Type 2 Diabetes
Conditions
Keywords
diabetes, exenatide, LY2148568, Byetta, Lilly, Amylin
Brief summary
This long term, placebo-controlled trial is intended to assess the efficacy and safety of exenatide, dosed twice a day, in Japanese patients with Type 2 Diabetes who are treated with oral antidiabetic(s) but not well controlled.
Interventions
DRUGexenatide
subcutaneous injection, 5mcg, twice a day
DRUGplacebo
subcutaneous injection, volume equivalent to 5mcg or 10mcg exenatide, twice a day
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
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with type 2 diabetes. * Has been treated by sulfonylurea (SU) alone, SU and biguanide, or SU and thiazolidinedione for at least 90 days prior to study start. In a patient receiving SU alone, the dose must be within the dose range from maximum maintenance dose to maximum approved dose. The patients with concomitant use of alpha glucosidase inhibitors (acarbose, voglibose or miglitol) or meglitinide derivatives (mitiglinide or nateglinide) can be included in this study, but these drugs must be discontinued at study start. * Have HbA1c 7.0% to 10% at study start. * Have a body weight \>=50 kg.
Exclusion criteria
* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. * Have participated in this study previously or any other study using exenatide or glucagon-like peptide-1 (GLP-1) analogs within the last 90 days. * Have been treated with any exogenous insulin within 90 days before study start. * Have been continuously treated with any drug that directly affects gastrointestinal motility for more than a total of 21 days in the 90 days prior to study start. * The combination therapy of sulfonylurea, biguanide and thiazolidinedione is not allowed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24 | baseline, 24 weeks | Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Achieving HbA1c < 6.5% | 24 weeks | Percentage of subjects whose HbA1c was \>=6.5% at baseline who achieved an HbA1c \< 6.5% at endpoint (i.e., number of eligible subjects who achieved HbA1c \< 6.5% divided by total number of eligible subjects times 100) |
| Change in Fasting Blood Glucose | baseline, week 24 | Change in fasting blood glucose from baseline to endpoint (i.e., fasting blood glucose at week 24 minus fasting blood glucose at week 0) |
| Change in Body Weight | baseline, week 24 | Change in body weight form baseline to endpoint (i.e., body weight at week 24 minus body weight at week 0) |
| Change in Total Cholesterol | baseline, week 24 | Change in total cholesterol from baseline to endpoint (i.e., total cholesterol at week 24 minus total cholesterol at week 0) |
| Change in Low Density Lipoprotein Cholesterol (LDL-C) | baseline, week 24 | Change in LDL-C from baseline to endpoint (i.e., LDL-C at week 24 minus LDL-C at week 0) |
| Change in High Density Lipoprotein Cholesterol (HDL-C) | baseline, week 24 | Change in HDL-C from baseline to endpoint (i.e., HDL-C at week 24 minus HDL-C at week 0) |
| Change in Triglycerides | baseline, week 24 | Change in triglycerides from baseline to endpoint (i.e., triglycerides at week 24 minus triglycerides at week 0) |
| Percentage of Patients Achieving HbA1c < 7.0% | 24 weeks | Percentage of subjects whose HbA1c was \>=7.0% at baseline who achieved an HbA1c \< 7.0% at endpoint (i.e., number of eligible subjects who achieved HbA1c \< 7.0% divided by total number of eligible subjects times 100) |
| Change in Waist-to-hip Ratio | baseline, week 24 | Change in waist-to-hip ratio from baseline to endpoint (i.e., waist-to-hip ratio at week 24 minus waist-to-hip ratio at week 0). Waist-to-hip ratio is waist circumference divided by hip circumference. |
