Trial Outcomes & Findings for A Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes (NCT NCT00960661)
NCT ID: NCT00960661
Last Updated: 2015-04-07
Results Overview
Change in HbA1c from baseline following 30 weeks of therapy (i.e. HbA1c at week 30 minus HbA1c at baseline).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1036 participants
Primary outcome timeframe
Baseline, 30 weeks
Results posted on
2015-04-07
Participant Flow
1036 patients entered the study, 637 were assigned to the two interventional study groups. 10 patients assigned to treatment groups did not receive study drug.
Participant milestones
| Measure |
Enrolled
Patients who enrolled in the basal insulin optimization (BIO) phase
|
Exenatide (BET)
Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
|
Insulin Lispro (BBT)
Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
|
|---|---|---|---|
|
Basal Insulin Optimization Phase (BIO)
STARTED
|
1036
|
0
|
0
|
|
Basal Insulin Optimization Phase (BIO)
COMPLETED
|
637
|
0
|
0
|
|
Basal Insulin Optimization Phase (BIO)
NOT COMPLETED
|
399
|
0
|
0
|
|
Interventional Phase
STARTED
|
0
|
316
|
321
|
|
Interventional Phase
Intent to Treat Population
|
0
|
315
|
312
|
|
Interventional Phase
Per Protocol Population
|
0
|
247
|
263
|
|
Interventional Phase
COMPLETED
|
0
|
264
|
275
|
|
Interventional Phase
NOT COMPLETED
|
0
|
52
|
46
|
Reasons for withdrawal
| Measure |
Enrolled
Patients who enrolled in the basal insulin optimization (BIO) phase
|
Exenatide (BET)
Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
|
Insulin Lispro (BBT)
Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
|
|---|---|---|---|
|
Basal Insulin Optimization Phase (BIO)
Adverse Event
|
6
|
0
|
0
|
|
Basal Insulin Optimization Phase (BIO)
Lost to Follow-up
|
4
|
0
|
0
|
|
Basal Insulin Optimization Phase (BIO)
Entry criteria not met
|
331
|
0
|
0
|
|
Basal Insulin Optimization Phase (BIO)
Withdrawal by Subject
|
47
|
0
|
0
|
|
Basal Insulin Optimization Phase (BIO)
Physician Decision
|
8
|
0
|
0
|
|
Basal Insulin Optimization Phase (BIO)
Sponsor decision
|
3
|
0
|
0
|
|
Interventional Phase
Adverse Event
|
0
|
17
|
8
|
|
Interventional Phase
Death
|
0
|
1
|
0
|
|
Interventional Phase
Lost to Follow-up
|
0
|
0
|
2
|
|
Interventional Phase
entry criteria not met
|
0
|
3
|
0
|
|
Interventional Phase
Protocol Violation
|
0
|
7
|
2
|
|
Interventional Phase
Withdrawal by Subject
|
0
|
18
|
29
|
|
Interventional Phase
Physician Decision
|
0
|
3
|
5
|
|
Interventional Phase
sponsor decision
|
0
|
1
|
0
|
|
Interventional Phase
Lack of Efficacy
|
0
|
2
|
0
|
Baseline Characteristics
A Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Exenatide (BET)
n=247 Participants
Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
|
Insulin Lispro (BBT)
n=263 Participants
Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
|
Total
n=510 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
180 Participants
n=93 Participants
|
182 Participants
n=4 Participants
|
362 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
67 Participants
n=93 Participants
|
81 Participants
n=4 Participants
|
148 Participants
n=27 Participants
|
|
Age, Continuous
|
59.5 years
STANDARD_DEVIATION 9.6 • n=93 Participants
|
59.4 years
STANDARD_DEVIATION 9.27 • n=4 Participants
|
59.5 years
STANDARD_DEVIATION 9.43 • n=27 Participants
|
|
Sex: Female, Male
Female
|
119 Participants
n=93 Participants
|
130 Participants
n=4 Participants
|
249 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
128 Participants
n=93 Participants
|
133 Participants
n=4 Participants
|
261 Participants
n=27 Participants
|
|
prior use of Sulfonylurea (SU)
YES
|
85 participants
n=93 Participants
|
99 participants
n=4 Participants
|
184 participants
n=27 Participants
|
|
prior use of Sulfonylurea (SU)
NO
|
162 participants
n=93 Participants
|
164 participants
n=4 Participants
|
326 participants
n=27 Participants
|
|
Glycosylated hemoglobin (HbA1c)
|
8.27 Percent
STANDARD_DEVIATION 0.983 • n=93 Participants
|
8.21 Percent
STANDARD_DEVIATION 0.871 • n=4 Participants
|
8.24 Percent
STANDARD_DEVIATION 0.927 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, 30 weeksPopulation: Participants analyzed for this endpoint included the per protocol population, 247 and 263, respectively.
Change in HbA1c from baseline following 30 weeks of therapy (i.e. HbA1c at week 30 minus HbA1c at baseline).
Outcome measures
| Measure |
Exenatide (BET)
n=247 Participants
Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
|
Insulin Lispro (BBT)
n=263 Participants
Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
|
|---|---|---|
|
Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 30
|
-1.13 percent of hemoglobin
Standard Error 0.053
|
-1.10 percent of hemoglobin
Standard Error 0.051
|
SECONDARY outcome
Timeframe: Week 30Population: Participants included in the analysis = 244 and 263, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (244, 263, respectively).
Percentage of participants achieving HbA1C \< 7.0%
Outcome measures
| Measure |
Exenatide (BET)
n=244 Participants
Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
|
Insulin Lispro (BBT)
n=263 Participants
Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
|
|---|---|---|
|
Percentage of Participants Achieving HbA1C < 7.0%
|
46.7 Percentage of participants
|
42.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 30Population: Participants included in the analysis = 244 and 263, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (244, 263, respectively).
Percent of participants achieving HbA1c ≤ 6.5%.
Outcome measures
| Measure |
Exenatide (BET)
n=244 Participants
Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
|
Insulin Lispro (BBT)
n=263 Participants
Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
|
|---|---|---|
|
Percent of Participants Achieving HbA1c ≤ 6.5%.
|
26.2 percentage of participants
|
25.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 30Population: Participants included in the analysis = 243 and 262, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (243, 262, respectively).
Change in fasting blood glucose (FBG) from Baseline to Week 30 using MMRM model. The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.
Outcome measures
| Measure |
Exenatide (BET)
n=243 Participants
Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
|
Insulin Lispro (BBT)
n=262 Participants
Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
|
|---|---|---|
|
Change in Fasting Blood Glucose (FBG) From Baseline to Week 30.
|
-0.46 mmol/L
Standard Error 0.155
|
0.18 mmol/L
Standard Error 0.150
|
SECONDARY outcome
Timeframe: Baseline, week 30Population: Participants included in the analysis = 237 and 254, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (237, 254, respectively).
Change in total cholesterol from baseline to Week 30 using ANCOVA model. The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate.
Outcome measures
| Measure |
Exenatide (BET)
n=237 Participants
Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
|
Insulin Lispro (BBT)
n=254 Participants
Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
|
|---|---|---|
|
Change in Total Cholesterol From Baseline to Week 30
|
-0.14 mmol/L
Standard Error 0.050
|
-0.03 mmol/L
Standard Error 0.049
|
SECONDARY outcome
Timeframe: Baseline, week 30Population: Participants included in the analysis = 237 and 254, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (237, 254, respectively).
Change in High Density Lipoprotein (HDL) from baseline to Week 30 using ANCOVA model.The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate.
Outcome measures
| Measure |
Exenatide (BET)
n=237 Participants
Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
|
Insulin Lispro (BBT)
n=254 Participants
Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
|
|---|---|---|
|
Change in High Density Lipoprotein (HDL) From Baseline to Week 30
|
-0.04 mmol/L
Standard Error 0.012
|
0.03 mmol/L
Standard Error 0.012
|
SECONDARY outcome
Timeframe: Baseline, Week 30Population: Participants included in the analysis = 232 and 245, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (232, 245, respectively).
Change in Low Density Lipoprotein (LDL) from baseline to week 30 using ANCOVA model.The model included the respective secondary outcome as dependent variable, country, prior use of SU's and treatment groups as factors, and the respective outcomes baseline value as a covariate.
Outcome measures
| Measure |
Exenatide (BET)
n=232 Participants
Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
|
Insulin Lispro (BBT)
n=245 Participants
Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
|
|---|---|---|
|
Change in Low Density Lipoprotein (LDL) From Baseline to Week 30
|
-0.12 mmol/L
Standard Error 0.042
|
-0.03 mmol/L
Standard Error 0.042
|
SECONDARY outcome
Timeframe: baseline, week 30Population: Participants analyzed were 247 and 263, respectively. These were from the per protocol population (247, 263, respectively) with no missing data (247, 263, respectively).
Change in body weight from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.
Outcome measures
| Measure |
Exenatide (BET)
n=247 Participants
Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
|
Insulin Lispro (BBT)
n=263 Participants
Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
|
|---|---|---|
|
Change in Body Weight From Baseline to Week 30.
|
-2.45 kg
Standard Error 0.255
|
2.11 kg
Standard Error 0.247
|
SECONDARY outcome
Timeframe: Baseline, Week 30Population: Participants included in the analysis = 207 and 227, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (207, 227, respectively).
Change in Systolic Blood Pressure (SBP) from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.
Outcome measures
| Measure |
Exenatide (BET)
n=207 Participants
Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
|
Insulin Lispro (BBT)
n=227 Participants
Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
|
|---|---|---|
|
Change in Systolic Blood Pressure (SBP) From Baseline to Week 30
|
-4.13 mmHg
Standard Error 0.952
|
0.37 mmHg
Standard Error 0.919
|
SECONDARY outcome
Timeframe: baseline, Week 30Population: Participants included in the analysis = 207 and 227, respectively. These numbers derived from the per protocol population (247 and 263, respectively) with no missing data for this endpoint (207, 227, respectively).
Change in Diastolic Blood Pressure (DBP) from baseline to Week 30 using MMRM model.The model included the respective baseline outcome as covariate, treatment, country, prior use of SUs, week of visit, and treatment-by-week interaction as fixed effects and patient and error as random effects.
Outcome measures
| Measure |
Exenatide (BET)
n=207 Participants
Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
|
Insulin Lispro (BBT)
n=227 Participants
Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
|
|---|---|---|
|
Change in Diastolic Blood Pressure (DBP) From Baseline to Week 30
|
-0.64 mmHg
Standard Error 0.594
|
-0.14 mmHg
Standard Error 0.572
|
SECONDARY outcome
Timeframe: Baseline, week 30Population: Participants analyzed were from the per protocol population (247, 263) with no missing data for this endpoint (247, 263, respectively).
Daily Insulin Glargine Dose at baseline and at Week 30
Outcome measures
| Measure |
Exenatide (BET)
n=247 Participants
Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
|
Insulin Lispro (BBT)
n=263 Participants
Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
|
|---|---|---|
|
Daily Insulin Glargine Dose at Baseline and at Week 30
Baseline
|
61.5 IU/day
Standard Deviation 30.94
|
61.1 IU/day
Standard Deviation 35.24
|
|
Daily Insulin Glargine Dose at Baseline and at Week 30
Week 30
|
56.9 IU/day
Standard Deviation 29.35
|
51.5 IU/day
Standard Deviation 31.44
|
SECONDARY outcome
Timeframe: 30 weeksPopulation: The As-treated population includes all randomized participants who had taken at least one dose of study drug.
Mean (standard deviation) of major hyperglycemia episodes experienced per year. Rates per year were calculated for each individual as the number of episodes divided by the total number of days in the study (from randomization to last visit date), then multiplied by 365.25. Major hypoglycemia was defined as any symptoms consistent with hypoglycemia resulting in loss of consciousness or seizure that shows prompt recovery in response to administration of glucagon or glucose OR documented hypoglycemia (blood glucose \<3.0 mmol/L \[54 mg/dL\]) and requiring the assistance of another person because of severe impairment in consciousness or behavior.
Outcome measures
| Measure |
Exenatide (BET)
n=315 Participants
Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
|
Insulin Lispro (BBT)
n=312 Participants
Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
|
|---|---|---|
|
Major Hypoglycemia Rate Per Year
|
0.0 rate per year
Standard Deviation 0.23 • Interval 0.0 to 0.0
|
0.1 rate per year
Standard Deviation 0.39 • Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 30 weeksPopulation: The As-treated population includes all randomized participants who had taken at least one dose of study drug.
Mean (standard deviation) of minor hyperglycemia episodes experienced per year. Rates per year were calculated for each individual as the number of episodes divided by the total number of days in the study (from randomization to last visit date), then multiplied by 365.25. Minor hypoglycemia was defined as any time a participant feels that he or she is experiencing a sign or symptom associated with hypoglycemia that is either self-treated by the participant or resolves on its own AND has a concurrent finger stick blood glucose \<3.0 mmol/L (54 mg/dL)
Outcome measures
| Measure |
Exenatide (BET)
n=315 Participants
Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
|
Insulin Lispro (BBT)
n=312 Participants
Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
|
|---|---|---|
|
Minor Hypoglycemia Rate Per Year
|
2.1 rate per year
Standard Deviation 5.08 • Interval 1.45 to 2.07
|
5.0 rate per year
Standard Deviation 12.83 • Interval 3.26 to 4.54
|
Adverse Events
Exenatide (BET)
Serious events: 23 serious events
Other events: 228 other events
Deaths: 0 deaths
Insulin Lispro (BBT)
Serious events: 26 serious events
Other events: 175 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Exenatide (BET)
n=315 participants at risk
Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
|
Insulin Lispro (BBT)
n=312 participants at risk
Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
|
|---|---|---|
|
Eye disorders
Glaucoma
|
0.00%
0/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.32%
1/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.32%
1/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.00%
0/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.32%
1/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Cardiac disorders
Angina unstable
|
0.63%
2/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.32%
1/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.32%
1/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.00%
0/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Cardiac disorders
Coronary artery disease
|
0.32%
1/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.32%
1/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.64%
2/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.32%
1/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.32%
1/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.32%
1/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Eye disorders
Vitreous haemorrhage
|
0.63%
2/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.00%
0/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Eye disorders
Diabetic retinopathy
|
0.32%
1/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.00%
0/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Eye disorders
Cataract
|
0.00%
0/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.32%
1/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.32%
1/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.00%
0/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Gastrointestinal disorders
Nausea
|
0.32%
1/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.00%
0/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.32%
1/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.32%
1/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.32%
1/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Infections and infestations
Osteomyelitis
|
0.32%
1/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.00%
0/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Infections and infestations
Pyelonephritis
|
0.32%
1/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.00%
0/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Infections and infestations
Urinary tract infection
|
0.32%
1/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.32%
1/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.32%
1/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.32%
1/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.64%
2/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.32%
1/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.32%
1/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.32%
1/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.00%
0/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Injury, poisoning and procedural complications
Fall
|
0.32%
1/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.00%
0/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.32%
1/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.00%
0/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.00%
0/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.32%
1/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Investigations
Ureteroscopy
|
0.32%
1/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.00%
0/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.32%
1/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.00%
0/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.32%
1/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.32%
1/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.32%
1/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.32%
1/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.00%
0/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.32%
1/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.32%
1/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Nervous system disorders
Carotid artery thrombosis
|
0.32%
1/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.00%
0/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Nervous system disorders
Encephalopathy
|
0.32%
1/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.00%
0/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.32%
1/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.00%
0/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Nervous system disorders
Ischaemic stroke
|
0.32%
1/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.00%
0/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.32%
1/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.00%
0/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.32%
1/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.32%
1/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.00%
0/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Renal and urinary disorders
Calculus urinary
|
0.32%
1/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.00%
0/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Renal and urinary disorders
Renal failure acute
|
0.32%
1/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.00%
0/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.64%
2/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.32%
1/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.00%
0/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.32%
1/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Surgical and medical procedures
Arterial bypass operation
|
0.00%
0/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.32%
1/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
0.00%
0/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.32%
1/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Vascular disorders
Hypertensive crisis
|
0.32%
1/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.00%
0/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
Other adverse events
| Measure |
Exenatide (BET)
n=315 participants at risk
Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
|
Insulin Lispro (BBT)
n=312 participants at risk
Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
10.8%
34/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
5.1%
16/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.0%
19/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.96%
3/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Gastrointestinal disorders
Nausea
|
32.4%
102/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
1.6%
5/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Gastrointestinal disorders
Vomiting
|
12.4%
39/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.96%
3/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Infections and infestations
Bronchitis
|
5.7%
18/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
1.9%
6/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Infections and infestations
Influenza
|
5.7%
18/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
5.1%
16/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Infections and infestations
Nasopharyngitis
|
11.7%
37/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
6.4%
20/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Nervous system disorders
Headache
|
5.7%
18/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
3.5%
11/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.8%
12/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
1.6%
5/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
3.8%
12/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.00%
0/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.5%
11/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.32%
1/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Infections and infestations
Urinary tract infection
|
3.5%
11/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
2.2%
7/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Nervous system disorders
Dizziness
|
3.2%
10/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
1.3%
4/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Infections and infestations
Pharyngitis
|
2.9%
9/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
2.2%
7/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Infections and infestations
Gastroenteritis
|
2.5%
8/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.64%
2/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Gastrointestinal disorders
Constipation
|
2.2%
7/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.64%
2/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Gastrointestinal disorders
Gastritis
|
1.9%
6/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.96%
3/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.9%
6/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.64%
2/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
General disorders
pain in extremity
|
1.6%
5/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
1.9%
6/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.6%
5/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
1.3%
4/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Immune system disorders
seasonal allergy
|
1.6%
5/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
0.32%
1/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
1.3%
4/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
2.9%
9/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
0.95%
3/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
2.2%
7/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Infections and infestations
upper respiratory tract infection
|
0.95%
3/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
1.9%
6/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Infections and infestations
tooth infection
|
0.63%
2/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
2.2%
7/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Vascular disorders
hypertension
|
0.63%
2/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
1.9%
6/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.63%
2/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
1.6%
5/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Psychiatric disorders
anxiety
|
0.63%
2/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
1.6%
5/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Gastrointestinal disorders
toothache
|
0.32%
1/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
1.9%
6/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
|
Blood and lymphatic system disorders
anemia
|
0.32%
1/315
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
1.6%
5/312
As treated population, non-serious includes treatment emergent adverse events in both BIO (lead in) and intervention phases.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place