Trial Outcomes & Findings for IDegLira HIGH Trial (NCT NCT03737240)
NCT ID: NCT03737240
Last Updated: 2023-09-08
Results Overview
HbA1c will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
145 participants
Primary outcome timeframe
Baseline, Week 26
Results posted on
2023-09-08
Participant Flow
Participant milestones
| Measure |
IDegLira
Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks.
IDegLira: Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL).
|
Basal-Bolus Insulin
Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart.
Insulin Degludec (U-100): Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose.
Insulin Aspart: Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL.
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|---|---|---|
|
Overall Study
STARTED
|
72
|
73
|
|
Overall Study
COMPLETED
|
56
|
58
|
|
Overall Study
NOT COMPLETED
|
16
|
15
|
Reasons for withdrawal
| Measure |
IDegLira
Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks.
IDegLira: Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL).
|
Basal-Bolus Insulin
Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart.
Insulin Degludec (U-100): Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose.
Insulin Aspart: Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL.
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|---|---|---|
|
Overall Study
Lost to Follow-up
|
16
|
15
|
Baseline Characteristics
IDegLira HIGH Trial
Baseline characteristics by cohort
| Measure |
IDegLira
n=72 Participants
Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks.
IDegLira: Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL).
|
Basal-Bolus Insulin
n=73 Participants
Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart.
Insulin Degludec (U-100): Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose.
Insulin Aspart: Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL.
|
Total
n=145 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
54.5 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
53.8 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
54.21 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
63 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
72 participants
n=5 Participants
|
73 participants
n=7 Participants
|
145 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 26Population: Number of patients analyzed include participants that completed the visit and had a valid HbA1c result.
HbA1c will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable.
Outcome measures
| Measure |
IDegLira
n=56 Participants
Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks.
IDegLira: Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL).
|
Basal-Bolus Insulin
n=58 Participants
Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart.
Insulin Degludec (U-100): Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose.
Insulin Aspart: Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL.
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|---|---|---|
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Change in Hemoglobin A1c (HbA1c)
|
-3.18 percentage of HbA1c
Standard Deviation 2.29
|
-3.00 percentage of HbA1c
Standard Deviation 1.79
|
SECONDARY outcome
Timeframe: Week1, Week 12, Week 26Population: Number of participants analyzed include total patients that completed each study visit and provided data for each study visit.
Mean fasting blood glucose will be compared between study arms. Participants will perform an 8-point, self-monitored blood glucose (SMBG) check by testing their blood sugar at 8 different time points. The measurement taken before breakfast is used to assess fasting blood glucose. For people without diabetes, fasting blood glucose is typically between 70-100 mg/dL while fasting blood glucose for those with diabetes is in the range of 70-130 mg/dL.
Outcome measures
| Measure |
IDegLira
n=72 Participants
Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks.
IDegLira: Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL).
|
Basal-Bolus Insulin
n=73 Participants
Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart.
Insulin Degludec (U-100): Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose.
Insulin Aspart: Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL.
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|---|---|---|
|
Average Fasting Blood Glucose
Baseline (Week 1)
|
202.37 mg/dL
Standard Deviation 63.73
|
206.53 mg/dL
Standard Deviation 58.04
|
|
Average Fasting Blood Glucose
Week 12
|
131.94 mg/dL
Standard Deviation 45.59
|
125.18 mg/dL
Standard Deviation 29.29
|
|
Average Fasting Blood Glucose
Week 26
|
143.31 mg/dL
Standard Deviation 89.55
|
143.14 mg/dL
Standard Deviation 62.81
|
SECONDARY outcome
Timeframe: Week1, Week 12, Week 26Population: Number of participants analyzed include total patients that completed each study visit and provided data for each study visit.
Mean daily blood glucose will be compared between study arms. Participants will perform an 8-point, self-monitored blood glucose (SMBG) check by testing their blood sugar at 8 different time points. Blood glucose levels vary depending on when and what food has been consumed. A blood glucose level taken regardless of timing of meals of greater than 200 mg/dL often indicates diabetes. Blood glucose decreases with improved diabetes management.
