutaneous (s.c.) injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
Insulin 287 (With 100% Loading Dose)
n=54 Participants
Participants were to receive once weekly s.c. injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants with additional loading dose ('unit to unit switch with an additional 100% loading dose' approach: current daily dose x 7 x 2). Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: insulin dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
Insulin Glargine U100
n=50 Participants
Participants were to receive once daily s.c. injection of insulin glargine U100 for 16 weeks, using SoloSTAR prefilled pen-injector at a starting dose same as the pre-trial basal insulin. Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 4 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: insulin dose increased by 4 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
|---|---|---|---|
|
Weekly Insulin Dose
|
242.31 Units of insulin (U)
Interval 205.49 to 285.74
|
191.03 Units of insulin (U)
Interval 163.06 to 223.81
|
195.91 Units of insulin (U)
Interval 166.19 to 230.94
|
SECONDARY outcome
Timeframe: From baseline week 0 (V2) to week 21 (V20)Population: Safety analysis set (SAS) included all participants exposed to at least one dose of trial product.
An adverse event(AE) is any untoward medical occurrence in a clinical trial subject administered or using a medicinal product, whether or not considered related to the medicinal product or usage.. A TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period. The on-treatment observation period was the time period from first dose of trial product until the follow-up visit or the last date on trial product + 5 weeks for once daily insulin and +6 weeks for once weekly insulin. Safety analysis set (SAS) included all subjects exposed to at least one dose of trial product.
Outcome measures
| Measure |
Insulin 287 (Without Loading Dose)
n=50 Participants
Participants were to receive once weekly subcutaneous (s.c.) injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
Insulin 287 (With 100% Loading Dose)
n=54 Participants
Participants were to receive once weekly s.c. injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants with additional loading dose ('unit to unit switch with an additional 100% loading dose' approach: current daily dose x 7 x 2). Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: insulin dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
Insulin Glargine U100
n=50 Participants
Participants were to receive once daily s.c. injection of insulin glargine U100 for 16 weeks, using SoloSTAR prefilled pen-injector at a starting dose same as the pre-trial basal insulin. Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 4 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: insulin dose increased by 4 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
|---|---|---|---|
|
Number of Treatment-emergent Adverse Events (TEAEs)
|
77 Count of events
|
85 Count of events
|
76 Count of events
|
SECONDARY outcome
Timeframe: From baseline week 0 (V2) to week 16 (V18)Population: SAS included all participants exposed to at least one dose of trial product.
Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. Number of severe hypoglycaemic episodes that occurred during weeks 0-16 are presented.
Outcome measures
| Measure |
Insulin 287 (Without Loading Dose)
n=50 Participants
Participants were to receive once weekly subcutaneous (s.c.) injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
Insulin 287 (With 100% Loading Dose)
n=54 Participants
Participants were to receive once weekly s.c. injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants with additional loading dose ('unit to unit switch with an additional 100% loading dose' approach: current daily dose x 7 x 2). Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: insulin dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
Insulin Glargine U100
n=50 Participants
Participants were to receive once daily s.c. injection of insulin glargine U100 for 16 weeks, using SoloSTAR prefilled pen-injector at a starting dose same as the pre-trial basal insulin. Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 4 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: insulin dose increased by 4 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
|---|---|---|---|
|
Number of Severe Hypoglycaemic Episodes (Level 3)
|
0 Count of events
|
0 Count of events
|
0 Count of events
|
SECONDARY outcome
Timeframe: From baseline week 0 (V2) to week 16 (V18)Population: SAS included all participants exposed to at least one dose of trial product.
Clinically significant hypoglycaemic episodes (level 2) were defined as episodes that were sufficiently low to indicate serious, clinically important hypoglycaemia with plasma glucose value of \<3.0 mmol/L (54 mg/dL). Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. Number of clinically significant hypoglycaemic episodes (level 2), confirmed by blood glucose (BG)meter or severe hypoglycaemic episodes (level 3) that occured during weeks 0-16 are presented.
Outcome measures
| Measure |
Insulin 287 (Without Loading Dose)
n=50 Participants
Participants were to receive once weekly subcutaneous (s.c.) injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
Insulin 287 (With 100% Loading Dose)
n=54 Participants
Participants were to receive once weekly s.c. injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants with additional loading dose ('unit to unit switch with an additional 100% loading dose' approach: current daily dose x 7 x 2). Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: insulin dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
Insulin Glargine U100
n=50 Participants
Participants were to receive once daily s.c. injection of insulin glargine U100 for 16 weeks, using SoloSTAR prefilled pen-injector at a starting dose same as the pre-trial basal insulin. Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 4 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: insulin dose increased by 4 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
|---|---|---|---|
|
Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Below 3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3)
|
3 Count of events
|
17 Count of events
|
16 Count of events
|
SECONDARY outcome
Timeframe: From baseline week 0 (V2) to week 16 (V18)Population: SAS included all participants exposed to at least one dose of trial product.
Hypoglycaemia alert value (level 1) was defined as episodes that were sufficiently low for treatment with fast-acting carbohydrate and dose adjustment of glucose-lowering therapy. Number of hypoglycaemic alert episodes (level 1) (equal to or above 3.0 and below 3.9 mmol/L (equal to or above 54 and below 70 mg/dL), confirmed by BG meter) that occured during weeks 0-16 are presented.
