Type 2 Diabetes Mellitus
Conditions
Keywords
diabetes, exenatide, Byetta, Amylin, Lilly
Brief summary
This study in Germany is designed to compare the effects of twice-daily exenatide plus metformin and twice-daily premixed human insulin aspart plus metformin with respect to glycemic control, as measured by HbA1c, combined with the percentage of patients with at least one treatment-emergent hypoglycemic episode. Patients will be treated with study therapy for approximately 26 weeks.
Interventions
subcutaneous injection (5 mcg or 10 mcg), twice a day
DRUGpremixed insulin aspart twice daily (BID)
subcutaneous injection (titrated appropriately), twice a day
Sponsors
Eli Lilly and Company
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Have been treated with diet and exercise and a stable, maximally tolerated dose of immediate-release or extended-release metformin, or the combination of metformin (any dosage) with sulfonylurea/meglitinides for at least 3 months prior to study start * Have not received thiazolidinediones, or alpha-glucosidase inhibitors for longer than 2 weeks within 3 months prior to study start, and have not received any insulin formulation for more than 14 days (other than in emergency situations) and within 14 days prior to study start * Have an HbA1c between 6.5% and 10.0%, inclusive * Have a body mass index (BMI) between 25 kg/m\^2 and 40 kg/m\^2, inclusive
Exclusion criteria
* Have type 1 diabetes or known latent autoimmune diabetes in adults * Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks prior to study start * Are receiving treatment for gastrointestinal disease with a drug directly affecting gastrointestinal motility (e.g., metoclopramide, cisapride, and chronic macrolide antibiotics) * Have used any prescription drug to promote weight loss within 3 months prior to study start * Have received treatment within 30 days prior to study start with a drug that has not received regulatory approval for any indication at the time of study entry * Have previously completed or withdrawn from this study or any other study investigating exenatide or GLP-1 analogs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycosylated Hemoglobin (HbA1c) | Baseline and 26 weeks | Change in HbA1c from baseline after 26 weeks of treatment (i.e., HbA1c at week 26 minus HbA1c at week 0) |
| Incidence of Hypoglycemia (Percentage of Participants With at Least One Hypoglycemic Episode) | 26 weeks | Risk for first hypoglycemic episode (blood glucose \<=3.9 mmol/L or severe episode) to occur up to week 26 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Hypoglycemic Episodes [Blood Glucose <= 3.0 mmol/L or Severe] (Percentage of Subjects Who Experienced at Least One Treatment-emergent Hypoglycemic Episode During the 26-week Treatment Period) | 26 weeks | Risk for the first hypoglycemic episode to occur up to Week 26 (percentage of subjects who experienced at least one treatment-emergent hypoglycemic episode during the 26-week treatment period)\[ i.e., number of subjects experiencing at least one hypoglycemic episode divided by total number of subjects times 100%\] |
| Incidence of Nocturnal Hypoglycemia (Percentage of Subjects Who Experienced at Least One Episode of Nocturnal Hypoglycemia During the 26 Week Treatment Period) | 26 weeks | Risk for first nocturnal (night-time) hypoglycemic episode to occur up to week 26 (percentage of subjects who experienced at least one episode of nocturnal hypoglycemia during the 26 week treatment period) \[i.e., number of subjects who experienced nocturnal hypoglycemia divided by total number of subjects times 100%\]. |
| 7 Point Self-monitored Blood Glucose (SMBG) Profiles | Baseline and 26 weeks | 7-point self-monitored blood glucose profiles at baseline and the end of the study, measured at 7 times during the day (pre-breakfast, 2 hours post-breakfast, pre-lunch, 2 hours post-lunch, pre-dinner, 2 hours post-dinner, and 3:00am). |
| Blood Lipid Levels | Baseline and 26 weeks | Total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol (calculated), and triglyceride levels at baseline (week 0) and the end of the study (week 26) |
| Percentage of Subjects Achieving HbA1c Target of < 6.5% | 26 weeks | Percentage of subjects achieving HbA1c target of \< 6.5% at the end of study (week 26) \[i.e., number of subjects who achieved HbA1c \< 6.5% divided by total number of subjects times 100%\]. |
| Change in Body Mass Index (BMI) | Baseline and 26 weeks | Change in BMI from baseline after 26 weeks of treatment (i.e., BMI at week 26 minus BMI at week 0) |
| Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ) | Baseline and 26 weeks | Total DTSQ treatment satisfaction score at baseline (week 0) and after 26 weeks of treatment (LOCF). Total DTSQ treatment satisfaction score is derived as sum score of the individual components 1 and 4-8 of the DTSQ questionnaire. Each component is scored on a scale of 0 (worst case) to 6 (best case). Higher values represent higher treatment satisfaction. |
| Patient Reported Outcomes: Quality of Life (SF-12) | Baseline and 26 weeks | SF-12 Physical and Mental Component Summary Scores at baseline (week 0) and after 26 weeks of treatment (LOCF). SF-12 Physical and Mental Component Summary Scores are normalized scores ranging from 0 (worst case) to 100 (best case), and are derived from responses to 12 questions. Scores \> 50 indicate an above-average health status. |
| Change in Body Weight | Baseline and 26 weeks | Change in body weight from baseline after 26 weeks of treatment (i.e., body weight at week 26 minus body weight at week 0) |
| Percentage of Subjects Achieving HbA1c Target of < 7.0% | 26 weeks | Percentage of subjects achieving HbA1c target of \< 7.0% at the end of study (week 26) \[i.e., number of subjects who achieved HbA1c \< 7.0% divided by total number of subjects times 100%\]. |
Countries
Germany
Participant flow
Pre-assignment details
Patients treated with metformin (MET only;confirmatory population used for primary analysis) and additional patients treated with metformin plus either sulfonylurea or meglitinide (MET+SU; exploratory population) were enrolled at a 3:1 ratio; metformin was continued.Within each population, patients were then randomly assigned 1:1 to study treatment
Participants by arm
| Arm | Count |
|---|---|
| Exenatide Twice Daily Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks | 181 |
| Premixed Insulin Aspart Twice Daily Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks | 173 |
| Total | 354 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 17 | 2 |
| Overall Study | Entry criteria not met | 14 | 16 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Physician Decision | 6 | 3 |
| Overall Study | Protocol Violation | 36 | 27 |
| Overall Study | Sponsor decision | 1 | 0 |
| Overall Study | Subject decision | 8 | 22 |
Baseline characteristics
| Characteristic | Exenatide Twice Daily | Premixed Insulin Aspart Twice Daily | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 43 Participants | 40 Participants | 83 Participants |
| Age, Categorical Between 18 and 65 years | 138 Participants | 133 Participants | 271 Participants |
| Age, Continuous | 57.2 years STANDARD_DEVIATION 10.03 | 56.9 years STANDARD_DEVIATION 9.94 | 57.1 years STANDARD_DEVIATION 9.97 |
| Body Mass Index (BMI) | 33.4 kg / m^2 STANDARD_DEVIATION 4.23 | 32.9 kg / m^2 STANDARD_DEVIATION 4.37 | 33.2 kg / m^2 STANDARD_DEVIATION 4.3 |
| Body Weight | 99.4 kg STANDARD_DEVIATION 16.22 | 96.6 kg STANDARD_DEVIATION 17.4 | 98.0 kg STANDARD_DEVIATION 16.85 |
| Duration of Diabetes | 4.8 years STANDARD_DEVIATION 4.39 | 5.2 years STANDARD_DEVIATION 4.67 | 5.0 years STANDARD_DEVIATION 4.53 |
| Glycosylated hemoglobin (HbA1c) | 7.89 percentage STANDARD_DEVIATION 0.822 | 7.88 percentage STANDARD_DEVIATION 0.918 | 7.88 percentage STANDARD_DEVIATION 0.869 |
| Sex: Female, Male Female | 73 Participants | 77 Participants | 150 Participants |
| Sex: Female, Male Male | 108 Participants | 96 Participants | 204 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 102 / 247 | 66 / 233 |
| serious Total, serious adverse events | 9 / 247 | 8 / 233 |
Outcome results
Primary
Change in Glycosylated Hemoglobin (HbA1c)
Change in HbA1c from baseline after 26 weeks of treatment (i.e., HbA1c at week 26 minus HbA1c at week 0)
Time frame: Baseline and 26 weeks
Population: All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS) and had baseline and at least one post-baseline value available
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Exenatide Twice Daily | Change in Glycosylated Hemoglobin (HbA1c) | -1.00 Percentage of glycosylated hemoglobin | Standard Error 0.05 |
| Premixed Insulin Aspart Twice Daily | Change in Glycosylated Hemoglobin (HbA1c) | -1.14 Percentage of glycosylated hemoglobin | Standard Error 0.05 |
Comparison: The hypothesis was tested hierarchically that 1) exenatide BID is non-inferior to insulin aspart 70/30 BID for glycemic control (change in HbA1c, outcome measure 1), and 2) superior regarding the incidence of hypoglycemia (outcome measure 2). This is the first part of the hierarchical test.p-value: 0.05595% CI: [-0.003, 0.291]Mixed effect model repeat measures(MMRM)
Primary
Incidence of Hypoglycemia (Percentage of Participants With at Least One Hypoglycemic Episode)
Risk for first hypoglycemic episode (blood glucose \<=3.9 mmol/L or severe episode) to occur up to week 26
Time frame: 26 weeks
Population: All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exenatide Twice Daily | Incidence of Hypoglycemia (Percentage of Participants With at Least One Hypoglycemic Episode) | 8.0 Percentage of participants |
| Premixed Insulin Aspart Twice Daily | Incidence of Hypoglycemia (Percentage of Participants With at Least One Hypoglycemic Episode) | 20.5 Percentage of participants |
Comparison: The hypothesis was tested hierarchically that 1) exenatide BID is non-inferior to insulin aspart BID for glycemic control (outcome measure 1), and 2) superior regarding the incidence of hypoglycemia (outcome measure 2).The planned sample size of 366 patients treated with metformin only (assumed dropout rate 25%) gave 96% power to detect superiority of exenatide BID for the risk of hypoglycemia, assuming incidences of 3.6% for exenatide BID and 17.5% for insulin aspart BID (alpha=0.05).p-value: <0.05Kaplan-Meier analysis
Secondary
7 Point Self-monitored Blood Glucose (SMBG) Profiles
7-point self-monitored blood glucose profiles at baseline and the end of the study, measured at 7 times during the day (pre-breakfast, 2 hours post-breakfast, pre-lunch, 2 hours post-lunch, pre-dinner, 2 hours post-dinner, and 3:00am).
Time frame: Baseline and 26 weeks
Population: All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exenatide Twice Daily | 7 Point Self-monitored Blood Glucose (SMBG) Profiles | Pre-breakfast at baseline (week 0) | 8.933 mg/dL | Standard Deviation 1.7138 |
