Trial Outcomes & Findings for Continuous Glucose Monitoring Evaluation of Exenatide Twice Daily Versus Insulin Glargine (NCT NCT01089569)
NCT ID: NCT01089569
Last Updated: 2017-05-23
Results Overview
Measure the changes in HbA1C attributable to exenatide, insulin glargine and their combination. Employ CGM with AGP analysis to determine if there is an incremental benefit for subjects who do not reach target to add exenatide to insulin glargine or insulin glargine to exenatide in patients taking metformin.
COMPLETED
NA
60 participants
baseline to final visit (32 weeks)
2017-05-23
Participant Flow
Participant milestones
| Measure |
Exenatide
5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
|
Insulin Glargine
.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
|
Exenatide + Insulin Glargine
Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
\+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
16
|
17
|
16
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Continuous Glucose Monitoring Evaluation of Exenatide Twice Daily Versus Insulin Glargine
Baseline characteristics by cohort
| Measure |
Exenatide
n=16 Participants
5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study
Exenatide: refer to Arm detail
|
Insulin Glargine
n=17 Participants
.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
Insulin Glargine: refer to Arm detail
|
Exenatide + Insulin Glargine
n=16 Participants
Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
\+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.6 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
53.8 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
56.7 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
56.3 years
STANDARD_DEVIATION 8.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline to final visit (32 weeks)Measure the changes in HbA1C attributable to exenatide, insulin glargine and their combination. Employ CGM with AGP analysis to determine if there is an incremental benefit for subjects who do not reach target to add exenatide to insulin glargine or insulin glargine to exenatide in patients taking metformin.
Outcome measures
| Measure |
Exenatide
n=16 Participants
5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study
|
Insulin Glargine
n=17 Participants
.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
|
Exenatide + Insulin Glargine
n=16 Participants
Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
\+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
|
|---|---|---|---|
|
HbA1c Change
Baseline
|
6.4 %HbA1c
Standard Deviation 0.3
|
6.4 %HbA1c
Standard Deviation 0.5
|
6.2 %HbA1c
Standard Deviation 0.5
|
|
HbA1c Change
Final - Week 32
|
7.8 %HbA1c
Standard Deviation .6
|
7.6 %HbA1c
Standard Deviation .5
|
7.6 %HbA1c
Standard Deviation .7
|
SECONDARY outcome
Timeframe: baseline to final visit (32 weeks)Employ Continuous Glucose Monitoring (CGM) with Ambulatory Glucose Profile (AGP) analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes. Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves- iv. Incidence of hypoglycemia (frequency) Change from baseline was calculated as mean incidence rate at baseline minus mean incidence rate at final visit (32 weeks)
Outcome measures
| Measure |
Exenatide
n=16 Participants
5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study
|
Insulin Glargine
n=17 Participants
.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
|
Exenatide + Insulin Glargine
n=16 Participants
Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
\+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
|
|---|---|---|---|
|
Change From Baseline in Incidence of Hypoglycemia (Frequency)
|
.7 episodes/day
Standard Deviation 0.8
|
.8 episodes/day
Standard Deviation 0.8
|
.6 episodes/day
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: baseline to final visit (32 weeks)Employ Continuous Glucose Monitoring (CGM) with Ambulatory Glucose Profile (AGP) analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes. Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves- iv. Incidence of hypoglycemia (degree) Change from baseline was calculated as mean incidence percentage at baseline minus mean incidence percentage at final visit (32 weeks)
Outcome measures
| Measure |
Exenatide
n=16 Participants
5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study
|
Insulin Glargine
n=17 Participants
.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
|
Exenatide + Insulin Glargine
n=16 Participants
Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
\+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
|
|---|---|---|---|
|
Change From Baseline in Incidence of Hypoglycemia (Degree)
|
1.7 percentage of measures under 70 mg/dL
Standard Deviation 2.7
|
1.7 percentage of measures under 70 mg/dL
Standard Deviation 1.8
|
1.3 percentage of measures under 70 mg/dL
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: baseline to final visit (32 weeks)Employ Continuous Glucose Monitoring (CGM) with Ambulatory Glucose Profile (AGP) analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes. Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves iii. Glucose stability (absolute hourly rate of change in median curve) Change from baseline was calculated as mean absolute hourly rate of change in median curve at baseline minus rate at final visit (32 weeks). Mean absolute hourly rate of change in the smoothed median curve is calculated as delta subscript MC = (\|p subscript 50 zero - p subscript 50 23\|+Sum superscript 23 subscript i = 1\| p subscript 50i - p subscript 50 i-1\| over T. i = hour of day p subscript 50i = smoothed 50th percentile value for ith hour of day T = total # of non-missing hourly smoothed percentiles
Outcome measures
| Measure |
Exenatide
n=16 Participants
5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study
|
Insulin Glargine
n=17 Participants
.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
|
Exenatide + Insulin Glargine
n=16 Participants
Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
\+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
|
|---|---|---|---|
|
Change From Baseline in Glucose Stability (Absolute Hourly Rate of Change in Median Curve)
|
-2 mg/dL/hr
Standard Deviation 2.7
|
-2.9 mg/dL/hr
Standard Deviation 4.4
|
-2 mg/dL/hr
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: baseline to final visit (32 weeks)Employ Continuous Glucose Monitoring (CGM) with Ambulatory Glucose Profile (AGP) analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes. Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves- ii. Glucose variability (inter-quartile range) IQR is the difference between the 75th and 25th percentiles. Change from baseline was calculated as IQR at baseline minus IQR value at final visit (32 weeks).
