Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes Mellitus, Type 2
Brief summary
This drug is being evaluated for possible treatment of type 2 diabetes mellitus. Participation in this study is expected to last up to 18 weeks. A goal of this study is to determine the safety and effectiveness of LY2409021.
Interventions
DRUGLY2409021
4 capsules by mouth taken once daily for 12 weeks
DRUGPlacebo
4 capsules by mouth once daily for 12 weeks
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Inclusion: * Participants must either be male or a female who cannot become pregnant, who has type 2 diabetes and is either controlling your diabetes through diet and exercise alone, or with diet and exercise taking metformin. * If participants are male, participants are willing to talk to the study doctor about birth control options during the study and for 3 months after the last dose of study medication. * Participants must have an Hemoglobin A1c (HbA1c) test of 6.5% to 10% * Participants must have a body mass index (BMI) between 25 to 40 kilograms/square meter (kg/m²). * Participants must be willing and able to test your blood sugar levels at home with a blood sugar meter. * Participants must complete a study diary as instructed by your study doctor and staff and return the study diary as instructed by the study doctor. * Participants must maintain consistent dietary, physical activity, and sleeping patterns throughout the study.
Exclusion criteria
* Insulin, exenatide, or any diabetic medication other than metformin 3 months prior to screening to control you diabetes, * Medications to increase movement in your digestive tract or that slow movement in your digestive tract * Over-the-counter drugs or drugs prescribed by your doctor that cause weight loss or high or low blood sugar, * Chronically use oral glucocorticoids therapy or have received this type of medication within 8 weeks prior to beginning this study, * Class II and III antiarrhythmic agents (commonly used to prevent or relieve an irregular heartbeat), * Drugs that damage the liver * Fibrates and niacin (both commonly used to treat high cholesterol) more than 1 gram/day (gm/day), * Central nervous stimulants, alcohol intake for males that is more than 2 units per day and for females that is more than 1 unit per day \[1 unit=12 ounces (oz) or 360 milliliter (mL) of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits\]. * You have had one (1) or more cases of uncontrolled diabetes (very high blood sugars) which required hospitalization in the 6 months prior to the screening visit or have a diagnosis of hypoglycemia (low blood sugar) unawareness. * You had two (2) or more emergency room visits or were hospitalized for poor control of your diabetes (for example, keto-acidotic episode) in the last 6 months. * Participants have a problem with your stomach such that it empties slowly (diabetic gastroparesis) or you have had gastric bypass (bariatric) surgery. * Participants have a personal or family history of pancreatic neoplasia. * Participants have abnormal lipids (for example triglycerides). * Participants have had problems with your heart in the past 6 months, such as a heart attack, chest pain (angina), heart failure, heart bypass operation, angioplasty (a medical procedure to open a narrow or clogged blood vessel of the heart) or stent insertion (a procedure to insert a wire mesh tube to prop open a blood vessel after angioplasty), a heart rhythm problem, or a stroke. * Participants have an elevated or uncontrolled blood pressure. * Participant's electrocardiogram (ECG, a test that measures the electrical activity of your heart) is outside the normal limits, as determined by the study doctor. * Participants have a problem with your kidneys or are on dialysis. * Participants have a problem with your pancreas. * Participants must not have nor had liver disease (for example, Hepatitis B or C). * Participants have cancer, except for skin cancer or have been in remission (the absence of disease activity) from cancer for less than 5 years. * Participants have a serious or uncontrolled health problems (other than type 2 diabetes), blood disorders or laboratory tests that in the opinion of the doctor, could interfere with understanding the results of this study. The doctor will let you know if this applies to you. * Participants previously completed or withdrew from this study or any other study investigating LY2409021. * Participants are allergic to the study drug or other related drugs. You cannot be in this study if you are a woman and you possibly could become pregnant during this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Glycosylated Hemoglobin A1c (HbA1c) | Baseline, Week 12 | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was calculated using a mixed-model repeated measures analysis (MMRM) that included terms for treatment group, baseline HbA1c, metformin use, visit, and visit-by-treatment interaction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline for Glucose Area Under the Curve (AUC) From Oral Glucose Tolerance Test (OGTT) | Baseline, Week 12 | LS mean was calculated using analysis of covariance (ANCOVA) model that included terms for treatment group, baseline value and metformin use. |
| Change From Baseline to Endpoint for Fasting Triglycerides | Baseline, Week 12 | LS mean was calculated using ANCOVA model that included terms for treatment group, baseline value and metformin use. |
| Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Baseline, Week 12 | The DSC-R was a participant completed questionnaire that was designed to assess the presence and perceived burden of diabetes-related symptoms. Participants were asked to recall the last 4 weeks and consider each symptom/item in terms of whether they experienced it and if so, how troublesomeness it was. Participants were to consider troublesomeness of the symptom on a 1 (not at all) to 5 (extremely) point scale. There were a total of 34 items, grouped into 8 subscales: cardiovascular (4 items), psychological-cognitive distress (4 items), psychological-fatigue (4 items), hyperglycemic (4 items), hypoglycemic (3 items), neurological-pain (4 items), neurological-sensory (6 items) and visual (5 items). Sub-domain score calculated as: (sum of item scores) divided by (number of items), scores ranged from 1 to 5. Total score was the sum of all sub-domains and ranged from 8 to 40. Higher scores of total and subscales indicated worsened symptoms. |
| Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Baseline, Week 12 | The Diabetes Medicines Survey was a participant reported questionnaire consisting of 25 items: perceived effectiveness of diabetes medicines (items 1-10) and physical side-effects (items 11-25). Both domains had a scores range from 1 (all of the time) to 4 (none of the time) and a possible total scores range from 25 to 100. Lower scores for perceived effectiveness items indicated a better perceived effectiveness. Lower scores for physical side-effects items indicated a greater frequency of physical side-effects. |
| Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles | Baseline, Week 12 | Participants obtained 7-point SMBG values immediately before and 2 hours after each meal and at bedtime. LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction. |
| Change From Baseline Values for Fasting Insulin | Baseline, Week 12 | LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction. |
| Change From Baseline Values for Fasting Glucagon | Baseline, Week 12 | LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction. |
| Change From Baseline Values for Fasting Blood Glucose (FBG) | Baseline, Week 12 | LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction. |
| Change From Baseline for Insulin AUC From OGTT | Baseline, Week 12 | LS mean was calculated using an ANCOVA that included terms for treatment group, baseline value and metformin use. |
| Change From Baseline for C-Peptide AUC From OGTT | Baseline, Week 12 | LS mean was calculated using an ANCOVA model that included terms for treatment group, baseline value and metformin use. |
| Change From Baseline to Endpoint for Low Density Lipoprotein (LDL) | Baseline, Week 12 | Fasting LDL LS mean was calculated using ANCOVA that included terms for baseline and treatment. |
| Change From Baseline to Endpoint for High Density Lipoprotein (HDL) | Baseline, Week 12 | Fasting HDL LS mean was calculated using ANCOVA that included terms for baseline and treatment. |
| Change From Baseline to Endpoint for Non-HDL Cholesterol | Baseline, Week 12 | Fasting non-HDL cholesterol LS mean was calculated using ANCOVA that included terms for baseline and treatment. |
| Change From Baseline to Endpoint for Total Cholesterol | Baseline, Week 12 | Fasting total cholesterol LS mean was calculated using ANCOVA that included terms for baseline and treatment. |
| Change From Baseline Values for Fasting Glucagon-Like Peptide 1 (GLP-1) | Baseline, Week 12 | LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction. |
Countries
Germany, Lithuania, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo was administered orally once daily as 4 capsules for 12 weeks. | 10 |
| 10 mg LY2409021 10 mg LY2409021 was administered orally once daily as 4 capsules of 2.5 mg LY2409021 for 12 weeks. | 17 |
| 30 mg LY2409021 30 mg LY2409021 was administered orally once daily as 2 capsules of 15 mg LY2409021 and 2 capsules of placebo for 12 weeks. | 34 |
| 60 mg LY2409021 60 mg LY2409021 was administered orally once daily as 4 capsules of 15 mg LY2409021 for 12 weeks. | 26 |
| Total | 87 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 | 0 | 3 |
| Overall Study | Investigator Decision | 0 | 1 | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 0 | 1 | 1 |
| Overall Study | Sponsor Decision | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 3 | 1 |
Baseline characteristics
| Characteristic | Placebo | Total | 60 mg LY2409021 | 30 mg LY2409021 | 10 mg LY2409021 |
|---|---|---|---|---|---|
| Age, Continuous | 50.8 years STANDARD_DEVIATION 4.92 | 52.3 years STANDARD_DEVIATION 8.93 | 52.5 years STANDARD_DEVIATION 6.41 | 52.0 years STANDARD_DEVIATION 10.88 | 53.3 years STANDARD_DEVIATION 10.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 48 Participants | 16 Participants | 15 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 39 Participants | 10 Participants | 19 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 23 Participants | 9 Participants | 9 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 6 Participants | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 15 Participants | 3 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 41 Participants | 11 Participants | 18 Participants | 7 Participants |
| Region of Enrollment United States | 10 Participants | 87 Participants | 26 Participants | 34 Participants | 17 Participants |
| Sex: Female, Male Female | 5 Participants | 47 Participants | 18 Participants | 18 Participants | 6 Participants |
| Sex: Female, Male Male | 5 Participants | 40 Participants | 8 Participants | 16 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 9 | 14 / 17 | 25 / 34 | 18 / 25 |
| serious Total, serious adverse events | 0 / 9 | 1 / 17 | 0 / 34 | 1 / 25 |
Outcome results
Primary
Mean Change in Glycosylated Hemoglobin A1c (HbA1c)
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was calculated using a mixed-model repeated measures analysis (MMRM) that included terms for treatment group, baseline HbA1c, metformin use, visit, and visit-by-treatment interaction.
Time frame: Baseline, Week 12
Population: Modified Intent-to-Treat (mITT): All randomized participants with at least 1 post baseline HbA1c measurement and analyzed according to the assigned treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Mean Change in Glycosylated Hemoglobin A1c (HbA1c) | 0.11 percentage of HbA1c |
| 10 mg LY2409021 | Mean Change in Glycosylated Hemoglobin A1c (HbA1c) | -0.83 percentage of HbA1c |
| 30 mg LY2409021 | Mean Change in Glycosylated Hemoglobin A1c (HbA1c) | -0.65 percentage of HbA1c |
| 60 mg LY2409021 | Mean Change in Glycosylated Hemoglobin A1c (HbA1c) | -0.66 percentage of HbA1c |
p-value: 0.029690% CI: [-1.64, -0.23]Mixed Models Analysis
p-value: 0.041890% CI: [-1.37, -0.15]Mixed Models Analysis
p-value: 0.051490% CI: [-1.41, -0.12]Mixed Models Analysis
Secondary
Change From Baseline for C-Peptide AUC From OGTT
LS mean was calculated using an ANCOVA model that included terms for treatment group, baseline value and metformin use.
Time frame: Baseline, Week 12
Population: mITT: all randomized participants with at least 1 post baseline C-peptide AUC from OGTTmeasurement and analyzed according to the assigned treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline for C-Peptide AUC From OGTT | 20380.84 pmol/L |
| 10 mg LY2409021 | Change From Baseline for C-Peptide AUC From OGTT | 38475.16 pmol/L |
| 30 mg LY2409021 | Change From Baseline for C-Peptide AUC From OGTT | 26164.43 pmol/L |
| 60 mg LY2409021 | Change From Baseline for C-Peptide AUC From OGTT | 56599.82 pmol/L |
p-value: 0.620995% CI: [-54734.08, 90922.71]ANCOVA
p-value: 0.858195% CI: [-58650.71, 70217.89]ANCOVA
p-value: 0.28595% CI: [-30955.5, 103393.46]ANCOVA
Secondary
Change From Baseline for Glucose Area Under the Curve (AUC) From Oral Glucose Tolerance Test (OGTT)
LS mean was calculated using analysis of covariance (ANCOVA) model that included terms for treatment group, baseline value and metformin use.
Time frame: Baseline, Week 12
Population: mITT: All randomized participants with at least 1 post baseline OGTT measurement and analyzed according to the assigned treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline for Glucose Area Under the Curve (AUC) From Oral Glucose Tolerance Test (OGTT) | 172.89 mmol/L |
| 10 mg LY2409021 | Change From Baseline for Glucose Area Under the Curve (AUC) From Oral Glucose Tolerance Test (OGTT) | 48.34 mmol/L |
| 30 mg LY2409021 | Change From Baseline for Glucose Area Under the Curve (AUC) From Oral Glucose Tolerance Test (OGTT) | -165.74 mmol/L |
| 60 mg LY2409021 | Change From Baseline for Glucose Area Under the Curve (AUC) From Oral Glucose Tolerance Test (OGTT) | -293.94 mmol/L |
p-value: 0.497895% CI: [-490.02, 240.9]ANCOVA
p-value: 0.037295% CI: [-656.55, -20.72]ANCOVA
p-value: 0.006895% CI: [-799.48, -134.18]ANCOVA
Secondary
Change From Baseline for Insulin AUC From OGTT
LS mean was calculated using an ANCOVA that included terms for treatment group, baseline value and metformin use.
Time frame: Baseline, Week 12
Population: mITT: All randomized participants with at least 1 post baseline AUC from OGTT measurement and analyzed according to the assigned treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline for Insulin AUC From OGTT | 2357.88 pmol/L |
| 10 mg LY2409021 | Change From Baseline for Insulin AUC From OGTT | 10376.38 pmol/L |
| 30 mg LY2409021 | Change From Baseline for Insulin AUC From OGTT | 7532.72 pmol/L |
| 60 mg LY2409021 | Change From Baseline for Insulin AUC From OGTT | 20511.79 pmol/L |
p-value: 0.4595% CI: [-13104.14, 29141.16]ANCOVA
p-value: 0.573995% CI: [-13158.65, 23508.35]ANCOVA
p-value: 0.065395% CI: [-1188.23, 37496.06]ANCOVA
Secondary
Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021)
The Diabetes Medicines Survey was a participant reported questionnaire consisting of 25 items: perceived effectiveness of diabetes medicines (items 1-10) and physical side-effects (items 11-25). Both domains had a scores range from 1 (all of the time) to 4 (none of the time) and a possible total scores range from 25 to 100. Lower scores for perceived effectiveness items indicated a better perceived effectiveness. Lower scores for physical side-effects items indicated a greater frequency of physical side-effects.
Time frame: Baseline, Week 12
Population: mITT: All randomized participants with at least 1 post baseline Diabetes Medicines Survey measurement and analyzed according to the assigned treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Diarrhea | 3.38 units on a scale | Standard Deviation 0.744 |
| Placebo | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Bloating | 3.63 units on a scale | Standard Deviation 0.518 |
| Placebo | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Stomach Pain | 3.75 units on a scale | Standard Deviation 0.707 |
| Placebo | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication giving 24-hour control | 2.13 units on a scale | Standard Deviation 1.126 |
| Placebo | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Excessive Sweating | 3.75 units on a scale | Standard Deviation 0.463 |
| Placebo | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication working well | 1.75 units on a scale | Standard Deviation 0.886 |
| Placebo | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication making me feel better | 2.00 units on a scale | Standard Deviation 1.069 |
| Placebo | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication therapy is effective | 1.88 units on a scale | Standard Deviation 0.835 |
| Placebo | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Heartburn | 3.75 units on a scale | Standard Deviation 0.463 |
| Placebo | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Meeting medical needs | 1.75 units on a scale | Standard Deviation 0.886 |
| Placebo | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Hypoglycemia | 4.00 units on a scale | Standard Deviation 0 |
| Placebo | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication keeping BS stable | 2.00 units on a scale | Standard Deviation 0.926 |
| Placebo | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Upset Stomach | 3.63 units on a scale | Standard Deviation 0.744 |
| Placebo | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication controlling blood sugar(BS) | 1.75 units on a scale | Standard Deviation 0.886 |
| Placebo | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication taking care of illness | 2.00 units on a scale | Standard Deviation 1.069 |
| Placebo | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Constipation | 3.88 units on a scale | Standard Deviation 0.354 |
| Placebo | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Muscle Cramps | 3.88 units on a scale | Standard Deviation 0.354 |
| Placebo | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Muscle Soreness | 3.75 units on a scale | Standard Deviation 0.463 |
| Placebo | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Itching | 3.88 units on a scale | Standard Deviation 0.354 |
| Placebo | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Feet or hands swelling | 3.75 units on a scale | Standard Deviation 0.463 |
| Placebo | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Dizziness/Lightheaded | 3.75 units on a scale | Standard Deviation 0.463 |
| Placebo | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication giving good results | 1.88 units on a scale | Standard Deviation 0.835 |
| Placebo | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Weight gain | 3.63 units on a scale | Standard Deviation 0.518 |
| Placebo | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Headaches | 3.63 units on a scale | Standard Deviation 0.518 |
| Placebo | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication therapy is failing | 3.63 units on a scale | Standard Deviation 0.744 |
| 10 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Headaches | 3.45 units on a scale | Standard Deviation 0.688 |
| 10 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Weight gain | 3.73 units on a scale | Standard Deviation 0.467 |
| 10 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Muscle Soreness | 3.82 units on a scale | Standard Deviation 0.603 |
| 10 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Heartburn | 3.73 units on a scale | Standard Deviation 0.647 |
| 10 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Dizziness/Lightheaded | 3.73 units on a scale | Standard Deviation 0.467 |
| 10 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Upset Stomach | 4.00 units on a scale | Standard Deviation 0 |
| 10 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Muscle Cramps | 3.64 units on a scale | Standard Deviation 0.809 |
| 10 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Diarrhea | 3.73 units on a scale | Standard Deviation 0.467 |
| 10 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Bloating | 3.82 units on a scale | Standard Deviation 0.405 |
| 10 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication making me feel better | 2.09 units on a scale | Standard Deviation 0.831 |
| 10 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication taking care of illness | 2.09 units on a scale | Standard Deviation 0.831 |
| 10 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Meeting medical needs | 2.09 units on a scale | Standard Deviation 0.831 |
| 10 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Stomach Pain | 3.73 units on a scale | Standard Deviation 0.647 |
| 10 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication therapy is failing | 3.18 units on a scale | Standard Deviation 0.874 |
| 10 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication controlling blood sugar(BS) | 2.00 units on a scale | Standard Deviation 0.894 |
| 10 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication giving 24-hour control | 2.27 units on a scale | Standard Deviation 1.104 |
| 10 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Hypoglycemia | 3.82 units on a scale | Standard Deviation 0.405 |
| 10 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication therapy is effective | 2.09 units on a scale | Standard Deviation 0.944 |
| 10 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication working well | 2.00 units on a scale | Standard Deviation 0.894 |
| 10 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication keeping BS stable | 2.18 units on a scale | Standard Deviation 0.982 |
| 10 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Itching | 3.73 units on a scale | Standard Deviation 0.467 |
| 10 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Constipation | 3.18 units on a scale | Standard Deviation 1.168 |
| 10 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Feet or hands swelling | 3.91 units on a scale | Standard Deviation 0.302 |
| 10 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Excessive Sweating | 3.64 units on a scale | Standard Deviation 0.809 |
| 10 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication giving good results | 2.00 units on a scale | Standard Deviation 0.894 |
| 30 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Muscle Cramps | 3.87 units on a scale | Standard Deviation 0.346 |
| 30 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication controlling blood sugar(BS) | 1.77 units on a scale | Standard Deviation 0.679 |
| 30 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Meeting medical needs | 1.80 units on a scale | Standard Deviation 0.805 |
| 30 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication working well | 1.70 units on a scale | Standard Deviation 0.794 |
| 30 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication giving good results | 1.87 units on a scale | Standard Deviation 0.776 |
| 30 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication making me feel better | 1.90 units on a scale | Standard Deviation 0.712 |
| 30 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication taking care of illness | 1.83 units on a scale | Standard Deviation 0.834 |
| 30 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication therapy is failing | 3.17 units on a scale | Standard Deviation 0.928 |
| 30 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication giving 24-hour control | 2.03 units on a scale | Standard Deviation 0.823 |
| 30 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication therapy is effective | 1.87 units on a scale | Standard Deviation 0.73 |
| 30 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication keeping BS stable | 1.97 units on a scale | Standard Deviation 0.718 |
| 30 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Constipation | 3.83 units on a scale | Standard Deviation 0.379 |
| 30 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Feet or hands swelling | 3.80 units on a scale | Standard Deviation 0.407 |
| 30 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Headaches | 3.60 units on a scale | Standard Deviation 563 |
| 30 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Weight gain | 3.57 units on a scale | Standard Deviation 0.728 |
| 30 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Dizziness/Lightheaded | 3.90 units on a scale | Standard Deviation 0.403 |
| 30 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Bloating | 3.83 units on a scale | Standard Deviation 0.379 |
| 30 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Diarrhea | 3.70 units on a scale | Standard Deviation 0.596 |
| 30 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Heartburn | 3.72 units on a scale | Standard Deviation 0.528 |
| 30 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Excessive Sweating | 3.77 units on a scale | Standard Deviation 0.568 |
| 30 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Itching | 3.90 units on a scale | Standard Deviation 0.403 |
| 30 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Hypoglycemia | 3.90 units on a scale | Standard Deviation 0.305 |
| 30 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Stomach Pain | 3.93 units on a scale | Standard Deviation 0.254 |
| 30 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Upset Stomach | 3.90 units on a scale | Standard Deviation 0.305 |
| 30 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Muscle Soreness | 3.77 units on a scale | Standard Deviation 0.504 |
| 60 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Heartburn | 3.79 units on a scale | Standard Deviation 0.535 |
| 60 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Headaches | 3.79 units on a scale | Standard Deviation 0.419 |
| 60 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Feet or hands swelling | 3.84 units on a scale | Standard Deviation 0.375 |
| 60 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Muscle Soreness | 3.63 units on a scale | Standard Deviation 0.597 |
| 60 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Excessive Sweating | 3.79 units on a scale | Standard Deviation 0.535 |
| 60 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Constipation | 3.63 units on a scale | Standard Deviation 0.761 |
| 60 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication keeping BS stable | 1.68 units on a scale | Standard Deviation 0.671 |
| 60 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Upset Stomach | 3.79 units on a scale | Standard Deviation 0.535 |
| 60 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Itching | 3.84 units on a scale | Standard Deviation 0.501 |
| 60 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication therapy is effective | 1.74 units on a scale | Standard Deviation 0.733 |
| 60 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication giving 24-hour control | 1.68 units on a scale | Standard Deviation 0.671 |
| 60 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication working well | 1.63 units on a scale | Standard Deviation 0.831 |
| 60 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Hypoglycemia | 3.89 units on a scale | Standard Deviation 0.315 |
| 60 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication therapy is failing | 3.58 units on a scale | Standard Deviation 769 |
| 60 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication taking care of illness | 1.58 units on a scale | Standard Deviation 0.692 |
| 60 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication controlling blood sugar(BS) | 1.53 units on a scale | Standard Deviation 0.697 |
| 60 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Stomach Pain | 3.84 units on a scale | Standard Deviation 0.375 |
| 60 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Bloating | 3.79 units on a scale | Standard Deviation 0.419 |
| 60 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Muscle Cramps | 3.58 units on a scale | Standard Deviation 0.769 |
| 60 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Meeting medical needs | 1.58 units on a scale | Standard Deviation 0.769 |
| 60 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication making me feel better | 1.84 units on a scale | Standard Deviation 0.688 |
| 60 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Diarrhea | 3.74 units on a scale | Standard Deviation 0.452 |
| 60 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Dizziness/Lightheaded | 3.89 units on a scale | Standard Deviation 0.315 |
| 60 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Side Effect: Weight gain | 3.79 units on a scale | Standard Deviation 0.419 |
| 60 mg LY2409021 | Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021) | Medication giving good results | 1.58 units on a scale | Standard Deviation 692 |
Secondary
Change From Baseline to Endpoint for Fasting Triglycerides
LS mean was calculated using ANCOVA model that included terms for treatment group, baseline value and metformin use.
Time frame: Baseline, Week 12
Population: mITT: All randomized participants with at least 1 post baseline fasting triglyceride measurement and analyzed according to the assigned treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Endpoint for Fasting Triglycerides | 0.1 mmol/L | Standard Error 0.24 |
| 10 mg LY2409021 | Change From Baseline to Endpoint for Fasting Triglycerides | 0.2 mmol/L | Standard Error 0.2 |
| 30 mg LY2409021 | Change From Baseline to Endpoint for Fasting Triglycerides | 0.2 mmol/L | Standard Error 0.12 |
| 60 mg LY2409021 | Change From Baseline to Endpoint for Fasting Triglycerides | 0 mmol/L | Standard Error 0.14 |
p-value: 0.81495% CI: [-0.5, 0.7]ANCOVA
p-value: 0.68195% CI: [-0.4, 0.7]ANCOVA
p-value: 0.71595% CI: [-0.7, 0.5]ANCOVA
Secondary
Change From Baseline to Endpoint for High Density Lipoprotein (HDL)
Fasting HDL LS mean was calculated using ANCOVA that included terms for baseline and treatment.
Time frame: Baseline, Week 12
Population: mITT: All randomized participants with at least 1 post baseline fasting HDL measurement and analyzed according to the assigned treatment; LOCF.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Endpoint for High Density Lipoprotein (HDL) | -0.1 mmol/L | Standard Error 0.11 |
| 10 mg LY2409021 | Change From Baseline to Endpoint for High Density Lipoprotein (HDL) | 0 mmol/L | Standard Error 0.07 |
| 30 mg LY2409021 | Change From Baseline to Endpoint for High Density Lipoprotein (HDL) | 0.1 mmol/L | Standard Error 0.05 |
| 60 mg LY2409021 | Change From Baseline to Endpoint for High Density Lipoprotein (HDL) | 0 mmol/L | Standard Error 0.06 |
p-value: 0.19195% CI: [-0.1, 0.4]ANCOVA
p-value: 0.29795% CI: [-0.1, 0.4]ANCOVA
p-value: 0.36595% CI: [-0.1, 0.4]ANCOVA
Secondary
Change From Baseline to Endpoint for Low Density Lipoprotein (LDL)
Fasting LDL LS mean was calculated using ANCOVA that included terms for baseline and treatment.
Time frame: Baseline, Week 12
Population: mITT: All randomized participants with at least 1 post baseline fasting LDL measurement and analyzed according to the assigned treatment; last observation carried forward (LOCF).
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Endpoint for Low Density Lipoprotein (LDL) | 0.4 mmol/L | Standard Error 0.21 |
| 10 mg LY2409021 | Change From Baseline to Endpoint for Low Density Lipoprotein (LDL) | 0.3 mmol/L | Standard Error 0.15 |
| 30 mg LY2409021 | Change From Baseline to Endpoint for Low Density Lipoprotein (LDL) | 0.2 mmol/L | Standard Error 0.11 |
| 60 mg LY2409021 | Change From Baseline to Endpoint for Low Density Lipoprotein (LDL) | 0.3 mmol/L | Standard Error 0.13 |
p-value: 0.58495% CI: [-0.7, 0.4]ANCOVA
p-value: 0.42695% CI: [-0.7, 0.3]ANCOVA
p-value: 0.65795% CI: [-0.6, 0.4]ANCOVA
Secondary
Change From Baseline to Endpoint for Non-HDL Cholesterol
Fasting non-HDL cholesterol LS mean was calculated using ANCOVA that included terms for baseline and treatment.
Time frame: Baseline, Week 12
Population: mITT: All randomized participants with at least 1 post baseline fasting non-HDL cholesterol measurement and analyzed according to the assigned treatment; LOCF.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Endpoint for Non-HDL Cholesterol | 0.5 mmol/L | Standard Error 0.24 |
| 10 mg LY2409021 | Change From Baseline to Endpoint for Non-HDL Cholesterol | 0.3 mmol/L | Standard Error 0.17 |
| 30 mg LY2409021 | Change From Baseline to Endpoint for Non-HDL Cholesterol | 0.3 mmol/L | Standard Error 0.12 |
| 60 mg LY2409021 | Change From Baseline to Endpoint for Non-HDL Cholesterol | 0.3 mmol/L | Standard Error 0.14 |
p-value: 0.52395% CI: [-0.8, 0.4]ANCOVA
p-value: 0.47695% CI: [-0.7, 0.3]ANCOVA
p-value: 0.63495% CI: [-0.7, 0.4]ANCOVA
Secondary
Change From Baseline to Endpoint for Total Cholesterol
Fasting total cholesterol LS mean was calculated using ANCOVA that included terms for baseline and treatment.
Time frame: Baseline, Week 12
Population: mITT: All randomized participants with at least 1 post baseline fasting total cholesterol measurement and analyzed according to the assigned treatment; LOCF.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Endpoint for Total Cholesterol | 0.3 mmol/L | Standard Error 0.24 |
| 10 mg LY2409021 | Change From Baseline to Endpoint for Total Cholesterol | 0.3 mmol/L | Standard Error 0.18 |
| 30 mg LY2409021 | Change From Baseline to Endpoint for Total Cholesterol | 0.3 mmol/L | Standard Error 0.12 |
| 60 mg LY2409021 | Change From Baseline to Endpoint for Total Cholesterol | 0.4 mmol/L | Standard Error 0.15 |
p-value: 0.91995% CI: [-0.6, 0.6]ANCOVA
p-value: 0.86495% CI: [-0.5, 0.6]ANCOVA
p-value: 0.72695% CI: [-0.5, 0.7]ANCOVA
Secondary
Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles
Participants obtained 7-point SMBG values immediately before and 2 hours after each meal and at bedtime. LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.
Time frame: Baseline, Week 12
Population: mITT: All randomized participants with at least 1 post baseline 7-Point SMBG measurement and analyzed according to the assigned treatment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo | Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles | Pre-Morning Meal Fasting | 13.46 milligrams/deciliter (mg/dL) |
| Placebo | Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles | 2 Hours After Evening Meal | 12.02 milligrams/deciliter (mg/dL) |
| Placebo | Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles | Pre Evening Meal | 28.16 milligrams/deciliter (mg/dL) |
| Placebo | Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles | 2 Hours After Morning Meal | -27.48 milligrams/deciliter (mg/dL) |
| Placebo | Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles | Bedtime | 17.19 milligrams/deciliter (mg/dL) |
| Placebo | Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles | Pre Mid-Day Meal | 16.43 milligrams/deciliter (mg/dL) |
| Placebo | Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles | 2 Hours After Mid-Day Meal | -6.86 milligrams/deciliter (mg/dL) |
| 10 mg LY2409021 | Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles | 2 Hours After Evening Meal | -27.80 milligrams/deciliter (mg/dL) |
| 10 mg LY2409021 | Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles | 2 Hours After Mid-Day Meal | -35.34 milligrams/deciliter (mg/dL) |
| 10 mg LY2409021 | Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles | Pre Mid-Day Meal | -19.39 milligrams/deciliter (mg/dL) |
| 10 mg LY2409021 | Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles | Pre Evening Meal | -16.62 milligrams/deciliter (mg/dL) |
| 10 mg LY2409021 | Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles | Bedtime | -19.69 milligrams/deciliter (mg/dL) |
| 10 mg LY2409021 | Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles | 2 Hours After Morning Meal | -33.90 milligrams/deciliter (mg/dL) |
| 10 mg LY2409021 | Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles | Pre-Morning Meal Fasting | -10.09 milligrams/deciliter (mg/dL) |
| 30 mg LY2409021 | Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles | 2 Hours After Mid-Day Meal | -22.51 milligrams/deciliter (mg/dL) |
| 30 mg LY2409021 | Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles | Pre-Morning Meal Fasting | -21.82 milligrams/deciliter (mg/dL) |
| 30 mg LY2409021 | Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles | 2 Hours After Morning Meal | -35.68 milligrams/deciliter (mg/dL) |
| 30 mg LY2409021 | Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles | Pre Mid-Day Meal | -16.72 milligrams/deciliter (mg/dL) |