Outcome measures
| Measure |
IDegLira
n=72 Participants
Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks.
IDegLira: Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL).
|
Basal-Bolus Insulin
n=73 Participants
Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart.
Insulin Degludec (U-100): Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose.
Insulin Aspart: Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL.
|
|---|---|---|
|
Average Daily Blood Glucose
Week 1 (Baseline)
|
220.81 mg/dL
Standard Deviation 64.43
|
225.18 mg/dL
Standard Deviation 65.74
|
|
Average Daily Blood Glucose
Week 12
|
143.80 mg/dL
Standard Deviation 47.72
|
135.08 mg/dL
Standard Deviation 33.51
|
|
Average Daily Blood Glucose
Week 26
|
134.59 mg/dL
Standard Deviation 36.35
|
144.25 mg/dL
Standard Deviation 40.70
|
SECONDARY outcome
Timeframe: Week 26Percent of study participants experiencing HbA1c \<7.0% and no hypoglycemia will be compared between groups. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. Hypoglycemia is defined as a blood glucose level of \< 70 mg/dL.
Outcome measures
| Measure |
IDegLira
n=72 Participants
Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks.
IDegLira: Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL).
|
Basal-Bolus Insulin
n=73 Participants
Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart.
Insulin Degludec (U-100): Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose.
Insulin Aspart: Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL.
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|---|---|---|
|
Participants With HbA1c <7.0% and no Hypoglycemia
|
19 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Week 26Percent of study participants reaching A1c \< 7% without weight gain and no hypoglycemia will be compared between groups. Weight control is typically important in persons with type 2 diabetes and basal-bolus insulin is associated with weight gain. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. Hypoglycemia is defined as a blood glucose level of \< 70 mg/dL.
Outcome measures
| Measure |
IDegLira
n=72 Participants
Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks.
IDegLira: Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL).
|
Basal-Bolus Insulin
n=73 Participants
Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart.
Insulin Degludec (U-100): Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose.
Insulin Aspart: Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL.
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|---|---|---|
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Participants With HbA1c <7.0% and no Weight Gain and no Hypoglycemia
|
8 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 26Population: This outcome include participants with a baseline HbA1c \<7.5%.
Percent of study participants reaching A1c \< 7.5% without weight gain and no hypoglycemia will be compared between groups. Weight control is typically important in persons with type 2 diabetes and basal-bolus insulin is associated with weight gain. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable. Hypoglycemia is defined as a blood glucose level of \< 70 mg/dL.
Outcome measures
| Measure |
IDegLira
n=56 Participants
Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks.
IDegLira: Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL).
|
Basal-Bolus Insulin
n=57 Participants
Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart.
Insulin Degludec (U-100): Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose.
Insulin Aspart: Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL.
|
|---|---|---|
|
Participants With HbA1c <7.5% and no Weight Gain and no Hypoglycemia
|
19.6 percentage of participants
|
5.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: This outcome includes participants with a baseline HbA1c \>10%.
Percent of study participants with baseline HbA1c \>10% reaching A1c \< 7.5% will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable.
Outcome measures
| Measure |
IDegLira
n=44 Participants
Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks.
IDegLira: Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL).
|
Basal-Bolus Insulin
n=48 Participants
Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart.
Insulin Degludec (U-100): Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose.
Insulin Aspart: Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL.
|
|---|---|---|
|
Participants With HbA1c >10% Achieving HbA1c <7.5%
|
56.8 percentage of participants
|
37.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: This outcome includes study participants with baseline HbA1c \>10%.
Percent of study participants with baseline HbA1c \>10% reaching A1c \< 8.0% will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable.
Outcome measures
| Measure |
IDegLira
n=44 Participants
Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks.
IDegLira: Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL).
|
Basal-Bolus Insulin
n=48 Participants
Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart.
Insulin Degludec (U-100): Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose.
Insulin Aspart: Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL.
|
|---|---|---|
|
Participants With HbA1c >10% Achieving HbA1c <8.0%
|
61.4 percentage of participants
|
45.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: This outcome includes study participants with baseline HbA1c \>11%.
Percent of study participants with baseline HbA1c \>11% reaching A1c \< 7.5% will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable.