Outcome measures
| Measure |
Exenatide
n=16 Participants
5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study
|
Insulin Glargine
n=17 Participants
.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
|
Exenatide + Insulin Glargine
n=16 Participants
Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
\+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
|
|---|---|---|---|
|
Change From Baseline in CGM Glucose Variability
|
-9 mg/dL
Standard Deviation 9.1
|
-7.7 mg/dL
Standard Deviation 19.4
|
-12.1 mg/dL
Standard Deviation 14
|
SECONDARY outcome
Timeframe: baseline - final visit (32 weeks)Employ Continuous Glucose Monitoring (CGM) with Ambulatory Glucose Profile (AGP) analysis to characterize the diurnal patterns produced by oral medications (metformin) used in the treatment of type 2 diabetes. Employ CGM to measure the effect of exenatide, insulin glargine and exenatide plus insulin glargine in terms of underlying physiological defects and alter medications in a manner that improves- i. Glucose exposure (area under the diurnal median curve) Change from baseline was calculated as area under the diurnal median curve at baseline minus AUC value at final visit (32 weeks). AUC is calculated using modified rectangle method AUC = sum of superscript 23, subscript i=0 P subscript 50i I = hour of day P subscript 50i = smoother 50th percentile value for ith hour of day
Outcome measures
| Measure |
Exenatide
n=16 Participants
5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study
|
Insulin Glargine
n=17 Participants
.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
|
Exenatide + Insulin Glargine
n=16 Participants
Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
\+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
|
|---|---|---|---|
|
Change From Baseline in Glucose Exposure (Area Under the Diurnal Median Curve or AUC)
|
-1207.1 mg/dL*24hr
Standard Deviation 661.1
|
-1476.2 mg/dL*24hr
Standard Deviation 849.2
|
-1315 mg/dL*24hr
Standard Deviation 953.9
|
SECONDARY outcome
Timeframe: baseline - final visit (32 weeks)Measure the changes in weight attributable to exenatide, insulin glargine and their combinations. Employ CGM with AGP analysis to determine if there is an incremental benefit for subjects who do not reach target to add exenatide to insulin glargine or insulin glargine to exenatide in patients taking metformin. Change from baseline was calculated as weight in pounds at baseline minus weight in pounds at final visit (32 weeks).
Outcome measures
| Measure |
Exenatide
n=16 Participants
5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study
|
Insulin Glargine
n=17 Participants
.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
|
Exenatide + Insulin Glargine
n=16 Participants
Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
\+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
|
|---|---|---|---|
|
Change From Baseline in Weight Changes
|
-13.5 lbs (pounds)
Standard Deviation 10.2
|
-0.5 lbs (pounds)
Standard Deviation 7.7
|
-10.3 lbs (pounds)
Standard Deviation 10.5
|
Adverse Events
Exenatide
Insulin Glargine
Exenatide + Insulin Glargine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Exenatide
n=20 participants at risk
5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study
Exenatide: refer to Arm detail
|
Insulin Glargine
n=20 participants at risk
.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
Insulin Glargine: refer to Arm detail
|
Exenatide + Insulin Glargine
n=20 participants at risk
Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
\+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
|
|---|---|---|---|
|
Gastrointestinal disorders
nausea and vomiting
|
85.0%
17/20 • Number of events 17 • Adverse Events were collected for the 32 weeks subjects actively enrolled in trial
|
0.00%
0/20 • Adverse Events were collected for the 32 weeks subjects actively enrolled in trial
|
0.00%
0/20 • Adverse Events were collected for the 32 weeks subjects actively enrolled in trial
|
|
Immune system disorders
Allergic reaction
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected for the 32 weeks subjects actively enrolled in trial
|
0.00%
0/20 • Adverse Events were collected for the 32 weeks subjects actively enrolled in trial
|
0.00%
0/20 • Adverse Events were collected for the 32 weeks subjects actively enrolled in trial
|
|
Skin and subcutaneous tissue disorders
Itching
|
0.00%
0/20 • Adverse Events were collected for the 32 weeks subjects actively enrolled in trial
|
5.0%
1/20 • Number of events 1 • Adverse Events were collected for the 32 weeks subjects actively enrolled in trial
|
0.00%
0/20 • Adverse Events were collected for the 32 weeks subjects actively enrolled in trial
|
|
Gastrointestinal disorders
diarrhea
|
10.0%
2/20 • Number of events 2 • Adverse Events were collected for the 32 weeks subjects actively enrolled in trial
|
0.00%
0/20 • Adverse Events were collected for the 32 weeks subjects actively enrolled in trial
|
0.00%
0/20 • Adverse Events were collected for the 32 weeks subjects actively enrolled in trial
|
|
Endocrine disorders
Hypoglycemia
|
20.0%
4/20 • Number of events 14 • Adverse Events were collected for the 32 weeks subjects actively enrolled in trial
|
45.0%
9/20 • Number of events 24 • Adverse Events were collected for the 32 weeks subjects actively enrolled in trial
|
65.0%
13/20 • Number of events 26 • Adverse Events were collected for the 32 weeks subjects actively enrolled in trial
|
Additional Information
Dr. Richard M. Bergenstal
International Diabetes Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place