| 30 mg LY2409021 | Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles | Pre Evening Meal | -26.29 milligrams/deciliter (mg/dL) |
| 30 mg LY2409021 | Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles | 2 Hours After Evening Meal | -31.78 milligrams/deciliter (mg/dL) |
| 30 mg LY2409021 | Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles | Bedtime | -29.31 milligrams/deciliter (mg/dL) |
| 60 mg LY2409021 | Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles | Pre Mid-Day Meal | -21.44 milligrams/deciliter (mg/dL) |
| 60 mg LY2409021 | Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles | Bedtime | -24.88 milligrams/deciliter (mg/dL) |
| 60 mg LY2409021 | Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles | 2 Hours After Evening Meal | -27.54 milligrams/deciliter (mg/dL) |
| 60 mg LY2409021 | Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles | 2 Hours After Morning Meal | -34.68 milligrams/deciliter (mg/dL) |
| 60 mg LY2409021 | Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles | Pre-Morning Meal Fasting | -25.86 milligrams/deciliter (mg/dL) |
| 60 mg LY2409021 | Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles | Pre Evening Meal | -18.03 milligrams/deciliter (mg/dL) |
| 60 mg LY2409021 | Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles | 2 Hours After Mid-Day Meal | -29.42 milligrams/deciliter (mg/dL) |
p-value: 0.024895% CI: [-44.03, -3.09]Mixed Models Analysis
p-value: 0.000295% CI: [-53.08, -17.48]Mixed Models Analysis
p-value: <0.000195% CI: [-58.12, -20.53]Mixed Models Analysis
p-value: 0.651395% CI: [-34.66, 21.82]Mixed Models Analysis
p-value: 0.504595% CI: [-32.61, 16.21]Mixed Models Analysis
p-value: 0.577495% CI: [-32.9, 18.49]Mixed Models Analysis
p-value: 0.004595% CI: [-60.1, -11.53]Mixed Models Analysis
p-value: 0.002495% CI: [-54.1, -12.21]Mixed Models Analysis
p-value: 0.001195% CI: [-59.98, -15.75]Mixed Models Analysis
p-value: 0.038995% CI: [-55.47, -1.49]Mixed Models Analysis
p-value: 0.189695% CI: [-39.24, 7.94]Mixed Models Analysis
p-value: 0.072995% CI: [-47.28, 2.16]Mixed Models Analysis
p-value: 0.004195% CI: [-74.79, -14.77]Mixed Models Analysis
p-value: <0.000195% CI: [-80.42, -28.48]Mixed Models Analysis
p-value: 0.001395% CI: [-73.57, -18.81]Mixed Models Analysis
p-value: 0.011895% CI: [-70.51, -9.13]Mixed Models Analysis
p-value: 0.001695% CI: [-70.42, -17.18]Mixed Models Analysis
p-value: 0.006595% CI: [-67.63, -11.48]Mixed Models Analysis
p-value: 0.015495% CI: [-66.43, -7.33]Mixed Models Analysis
p-value: 0.000695% CI: [-71.93, -21.07]Mixed Models Analysis
p-value: 0.002995% CI: [-69.13, -15.01]Mixed Models Analysis
Secondary
Change From Baseline Values for Fasting Blood Glucose (FBG)
LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.
Time frame: Baseline, Week 12
Population: mITT: All randomized participants with at least 1 post baseline FBG measurement and analyzed according to the assigned treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline Values for Fasting Blood Glucose (FBG) | 1.19 millimoles/liter (mmol/L) |
| 10 mg LY2409021 | Change From Baseline Values for Fasting Blood Glucose (FBG) | -0.43 millimoles/liter (mmol/L) |
| 30 mg LY2409021 | Change From Baseline Values for Fasting Blood Glucose (FBG) | -0.67 millimoles/liter (mmol/L) |
| 60 mg LY2409021 | Change From Baseline Values for Fasting Blood Glucose (FBG) | -1.22 millimoles/liter (mmol/L) |
p-value: 0.256595% CI: [-4.46, 1.21]Mixed Models Analysis
p-value: 0.124595% CI: [-4.25, 0.53]Mixed Models Analysis
p-value: 0.059495% CI: [-4.92, 0.1]Mixed Models Analysis
Secondary
Change From Baseline Values for Fasting Glucagon
LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.
Time frame: Baseline, Week 12
Population: mITT: All randomized participants with at least 1 post baseline fasting glucagon measurement and analyzed according to the assigned treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline Values for Fasting Glucagon | -2.36 pmol/L |
| 10 mg LY2409021 | Change From Baseline Values for Fasting Glucagon | 52.71 pmol/L |
| 30 mg LY2409021 | Change From Baseline Values for Fasting Glucagon | 87.32 pmol/L |
| 60 mg LY2409021 | Change From Baseline Values for Fasting Glucagon | 104.90 pmol/L |
p-value: 0.213195% CI: [-32.24, 142.37]Mixed Models Analysis
p-value: 0.02295% CI: [13.27, 166.1]Mixed Models Analysis
p-value: 0.010195% CI: [26.29, 188.22]Mixed Models Analysis
Secondary
Change From Baseline Values for Fasting Glucagon-Like Peptide 1 (GLP-1)
LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.
Time frame: Baseline, Week 12
Population: mITT: All randomized participants with at least 1 post baseline fasting GLP-1 measurement and analyzed according to the assigned treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline Values for Fasting Glucagon-Like Peptide 1 (GLP-1) | -1.43 pmol/L |
| 10 mg LY2409021 | Change From Baseline Values for Fasting Glucagon-Like Peptide 1 (GLP-1) | 0.44 pmol/L |
| 30 mg LY2409021 | Change From Baseline Values for Fasting Glucagon-Like Peptide 1 (GLP-1) | 0.61 pmol/L |
| 60 mg LY2409021 | Change From Baseline Values for Fasting Glucagon-Like Peptide 1 (GLP-1) | 0.28 pmol/L |
p-value: 0.159695% CI: [-0.75, 4.49]Mixed Models Analysis
p-value: 0.079195% CI: [-0.24, 4.31]Mixed Models Analysis
p-value: 0.156495% CI: [-0.67, 4.1]Mixed Models Analysis
Secondary
Change From Baseline Values for Fasting Insulin
LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.