Outcome measures
| Measure |
Insulin 287 (Without Loading Dose)
n=50 Participants
Participants were to receive once weekly subcutaneous (s.c.) injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
Insulin 287 (With 100% Loading Dose)
n=54 Participants
Participants were to receive once weekly s.c. injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants with additional loading dose ('unit to unit switch with an additional 100% loading dose' approach: current daily dose x 7 x 2). Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: insulin dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
Insulin Glargine U100
n=50 Participants
Participants were to receive once daily s.c. injection of insulin glargine U100 for 16 weeks, using SoloSTAR prefilled pen-injector at a starting dose same as the pre-trial basal insulin. Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 4 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: insulin dose increased by 4 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
|---|---|---|---|
|
Number of Hypoglycaemic Alert Episodes(Level 1) (Greater Than or Equal to 3.0 and Below 3.9 mmol/L (Greater Than or Equal to 54 and Below 70 mg/dL), Confirmed by BG Meter)
|
79 Count of events
|
78 Count of events
|
71 Count of events
|
Adverse Events
Insulin 287 (Without Loading Dose)
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Insulin 287 (With 100% Loading Dose)
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Insulin Glargine U100
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Insulin 287 (Without Loading Dose)
n=50 participants at risk
Participants were to receive once weekly subcutaneous (s.c.) injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
Insulin 287 (With 100% Loading Dose)
n=54 participants at risk
Participants were to receive once weekly s.c. injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants with additional loading dose ('unit to unit switch with an additional 100% loading dose' approach: current daily dose x 7 x 2). Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: insulin dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
Insulin Glargine U100
n=50 participants at risk
Participants were to receive once daily s.c. injection of insulin glargine U100 for 16 weeks, using SoloSTAR prefilled pen-injector at a starting dose same as the pre-trial basal insulin. Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 4 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: insulin dose increased by 4 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/50 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
1.9%
1/54 • Number of events 1 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
0.00%
0/50 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/50 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
1.9%
1/54 • Number of events 2 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
0.00%
0/50 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/50 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
1.9%
1/54 • Number of events 1 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
0.00%
0/50 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/50 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
1.9%
1/54 • Number of events 1 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
0.00%
0/50 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
|
Infections and infestations
Muscle abscess
|
0.00%
0/50 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
1.9%
1/54 • Number of events 1 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
0.00%
0/50 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/50 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
0.00%
0/54 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
2.0%
1/50 • Number of events 1 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/50 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
1.9%
1/54 • Number of events 1 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
0.00%
0/50 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
Other adverse events
| Measure |
Insulin 287 (Without Loading Dose)
n=50 participants at risk
Participants were to receive once weekly subcutaneous (s.c.) injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
Insulin 287 (With 100% Loading Dose)
n=54 participants at risk
Participants were to receive once weekly s.c. injection of insulin 287 for 16 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial basal insulin dose of the respective participants with additional loading dose ('unit to unit switch with an additional 100% loading dose' approach: current daily dose x 7 x 2). Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 28 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: insulin dose increased by 28 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
Insulin Glargine U100
n=50 participants at risk
Participants were to receive once daily s.c. injection of insulin glargine U100 for 16 weeks, using SoloSTAR prefilled pen-injector at a starting dose same as the pre-trial basal insulin. Participants were to perform once daily pre-breakfast SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: \< 4.4 millimoles per litre (mmol/L): dose reduced by 4 U; 4.4-7.2 mmol/L: no adjustment; \> 7.2 mmol/L: insulin dose increased by 4 U. If the participant received a twice-daily regimen with any basal insulin analogue or a once-daily regimen with insulin glargine U300 prior to randomisation, the total daily insulin dose prior to randomisation was reduced by 20%.
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/50 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
1.9%
1/54 • Number of events 1 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
8.0%
4/50 • Number of events 4 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
|
Eye disorders
Diabetic retinopathy
|
4.0%
2/50 • Number of events 2 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
3.7%
2/54 • Number of events 2 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
6.0%
3/50 • Number of events 3 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
1/50 • Number of events 1 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
3.7%
2/54 • Number of events 2 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
6.0%
3/50 • Number of events 4 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
|
Nervous system disorders
Headache
|
2.0%
1/50 • Number of events 1 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
5.6%
3/54 • Number of events 3 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
6.0%
3/50 • Number of events 3 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
|
Vascular disorders
Hypertension
|
6.0%
3/50 • Number of events 3 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
1.9%
1/54 • Number of events 1 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
2.0%
1/50 • Number of events 1 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
|
Infections and infestations
Influenza
|
6.0%
3/50 • Number of events 3 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
1.9%
1/54 • Number of events 1 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
0.00%
0/50 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
|
General disorders
Instillation site haemorrhage
|
0.00%
0/50 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
0.00%
0/54 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
8.0%
4/50 • Number of events 7 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
|
General disorders
Medical device site haemorrhage
|
4.0%
2/50 • Number of events 2 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
9.3%
5/54 • Number of events 7 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
2.0%
1/50 • Number of events 3 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
|
Infections and infestations
Nasopharyngitis
|
14.0%
7/50 • Number of events 8 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
14.8%
8/54 • Number of events 9 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
4.0%
2/50 • Number of events 3 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/50 • Number of events 1 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
0.00%
0/54 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
6.0%
3/50 • Number of events 4 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.0%
3/50 • Number of events 4 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
1.9%
1/54 • Number of events 1 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
2.0%
1/50 • Number of events 2 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
1/50 • Number of events 1 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
3.7%
2/54 • Number of events 2 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
8.0%
4/50 • Number of events 4 • Weeks 0-21.
Results are based on the safety analysis set which included all participants exposed to at least one dose of trial product. All presented adverse events are TEAEs. TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
|
Additional Information
Clinical Reporting Anchor and Disclosure (1452)
Novo Nordisk A/S
Phone: (+1) 866-867-7178
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER