Trial Outcomes & Findings for Cooperation of Insulin and GLP-1 on Myocardial Glucose Uptake (NCT NCT01232946)
NCT ID: NCT01232946
Last Updated: 2019-08-07
Results Overview
PET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
3 months
Results posted on
2019-08-07
Participant Flow
Participant milestones
| Measure |
Iiraglutide
Type 2 diabetic subjects will be assigned to 3 months of treatment with 1.8mg liraglutide administered once daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.
liraglutide: 1.8mg subcutaneous qd for 3 months
|
Insulin Detemir
Type 2 diabetic subjects will be assigned to 3 months of treatment with insulin detemir administered twice daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.
insulin detemir: 5units subcutaneous bid titrated to fasting glucose of \<130mg/dL for 3 months
|
Liraglutide Plus Insulin Detemir
Type 2 diabetic subjects will be assigned to 3 months of treatment with a combination of liraglutide and insulin detemir in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.
liraglutide plus insulin detemir: liraglutide 1.8mg subq qd plus insulin detemir 5units bid titrated to fasting blood glucose \<130mg/dL for 3 months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
11
|
|
Overall Study
COMPLETED
|
9
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cooperation of Insulin and GLP-1 on Myocardial Glucose Uptake
Baseline characteristics by cohort
| Measure |
Iiraglutide
n=9 Participants
Type 2 diabetic subjects will be assigned to 3 months of treatment with 1.8mg liraglutide administered once daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.
liraglutide: 1.8mg subcutaneous qd for 3 months
|
Insulin Detemir
n=9 Participants
Type 2 diabetic subjects will be assigned to 3 months of treatment with insulin detemir administered twice daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.
insulin detemir: 5units subcutaneous bid titrated to fasting glucose of \<130mg/dL for 3 months
|
Liraglutide Plus Insulin Detemir
n=9 Participants
Type 2 diabetic subjects will be assigned to 3 months of treatment with a combination of liraglutide and insulin detemir in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.
liraglutide plus insulin detemir: liraglutide 1.8mg subq qd plus insulin detemir 5units bid titrated to fasting blood glucose \<130mg/dL for 3 months.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.9 years
STANDARD_DEVIATION 5.3 • n=93 Participants
|
52.1 years
STANDARD_DEVIATION 8.6 • n=4 Participants
|
49.2 years
STANDARD_DEVIATION 9.0 • n=27 Participants
|
51.7 years
STANDARD_DEVIATION 7.6 • n=483 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=93 Participants
|
9 participants
n=4 Participants
|
9 participants
n=27 Participants
|
27 participants
n=483 Participants
|
|
HbA1c, %
|
7.59 %
STANDARD_DEVIATION 0.96 • n=93 Participants
|
7.00 %
STANDARD_DEVIATION 0.79 • n=4 Participants
|
8.13 %
STANDARD_DEVIATION 0.99 • n=27 Participants
|
7.57 %
STANDARD_DEVIATION 0.91 • n=483 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir
Outcome measures
| Measure |
Iiraglutide
n=9 Participants
Type 2 diabetic subjects will be assigned to 3 months of treatment with 1.8mg liraglutide administered once daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.
liraglutide: 1.8mg subcutaneous qd for 3 months
|
Insulin Detemir
n=9 Participants
Type 2 diabetic subjects will be assigned to 3 months of treatment with insulin detemir administered twice daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.
insulin detemir: 5units subcutaneous bid titrated to fasting glucose of \<130mg/dL for 3 months
|
Liraglutide Plus Insulin Detemir
n=9 Participants
Type 2 diabetic subjects will be assigned to 3 months of treatment with a combination of liraglutide and insulin detemir in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.
liraglutide plus insulin detemir: liraglutide 1.8mg subq qd plus insulin detemir 5units bid titrated to fasting blood glucose \<130mg/dL for 3 months.
|
|---|---|---|---|
|
Myocardial Glucose Uptake
|
0.055 umol/g/min
Interval 0.0186 to 0.1047
|
0.0399 umol/g/min
Interval 0.0129 to 0.0494
|
0.0373 umol/g/min
Interval 0.0085 to 0.0455
|
PRIMARY outcome
Timeframe: 3 monthsPET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir
Outcome measures
| Measure |
Iiraglutide
n=9 Participants
Type 2 diabetic subjects will be assigned to 3 months of treatment with 1.8mg liraglutide administered once daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.
liraglutide: 1.8mg subcutaneous qd for 3 months
|
Insulin Detemir
n=9 Participants
Type 2 diabetic subjects will be assigned to 3 months of treatment with insulin detemir administered twice daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.
