Trial Outcomes & Findings for A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients (NCT NCT00360334)
NCT ID: NCT00360334
Last Updated: 2015-04-07
Results Overview
Composite endpoint evaluating effect of treatment on glycemic control and weight
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
235 participants
Primary outcome timeframe
26 weeks
Results posted on
2015-04-07
Participant Flow
This study was conducted at 35 study centers in the United Kingdom. Recruitment occurred from June 2006 to October 2007.
One patient assigned to the Insulin Glargine group withdrew from the study prior to receiving study drug. This patient is not included in the analysis set.
Participant milestones
| Measure |
Exenatide
5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
|
Insulin Glargine
dosing based on treat to target protocol
|
|---|---|---|
|
Overall Study
STARTED
|
118
|
117
|
|
Overall Study
Full Analysis Set (FAS)
|
118
|
116
|
|
Overall Study
COMPLETED
|
99
|
104
|
|
Overall Study
NOT COMPLETED
|
19
|
13
|
Reasons for withdrawal
| Measure |
Exenatide
5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
|
Insulin Glargine
dosing based on treat to target protocol
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
4
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Physician Decision
|
2
|
3
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Entry criterion not met
|
1
|
2
|
|
Overall Study
Subject decision
|
8
|
2
|
Baseline Characteristics
A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients
Baseline characteristics by cohort
| Measure |
Exenatide
n=118 Participants
5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
|
Insulin Glargine
n=116 Participants
dosing based on treat to target protocol
|
Total
n=234 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
56.2 years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
56.5 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
118 participants
n=5 Participants
|
116 participants
n=7 Participants
|
234 participants
n=5 Participants
|
|
Types of oral antidiabetic medication combinations administered at baseline
metformin and sulfonylurea
|
50 participants
n=5 Participants
|
49 participants
n=7 Participants
|
99 participants
n=5 Participants
|
|
Types of oral antidiabetic medication combinations administered at baseline
metformin and thiazolidinedione
|
17 participants
n=5 Participants
|
15 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Types of oral antidiabetic medication combinations administered at baseline
sulfonylurea and thiazolidinedione
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Types of oral antidiabetic medication combinations administered at baseline
metformin, sulfonylurea, and thiazolidinedione
|
48 participants
n=5 Participants
|
47 participants
n=7 Participants
|
95 participants
n=5 Participants
|
|
Types of oral antidiabetic medication combinations administered at baseline
other
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Baseline apolipoprotein-B
|
0.84 g/L
STANDARD_DEVIATION 0.24 • n=5 Participants
|
0.88 g/L
STANDARD_DEVIATION 0.24 • n=7 Participants
|
0.86 g/L
STANDARD_DEVIATION 0.24 • n=5 Participants
|
|
Baseline fasting serum glucose
|
10.84 mmol/L
STANDARD_DEVIATION 2.23 • n=5 Participants
|
10.12 mmol/L
STANDARD_DEVIATION 2.22 • n=7 Participants
|
10.48 mmol/L
STANDARD_DEVIATION 2.25 • n=5 Participants
|
|
Baseline fasting serum total cholesterol (TC)
|
4.45 mmol/L
STANDARD_DEVIATION 1.05 • n=5 Participants
|
4.63 mmol/L
STANDARD_DEVIATION 1.20 • n=7 Participants
|
4.54 mmol/L
STANDARD_DEVIATION 1.13 • n=5 Participants
|
|
Baseline fasting serum triglycerides
|
1.94 mmol/L
STANDARD_DEVIATION 1.01 • n=5 Participants
|
2.31 mmol/L
STANDARD_DEVIATION 2.24 • n=7 Participants
|
2.13 mmol/L
STANDARD_DEVIATION 1.75 • n=5 Participants
|
|
Baseline high density lipoprotein (HDL) cholesterol
|
1.14 mmol/L
STANDARD_DEVIATION 0.24 • n=5 Participants
|
1.15 mmol/L
STANDARD_DEVIATION 0.29 • n=7 Participants
|
1.15 mmol/L
STANDARD_DEVIATION 0.27 • n=5 Participants
|
|
Baseline low density lipoprotein (LDL) cholesterol
|
2.38 mmol/L
STANDARD_DEVIATION 0.82 • n=5 Participants
|
2.49 mmol/L
STANDARD_DEVIATION 1.02 • n=7 Participants
|
2.43 mmol/L
STANDARD_DEVIATION 0.93 • n=5 Participants
|
|
Baseline total cholesterol to high density lipoprotein cholesterol ratio
|
4.00 ratio
STANDARD_DEVIATION 1.10 • n=5 Participants
|
4.29 ratio
STANDARD_DEVIATION 2.15 • n=7 Participants
|
4.15 ratio
STANDARD_DEVIATION 1.72 • n=5 Participants
|
PRIMARY outcome
Timeframe: 26 weeksPopulation: Full Analysis Set; The last post-baseline measurement set of both non-missing HbA1c and weight was used as endpoint value. Patients who did not have a baseline weight measurement and/or missing post-baseline measurements for HbA1c and/or weight were included in the analysis as non-responders.