Outcome measures
| Measure |
IDegLira
n=25 Participants
Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks.
IDegLira: Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL).
|
Basal-Bolus Insulin
n=27 Participants
Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart.
Insulin Degludec (U-100): Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose.
Insulin Aspart: Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL.
|
|---|---|---|
|
Participants With HbA1c >11% Achieving HbA1c <7.5%
|
52.0 percentage of participants
|
25.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: This outcome includes study participants with baseline HbA1c \>11%.
Percent of study participants with baseline HbA1c \>11% reaching A1c \< 8.0% will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable.
Outcome measures
| Measure |
IDegLira
n=25 Participants
Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks.
IDegLira: Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL).
|
Basal-Bolus Insulin
n=27 Participants
Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart.
Insulin Degludec (U-100): Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose.
Insulin Aspart: Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL.
|
|---|---|---|
|
Participants With HbA1c >11% Achieving HbA1c <8.0%
|
60.0 percentage of participants
|
29.6 percentage of participants
|
SECONDARY outcome
Timeframe: Week 26Percent of study participants reaching A1c \< 7% without weight gain will be compared between groups.
Outcome measures
| Measure |
IDegLira
n=72 Participants
Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks.
IDegLira: Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL).
|
Basal-Bolus Insulin
n=73 Participants
Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart.
Insulin Degludec (U-100): Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose.
Insulin Aspart: Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL.
|
|---|---|---|
|
Participants With HbA1c <7.0% and no Weight Gain
|
13 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Week 12Percent of study participants reaching A1c \< 7% without hypoglycemia will be compared between groups. Hypoglycemia is defined as a blood glucose level of \< 70 mg/dL.
Outcome measures
| Measure |
IDegLira
n=72 Participants
Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks.
IDegLira: Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL).
|
Basal-Bolus Insulin
n=73 Participants
Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart.
Insulin Degludec (U-100): Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose.
Insulin Aspart: Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL.
|
|---|---|---|
|
Participants With HbA1c <7.0% and no Hypoglycemia
|
21 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline through Week 26Population: CGM hypoglycemia BG \< 54 mg/dL was reported only in participants who did not have any issues with the CGM device.
Documented symptomatic hypoglycemia is defined as an event with typical symptoms of hypoglycemia accompanied by SMBG \<70 mg/dL or continuous glucose monitoring (CGM) \< 54 mg/dL that occurs at any time of the day. Number of participants with documented hypoglycemic events will be compared between study groups.
Outcome measures
| Measure |
IDegLira
n=72 Participants
Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks.
IDegLira: Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL).
|
Basal-Bolus Insulin
n=73 Participants
Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart.
Insulin Degludec (U-100): Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose.
Insulin Aspart: Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL.
|
|---|---|---|
|
Number of Participants With Documented Symptomatic Hypoglycemic Events
Hypoglycemia < 70 mg/dL
|
20 participants
|
35 participants
|
|
Number of Participants With Documented Symptomatic Hypoglycemic Events
Hypoglycemia < 54 mg/dL by CGM
|
21 participants
|
26 participants
|
SECONDARY outcome
Timeframe: Baseline through Week 26Population: Data for this outcome was not collected. Participants did not record details about symptoms when providing the blood glucose records.
Asymptomatic hypoglycemia is defined as no typical symptoms reported by the study participant but detected by SMBG \<70 mg/dL or continuous glucose monitoring (CGM) \< 54 mg/dL. Incidence of asymptomatic hypoglycemic events will be compared between study groups.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline through Week 26Population: Participants who reported any BG\<54 mg/dL during study participation up to 6 months
Severe hypoglycemia is defined as severe cognitive impairment requiring assistance from another person. Number of participants with severe hypoglycemic events will be compared between study groups.
Outcome measures
| Measure |
IDegLira
n=72 Participants
Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks.
IDegLira: Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL).
|
Basal-Bolus Insulin
n=73 Participants
Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart.
Insulin Degludec (U-100): Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose.
Insulin Aspart: Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL.
|
|---|---|---|
|
Number of Participants With Severe Hypoglycemic Events
|
7 participants
|
14 participants
|
SECONDARY outcome
Timeframe: Baseline through Week 26Nocturnal symptomatic hypoglycemia is defined as an event with typical symptoms of hypoglycemia accompanied by SMBG \<70 mg/dL or continuous glucose monitoring (CGM) \< 54 mg/dL that occurs between midnight and 5:59 am. Incidence of nocturnal symptomatic hypoglycemic events will be compared between study groups.
Outcome measures
| Measure |
IDegLira
n=72 Participants
Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks.
IDegLira: Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL).
|
Basal-Bolus Insulin
n=73 Participants
Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart.
Insulin Degludec (U-100): Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose.
Insulin Aspart: Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL.
|
|---|---|---|
|
Nocturnal Symptomatic Hypoglycemic Events
|
0.15 Number of events
Standard Deviation 1.30
|
0.16 Number of events
Standard Deviation 0.65
|
SECONDARY outcome
Timeframe: Baseline through Week 26Nocturnal asymptomatic hypoglycemia is defined as SMBG \<70 mg/dL or continuous glucose monitoring (CGM) \< 54 mg/dL between midnight and 5:59 am. Incidence of nocturnal asymptomatic hypoglycemic events will be compared between study groups.
Outcome measures
| Measure |
IDegLira
n=72 Participants
Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks.
IDegLira: Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL).
|
Basal-Bolus Insulin
n=73 Participants
Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart.
Insulin Degludec (U-100): Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose.
Insulin Aspart: Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL.
|
|---|---|---|
|
Nocturnal Asymptomatic Hypoglycemic Events
|
4.81 Number of events
Standard Deviation 7.85
|
3.45 Number of events
Standard Deviation 6.30
|
SECONDARY outcome
Timeframe: Baseline through Week 26Population: Number of participants analyzed include total patients that completed the study visit and provided CGM data.
Percentage of time with a interstitial glucose level below 70 mg/dL as obtained by CGM will be compared between study groups.
Outcome measures
| Measure |
IDegLira
n=36 Participants
Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks.
IDegLira: Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL).
|
Basal-Bolus Insulin
n=43 Participants
Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart.
Insulin Degludec (U-100): Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose.
Insulin Aspart: Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL.
|
|---|---|---|
|
Percentage of Time With Interstitial Glucose <70 mg/dL
|
2.67 % of time
Standard Deviation 7.08
|
1.23 % of time
Standard Deviation 2.82
|
SECONDARY outcome
Timeframe: Baseline through Week 26Population: Number of participants analyzed include total patients that completed the study visit and provided CGM data.
Percentage of time with a interstitial glucose level below \<54 mg/dL as obtained by CGM will be compared between study groups.
Outcome measures
| Measure |
IDegLira
n=36 Participants
Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks.
IDegLira: Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL).
|
Basal-Bolus Insulin
n=43 Participants
Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart.
Insulin Degludec (U-100): Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose.
Insulin Aspart: Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL.
|
|---|---|---|
|
Percentage of Time With Interstitial Glucose <54 mg/dL
|
0.31 % of time
Standard Deviation 1.22
|
0.72 % of time
Standard Deviation 2.48
|
SECONDARY outcome
Timeframe: Baseline through Week 26Population: Number of participants analyzed include total patients that completed the study visit and provided CGM data.
Percentage of time with interstitial glucose in the range of 70-180 mg/dL as measured by CGM will be compared between study groups.
Outcome measures
| Measure |
IDegLira
n=36 Participants
Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks.
IDegLira: Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL).
|
Basal-Bolus Insulin
n=43 Participants
Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart.
Insulin Degludec (U-100): Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose.
Insulin Aspart: Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL.
|
|---|---|---|
|
Percentage of Time With Interstitial Glucose Between 70 and 180 mg/dL
|
38.39 % of time
Standard Deviation 30.69
|
31.17 % of time
Standard Deviation 29.00
|
SECONDARY outcome
Timeframe: Week1, Week 12, Week 26Population: This analyses included participants that had valid CGM data at each study visit.
