Type 2 Diabetes
Conditions
Keywords
diabetes, exenatide, Amylin, Lilly, metformin, pioglitazone, insulin glargine
Brief summary
This study will compare the efficacy and safety of exenatide versus placebo in adults whose diabetes is not fully controlled by insulin glargine with or without metformin and/or pioglitazone.
Interventions
DRUGplacebo
subcutaneous injection, twice a day
DRUGexenatide
subcutaneous injection, twice a day, 10mcg
Sponsors
Eli Lilly and Company
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have type 2 diabetes. * Have been taking insulin glargine at a dose of ≥20 units/day for at least 3 months before entering the study. Have been taking insulin glargine alone or in combination with one of the following for at least 3 months before entering the study: 1. metformin (stable dose for 6 weeks) 2. pioglitazone (stable dose for 6 weeks) 3. a combination of metformin and pioglitazone (stable dose for 6 weeks) * Have HbA1C between 7.1% and 10.5%, inclusive. * Have a body mass index (BMI) ≤45 kg/m2. * Have a history of stable body weight (not varying by \>5% for at least 3 months prior to screening).
Exclusion criteria
* Have taken medications to lower blood sugar other than insulin glargine, pioglitazone, or metformin in the 3 months before entering the study for more than a 1-week period, or within 1 week of entering the study. * Have had more than one episode of major (severe) hypoglycemia in the 6 months before entering the study. * Are pregnant or intend to become pregnant during the study or are sexually active women not actively practicing birth control. * Women who are breastfeeding. * Have any significant diseases of the blood, heart, kidney, gastrointestinal system, or other significant diseases such as cancer. * Have had a kidney transplant or are currently on kidney dialysis. * Have a cancer that's never been treated, that's currently being treated, or that was diagnosed within the last 5 years. * Have had a bad reaction to exenatide in the past or have a condition that is not recommended to be exposed to exenatide or any of exenatide's other ingredients. * Have used a drug for weight loss in the 3 months before entering the study for more than a 1-week period, or within 1 month of entering the study. * Are currently on a weight-loss program or have been on one within 3 months of entering the study. * Have had a blood transfusion or severe blood loss within 3 months of entering the study. * Are taking systemic glucocorticoids or have received systemic glucocorticoids within 8 weeks of entering the study. * Have an irregular sleep cycle (for example, sleeping during the day and working during the night). * Have a history of pancreatitis. * Have received treatment with an experimental drug within 30 days of entering the study. * If on metformin, have a condition that is not recommended to be exposed to metformin, or any condition associated with hypoperfusion, hypoxemia, dehydration, or sepsis. * If on metformin, have had a radiologic contrast study performed within 48 hours of entering the study. * If on pioglitazone, have a condition that is not recommended to be exposed to pioglitazone, including congestive heart failure, or are taking pioglitazone at a dose that is not approved for use with insulin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycosylated Hemoglobin (HbA1c) | baseline and 30 weeks | Change in HbA1c from baseline following 30 weeks of therapy (i.e., HbA1c at week 30 minus HbA1c at baseline). Unit of measure is percent of hemoglobin that is glycosylated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Achieving HbA1c <=6.5% | baseline and 30 weeks | Percentage of patients in each arm who had HbA1c \>6.5% at baseline and had HbA1c \<=6.5% at week 30 (percentage = \[number of subjects with HbA1c \<=6.5% at week 30 divided by number of subjects with HbA1c \>6.5% at baseline\] \* 100%). |
| Change in Fasting Serum Glucose | baseline and 30 weeks | Change in fasting serum glucose following 30 weeks of therapy (i.e., fasting serum glucose at week 30 minus fasting serum glucose at baseline) |
| Change in 7-point Self-monitored Blood Glucose (SMBG) Profile | baseline and 30 weeks | Change in 7-point (pre-breakfast, 2 hour post-breakfast, pre-lunch, 2 hour post-lunch, pre-dinner, 2 hour post-dinner, 0300 hours) SMBG profile from baseline to week 30 (change = blood glucose value at week 30 minus blood glucose value at baseline) |
| Change in Total Cholesterol | baseline and 30 weeks | Change in total cholesterol following 30 weeks of therapy (i.e., total cholesterol at week 30 minus total cholesterol at baseline) |
| Change in Low Density Lipoprotein (LDL) Cholesterol | baseline and 30 weeks | Change in LDL cholesterol following 30 weeks of therapy (i.e., LDL cholesterol at week 30 minus LDL cholesterol at baseline) |
| Change in High Density Lipoprotein (HDL) Cholesterol | baseline and 30 weeks | Change in HDL cholesterol following 30 weeks of therapy (i.e., HDL cholesterol at week 30 minus HDL cholesterol at baseline) |
| Change in Triglycerides | baseline and 30 weeks | Change in triglycerides following 30 weeks of therapy (i.e., triglycerides at week 30 minus triglycerides at baseline) |
| Percentage of Patients Achieving HbA1c <=7% | baseline and 30 weeks | Percentage of patients in each arm who had HbA1c \>7% at baseline and had HbA1c \<=7% at week 30 (percentage = \[number of subjects with HbA1c \<=7% at week 30 divided by number of subjects with HbA1c \>7% at baseline\] \* 100%). |
| Change in Waist Circumference | baseline and 30 weeks | Change in waist circumference following 30 weeks of therapy (i.e., waist circumference at week 30 minus waist circumference at baseline) |
| Change in Daily Insulin Dose | baseline and 30 weeks | Change in daily insulin dose following 30 weeks of therapy (i.e., daily insulin dose at week 30 minus daily insulin dose at baseline) |
| Change in Daily Insulin Dose (on a Per Body Weight Basis) | baseline and 30 weeks | Change in daily insulin dose per kilogram (kg) following 30 weeks of therapy (i.e., daily insulin dose per kg at week 30 minus daily insulin dose per kg at baseline) |
| Change in Systolic Blood Pressure (SBP) | baseline and 30 weeks | Change in SBP following 30 weeks of therapy (i.e., SBP at week 30 minus SBP at baseline) |
| Change in Diastolic Blood Pressure (DBP) | baseline and 30 weeks | Change in DBP following 30 weeks of therapy (i.e., DBP at week 30 minus DBP at baseline) |
| Minor Hypoglycemia Rate Per Year | baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30 | Number of minor hypoglycemia events experienced per subject per year. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose \<3.0 mmol/L (54 mg/dL). |
| Percentage of Subjects Experiencing Minor Hypoglycemia | baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30 | Percentage of subjects in each arm experiencing at least one episode of minor hypoglycemia at any point during the study. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose \<3.0 mmol/L (54 mg/dL). |
| Change in Body Weight | baseline and 30 weeks | Change in body weight following 30 weeks of therapy (i.e., body weight at week 30 minus body weight at baseline) |
Countries
Greece, Israel, Mexico, Puerto Rico, United Kingdom, United States
Participant flow
Pre-assignment details
Two subjects who started the study, subsequently withdrew prior to receiving study medication and are not part of the full analysis set
Participants by arm
| Arm | Count |
|---|---|
| Exenatide Arm Exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 26 weeks (with a background of titrated insulin glargine and other oral antidiabetic agents) | 137 |
| Placebo Arm Placebo volume equivalent to the active volume injected in the exenatide arm (with a background of titrated insulin glargine and other oral antidiabetic agents) | 122 |
| Total | 259 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 13 | 1 |
| Overall Study | Death | 0 | 1 |
| Overall Study | Entry criteria not met | 2 | 2 |
| Overall Study | Loss of glucose control | 0 | 2 |
| Overall Study | Lost to Follow-up | 1 | 3 |
| Overall Study | Physician Decision | 2 | 1 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Subject decision | 7 | 11 |
Baseline characteristics
| Characteristic | Exenatide Arm | Placebo Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 37 Participants | 38 Participants | 75 Participants |
| Age, Categorical Between 18 and 65 years | 100 Participants | 84 Participants | 184 Participants |
| Age, Continuous | 58.67 years STANDARD_DEVIATION 8.91 | 59.40 years STANDARD_DEVIATION 9.96 | 59.01 years STANDARD_DEVIATION 9.41 |
| Sex: Female, Male Female | 67 Participants | 44 Participants | 111 Participants |
| Sex: Female, Male Male | 70 Participants | 78 Participants | 148 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 109 / 138 | 66 / 123 |
| serious Total, serious adverse events | 8 / 137 | 11 / 122 |
Outcome results
Primary
Change in Glycosylated Hemoglobin (HbA1c)
Change in HbA1c from baseline following 30 weeks of therapy (i.e., HbA1c at week 30 minus HbA1c at baseline). Unit of measure is percent of hemoglobin that is glycosylated.