Composite endpoint evaluating effect of treatment on glycemic control and weight
Outcome measures
| Measure |
Exenatide
n=118 Participants
5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
|
Insulin Glargine
n=116 Participants
dosing based on treat to target protocol
|
|---|---|---|
|
Percent of Patients Who Achieved HbA1c ≤ 7.4% With Minimal Weight Gain (≤ 1kg)
|
53.4 percentage of participants
|
19.8 percentage of participants
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Full Analysis Set; The last post-baseline measurement set of both non-missing HbA1c and weight was used as endpoint value. Patients who did not have a baseline weight measurement and/or missing post-baseline measurements for HbA1c and/or weight were included in the analysis as non-responders.
Composite endpoint evaluating effect of treatment on glycemic control and weight
Outcome measures
| Measure |
Exenatide
n=118 Participants
5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
|
Insulin Glargine
n=116 Participants
dosing based on treat to target protocol
|
|---|---|---|
|
Percent of Patients Who Achieved HbA1c ≤ 7.4% and Weight Gain ≤ 0.5kg
|
52.5 Percentage of participants
|
16.4 Percentage of participants
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Full Analysis Set, Last Observation Carried Forward
Change in fasting serum glucose from baseline (week 0) to endpoint (week 26)
Outcome measures
| Measure |
Exenatide
n=103 Participants
5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
|
Insulin Glargine
n=101 Participants
dosing based on treat to target protocol
|
|---|---|---|
|
Change in Fasting Serum Glucose
|
-2.12 mmol/L
Standard Error 0.25
|
-3.61 mmol/L
Standard Error 0.25
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Full Analysis Set, Last Observation Carried Forward. Patients with no post-baseline HbA1c measurement are regarded as non-responders in the analysis.
Percent of patients achieving specified HbA1c target at endpoint
Outcome measures
| Measure |
Exenatide
n=118 Participants
5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
|
Insulin Glargine
n=116 Participants
dosing based on treat to target protocol
|
|---|---|---|
|
Percent of Patients Achieving HbA1c ≤ 7.4%
|
54.2 Percentage of participants
|
61.2 Percentage of participants
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Full Analysis Set, Last Observation Carried Forward. Patients with no post-baseline HbA1c measurement are regarded as non-responders in the analysis.
Percent of patients achieving specified HbA1c target at endpoint
Outcome measures
| Measure |
Exenatide
n=118 Participants
5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
|
Insulin Glargine
n=116 Participants
dosing based on treat to target protocol
|
|---|---|---|
|
Percent of Patients Achieving HbA1c < 7%
|
34.7 Percentage of participants
|
43.1 Percentage of participants
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Full Analysis Set, Last Observation Carried Forward. Patients with no post-baseline HbA1c measurement are regarded as non-responders in the analysis.
Percent of patients achieving specified HbA1c target at endpoint
Outcome measures
| Measure |
Exenatide
n=118 Participants
5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
|
Insulin Glargine
n=116 Participants
dosing based on treat to target protocol
|
|---|---|---|
|
Percent of Patients Achieving HbA1c < 6.5%
|
15.3 Percentage of participants
|
11.2 Percentage of participants
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Full Analysis Set, Last Observation Carried Forward
Change from baseline to endpoint in self monitored blood glucose levels measured at 7 time points during the day
Outcome measures
| Measure |
Exenatide
n=118 Participants
5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
|
Insulin Glargine
n=116 Participants
dosing based on treat to target protocol
|
|---|---|---|
|
Change in 7 Point Self Monitored Blood Glucose Profile
Pre-breakfast: Baseline (Week 0)
|
9.98 mmol/L
Standard Deviation 2.11
|
9.88 mmol/L
Standard Deviation 2.07
|
|
Change in 7 Point Self Monitored Blood Glucose Profile
Pre-breakfast: Change at endpoint (Week 26)
|
-2.01 mmol/L
Standard Deviation 2.14
|
-3.99 mmol/L
Standard Deviation 2.39
|
|
Change in 7 Point Self Monitored Blood Glucose Profile
2 hrs after breakfast: Baseline (Week 0)
|
13.53 mmol/L
Standard Deviation 3.07
|
13.33 mmol/L
Standard Deviation 2.87
|
|
Change in 7 Point Self Monitored Blood Glucose Profile
2 hrs after breakfast: Change at endpt (Week 26)
|
-5.09 mmol/L
Standard Deviation 3.52
|
-3.95 mmol/L
Standard Deviation 3.89
|
|
Change in 7 Point Self Monitored Blood Glucose Profile
Pre-lunch: Baseline (Week 0)
|
9.95 mmol/L
Standard Deviation 3.24
|
9.54 mmol/L
Standard Deviation 2.71
|
|
Change in 7 Point Self Monitored Blood Glucose Profile
Pre-lunch: Change at endpoint (Week 26)
|
-2.21 mmol/L
Standard Deviation 3.11
|
-2.59 mmol/L
Standard Deviation 3.27
|
|
Change in 7 Point Self Monitored Blood Glucose Profile
2 hrs after lunch: Baseline (Week 0)
|
12.07 mmol/L
Standard Deviation 3.27
|
11.15 mmol/L
Standard Deviation 2.59
|
|
Change in 7 Point Self Monitored Blood Glucose Profile
2 hrs after lunch: Change at endpoint (Week 26)
|
-3.20 mmol/L
Standard Deviation 3.30
|
-2.48 mmol/L
Standard Deviation 3.17
|
|
Change in 7 Point Self Monitored Blood Glucose Profile
Pre-dinner: Baseline (Week 0)
|
9.95 mmol/L
Standard Deviation 2.97
|
9.37 mmol/L
Standard Deviation 2.73
|
|
Change in 7 Point Self Monitored Blood Glucose Profile
Pre-dinner: Change at endpoint (Week 26)
|
-2.13 mmol/L
Standard Deviation 2.89
|
-1.46 mmol/L
Standard Deviation 4.76
|
|
Change in 7 Point Self Monitored Blood Glucose Profile
2 hrs after dinner: Baseline (Week 0)
|
12.59 mmol/L
Standard Deviation 3.28
|
11.80 mmol/L
Standard Deviation 2.62
|
|
Change in 7 Point Self Monitored Blood Glucose Profile
2 hrs after dinner: Change at endpoint (Week 26)
|
-4.59 mmol/L
Standard Deviation 3.30
|
-2.06 mmol/L
Standard Deviation 3.22
|
|
Change in 7 Point Self Monitored Blood Glucose Profile
Bedtime: Baseline (Week 0)
|
11.63 mmol/L
Standard Deviation 3.23
|
11.24 mmol/L
Standard Deviation 3.05
|
|
Change in 7 Point Self Monitored Blood Glucose Profile
Bedtime: Change at endpoint (Week 26)
|
-3.56 mmol/L
Standard Deviation 3.19
|
-2.20 mmol/L
Standard Deviation 3.47
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Full Analysis Set
Change in BMI from baseline to endpoint
Outcome measures
| Measure |
Exenatide
n=117 Participants
5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
|
Insulin Glargine
n=114 Participants
dosing based on treat to target protocol
|
|---|---|---|
|
Change in Body Mass Index (BMI)
Baseline (Week 0)
|
34.49 kg/m^2
Standard Error 0.49
|
33.71 kg/m^2
Standard Error 0.49
|
|
Change in Body Mass Index (BMI)
Change at endpoint (Week 26)
|
-0.95 kg/m^2
Standard Error 0.11
|
1.01 kg/m^2
Standard Error 0.11
|
SECONDARY outcome
Timeframe: 26 WeeksPopulation: Full Analysis Set
Change in waist circumference from baseline to endpoint
Outcome measures
| Measure |
Exenatide
n=117 Participants
5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
|
Insulin Glargine
n=113 Participants
dosing based on treat to target protocol
|
|---|---|---|
|
Change in Waist Circumference
Baseline (Week 0)
|
112.07 cm
Standard Error 1.30
|
110.64 cm
Standard Error 1.32
|
|
Change in Waist Circumference
Change at endpoint (Week 26)
|
-2.19 cm
Standard Error 0.54
|
1.97 cm
Standard Error 0.54
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Full Analysis Set
Change in waist-to-hip ratio from baseline to endpoint
Outcome measures
| Measure |
Exenatide
n=117 Participants
5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
|
Insulin Glargine
n=112 Participants
dosing based on treat to target protocol
|
|---|---|---|
|
Change in Waist-to-hip Ratio
Baseline (Week 0)
|
0.99 Ratio
Standard Error 0.01
|
0.98 Ratio
Standard Error 0.01
|
|
Change in Waist-to-hip Ratio
Change at endpoint (Week 26)
|
-0.02 Ratio
Standard Error 0.00
|
0.01 Ratio
Standard Error 0.00
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Full Analysis Set
Change in body weight from baseline to endpoint
Outcome measures
| Measure |
Exenatide
n=117 Participants
5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
|
Insulin Glargine
n=113 Participants
dosing based on treat to target protocol
|
|---|---|---|
|
Change in Body Weight
Baseline (Week 0)
|
101.19 kg
Standard Error 1.68
|
97.93 kg
Standard Error 1.70
|
|
Change in Body Weight
Change at endpoint (Week 26)
|
-2.73 kg
Standard Error 0.31
|
2.98 kg
Standard Error 0.31
|
SECONDARY outcome
Timeframe: 26 WeeksPopulation: Full Analysis Set
Percent change in baseline body weight at endpoint
Outcome measures
| Measure |
Exenatide
n=117 Participants
5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
|
Insulin Glargine
n=113 Participants
dosing based on treat to target protocol
|
|---|---|---|
|
Percent Change in Body Weight
|
-2.8 Percentage
Standard Error 0.3
|
3.1 Percentage
Standard Error 0.3
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Full Analysis Set, Last Observation Carried Forward. For change in weight, patients should have a baseline and at least one post-baseline weight measurement. Otherwise, these patients are included as non-responders in the analysis.
Percent of patients who lost at least 5% of baseline body weight at endpoint
Outcome measures
| Measure |
Exenatide
n=118 Participants
5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
|
Insulin Glargine
n=116 Participants
dosing based on treat to target protocol
|
|---|---|---|
|
Percent of Patients Achieving 5% Weight Loss
|
19.5 Percentage of participants
|
0.9 Percentage of participants
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Full Analysis Set, Last Observation Carried Forward. For change in weight, patients should have a baseline and at least one post-baseline weight measurement. Otherwise, these patients are included as non-responders in the analysis.
Percent of patients who lost at least 10% of baseline body weight at endpoint
Outcome measures
| Measure |
Exenatide
n=118 Participants
5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
|
Insulin Glargine
n=116 Participants
dosing based on treat to target protocol
|
|---|---|---|
|
Percent of Patients Achieving 10% Weight Loss
|
4.2 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Full Analysis Set
Change in systolic blood pressure from baseline to endpoint
Outcome measures
| Measure |
Exenatide
n=117 Participants
5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
|
Insulin Glargine
n=113 Participants
dosing based on treat to target protocol
|
|---|---|---|
|
Change in Systolic Blood Pressure
Baseline (Week 0)
|
134.0 mmHg
Standard Error 1.5
|
134.7 mmHg
Standard Error 1.5
|
|
Change in Systolic Blood Pressure
Change at endpoint (Week 26)
|
-3.6 mmHg
Standard Error 1.2
|
0.6 mmHg
Standard Error 1.2
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Full Analysis Set
Change in diastolic blood pressure from baseline to endpoint
Outcome measures
| Measure |
Exenatide
n=117 Participants
5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
|
Insulin Glargine
n=113 Participants
dosing based on treat to target protocol
|
|---|---|---|
|
Change in Diastolic Blood Pressure
Baseline (Week 0)
|
79.6 mmHg
Standard Error 0.8
|
79.7 mmHg
Standard Error 0.8
|
|
Change in Diastolic Blood Pressure
Change at endpoint (Week 26)
|
-0.8 mmHg
Standard Error 0.7
|
0.9 mmHg
Standard Error 0.7
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Full Analysis Set, Last Observation Carried Forward
Change in TC from baseline to endpoint
Outcome measures
| Measure |
Exenatide
n=105 Participants
5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
|
Insulin Glargine
n=108 Participants
dosing based on treat to target protocol
|
|---|---|---|
|