| 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | baseline, week 24 | Self-monitored blood glucose at 7 different time points during the day (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime). |
| Change in Homeostasis Model Assessment - Beta Cell Function (HOMA-B) | baseline, week 24 | Change in HOMA-B from baseline to endpoint (i.e., HOMA-B at week 24 minus HOMA-B at week 0). HOMA-B is a measurement of beta cell function. |
| Change in Homeostasis Model Assessment - Insulin Resistance (HOMA-R) | baseline, week 24 | Change in HOMA-R from baseline to endpoint (i.e., HOMA-R at week 24 minus HOMA-R at week 0). HOMA-R is a measurement of insulin resistance. |
| Change in Serum Insulin | baseline, week 24 | Change in serum insulin from baseline to endpoint (i.e., serum insulin at week 24 minus serum insulin at week 0) |
| Change in C-peptide | baseline, week 24 | Change in C-peptide from baseline to endpoint (i.e., C-peptide at week 24 minus C-peptide at week 0) |
| Change in 1,5-anhydroglucitol | baseline, week 24 | Change in 1,5-anhydroglucitol from baseline to endpoint (i.e., 1,5-anhydroglucitol at week 24 minus 1,5-anhydroglucitol at week 0) |
| Change in Waist Size | baseline, week 24 | Change in waist size from baseline to endpoint (i.e., waist size at week 24 minus waist size at week 0) |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 5mcg Exenatide BID exenatide SC 5mcg, twice daily | 72 |
| 10mcg Exenatide BID exenatide SC 10mcg, twice daily | 72 |
| Placebo BID placebo SC, twice daily | 35 |
| Total | 179 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 6 | 18 | 1 |
| Overall Study | Patient decision | 0 | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | 5mcg Exenatide BID | 10mcg Exenatide BID | Placebo BID | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 19 Participants | 26 Participants | 8 Participants | 53 Participants |
| Age, Categorical Between 18 and 65 years | 53 Participants | 46 Participants | 27 Participants | 126 Participants |
| Age, Continuous | 58.5 years STANDARD_DEVIATION 9.33 | 59.4 years STANDARD_DEVIATION 9.75 | 56.3 years STANDARD_DEVIATION 11.41 | 58.4 years STANDARD_DEVIATION 9.94 |
| Sex: Female, Male Female | 23 Participants | 23 Participants | 11 Participants | 57 Participants |
| Sex: Female, Male Male | 49 Participants | 49 Participants | 24 Participants | 122 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 63 / 72 | 63 / 72 | 22 / 35 |
| serious Total, serious adverse events | 2 / 72 | 0 / 72 | 4 / 35 |
Outcome results
Primary
Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24
Change in HbA1c from baseline following 24 weeks of treatment (i.e., HbA1c at week 24 minus HbA1c at week 0)
Time frame: baseline, 24 weeks
Population: Full analysis set; Last observation carried forward.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 5mcg Exenatide BID | Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24 | -1.34 Percentage of hemoglobin | Standard Error 0.11 |
| 10mcg Exenatide BID | Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24 | -1.62 Percentage of hemoglobin | Standard Error 0.11 |
| Placebo BID | Change in Glycosylated Hemoglobin (HbA1c) From Baseline to Week 24 | -0.28 Percentage of hemoglobin | Standard Error 0.15 |
p-value: <0.001ANCOVA
Secondary
7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24
Self-monitored blood glucose at 7 different time points during the day (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime).
Time frame: baseline, week 24
Population: Full Analysis Set; Last Observation Carried Forward
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 5mcg Exenatide BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 2hr post-dinner SMBG at week 0 | 246 mg/dL | Standard Deviation 53.4 |
| 5mcg Exenatide BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 30 minutes prior to lunch SMBG at week 24 | 155 mg/dL | Standard Deviation 43.9 |
| 5mcg Exenatide BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 2hr post-breakfast SMBG at week 0 | 261 mg/dL | Standard Deviation 50.5 |
| 5mcg Exenatide BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 30 minutes prior to dinner SMBG at week 24 | 149 mg/dL | Standard Deviation 45.1 |
| 5mcg Exenatide BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 2hr post-lunch SMBG at week 0 | 263 mg/dL | Standard Deviation 62.7 |
| 5mcg Exenatide BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 30 minutes prior to breakfast SMBG at week 24 | 150 mg/dL | Standard Deviation 36.4 |
| 5mcg Exenatide BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 30 minutes prior to dinner SMBG at week 0 | 166 mg/dL | Standard Deviation 53.7 |
| 5mcg Exenatide BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 2hr post-lunch SMBG at week 24 | 213 mg/dL | Standard Deviation 63.2 |
| 5mcg Exenatide BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 2hr post-dinner SMBG at week 24 | 160 mg/dL | Standard Deviation 62.8 |
| 5mcg Exenatide BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 2hr post-breakfast SMBG at week 24 | 178 mg/dL | Standard Deviation 61.1 |
| 5mcg Exenatide BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | bedtime SMBG at week 24 | 170 mg/dL | Standard Deviation 48.9 |
| 5mcg Exenatide BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 30 minutes prior to breakfast SMBG at week 0 | 169 mg/dL | Standard Deviation 36.3 |
| 5mcg Exenatide BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 30 minutes prior to lunch SMBG at week 0 | 179 mg/dL | Standard Deviation 48.4 |
| 5mcg Exenatide BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | bedtime SMBG at week 0 | 216 mg/dL | Standard Deviation 53.7 |
| 10mcg Exenatide BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 2hr post-dinner SMBG at week 0 | 247 mg/dL | Standard Deviation 63.6 |
| 10mcg Exenatide BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 30 minutes prior to breakfast SMBG at week 0 | 175 mg/dL | Standard Deviation 40.9 |
| 10mcg Exenatide BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 30 minutes prior to breakfast SMBG at week 24 | 140 mg/dL | Standard Deviation 32.2 |
| 10mcg Exenatide BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 2hr post-breakfast SMBG at week 0 | 263 mg/dL | Standard Deviation 55.1 |
| 10mcg Exenatide BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 2hr post-breakfast SMBG at week 24 | 149 mg/dL | Standard Deviation 54.4 |
| 10mcg Exenatide BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 30 minutes prior to lunch SMBG at week 0 | 189 mg/dL | Standard Deviation 68.4 |
| 10mcg Exenatide BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 30 minutes prior to lunch SMBG at week 24 | 152 mg/dL | Standard Deviation 41.3 |
| 10mcg Exenatide BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 2hr post-lunch SMBG at week 0 | 268 mg/dL | Standard Deviation 62.4 |
| 10mcg Exenatide BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 2hr post-lunch SMBG at week 24 | 195 mg/dL | Standard Deviation 60.7 |
| 10mcg Exenatide BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 30 minutes prior to dinner SMBG at week 0 | 176 mg/dL | Standard Deviation 51.4 |
| 10mcg Exenatide BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 30 minutes prior to dinner SMBG at week 24 | 140 mg/dL | Standard Deviation 35.5 |
| 10mcg Exenatide BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 2hr post-dinner SMBG at week 24 | 141 mg/dL | Standard Deviation 57.7 |
| 10mcg Exenatide BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | bedtime SMBG at week 0 | 225 mg/dL | Standard Deviation 66.2 |
| 10mcg Exenatide BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | bedtime SMBG at week 24 | 151 mg/dL | Standard Deviation 44.3 |
| Placebo BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | bedtime SMBG at week 0 | 206 mg/dL | Standard Deviation 46.8 |
| Placebo BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 30 minutes prior to dinner SMBG at week 24 | 181 mg/dL | Standard Deviation 57 |
| Placebo BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 30 minutes prior to lunch SMBG at week 0 | 179 mg/dL | Standard Deviation 49.2 |
| Placebo BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 2hr post-breakfast SMBG at week 24 | 257 mg/dL | Standard Deviation 74.5 |
| Placebo BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 2hr post-dinner SMBG at week 0 | 239 mg/dL | Standard Deviation 49.1 |
| Placebo BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 2hr post-breakfast SMBG at week 0 | 254 mg/dL | Standard Deviation 65.1 |
| Placebo BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 30 minutes prior to breakfast SMBG at week 0 | 170 mg/dL | Standard Deviation 38.6 |
| Placebo BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 2hr post-dinner SMBG at week 24 | 247 mg/dL | Standard Deviation 78.6 |
| Placebo BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 30 minutes prior to breakfast SMBG at week 24 | 167 mg/dL | Standard Deviation 37.9 |
| Placebo BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 2hr post-lunch SMBG at week 24 | 254 mg/dL | Standard Deviation 73.5 |
| Placebo BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 2hr post-lunch SMBG at week 0 | 264 mg/dL | Standard Deviation 51.7 |
| Placebo BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | bedtime SMBG at week 24 | 212 mg/dL | Standard Deviation 63.5 |
| Placebo BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 30 minutes prior to dinner SMBG at week 0 | 173 mg/dL | Standard Deviation 42.5 |
| Placebo BID | 7 Point Self-monitored Blood Glucose (SMBG) Profiles at Baseline and Week 24 | 30 minutes prior to lunch SMBG at week 24 | 182 mg/dL | Standard Deviation 57 |
Secondary
Change in 1,5-anhydroglucitol
Change in 1,5-anhydroglucitol from baseline to endpoint (i.e., 1,5-anhydroglucitol at week 24 minus 1,5-anhydroglucitol at week 0)
Time frame: baseline, week 24
Population: Full Analysis Set; Last Observation Carried Forward
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5mcg Exenatide BID | Change in 1,5-anhydroglucitol | 5.29 mcg/mL | Standard Error 0.55 |
| 10mcg Exenatide BID | Change in 1,5-anhydroglucitol | 4.52 mcg/mL | Standard Error 0.54 |
| Placebo BID | Change in 1,5-anhydroglucitol | 0.66 mcg/mL | Standard Error 0.3 |
p-value: <0.001t-test, 2 sided
Secondary
Change in Body Weight
Change in body weight form baseline to endpoint (i.e., body weight at week 24 minus body weight at week 0)
Time frame: baseline, week 24
Population: Full analysis set; Last observation carried forward
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 5mcg Exenatide BID | Change in Body Weight | -0.39 kg | Standard Error 0.28 |
| 10mcg Exenatide BID | Change in Body Weight | -1.54 kg | Standard Error 0.27 |
| Placebo BID | Change in Body Weight | -0.47 kg | Standard Error 0.39 |
p-value: 0.026ANCOVA
Secondary
Change in C-peptide
Change in C-peptide from baseline to endpoint (i.e., C-peptide at week 24 minus C-peptide at week 0)
Time frame: baseline, week 24
Population: Full Analysis Set; Last Observation Carried Forward
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5mcg Exenatide BID | Change in C-peptide | 0.05 ng/mL | Standard Error 0.11 |
| 10mcg Exenatide BID | Change in C-peptide | 0.07 ng/mL | Standard Error 0.07 |
| Placebo BID | Change in C-peptide | -0.08 ng/mL | Standard Error 0.06 |
p-value: 0.2t-test, 2 sided
Secondary
Change in Fasting Blood Glucose
Change in fasting blood glucose from baseline to endpoint (i.e., fasting blood glucose at week 24 minus fasting blood glucose at week 0)
Time frame: baseline, week 24
Population: Full analysis set; Last observation carried forward
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| 5mcg Exenatide BID | Change in Fasting Blood Glucose | -25.1 mg/dL | Standard Error 3.83 |
| 10mcg Exenatide BID | Change in Fasting Blood Glucose | -29.0 mg/dL | Standard Error 3.81 |
| Placebo BID | Change in Fasting Blood Glucose | -7.6 mg/dL | Standard Error 5.46 |
p-value: <0.002ANCOVA
Secondary
Change in High Density Lipoprotein Cholesterol (HDL-C)
Change in HDL-C from baseline to endpoint (i.e., HDL-C at week 24 minus HDL-C at week 0)
Time frame: baseline, week 24
Population: Full analysis set; Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5mcg Exenatide BID | Change in High Density Lipoprotein Cholesterol (HDL-C) | -4.63 mg/dL | Standard Error 0.91 |
| 10mcg Exenatide BID | Change in High Density Lipoprotein Cholesterol (HDL-C) | -4.22 mg/dL | Standard Error 0.7 |
| Placebo BID | Change in High Density Lipoprotein Cholesterol (HDL-C) | -0.97 mg/dL | Standard Error 1.2 |
p-value: 0.014t-test, 2 sided
Secondary
Change in Homeostasis Model Assessment - Beta Cell Function (HOMA-B)
Change in HOMA-B from baseline to endpoint (i.e., HOMA-B at week 24 minus HOMA-B at week 0). HOMA-B is a measurement of beta cell function.