Time frame: baseline and 30 weeks
Population: Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Exenatide Arm | Change in Glycosylated Hemoglobin (HbA1c) | -1.71 percentage of hemoglobin | Standard Error 0.09 |
| Placebo Arm | Change in Glycosylated Hemoglobin (HbA1c) | -1.00 percentage of hemoglobin | Standard Error 0.09 |
p-value: <0.001ANCOVA
Secondary
Change in 7-point Self-monitored Blood Glucose (SMBG) Profile
Change in 7-point (pre-breakfast, 2 hour post-breakfast, pre-lunch, 2 hour post-lunch, pre-dinner, 2 hour post-dinner, 0300 hours) SMBG profile from baseline to week 30 (change = blood glucose value at week 30 minus blood glucose value at baseline)
Time frame: baseline and 30 weeks
Population: Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Exenatide Arm | Change in 7-point Self-monitored Blood Glucose (SMBG) Profile | Pre-breakfast: baseline | 7.89 mmol/L | Standard Error 0.2 |
| Exenatide Arm | Change in 7-point Self-monitored Blood Glucose (SMBG) Profile | Pre-breakfast: change at week 30 | -1.58 mmol/L | Standard Error 0.1 |
| Exenatide Arm | Change in 7-point Self-monitored Blood Glucose (SMBG) Profile | 2 hour post-breakfast: baseline | 10.89 mmol/L | Standard Error 0.2 |
| Exenatide Arm | Change in 7-point Self-monitored Blood Glucose (SMBG) Profile | 2 hour post-breakfast: change at week 30 | -3.56 mmol/L | Standard Error 0.2 |
| Exenatide Arm | Change in 7-point Self-monitored Blood Glucose (SMBG) Profile | Pre-lunch: baseline | 8.95 mmol/L | Standard Error 0.2 |
| Exenatide Arm | Change in 7-point Self-monitored Blood Glucose (SMBG) Profile | Pre-lunch: change at week 30 | -2.23 mmol/L | Standard Error 0.2 |
| Exenatide Arm | Change in 7-point Self-monitored Blood Glucose (SMBG) Profile | 2 hour post-lunch: baseline | 11.35 mmol/L | Standard Error 0.2 |
| Exenatide Arm | Change in 7-point Self-monitored Blood Glucose (SMBG) Profile | 2 hour post-lunch: change at week 30 | -2.74 mmol/L | Standard Error 0.2 |
| Exenatide Arm | Change in 7-point Self-monitored Blood Glucose (SMBG) Profile | Pre-dinner: baseline | 9.85 mmol/L | Standard Error 0.2 |
| Exenatide Arm | Change in 7-point Self-monitored Blood Glucose (SMBG) Profile | Pre-dinner: change at week 30 | -2.25 mmol/L | Standard Error 0.2 |
| Exenatide Arm | Change in 7-point Self-monitored Blood Glucose (SMBG) Profile | 2 hour post-dinner: baseline | 12.03 mmol/L | Standard Error 0.3 |
| Exenatide Arm | Change in 7-point Self-monitored Blood Glucose (SMBG) Profile | 2 hour post-dinner: change at week 30 | -3.87 mmol/L | Standard Error 0.2 |
| Exenatide Arm | Change in 7-point Self-monitored Blood Glucose (SMBG) Profile | 0300: baseline | 8.95 mmol/L | Standard Error 0.2 |
| Exenatide Arm | Change in 7-point Self-monitored Blood Glucose (SMBG) Profile | 0300: change at week 30 | -2.27 mmol/L | Standard Error 0.2 |
| Placebo Arm | Change in 7-point Self-monitored Blood Glucose (SMBG) Profile | 2 hour post-dinner: baseline | 11.86 mmol/L | Standard Error 0.3 |
| Placebo Arm | Change in 7-point Self-monitored Blood Glucose (SMBG) Profile | Pre-breakfast: baseline | 8.27 mmol/L | Standard Error 0.2 |
| Placebo Arm | Change in 7-point Self-monitored Blood Glucose (SMBG) Profile | 2 hour post-lunch: change at week 30 | -1.38 mmol/L | Standard Error 0.2 |