| Exenatide Twice Daily | 7 Point Self-monitored Blood Glucose (SMBG) Profiles | Pre-breakfast at endpoint (week 26) | 7.774 mg/dL | Standard Deviation 1.773 |
| Exenatide Twice Daily | 7 Point Self-monitored Blood Glucose (SMBG) Profiles | 2 hrs post-breakfast at baseline (week 0) | 10.821 mg/dL | Standard Deviation 2.5306 |
| Exenatide Twice Daily | 7 Point Self-monitored Blood Glucose (SMBG) Profiles | 2 hrs post-breakfast at endpoint (week 26) | 8.014 mg/dL | Standard Deviation 2.0557 |
| Exenatide Twice Daily | 7 Point Self-monitored Blood Glucose (SMBG) Profiles | Pre-lunch at baseline (week 0) | 8.443 mg/dL | Standard Deviation 2.1814 |
| Exenatide Twice Daily | 7 Point Self-monitored Blood Glucose (SMBG) Profiles | Pre-lunch at endpoint (week 26) | 7.506 mg/dL | Standard Deviation 1.88 |
| Exenatide Twice Daily | 7 Point Self-monitored Blood Glucose (SMBG) Profiles | 2 hrs post-lunch at baseline (week 0) | 9.698 mg/dL | Standard Deviation 2.237 |
| Exenatide Twice Daily | 7 Point Self-monitored Blood Glucose (SMBG) Profiles | 2 hrs post-lunch at endpoint (week 26) | 8.513 mg/dL | Standard Deviation 5.8997 |
| Exenatide Twice Daily | 7 Point Self-monitored Blood Glucose (SMBG) Profiles | Pre-dinner at baseline (week 0) | 8.684 mg/dL | Standard Deviation 2.0059 |
| Exenatide Twice Daily | 7 Point Self-monitored Blood Glucose (SMBG) Profiles | Pre-dinner at endpoint (week 26) | 7.616 mg/dL | Standard Deviation 2.1727 |
| Exenatide Twice Daily | 7 Point Self-monitored Blood Glucose (SMBG) Profiles | 2 hrs post-dinner at baseline (week 0) | 10.241 mg/dL | Standard Deviation 2.288 |
| Exenatide Twice Daily | 7 Point Self-monitored Blood Glucose (SMBG) Profiles | 2 hrs post-dinner at endpoint (week 26) | 7.727 mg/dL | Standard Deviation 1.882 |
| Exenatide Twice Daily | 7 Point Self-monitored Blood Glucose (SMBG) Profiles | 3:00 am at baseline (week 0) | 8.323 mg/dL | Standard Deviation 1.8692 |
| Exenatide Twice Daily | 7 Point Self-monitored Blood Glucose (SMBG) Profiles | 3:00 am at endpoint (week 26) | 7.518 mg/dL | Standard Deviation 1.5861 |
| Premixed Insulin Aspart Twice Daily | 7 Point Self-monitored Blood Glucose (SMBG) Profiles | 2 hrs post-dinner at baseline (week 0) | 10.259 mg/dL | Standard Deviation 2.4868 |
| Premixed Insulin Aspart Twice Daily | 7 Point Self-monitored Blood Glucose (SMBG) Profiles | Pre-breakfast at baseline (week 0) | 9.005 mg/dL | Standard Deviation 2.0432 |
| Premixed Insulin Aspart Twice Daily | 7 Point Self-monitored Blood Glucose (SMBG) Profiles | 2 hrs post-lunch at endpoint (week 26) | 8.216 mg/dL | Standard Deviation 1.6108 |
| Premixed Insulin Aspart Twice Daily | 7 Point Self-monitored Blood Glucose (SMBG) Profiles | Pre-breakfast at endpoint (week 26) | 7.293 mg/dL | Standard Deviation 1.3349 |
| Premixed Insulin Aspart Twice Daily | 7 Point Self-monitored Blood Glucose (SMBG) Profiles | 3:00 am at baseline (week 0) | 8.475 mg/dL | Standard Deviation 2.2643 |
| Premixed Insulin Aspart Twice Daily | 7 Point Self-monitored Blood Glucose (SMBG) Profiles | 2 hrs post-breakfast at baseline (week 0) | 10.902 mg/dL | Standard Deviation 2.8499 |
| Premixed Insulin Aspart Twice Daily | 7 Point Self-monitored Blood Glucose (SMBG) Profiles | Pre-dinner at baseline (week 0) | 8.759 mg/dL | Standard Deviation 2.2174 |
| Premixed Insulin Aspart Twice Daily | 7 Point Self-monitored Blood Glucose (SMBG) Profiles | 2 hrs post-breakfast at endpoint (week 26) | 8.304 mg/dL | Standard Deviation 2.1212 |
| Premixed Insulin Aspart Twice Daily | 7 Point Self-monitored Blood Glucose (SMBG) Profiles | 2 hrs post-dinner at endpoint (week 26) | 8.143 mg/dL | Standard Deviation 1.5614 |
| Premixed Insulin Aspart Twice Daily | 7 Point Self-monitored Blood Glucose (SMBG) Profiles | Pre-lunch at baseline (week 0) | 8.357 mg/dL | Standard Deviation 2.3221 |
| Premixed Insulin Aspart Twice Daily | 7 Point Self-monitored Blood Glucose (SMBG) Profiles | Pre-dinner at endpoint (week 26) | 7.194 mg/dL | Standard Deviation 1.5572 |
| Premixed Insulin Aspart Twice Daily | 7 Point Self-monitored Blood Glucose (SMBG) Profiles | Pre-lunch at endpoint (week 26) | 6.656 mg/dL | Standard Deviation 1.7011 |
| Premixed Insulin Aspart Twice Daily | 7 Point Self-monitored Blood Glucose (SMBG) Profiles | 3:00 am at endpoint (week 26) | 6.999 mg/dL | Standard Deviation 1.5596 |
| Premixed Insulin Aspart Twice Daily | 7 Point Self-monitored Blood Glucose (SMBG) Profiles | 2 hrs post-lunch at baseline (week 0) | 9.899 mg/dL | Standard Deviation 2.6433 |
Secondary
Blood Lipid Levels
Total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol (calculated), and triglyceride levels at baseline (week 0) and the end of the study (week 26)
Time frame: Baseline and 26 weeks
Population: All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exenatide Twice Daily | Blood Lipid Levels | Total cholesterol at baseline (week 0) | 5.147 mmol/L | Standard Deviation 1.0008 |
| Exenatide Twice Daily | Blood Lipid Levels | Total cholesterol at endpoint (week 26) | 4.971 mmol/L | Standard Deviation 0.9653 |
| Exenatide Twice Daily | Blood Lipid Levels | HDL cholesterol at baseline (week 0) | 1.234 mmol/L | Standard Deviation 0.3065 |
| Exenatide Twice Daily | Blood Lipid Levels | HDL cholesterol at endpoint (week 26) | 1.244 mmol/L | Standard Deviation 0.2805 |
| Exenatide Twice Daily | Blood Lipid Levels | LDL cholesterol (calculated) at baseline (week 0) | 2.845 mmol/L | Standard Deviation 0.8308 |
| Exenatide Twice Daily | Blood Lipid Levels | LDL cholesterol (calculated) at endpoint (week 26) | 2.738 mmol/L | Standard Deviation 0.8472 |
| Exenatide Twice Daily | Blood Lipid Levels | Triglycerides at baseline (week 0) | 2.391 mmol/L | Standard Deviation 1.5497 |
| Exenatide Twice Daily | Blood Lipid Levels | Triglycerides at endpoint (week 26) | 2.234 mmol/L | Standard Deviation 1.1886 |
| Premixed Insulin Aspart Twice Daily | Blood Lipid Levels | Triglycerides at endpoint (week 26) | 2.006 mmol/L | Standard Deviation 1.204 |
| Premixed Insulin Aspart Twice Daily | Blood Lipid Levels | Total cholesterol at baseline (week 0) | 5.084 mmol/L | Standard Deviation 1.0079 |
| Premixed Insulin Aspart Twice Daily | Blood Lipid Levels | LDL cholesterol (calculated) at baseline (week 0) | 2.768 mmol/L | Standard Deviation 0.8103 |
| Premixed Insulin Aspart Twice Daily | Blood Lipid Levels | Total cholesterol at endpoint (week 26) | 5.050 mmol/L | Standard Deviation 0.8933 |
| Premixed Insulin Aspart Twice Daily | Blood Lipid Levels | Triglycerides at baseline (week 0) | 2.410 mmol/L | Standard Deviation 1.4398 |
| Premixed Insulin Aspart Twice Daily | Blood Lipid Levels | HDL cholesterol at baseline (week 0) | 1.255 mmol/L | Standard Deviation 0.3324 |
| Premixed Insulin Aspart Twice Daily | Blood Lipid Levels | LDL cholesterol (calculated) at endpoint (week 26) | 2.852 mmol/L | Standard Deviation 0.8134 |
| Premixed Insulin Aspart Twice Daily | Blood Lipid Levels | HDL cholesterol at endpoint (week 26) | 1.319 mmol/L | Standard Deviation 0.3394 |
Secondary
Change in Body Mass Index (BMI)
Change in BMI from baseline after 26 weeks of treatment (i.e., BMI at week 26 minus BMI at week 0)
Time frame: Baseline and 26 weeks
Population: All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS) and had baseline and at least one post-baseline value available; last observation carried forward
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Exenatide Twice Daily | Change in Body Mass Index (BMI) | -1.39 kg/m^2 | Standard Error 0.07 |
| Premixed Insulin Aspart Twice Daily | Change in Body Mass Index (BMI) | 0.32 kg/m^2 | Standard Error 0.07 |
p-value: <0.0001Mixed effects model repeated measures
Secondary
Change in Body Weight
Change in body weight from baseline after 26 weeks of treatment (i.e., body weight at week 26 minus body weight at week 0)
Time frame: Baseline and 26 weeks
Population: All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS) and had baseline and at least one post-baseline value available; last observation carried forward
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Exenatide Twice Daily | Change in Body Weight | -4.10 kg | Standard Error 0.22 |
| Premixed Insulin Aspart Twice Daily | Change in Body Weight | 1.02 kg | Standard Error 0.22 |
p-value: <0.0001Mixed effects model repeated measures
Secondary
Incidence of Hypoglycemic Episodes [Blood Glucose <= 3.0 mmol/L or Severe] (Percentage of Subjects Who Experienced at Least One Treatment-emergent Hypoglycemic Episode During the 26-week Treatment Period)
Risk for the first hypoglycemic episode to occur up to Week 26 (percentage of subjects who experienced at least one treatment-emergent hypoglycemic episode during the 26-week treatment period)\[ i.e., number of subjects experiencing at least one hypoglycemic episode divided by total number of subjects times 100%\]
Time frame: 26 weeks
Population: All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exenatide Twice Daily | Incidence of Hypoglycemic Episodes [Blood Glucose <= 3.0 mmol/L or Severe] (Percentage of Subjects Who Experienced at Least One Treatment-emergent Hypoglycemic Episode During the 26-week Treatment Period) | 1.8 Percentage of participants |
| Premixed Insulin Aspart Twice Daily | Incidence of Hypoglycemic Episodes [Blood Glucose <= 3.0 mmol/L or Severe] (Percentage of Subjects Who Experienced at Least One Treatment-emergent Hypoglycemic Episode During the 26-week Treatment Period) | 6.3 Percentage of participants |
Secondary
Incidence of Nocturnal Hypoglycemia (Percentage of Subjects Who Experienced at Least One Episode of Nocturnal Hypoglycemia During the 26 Week Treatment Period)
Risk for first nocturnal (night-time) hypoglycemic episode to occur up to week 26 (percentage of subjects who experienced at least one episode of nocturnal hypoglycemia during the 26 week treatment period) \[i.e., number of subjects who experienced nocturnal hypoglycemia divided by total number of subjects times 100%\].
Time frame: 26 weeks
Population: All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exenatide Twice Daily | Incidence of Nocturnal Hypoglycemia (Percentage of Subjects Who Experienced at Least One Episode of Nocturnal Hypoglycemia During the 26 Week Treatment Period) | 3.9 Percentage of participants |
| Premixed Insulin Aspart Twice Daily | Incidence of Nocturnal Hypoglycemia (Percentage of Subjects Who Experienced at Least One Episode of Nocturnal Hypoglycemia During the 26 Week Treatment Period) | 7.0 Percentage of participants |
Secondary
Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Total DTSQ treatment satisfaction score at baseline (week 0) and after 26 weeks of treatment (LOCF). Total DTSQ treatment satisfaction score is derived as sum score of the individual components 1 and 4-8 of the DTSQ questionnaire. Each component is scored on a scale of 0 (worst case) to 6 (best case). Higher values represent higher treatment satisfaction.
Time frame: Baseline and 26 weeks
Population: All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exenatide Twice Daily | Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ) | DTSQ score at baseline (week 0) | 29.5 scores on DTSQ scale | Standard Deviation 6.13 |
| Exenatide Twice Daily | Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ) | DTSQ score at endpoint (week 26) | 30.6 scores on DTSQ scale | Standard Deviation 6.05 |
| Premixed Insulin Aspart Twice Daily | Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ) | DTSQ score at baseline (week 0) | 29.7 scores on DTSQ scale | Standard Deviation 6.25 |
| Premixed Insulin Aspart Twice Daily | Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire (DTSQ) | DTSQ score at endpoint (week 26) | 29.3 scores on DTSQ scale | Standard Deviation 6.59 |
Secondary
Patient Reported Outcomes: Quality of Life (SF-12)
SF-12 Physical and Mental Component Summary Scores at baseline (week 0) and after 26 weeks of treatment (LOCF). SF-12 Physical and Mental Component Summary Scores are normalized scores ranging from 0 (worst case) to 100 (best case), and are derived from responses to 12 questions. Scores \> 50 indicate an above-average health status.
Time frame: Baseline and 26 weeks
Population: All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exenatide Twice Daily | Patient Reported Outcomes: Quality of Life (SF-12) | Physical Component at baseline (week 0) | 35.5 scores on SF-12 scale | Standard Deviation 13.99 |
| Exenatide Twice Daily | Patient Reported Outcomes: Quality of Life (SF-12) | Physical Component at endpoint (week 26) | 39.1 scores on SF-12 scale | Standard Deviation 14.3 |
| Exenatide Twice Daily | Patient Reported Outcomes: Quality of Life (SF-12) | Mental Component at baseline (week 0) | 31.3 scores on SF-12 scale | Standard Deviation 18.33 |
| Exenatide Twice Daily | Patient Reported Outcomes: Quality of Life (SF-12) | Mental Component at endpoint (week 26) | 31.1 scores on SF-12 scale | Standard Deviation 19.38 |
| Premixed Insulin Aspart Twice Daily | Patient Reported Outcomes: Quality of Life (SF-12) | Mental Component at endpoint (week 26) | 29.6 scores on SF-12 scale | Standard Deviation 18.36 |
| Premixed Insulin Aspart Twice Daily | Patient Reported Outcomes: Quality of Life (SF-12) | Physical Component at baseline (week 0) | 36.3 scores on SF-12 scale | Standard Deviation 14.45 |
| Premixed Insulin Aspart Twice Daily | Patient Reported Outcomes: Quality of Life (SF-12) | Mental Component at baseline (week 0) | 28.3 scores on SF-12 scale | Standard Deviation 19.43 |
| Premixed Insulin Aspart Twice Daily | Patient Reported Outcomes: Quality of Life (SF-12) | Physical Component at endpoint (week 26) | 37.7 scores on SF-12 scale | Standard Deviation 14.28 |
Secondary
Percentage of Subjects Achieving HbA1c Target of < 6.5%
Percentage of subjects achieving HbA1c target of \< 6.5% at the end of study (week 26) \[i.e., number of subjects who achieved HbA1c \< 6.5% divided by total number of subjects times 100%\].
Time frame: 26 weeks
Population: All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exenatide Twice Daily | Percentage of Subjects Achieving HbA1c Target of < 6.5% | 27.6 Percentage of participants |
| Premixed Insulin Aspart Twice Daily | Percentage of Subjects Achieving HbA1c Target of < 6.5% | 24.9 Percentage of participants |
p-value: 0.554Chi square test (Pearson)
Secondary
Percentage of Subjects Achieving HbA1c Target of < 7.0%
Percentage of subjects achieving HbA1c target of \< 7.0% at the end of study (week 26) \[i.e., number of subjects who achieved HbA1c \< 7.0% divided by total number of subjects times 100%\].
Time frame: 26 weeks
Population: All randomized patients who were previously treated with metformin only and who received at least one dose of study drug (MET only, FAS); last observation carried forward
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exenatide Twice Daily | Percentage of Subjects Achieving HbA1c Target of < 7.0% | 49.2 Percentage of participants |
| Premixed Insulin Aspart Twice Daily | Percentage of Subjects Achieving HbA1c Target of < 7.0% | 56.6 Percentage of participants |
p-value: 0.159Chi square test (Pearson)