Change in Fasting Serum Total Cholesterol (TC)
|
-0.36 mmol/L
Standard Error 0.07
|
-0.21 mmol/L
Standard Error 0.07
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Full Analysis Set, Last Observation Carried Forward
Change in HDL cholesterol from baseline to endpoint
Outcome measures
| Measure |
Exenatide
n=101 Participants
5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
|
Insulin Glargine
n=106 Participants
dosing based on treat to target protocol
|
|---|---|---|
|
Change in High Density Lipoprotein (HDL) Cholesterol
|
0.01 mmol/L
Standard Error 0.01
|
0.02 mmol/L
Standard Error 0.01
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Full Analysis Set, Last Observation Carried Forward
Change in TC to HDL cholesterol ratio from baseline to endpoint
Outcome measures
| Measure |
Exenatide
n=101 Participants
5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
|
Insulin Glargine
n=106 Participants
dosing based on treat to target protocol
|
|---|---|---|
|
Change in TC to HDL Cholesterol Ratio
|
-0.40 Ratio
Standard Error 0.10
|
-0.34 Ratio
Standard Error 0.09
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Full Analysis Set, Last Observation Carried Forward
Change in fasting serum triglycerides from baseline to endpoint
Outcome measures
| Measure |
Exenatide
n=105 Participants
5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
|
Insulin Glargine
n=108 Participants
dosing based on treat to target protocol
|
|---|---|---|
|
Change in Fasting Serum Triglycerides
|
-0.33 mmol/L
Standard Error 0.08
|
-0.38 mmol/L
Standard Error 0.08
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Full Analysis Set, Last Observation Carried Forward
Change in LDL cholesterol from baseline to endpoint
Outcome measures
| Measure |
Exenatide
n=95 Participants
5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
|
Insulin Glargine
n=101 Participants
dosing based on treat to target protocol
|
|---|---|---|
|
Change in Low Density Lipoprotein (LDL) Cholesterol
|
-0.25 mmol/L
Standard Error 0.06
|
-0.07 mmol/L
Standard Error 0.05
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Full Analysis Set, Last Observation Carried Forward
Change in apolipoprotein-B from baseline to endpoint
Outcome measures
| Measure |
Exenatide
n=104 Participants
5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
|
Insulin Glargine
n=109 Participants
dosing based on treat to target protocol
|
|---|---|---|
|
Change in Apolipoprotein-B
|
-0.09 g/L
Standard Error 0.02
|
-0.08 g/L
Standard Error 0.02
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Full Analysis Set
Percent of total patients in each arm experiencing hypoglycemia at any point in the 26 week study
Outcome measures
| Measure |
Exenatide
n=118 Participants
5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
|
Insulin Glargine
n=114 Participants
dosing based on treat to target protocol
|
|---|---|---|
|
Incidence of Hypoglycemic Episodes
|
50.0 percent
|
59.6 percent
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Full Analysis Set
Percent of total patients in each arm experiencing nocturnal hypoglycemia at any point in the 26 week study
Outcome measures
| Measure |
Exenatide
n=118 Participants
5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
|
Insulin Glargine
n=114 Participants
dosing based on treat to target protocol
|
|---|---|---|
|
Incidence of Nocturnal Hypoglycemic Episodes
|
11.9 percent
|
29.8 percent
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Full Analysis Set
Percent of total patients in each arm experiencing severe hypoglycemia at any point during the 26 week study
Outcome measures
| Measure |
Exenatide
n=118 Participants
5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
|
Insulin Glargine
n=114 Participants
dosing based on treat to target protocol
|
|---|---|---|
|
Incidence of Severe Hypoglycemic Episodes
|
4.2 percent
|
5.3 percent
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Full Analysis Set
Number of hypoglycemic episodes per patient adjusted per 30 days
Outcome measures
| Measure |
Exenatide
n=118 Participants
5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
|
Insulin Glargine
n=114 Participants
dosing based on treat to target protocol
|
|---|---|---|
|
Hypoglycemic Rate Per 30 Days
|
0.069 Number of episodes per 30 days
Interval 0.0 to 0.495
|
0.164 Number of episodes per 30 days
Interval 0.0 to 0.686