| Placebo Arm | Change in 7-point Self-monitored Blood Glucose (SMBG) Profile | Pre-breakfast: change at week 30 | -1.48 mmol/L | Standard Error 0.1 |
| Placebo Arm | Change in 7-point Self-monitored Blood Glucose (SMBG) Profile | 0300: baseline | 9.20 mmol/L | Standard Error 0.2 |
| Placebo Arm | Change in 7-point Self-monitored Blood Glucose (SMBG) Profile | 2 hour post-breakfast: baseline | 11.82 mmol/L | Standard Error 0.2 |
| Placebo Arm | Change in 7-point Self-monitored Blood Glucose (SMBG) Profile | Pre-dinner: baseline | 9.99 mmol/L | Standard Error 0.2 |
| Placebo Arm | Change in 7-point Self-monitored Blood Glucose (SMBG) Profile | 2 hour post-breakfast: change at week 30 | -1.72 mmol/L | Standard Error 0.2 |
| Placebo Arm | Change in 7-point Self-monitored Blood Glucose (SMBG) Profile | 2 hour post-dinner: change at week 30 | -1.34 mmol/L | Standard Error 0.3 |
| Placebo Arm | Change in 7-point Self-monitored Blood Glucose (SMBG) Profile | Pre-lunch: baseline | 9.77 mmol/L | Standard Error 0.2 |
| Placebo Arm | Change in 7-point Self-monitored Blood Glucose (SMBG) Profile | Pre-dinner: change at week 30 | -1.33 mmol/L | Standard Error 0.2 |
| Placebo Arm | Change in 7-point Self-monitored Blood Glucose (SMBG) Profile | Pre-lunch: change at week 30 | -1.15 mmol/L | Standard Error 0.2 |
| Placebo Arm | Change in 7-point Self-monitored Blood Glucose (SMBG) Profile | 0300: change at week 30 | -1.48 mmol/L | Standard Error 0.2 |
| Placebo Arm | Change in 7-point Self-monitored Blood Glucose (SMBG) Profile | 2 hour post-lunch: baseline | 11.70 mmol/L | Standard Error 0.2 |
Secondary
Change in Body Weight
Change in body weight following 30 weeks of therapy (i.e., body weight at week 30 minus body weight at baseline)
Time frame: baseline and 30 weeks
Population: Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Exenatide Arm | Change in Body Weight | -1.78 kg | Standard Error 0.3 |
| Placebo Arm | Change in Body Weight | 0.96 kg | Standard Error 0.3 |
p-value: <0.001ANCOVA
Secondary
Change in Daily Insulin Dose
Change in daily insulin dose following 30 weeks of therapy (i.e., daily insulin dose at week 30 minus daily insulin dose at baseline)
Time frame: baseline and 30 weeks
Population: Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Exenatide Arm | Change in Daily Insulin Dose | 13.19 insulin units (U) | Standard Error 2.02 |
| Placebo Arm | Change in Daily Insulin Dose | 19.71 insulin units (U) | Standard Error 2.11 |
p-value: 0.026ANCOVA
Secondary
Change in Daily Insulin Dose (on a Per Body Weight Basis)
Change in daily insulin dose per kilogram (kg) following 30 weeks of therapy (i.e., daily insulin dose per kg at week 30 minus daily insulin dose per kg at baseline)
Time frame: baseline and 30 weeks
Population: Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Exenatide Arm | Change in Daily Insulin Dose (on a Per Body Weight Basis) | 0.15 insulin units per kg (U/kg) | Standard Error 0.02 |
| Placebo Arm | Change in Daily Insulin Dose (on a Per Body Weight Basis) | 0.20 insulin units per kg (U/kg) | Standard Error 0.02 |
p-value: 0.07ANCOVA
Secondary
Change in Diastolic Blood Pressure (DBP)
Change in DBP following 30 weeks of therapy (i.e., DBP at week 30 minus DBP at baseline)
Time frame: baseline and 30 weeks