Time frame: baseline, week 24
Population: Full Analysis Set; Last Observation Carried Forward
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5mcg Exenatide BID | Change in Homeostasis Model Assessment - Beta Cell Function (HOMA-B) | 2.475 ratio | Standard Error 10.566 |
| 10mcg Exenatide BID | Change in Homeostasis Model Assessment - Beta Cell Function (HOMA-B) | 6.836 ratio | Standard Error 13.858 |
| Placebo BID | Change in Homeostasis Model Assessment - Beta Cell Function (HOMA-B) | -0.707 ratio | Standard Error 3.436 |
p-value: 0.708t-test, 2 sided
Secondary
Change in Homeostasis Model Assessment - Insulin Resistance (HOMA-R)
Change in HOMA-R from baseline to endpoint (i.e., HOMA-R at week 24 minus HOMA-R at week 0). HOMA-R is a measurement of insulin resistance.
Time frame: baseline, week 24
Population: Full Analysis Set; Last Observation Carried Forward
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5mcg Exenatide BID | Change in Homeostasis Model Assessment - Insulin Resistance (HOMA-R) | -0.541 ratio | Standard Error 0.402 |
| 10mcg Exenatide BID | Change in Homeostasis Model Assessment - Insulin Resistance (HOMA-R) | -0.366 ratio | Standard Error 0.188 |
| Placebo BID | Change in Homeostasis Model Assessment - Insulin Resistance (HOMA-R) | -0.375 ratio | Standard Error 0.164 |
p-value: 0.974t-test, 2 sided
Secondary
Change in Low Density Lipoprotein Cholesterol (LDL-C)
Change in LDL-C from baseline to endpoint (i.e., LDL-C at week 24 minus LDL-C at week 0)
Time frame: baseline, week 24
Population: Full analysis set; Last observation carried forward.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5mcg Exenatide BID | Change in Low Density Lipoprotein Cholesterol (LDL-C) | -8.89 mg/dL | Standard Error 3.01 |
| 10mcg Exenatide BID | Change in Low Density Lipoprotein Cholesterol (LDL-C) | -5.03 mg/dL | Standard Error 2.45 |
| Placebo BID | Change in Low Density Lipoprotein Cholesterol (LDL-C) | -2.66 mg/dL | Standard Error 3.5 |
p-value: 0.58t-test, 2 sided
Secondary
Change in Serum Insulin
Change in serum insulin from baseline to endpoint (i.e., serum insulin at week 24 minus serum insulin at week 0)
Time frame: baseline, week 24
Population: Full Analysis Set; Last Observation Carried Forward
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5mcg Exenatide BID | Change in Serum Insulin | -0.2 mcU/mL | Standard Deviation 5.03 |
| 10mcg Exenatide BID | Change in Serum Insulin | 0.2 mcU/mL | Standard Deviation 3.42 |
| Placebo BID | Change in Serum Insulin | -0.7 mcU/mL | Standard Deviation 2.42 |
Secondary
Change in Total Cholesterol
Change in total cholesterol from baseline to endpoint (i.e., total cholesterol at week 24 minus total cholesterol at week 0)
Time frame: baseline, week 24
Population: Full analysis set; Last observation carried forward
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5mcg Exenatide BID | Change in Total Cholesterol | -14.45 mg/dL | Standard Error 3.36 |
| 10mcg Exenatide BID | Change in Total Cholesterol | -7.01 mg/dL | Standard Error 3.13 |
| Placebo BID | Change in Total Cholesterol | -4.80 mg/dL | Standard Error 3.76 |
p-value: 0.672t-test, 2 sided
Secondary
Change in Triglycerides
Change in triglycerides from baseline to endpoint (i.e., triglycerides at week 24 minus triglycerides at week 0)