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Full Analysis Set
Number of nocturnal hypoglycemic episodes per patient adjusted per 30 days
Outcome measures
| Measure |
Exenatide
n=118 Participants
5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
|
Insulin Glargine
n=114 Participants
dosing based on treat to target protocol
|
|---|---|---|
|
Nocturnal Hypoglycemic Rate Per 30 Days
|
0.000 Number of episodes per 30 days
Interval 0.0 to 0.0
|
0.000 Number of episodes per 30 days
Interval 0.0 to 0.163
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Full Analysis Set
Number of severe hypoglycemic episodes per patient adjusted per 30 days
Outcome measures
| Measure |
Exenatide
n=118 Participants
5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
|
Insulin Glargine
n=114 Participants
dosing based on treat to target protocol
|
|---|---|---|
|
Severe Hypoglycemic Rate Per 30 Days
|
0.000 Number of episodes per 30 days
Interval 0.0 to 0.989
|
0.000 Number of episodes per 30 days
Interval 0.0 to 0.328
|
Adverse Events
Exenatide
Serious events: 5 serious events
Other events: 105 other events
Deaths: 0 deaths
Insulin Glargine
Serious events: 5 serious events
Other events: 94 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Exenatide
5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
|
Insulin Glargine
dosing based on treat to target protocol
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Infections and infestations
Campylobacter infection
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Psychiatric disorders
Confusional state
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Musculoskeletal and connective tissue disorders
Epistaxis
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Injury, poisoning and procedural complications
Fall
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Respiratory, thoracic and mediastinal disorders
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Renal and urinary disorders
Renal failure acute
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.85%
1/118 • Number of events 1
|
0.00%
0/116
|
|
Injury, poisoning and procedural complications
Wrong drug administered
|
0.00%
0/118
|
0.86%
1/116 • Number of events 1
|
Other adverse events
| Measure |
Exenatide
5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
|
Insulin Glargine
dosing based on treat to target protocol
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
48.3%
57/118
|
2.6%
3/116
|
|
Infections and infestations
Nasopharyngitis
|
20.3%
24/118
|
19.8%
23/116
|
|
Gastrointestinal disorders
Diarrhoea
|
18.6%
22/118
|
12.1%
14/116
|
|
Nervous system disorders
Headache
|
14.4%
17/118
|
15.5%
18/116
|
|
Gastrointestinal disorders
Vomiting
|
21.2%
25/118
|
5.2%
6/116
|
|
Infections and infestations
Lower respiratory tract infection
|
8.5%
10/118
|
10.3%
12/116
|
|
Gastrointestinal disorders
Abdominal distension
|
16.1%
19/118
|
0.86%
1/116
|
|
Gastrointestinal disorders
Dyspepsia
|
16.9%
20/118
|
0.00%
0/116
|
|
General disorders
Early satiety
|
16.9%
20/118
|
0.00%
0/116
|
|
Gastrointestinal disorders
Flatulence
|
15.3%
18/118
|
0.86%
1/116
|
|
Infections and infestations
Influenza
|
6.8%
8/118
|
9.5%
11/116
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.5%
3/118
|
12.9%
15/116
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.2%
5/118
|
10.3%
12/116
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.4%
4/118
|
11.2%
13/116
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
4.2%
5/118
|
8.6%
10/116
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.2%
5/118
|
7.8%
9/116
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
11.9%
14/118
|
0.00%
0/116
|
|
Gastrointestinal disorders
Eructation
|
11.0%
13/118
|
0.00%
0/116
|
|
Gastrointestinal disorders
Abdominal Pain
|
10.2%
12/118
|
0.00%
0/116
|
|
Metabolism and nutrition disorders
Anorexia
|
9.3%
11/118
|
0.86%
1/116
|
|
Nervous system disorders
Dysgeusia
|
8.5%
10/118
|
0.00%
0/116
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.1%
6/118
|
3.4%
4/116
|
|
General disorders
Oedema peripheral
|
0.85%
1/118
|
6.9%
8/116
|
|
General disorders
Injection site bruising
|
5.1%
6/118
|
1.7%
2/116
|
|
General disorders
Pain
|
1.7%
2/118
|
5.2%
6/116
|
|
Gastrointestinal disorders
Bowel sounds abnormal
|
5.9%
7/118
|
0.00%
0/116
|
|
Nervous system disorders
Dizziness
|
5.1%
6/118
|
0.86%
1/116
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60