Population: Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Exenatide Arm | Change in Diastolic Blood Pressure (DBP) | -1.73 mmHg | Standard Error 0.6 |
| Placebo Arm | Change in Diastolic Blood Pressure (DBP) | 1.69 mmHg | Standard Error 0.7 |
p-value: <0.001ANCOVA
Secondary
Change in Fasting Serum Glucose
Change in fasting serum glucose following 30 weeks of therapy (i.e., fasting serum glucose at week 30 minus fasting serum glucose at baseline)
Time frame: baseline and 30 weeks
Population: Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Exenatide Arm | Change in Fasting Serum Glucose | -1.28 mmol/L | Standard Error 0.2 |
| Placebo Arm | Change in Fasting Serum Glucose | -0.87 mmol/L | Standard Error 0.2 |
p-value: 0.174ANCOVA
Secondary
Change in High Density Lipoprotein (HDL) Cholesterol
Change in HDL cholesterol following 30 weeks of therapy (i.e., HDL cholesterol at week 30 minus HDL cholesterol at baseline)
Time frame: baseline and 30 weeks
Population: Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Exenatide Arm | Change in High Density Lipoprotein (HDL) Cholesterol | 0.01 mmol/L | Standard Error 0.02 |
| Placebo Arm | Change in High Density Lipoprotein (HDL) Cholesterol | 0.00 mmol/L | Standard Error 0.02 |
p-value: 0.745ANCOVA
Secondary
Change in Low Density Lipoprotein (LDL) Cholesterol
Change in LDL cholesterol following 30 weeks of therapy (i.e., LDL cholesterol at week 30 minus LDL cholesterol at baseline)
Time frame: baseline and 30 weeks
Population: Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Exenatide Arm | Change in Low Density Lipoprotein (LDL) Cholesterol | -0.19 mmol/L | Standard Error 0.07 |
| Placebo Arm | Change in Low Density Lipoprotein (LDL) Cholesterol | -0.00 mmol/L | Standard Error 0.07 |
p-value: 0.063ANCOVA
Secondary
Change in Systolic Blood Pressure (SBP)
Change in SBP following 30 weeks of therapy (i.e., SBP at week 30 minus SBP at baseline)
Time frame: baseline and 30 weeks
Population: Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Exenatide Arm | Change in Systolic Blood Pressure (SBP) | -2.74 mmHg | Standard Error 1.2 |
| Placebo Arm | Change in Systolic Blood Pressure (SBP) | 1.71 mmHg | Standard Error 1.3 |
p-value: 0.011ANCOVA
Secondary
Change in Total Cholesterol
Change in total cholesterol following 30 weeks of therapy (i.e., total cholesterol at week 30 minus total cholesterol at baseline)
Time frame: baseline and 30 weeks
Population: Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Exenatide Arm | Change in Total Cholesterol | -0.16 mmol/L | Standard Error 0.08 |
| Placebo Arm | Change in Total Cholesterol | -0.02 mmol/L | Standard Error 0.09 |
p-value: 0.203ANCOVA
Secondary
Change in Triglycerides
Change in triglycerides following 30 weeks of therapy (i.e., triglycerides at week 30 minus triglycerides at baseline)
Time frame: baseline and 30 weeks
Population: Full analysis set. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Exenatide Arm | Change in Triglycerides | -0.02 mmol/L | Standard Error 0.09 |
| Placebo Arm | Change in Triglycerides | -0.03 mmol/L | Standard Error 0.09 |
p-value: 0.933ANCOVA
Secondary
Change in Waist Circumference
Change in waist circumference following 30 weeks of therapy (i.e., waist circumference at week 30 minus waist circumference at baseline)