Glycemic variability will be assessed with continuous glucose monitoring (CGM). It will be calculated using CGM and Standard Deviation.
Outcome measures
| Measure |
IDegLira
n=51 Participants
Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks.
IDegLira: Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL).
|
Basal-Bolus Insulin
n=61 Participants
Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart.
Insulin Degludec (U-100): Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose.
Insulin Aspart: Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL.
|
|---|---|---|
|
Glycemic Variability
CGM Week 1
|
50.5 mg/dl
Standard Deviation 14.6
|
51.6 mg/dl
Standard Deviation 13.4
|
|
Glycemic Variability
CGM Week 12
|
41.8 mg/dl
Standard Deviation 14.8
|
47.1 mg/dl
Standard Deviation 15.4
|
|
Glycemic Variability
CGM Week 26
|
43.6 mg/dl
Standard Deviation 14.8
|
48.4 mg/dl
Standard Deviation 16.2
|
SECONDARY outcome
Timeframe: Baseline, Week 12Treatment satisfaction will be assessed with the DTSQs. The DTSQs contains eight items scored on a seven-point scale where 0 = very dissatisfied and 6 = very satisfied. The satisfaction score is obtained by summing responses to yield a total score between 0 to 48. Higher scores indicate higher satisfaction with diabetes treatment.
Outcome measures
| Measure |
IDegLira
n=72 Participants
Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks.
IDegLira: Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL).
|
Basal-Bolus Insulin
n=73 Participants
Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart.
Insulin Degludec (U-100): Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose.
Insulin Aspart: Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL.
|
|---|---|---|
|
Diabetes Treatment Satisfaction Questionnaire - Status (DTSQs) Score
Baseline
|
26.00 score on a scale
Standard Deviation 8.06
|
29.07 score on a scale
Standard Deviation 6.76
|
|
Diabetes Treatment Satisfaction Questionnaire - Status (DTSQs) Score
Follow up at 24 weeks
|
33.15 score on a scale
Standard Deviation 3.93
|
33.94 score on a scale
Standard Deviation 2.58
|
SECONDARY outcome
Timeframe: Week 26Satisfaction with the study treatment will be assessed with items 1, 4, 5, 6, 7, and 8 the DTSQc. Items are rated on a scale of -3 (much less satisfied compared to prior treatment) to 3 (much more satisfied compared to prior treatment). Total scores for these three items range from -18 to +18 with higher scores indicating greater satisfaction with the study treatment compared to their prior treatment.
Outcome measures
| Measure |
IDegLira
n=72 Participants
Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks.
IDegLira: Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL).
|
Basal-Bolus Insulin
n=73 Participants
Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart.
Insulin Degludec (U-100): Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose.
Insulin Aspart: Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL.
|
|---|---|---|
|
Diabetes Treatment Satisfaction Questionnaire - Change (DTSQc) Score
|
15.55 score on a scale
Standard Deviation 4.68
|
15.77 score on a scale
Standard Deviation 3.13
|
SECONDARY outcome
Timeframe: Baseline, Week 12, Week 26Satisfaction with the study treatment will be assessed with the TRIM-D survey. TRIM-D includes 28 items that are scored on a scale from 1 to 5. Total scores are transformed to a scale of 0 to 100 where higher scores indicate increased satisfaction.
Outcome measures
| Measure |
IDegLira
n=72 Participants
Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks.
IDegLira: Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL).
|
Basal-Bolus Insulin
n=73 Participants
Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart.
Insulin Degludec (U-100): Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose.
Insulin Aspart: Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL.
|
|---|---|---|
|
Treatment-Related Impact Measures for Diabetes (TRIM-D) Survey Score
Baseline
|
14.94 score on a scale
Standard Deviation 2.29
|
15.37 score on a scale
Standard Deviation 2.61
|
|
Treatment-Related Impact Measures for Diabetes (TRIM-D) Survey Score
3 months follow up
|
14.82 score on a scale
Standard Deviation 1.70
|
15.29 score on a scale
Standard Deviation 2.46
|
|
Treatment-Related Impact Measures for Diabetes (TRIM-D) Survey Score
6 months follow up
|
15.19 score on a scale
Standard Deviation 1.88
|
15.29 score on a scale
Standard Deviation 1.88
|
SECONDARY outcome
Timeframe: Baseline through Week 26Population: All participants that were randomized and received at least one dose of study medication and completed at least one follow-up.
