Trial Outcomes & Findings for Study to Evaluate the Effect of BYDUREON on 24-hour Glucose Control in Metformin Treated Patients With Type 2 Diabetes. (NCT NCT02288273)
NCT ID: NCT02288273
Last Updated: 2017-01-27
Results Overview
Change in 24-hour mean weighted glucose from baseline (Day -1/1) to Day 6 of Week 4 (Day 27/28) and to Day 6 of Week 10 (Day 69/70).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
239 participants
Primary outcome timeframe
Day 27/28
Results posted on
2017-01-27
Participant Flow
239 subjects were screened in order to randomize 117 subjects; however, 116 subjects were included in the modified intent to treat population, which consisted of all randomized patients who received at least one dose of randomized study drug.
Participant milestones
| Measure |
Once Weekly (EQW) + Met
Bydureon EQW + Metformin XR 1500-2000 mg
|
Placebo + Met
Placebo + Metformin 1500 + 2000 mg
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
56
|
|
Overall Study
COMPLETED
|
53
|
48
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate the Effect of BYDUREON on 24-hour Glucose Control in Metformin Treated Patients With Type 2 Diabetes.
Baseline characteristics by cohort
| Measure |
Once Weekly (EQW) + Met
n=60 Participants
Bydureon EQW + Metformin XR 1500-2000 mg
|
Placebo + Met
n=56 Participants
Placebo + Metformin 1500 + 2000 mg
|
Total
n=116 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55 Years
STANDARD_DEVIATION 10.63 • n=93 Participants
|
56 Years
STANDARD_DEVIATION 9.80 • n=4 Participants
|
55.6 Years
STANDARD_DEVIATION 10.21 • n=27 Participants
|
|
Gender
Female
|
27 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
|
Gender
Male
|
33 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
65 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Day 27/28Change in 24-hour mean weighted glucose from baseline (Day -1/1) to Day 6 of Week 4 (Day 27/28) and to Day 6 of Week 10 (Day 69/70).
Outcome measures
| Measure |
EQW + Met
n=60 (mg/dL)
Bydureon EQW + Metformin 1500-2000 mg
|
Placebo + Met
n=56 (mg/dL)
Placebo + Metformin 1500 + 2000 mg
|
|---|---|---|
|
Change in 24-hour Mean Weighted Glucose
Baseline (Day -1/1)
|
185.7 (mg/dL)
Standard Deviation 41.99
|
183.8 (mg/dL)
Standard Deviation 42.59
|
|
Change in 24-hour Mean Weighted Glucose
Day 27/28
|
158.3 (mg/dL)
Standard Deviation 35.72
|
176.9 (mg/dL)
Standard Deviation 44.03
|
|
Change in 24-hour Mean Weighted Glucose
Change from Baseline to Day 27/28
|
-26.0 (mg/dL)
Standard Deviation 3.58
|
-5.3 (mg/dL)
Standard Deviation 3.85
|
|
Change in 24-hour Mean Weighted Glucose
Change from Baseline to Day 69/70
|
-30.8 (mg/dL)
Standard Deviation 4.54
|
-3.0 (mg/dL)
Standard Deviation 4.78
|
SECONDARY outcome
Timeframe: Day 64/65Outcome measures
| Measure |
EQW + Met
n=60 Participants
Bydureon EQW + Metformin 1500-2000 mg
|
Placebo + Met
n=56 Participants
Placebo + Metformin 1500 + 2000 mg
|
|---|---|---|
|
Change in 24-hour Mean Weighted Glucose Between Day 1 of Week 10 (Day 64/65) and Day 6 of Week 10 (Day 69/70) Within Each EQW-treated Patient
|
5.2 mg/dL
Standard Error 3.46
|
-6.9 mg/dL
Standard Error 3.68
|
SECONDARY outcome
Timeframe: Day 22/Day70Outcome measures
| Measure |
EQW + Met
n=60 Participants
Bydureon EQW + Metformin 1500-2000 mg
|
Placebo + Met
n=56 Participants
Placebo + Metformin 1500 + 2000 mg
|
|---|---|---|
|
Change From Baseline (Day1) to Day 70 and Day 22 in FPG
Baseline to Day 22
|
-29.6 mg/dL
Standard Error 4.85
|
-1.9 mg/dL
Standard Error 4.99
|
|
Change From Baseline (Day1) to Day 70 and Day 22 in FPG
Baseline to Day 70
|
-41.9 mg/dL
Standard Error 5.21
|
-5.0 mg/dL
Standard Error 5.53
|
SECONDARY outcome
Timeframe: Day 22 and Day 64Outcome measures
| Measure |
EQW + Met
n=60 Participants