Time frame: baseline and 30 weeks
Population: Full analysis set, Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Exenatide Arm | Change in Waist Circumference | -1.08 cm | Standard Error 0.52 |
| Placebo Arm | Change in Waist Circumference | -0.25 cm | Standard Error 0.55 |
p-value: 0.226ANCOVA
Secondary
Minor Hypoglycemia Rate Per Year
Number of minor hypoglycemia events experienced per subject per year. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose \<3.0 mmol/L (54 mg/dL).
Time frame: baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30
Population: Full analysis set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exenatide Arm | Minor Hypoglycemia Rate Per Year | 1.61 events per subject per year | Standard Deviation 5.94 |
| Placebo Arm | Minor Hypoglycemia Rate Per Year | 1.55 events per subject per year | Standard Deviation 4.79 |
p-value: 0.666Negative binomial regression model
Secondary
Percentage of Patients Achieving HbA1c <=6.5%
Percentage of patients in each arm who had HbA1c \>6.5% at baseline and had HbA1c \<=6.5% at week 30 (percentage = \[number of subjects with HbA1c \<=6.5% at week 30 divided by number of subjects with HbA1c \>6.5% at baseline\] \* 100%).
Time frame: baseline and 30 weeks
Population: Full analysis set. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Only patients with baseline HbA1c \> target were included in calculation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exenatide Arm | Percentage of Patients Achieving HbA1c <=6.5% | 42.0 percentage |
| Placebo Arm | Percentage of Patients Achieving HbA1c <=6.5% | 13.3 percentage |
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Percentage of Patients Achieving HbA1c <=7%
Percentage of patients in each arm who had HbA1c \>7% at baseline and had HbA1c \<=7% at week 30 (percentage = \[number of subjects with HbA1c \<=7% at week 30 divided by number of subjects with HbA1c \>7% at baseline\] \* 100%).
Time frame: baseline and 30 weeks
Population: Full analysis set. Last observation carried forward. Only patients with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. Only patients with baseline HbA1c \> target were included in calculation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exenatide Arm | Percentage of Patients Achieving HbA1c <=7% | 58.3 percentage |
| Placebo Arm | Percentage of Patients Achieving HbA1c <=7% | 31.1 percentage |
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Percentage of Subjects Experiencing Minor Hypoglycemia
Percentage of subjects in each arm experiencing at least one episode of minor hypoglycemia at any point during the study. Minor hypoglycemia was defined as any time a subject felt he or she was experiencing a sign or symptom associated with hypoglycemia that was either self-treated by the subject or resolved on its own and had a concurrent finger stick blood glucose \<3.0 mmol/L (54 mg/dL).
Time frame: baseline and weeks 2, 4, 6, 8, 10, 14, 18, 22, 26, and 30
Population: Full analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exenatide Arm | Percentage of Subjects Experiencing Minor Hypoglycemia | 24.8 percentage |
| Placebo Arm | Percentage of Subjects Experiencing Minor Hypoglycemia | 28.7 percentage |
p-value: 0.486Fisher Exact