The number of emergency room visits occurring during the treatment period will be compared between study groups.
Outcome measures
| Measure |
IDegLira
n=72 Participants
Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks.
IDegLira: Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL).
|
Basal-Bolus Insulin
n=73 Participants
Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart.
Insulin Degludec (U-100): Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose.
Insulin Aspart: Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL.
|
|---|---|---|
|
Number of Emergency Room (ER) Visits
|
14 Number of ER visits
|
12 Number of ER visits
|
SECONDARY outcome
Timeframe: Baseline through Week 26Population: All participants who were randomized and received at least one dose of study medication and completed at least one follow-up.
The number of hospital readmissions occurring during the treatment period will be compared between study groups.
Outcome measures
| Measure |
IDegLira
n=72 Participants
Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks.
IDegLira: Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL).
|
Basal-Bolus Insulin
n=73 Participants
Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart.
Insulin Degludec (U-100): Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose.
Insulin Aspart: Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL.
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|---|---|---|
|
Number of Hospital Readmissions
|
0 Number of Hospital readmissions
|
4 Number of Hospital readmissions
|
SECONDARY outcome
Timeframe: Baseline, Week 26Population: All participants who were randomized and received at least one dose of study medication and completed at least one follow-up.
The total insulin dose measured in units per day will be compared between study groups.
Outcome measures
| Measure |
IDegLira
n=72 Participants
Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks.
IDegLira: Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL).
|
Basal-Bolus Insulin
n=73 Participants
Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart.
Insulin Degludec (U-100): Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose.
Insulin Aspart: Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL.
|
|---|---|---|
|
Total Daily Insulin Dose
Baseline
|
24.56 units per day
Standard Deviation 7.76
|
46.05 units per day
Standard Deviation 20.79
|
|
Total Daily Insulin Dose
26 weeks
|
35.74 units per day
Standard Deviation 17.53
|
75.65 units per day
Standard Deviation 43.43
|
Adverse Events
IDegLira
Serious events: 14 serious events
Other events: 30 other events
Deaths: 0 deaths
Basal-Bolus Insulin
Serious events: 12 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IDegLira
n=72 participants at risk
Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks.
IDegLira: Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL).
|
Basal-Bolus Insulin
n=73 participants at risk
Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart.
Insulin Degludec (U-100): Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose.
Insulin Aspart: Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL.
|
|---|---|---|
|
General disorders
Hospital Readmissions
|
0.00%
0/72 • Duration of the study participation from enrollment up to 6 months
|
5.5%
4/73 • Duration of the study participation from enrollment up to 6 months
|
|
General disorders
Emergency Room Visits
|
19.4%
14/72 • Duration of the study participation from enrollment up to 6 months
|
16.4%
12/73 • Duration of the study participation from enrollment up to 6 months
|
Other adverse events
| Measure |
IDegLira
n=72 participants at risk
Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks.
IDegLira: Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL).
|
Basal-Bolus Insulin
n=73 participants at risk
Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart.
Insulin Degludec (U-100): Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose.
Insulin Aspart: Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
37.5%
27/72 • Duration of the study participation from enrollment up to 6 months
|
4.1%
3/73 • Number of events 3 • Duration of the study participation from enrollment up to 6 months
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
9/72 • Duration of the study participation from enrollment up to 6 months
|
1.4%
1/73 • Number of events 1 • Duration of the study participation from enrollment up to 6 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
18.1%
13/72 • Number of events 13 • Duration of the study participation from enrollment up to 6 months
|
8.2%
6/73 • Duration of the study participation from enrollment up to 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
8/72 • Number of events 15 • Duration of the study participation from enrollment up to 6 months
|
8.2%
6/73 • Duration of the study participation from enrollment up to 6 months
|
Additional Information
Dr. Rodolfo Galindo
University of Miami Miller School of Medicine
Phone: 305-243-7707
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place