Bydureon EQW + Metformin 1500-2000 mg
|
Placebo + Met
n=56 Participants
Placebo + Metformin 1500 + 2000 mg
|
|---|---|---|
|
Change From Baseline (Day -1) to Day 64 and Day 22 in 2- Hour Mean Weighted PPG (After the Breakfast Meal)
Baseline to Day 22
|
-32.1 mg/dL
Standard Error 5.30
|
-2.0 mg/dL
Standard Error 5.51
|
|
Change From Baseline (Day -1) to Day 64 and Day 22 in 2- Hour Mean Weighted PPG (After the Breakfast Meal)
Baseline to Day 64
|
-44.4 mg/dL
Standard Error 5.62
|
-6.0 mg/dL
Standard Error 6.12
|
SECONDARY outcome
Timeframe: Week 4 and Week 10Outcome measures
| Measure |
EQW + Met
n=60 Participants
Bydureon EQW + Metformin 1500-2000 mg
|
Placebo + Met
n=56 Participants
Placebo + Metformin 1500 + 2000 mg
|
|---|---|---|
|
Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10
Change in mean weighted glucose baseline to Week 4
|
-4.5 mg/dL
Standard Error 1.09
|
-1.8 mg/dL
Standard Error 1.13
|
|
Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10
Change in mean weighted glucose baseline - Week 10
|
-6.3 mg/dL
Standard Error 1.31
|
0.7 mg/dL
Standard Error 1.36
|
|
Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10
Change in MAGE (mg/dL) from baseline to Week 4
|
-8.2 mg/dL
Standard Error 3.13
|
-3.8 mg/dL
Standard Error 3.25
|
|
Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10
Change in MAGE (mg/dL) from baseline to Week 10
|
-15.2 mg/dL
Standard Error 3.51
|
2.9 mg/dL
Standard Error 3.62
|
SECONDARY outcome
Timeframe: Day 22 and Day 70Outcome measures
| Measure |
EQW + Met
n=60 Participants
Bydureon EQW + Metformin 1500-2000 mg
|
Placebo + Met
n=56 Participants
Placebo + Metformin 1500 + 2000 mg
|
|---|---|---|
|
Change in HbA1c From Baseline to Day 22 and Baseline to Day 70
Change from baseline to Day 22
|
-0.30 % Alc
Standard Error 0.045
|
-0.10 % Alc
Standard Error 0.047
|
|
Change in HbA1c From Baseline to Day 22 and Baseline to Day 70
Change from baseline to Day 70
|
-0.92 % Alc
Standard Error 0.102
|
-0.20 % Alc
Standard Error 0.108
|
SECONDARY outcome
Timeframe: Week 4 and Week 10Outcome measures
| Measure |
EQW + Met
n=60 Participants
Bydureon EQW + Metformin 1500-2000 mg
|
Placebo + Met
n=56 Participants
Placebo + Metformin 1500 + 2000 mg
|
|---|---|---|
|
Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10
Change in times(%): PG<70 baseline to Week 4
|
0.5 % times patients had specific CGM/24-hr
Standard Error 0.19
|
0.2 % times patients had specific CGM/24-hr
Standard Error 0.19
|
|
Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10
Change in times (%): PG <70 baseline to Week 10
|
0.5 % times patients had specific CGM/24-hr
Standard Error 0.21
|
0.1 % times patients had specific CGM/24-hr
Standard Error 0.21
|
|
Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10
Change in %: 70 </= PG </=180 baseline to week 4
|
15.8 % times patients had specific CGM/24-hr
Standard Error 2.37
|
4.1 % times patients had specific CGM/24-hr
Standard Error 2.46
|
|
Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10
Change in %: 70 </= PG </=180 baseline to week 10
|
21.4 % times patients had specific CGM/24-hr
Standard Error 2.99
|
1.3 % times patients had specific CGM/24-hr
Standard Error 3.09
|
|
Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10
Change in times (%): PG >180 baseline to Week 4
|
-16.2 % times patients had specific CGM/24-hr
Standard Error 2.37
|
-4.3 % times patients had specific CGM/24-hr
Standard Error 2.47
|
|
Average of Change in 24-hour Mean Weighted Glucose From Baseline to Week 4 and Baseline to Week 10
Change in times (%): PG >180 baseline to Week 10
|
-22.0 % times patients had specific CGM/24-hr
Standard Error 3.04
|
-1.4 % times patients had specific CGM/24-hr
Standard Error 3.14
|
Adverse Events
EQW + Met
Serious events: 4 serious events
Other events: 35 other events
Deaths: 0 deaths
Placebo + Met
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EQW + Met
n=60 participants at risk
Bydureon EQW + Metformin 1500-2000 mg
|
Placebo + Met
n=56 participants at risk
Placebo + Metformin 1500 + 2000 mg
|
|---|---|---|
|
General disorders
Chest Pain
|
1.7%
1/60 • Number of events 1 • 18 weeks
|
0.00%
0/56 • 18 weeks
|
|
General disorders
Non-Cardiac Chest Pain
|
1.7%
1/60 • Number of events 1 • 18 weeks
|
0.00%
0/56 • 18 weeks
|
|
Gastrointestinal disorders
Acute Pancreatitis
|
1.7%
1/60 • Number of events 1 • 18 weeks
|
0.00%
0/56 • 18 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/60 • 18 weeks
|
1.8%
1/56 • Number of events 1 • 18 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.7%
1/60 • Number of events 1 • 18 weeks
|
0.00%
0/56 • 18 weeks
|
Other adverse events
| Measure |
EQW + Met
n=60 participants at risk
Bydureon EQW + Metformin 1500-2000 mg
|
Placebo + Met
n=56 participants at risk
Placebo + Metformin 1500 + 2000 mg
|
|---|---|---|
|
Infections and infestations
Urinary tract infection
|
6.7%
4/60 • Number of events 4 • 18 weeks
|
8.9%
5/56 • Number of events 5 • 18 weeks
|
|
Infections and infestations
Bronchitis
|
1.7%
1/60 • Number of events 1 • 18 weeks
|
3.6%
2/56 • Number of events 2 • 18 weeks
|
|
Infections and infestations
Gastroenteritis
|
3.3%
2/60 • Number of events 2 • 18 weeks
|
1.8%
1/56 • Number of events 1 • 18 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
3.3%
2/60 • Number of events 2 • 18 weeks
|
1.8%
1/56 • Number of events 1 • 18 weeks
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/60 • 18 weeks
|
3.6%
2/56 • Number of events 2 • 18 weeks
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/60 • 18 weeks
|
3.6%
2/56 • Number of events 2 • 18 weeks
|
|
General disorders
Injection site induration
|
5.0%
3/60 • Number of events 3 • 18 weeks
|
5.4%
3/56 • Number of events 3 • 18 weeks
|
|
General disorders
Injection site nodule
|
10.0%
6/60 • Number of events 6 • 18 weeks
|
0.00%
0/56 • 18 weeks
|
|
General disorders
Edema peripheral
|
0.00%
0/60 • 18 weeks
|
3.6%
2/56 • Number of events 2 • 18 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
3/60 • Number of events 3 • 18 weeks
|
3.6%
2/56 • Number of events 2 • 18 weeks
|
|
Gastrointestinal disorders
Nausea
|
6.7%
4/60 • Number of events 4 • 18 weeks
|
0.00%
0/56 • 18 weeks
|
|
Gastrointestinal disorders
Vomiting
|
3.3%
2/60 • Number of events 2 • 18 weeks
|
0.00%
0/56 • 18 weeks
|
|
Investigations
Lipase increased
|
3.3%
2/60 • Number of events 2 • 18 weeks
|
1.8%
1/56 • Number of events 1 • 18 weeks
|
|
Investigations
Amylase increased
|
3.3%
2/60 • Number of events 2 • 18 weeks
|
0.00%
0/56 • 18 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.0%
3/60 • Number of events 3 • 18 weeks
|
0.00%
0/56 • 18 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/60 • 18 weeks
|
3.6%
2/56 • Number of events 2 • 18 weeks
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/60 • 18 weeks
|
3.6%
2/56 • Number of events 2 • 18 weeks
|
|
Renal and urinary disorders
Proteinuria
|
5.0%
3/60 • Number of events 3 • 18 weeks
|
1.8%
1/56 • Number of events 1 • 18 weeks
|
|
Renal and urinary disorders
Hematuria
|
5.0%
3/60 • Number of events 3 • 18 weeks
|
0.00%
0/56 • 18 weeks
|
|
Renal and urinary disorders
Glycosuria
|
3.3%
2/60 • Number of events 2 • 18 weeks
|
0.00%
0/56 • 18 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
3.3%
2/60 • Number of events 2 • 18 weeks
|
0.00%
0/56 • 18 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institution \& PI agree they will not use or disclose and confidential information to third parties for a period of 10 years from receipt.
- Publication restrictions are in place
Restriction type: OTHER