Time frame: baseline, week 24
Population: Full analysis set; Last observation carried forward
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5mcg Exenatide BID | Change in Triglycerides | 4.00 mg/dL | Standard Error 15.59 |
| 10mcg Exenatide BID | Change in Triglycerides | 4.13 mg/dL | Standard Error 8.03 |
| Placebo BID | Change in Triglycerides | -4.60 mg/dL | Standard Error 7.25 |
p-value: 0.49t-test, 2 sided
Secondary
Change in Waist Size
Change in waist size from baseline to endpoint (i.e., waist size at week 24 minus waist size at week 0)
Time frame: baseline, week 24
Population: Full Analysis Set; Last Observation Carried Forward
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5mcg Exenatide BID | Change in Waist Size | -0.17 cm | Standard Error 0.36 |
| 10mcg Exenatide BID | Change in Waist Size | -1.81 cm | Standard Error 0.46 |
| Placebo BID | Change in Waist Size | 0.41 cm | Standard Error 0.45 |
p-value: 0.003t-test, 2 sided
Secondary
Change in Waist-to-hip Ratio
Change in waist-to-hip ratio from baseline to endpoint (i.e., waist-to-hip ratio at week 24 minus waist-to-hip ratio at week 0). Waist-to-hip ratio is waist circumference divided by hip circumference.
Time frame: baseline, week 24
Population: Full Analysis Set; Last Observation Carried Forward
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 5mcg Exenatide BID | Change in Waist-to-hip Ratio | 0.0016 ratio (cm/cm) | Standard Error 0.0047 |
| 10mcg Exenatide BID | Change in Waist-to-hip Ratio | -0.0108 ratio (cm/cm) | Standard Error 0.0047 |
| Placebo BID | Change in Waist-to-hip Ratio | -0.0007 ratio (cm/cm) | Standard Error 0.0061 |
p-value: 0.208t-test, 2 sided
Secondary
Percentage of Patients Achieving HbA1c < 6.5%
Percentage of subjects whose HbA1c was \>=6.5% at baseline who achieved an HbA1c \< 6.5% at endpoint (i.e., number of eligible subjects who achieved HbA1c \< 6.5% divided by total number of eligible subjects times 100)
Time frame: 24 weeks
Population: Full analysis set; Last observation carried forward. Only subjects whose HbA1c was \>=6.5% at baseline were included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5mcg Exenatide BID | Percentage of Patients Achieving HbA1c < 6.5% | 36.6 percentage of participants |
| 10mcg Exenatide BID | Percentage of Patients Achieving HbA1c < 6.5% | 47.2 percentage of participants |
| Placebo BID | Percentage of Patients Achieving HbA1c < 6.5% | 8.6 percentage of participants |
p-value: <0.001Cochran-Armitage
Secondary
Percentage of Patients Achieving HbA1c < 7.0%
Percentage of subjects whose HbA1c was \>=7.0% at baseline who achieved an HbA1c \< 7.0% at endpoint (i.e., number of eligible subjects who achieved HbA1c \< 7.0% divided by total number of eligible subjects times 100)
Time frame: 24 weeks
Population: Full analysis set; Last observation carried forward. Only those patients with HbA1c \>=7% at baseline included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 5mcg Exenatide BID | Percentage of Patients Achieving HbA1c < 7.0% | 67.1 percentage of participants |
| 10mcg Exenatide BID | Percentage of Patients Achieving HbA1c < 7.0% | 71.0 percentage of participants |
| Placebo BID | Percentage of Patients Achieving HbA1c < 7.0% | 15.2 percentage of participants |
p-value: <0.001Cochran-Armitage