insulin detemir: 5units subcutaneous bid titrated to fasting glucose of \<130mg/dL for 3 months
|
Liraglutide Plus Insulin Detemir
n=9 Participants
Type 2 diabetic subjects will be assigned to 3 months of treatment with a combination of liraglutide and insulin detemir in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.
liraglutide plus insulin detemir: liraglutide 1.8mg subq qd plus insulin detemir 5units bid titrated to fasting blood glucose \<130mg/dL for 3 months.
|
|---|---|---|---|
|
Myocardial Fatty Acid Oxidation Rate
|
0.1019 umol/g/min
Interval 0.0803 to 0.1399
|
0.1234 umol/g/min
Interval 0.0711 to 0.1836
|
0.0992 umol/g/min
Interval 0.0801 to 0.1352
|
PRIMARY outcome
Timeframe: 3 monthsPET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir
Outcome measures
| Measure |
Iiraglutide
n=9 Participants
Type 2 diabetic subjects will be assigned to 3 months of treatment with 1.8mg liraglutide administered once daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.
liraglutide: 1.8mg subcutaneous qd for 3 months
|
Insulin Detemir
n=9 Participants
Type 2 diabetic subjects will be assigned to 3 months of treatment with insulin detemir administered twice daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.
insulin detemir: 5units subcutaneous bid titrated to fasting glucose of \<130mg/dL for 3 months
|
Liraglutide Plus Insulin Detemir
n=9 Participants
Type 2 diabetic subjects will be assigned to 3 months of treatment with a combination of liraglutide and insulin detemir in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.
liraglutide plus insulin detemir: liraglutide 1.8mg subq qd plus insulin detemir 5units bid titrated to fasting blood glucose \<130mg/dL for 3 months.
|
|---|---|---|---|
|
Myocardial Fatty Acid Esterification Rate
|
0.00274 umol/g/min
Interval 0.00236 to 0.01234
|
0.00358 umol/g/min
Interval 0.00249 to 0.00917
|
0.00146 umol/g/min
Interval 0.00038 to 0.00863
|
Adverse Events
Iiraglutide
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Insulin Detemir
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Liraglutide Plus Insulin Detemir
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Iiraglutide
n=9 participants at risk
Type 2 diabetic subjects will be assigned to 3 months of treatment with 1.8mg liraglutide administered once daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.
liraglutide: 1.8mg subcutaneous qd for 3 months
|
Insulin Detemir
n=10 participants at risk
Type 2 diabetic subjects will be assigned to 3 months of treatment with insulin detemir administered twice daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.
insulin detemir: 5units subcutaneous bid titrated to fasting glucose of \<130mg/dL for 3 months
|
Liraglutide Plus Insulin Detemir
n=11 participants at risk
Type 2 diabetic subjects will be assigned to 3 months of treatment with a combination of liraglutide and insulin detemir in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.
liraglutide plus insulin detemir: liraglutide 1.8mg subq qd plus insulin detemir 5units bid titrated to fasting blood glucose \<130mg/dL for 3 months.
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal intolerance
|
0.00%
0/9 • Study interval is ~4 months for each participant. Total study duration from first participant entered to last participant completed was ~3 yrs.
|
0.00%
0/10 • Study interval is ~4 months for each participant. Total study duration from first participant entered to last participant completed was ~3 yrs.
|
0.00%
0/11 • Study interval is ~4 months for each participant. Total study duration from first participant entered to last participant completed was ~3 yrs.
|
Other adverse events
| Measure |
Iiraglutide
n=9 participants at risk
Type 2 diabetic subjects will be assigned to 3 months of treatment with 1.8mg liraglutide administered once daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.
liraglutide: 1.8mg subcutaneous qd for 3 months
|
Insulin Detemir
n=10 participants at risk
Type 2 diabetic subjects will be assigned to 3 months of treatment with insulin detemir administered twice daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.
insulin detemir: 5units subcutaneous bid titrated to fasting glucose of \<130mg/dL for 3 months
|
Liraglutide Plus Insulin Detemir
n=11 participants at risk
Type 2 diabetic subjects will be assigned to 3 months of treatment with a combination of liraglutide and insulin detemir in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.
liraglutide plus insulin detemir: liraglutide 1.8mg subq qd plus insulin detemir 5units bid titrated to fasting blood glucose \<130mg/dL for 3 months.
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal intolerance
|
0.00%
0/9 • Study interval is ~4 months for each participant. Total study duration from first participant entered to last participant completed was ~3 yrs.
|
0.00%
0/10 • Study interval is ~4 months for each participant. Total study duration from first participant entered to last participant completed was ~3 yrs.
|
18.2%
2/11 • Number of events 2 • Study interval is ~4 months for each participant. Total study duration from first participant entered to last participant completed was ~3 yrs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place