Time frame: Baseline, Week 12
Population: mITT: All randomized participants with at least 1 post baseline fasting insulin measurement and analyzed according to the assigned treatment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change From Baseline Values for Fasting Insulin | -10.91 picomole/liter (pmol/L) |
| 10 mg LY2409021 | Change From Baseline Values for Fasting Insulin | 14.71 picomole/liter (pmol/L) |
| 30 mg LY2409021 | Change From Baseline Values for Fasting Insulin | -5.51 picomole/liter (pmol/L) |
| 60 mg LY2409021 | Change From Baseline Values for Fasting Insulin | 13.34 picomole/liter (pmol/L) |
p-value: 0.381595% CI: [-32.44, 83.68]Mixed Models Analysis
p-value: 0.831595% CI: [-45.12, 55.93]Mixed Models Analysis
p-value: 0.365895% CI: [-28.93, 77.44]Mixed Models Analysis
Secondary
Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R)
The DSC-R was a participant completed questionnaire that was designed to assess the presence and perceived burden of diabetes-related symptoms. Participants were asked to recall the last 4 weeks and consider each symptom/item in terms of whether they experienced it and if so, how troublesomeness it was. Participants were to consider troublesomeness of the symptom on a 1 (not at all) to 5 (extremely) point scale. There were a total of 34 items, grouped into 8 subscales: cardiovascular (4 items), psychological-cognitive distress (4 items), psychological-fatigue (4 items), hyperglycemic (4 items), hypoglycemic (3 items), neurological-pain (4 items), neurological-sensory (6 items) and visual (5 items). Sub-domain score calculated as: (sum of item scores) divided by (number of items), scores ranged from 1 to 5. Total score was the sum of all sub-domains and ranged from 8 to 40. Higher scores of total and subscales indicated worsened symptoms.
Time frame: Baseline, Week 12
Population: mITT: All randomized participants with at least 1 post baseline DSC-R measurement and analyzed according to the assigned treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Psychological-Cognitive | 1.61 units on a scale | Standard Deviation 0.86 |
| Placebo | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Visual | 1.00 units on a scale | — |
| Placebo | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Total | NA units on a scale | — |
| Placebo | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Neurological-Pain | 2.00 units on a scale | — |
| Placebo | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Hypoglycemic | 1.50 units on a scale | Standard Deviation 707 |
| Placebo | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Hyperglycemic | 3.18 units on a scale | Standard Deviation 1.517 |
| Placebo | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Psychological-Fatigue | 1.91 units on a scale | Standard Deviation 0.219 |
| Placebo | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Neurological-Sensory | 2.39 units on a scale | Standard Deviation 0.438 |
| Placebo | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Cardiovascular | 2.5 units on a scale | — |
| 10 mg LY2409021 | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Neurological-Sensory | 1.89 units on a scale | Standard Deviation 0.587 |
| 10 mg LY2409021 | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Psychological-Cognitive | 2.31 units on a scale | Standard Deviation 0.875 |
| 10 mg LY2409021 | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Visual | 2.45 units on a scale | Standard Deviation 1.172 |
| 10 mg LY2409021 | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Hyperglycemic | 2.79 units on a scale | Standard Deviation 1.086 |
| 10 mg LY2409021 | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Cardiovascular | 1.52 units on a scale | Standard Deviation 0.372 |
| 10 mg LY2409021 | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Hypoglycemic | 2.42 units on a scale | Standard Deviation 1.258 |
| 10 mg LY2409021 | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Total | NA units on a scale | — |
| 10 mg LY2409021 | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Psychological-Fatigue | 2.06 units on a scale | Standard Deviation 0.734 |
| 10 mg LY2409021 | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Neurological-Pain | 1.91 units on a scale | Standard Deviation 0.717 |
| 30 mg LY2409021 | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Neurological-Sensory | 2.35 units on a scale | Standard Deviation 0.596 |
| 30 mg LY2409021 | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Cardiovascular | 1.52 units on a scale | Standard Deviation 0.475 |
| 30 mg LY2409021 | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Hyperglycemic | 2.30 units on a scale | Standard Deviation 0.437 |
| 30 mg LY2409021 | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Hypoglycemic | 2.50 units on a scale | Standard Deviation 0.98 |
| 30 mg LY2409021 | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Neurological-Pain | 1.88 units on a scale | Standard Deviation 0.396 |
| 30 mg LY2409021 | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Visual | 2.03 units on a scale | Standard Deviation 0.812 |
| 30 mg LY2409021 | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Psychological-Cognitive | 2.37 units on a scale | Standard Deviation 0.967 |
| 30 mg LY2409021 | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Psychological-Fatigue | 2.33 units on a scale | Standard Deviation 0.584 |
| 30 mg LY2409021 | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Total | NA units on a scale | — |
| 60 mg LY2409021 | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Psychological-Cognitive | 1.69 units on a scale | Standard Deviation 0.636 |
| 60 mg LY2409021 | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Neurological-Pain | 1.80 units on a scale | Standard Deviation 636 |
| 60 mg LY2409021 | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Hypoglycemic | 2.00 units on a scale | Standard Deviation 1.277 |
| 60 mg LY2409021 | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Total | NA units on a scale | — |
| 60 mg LY2409021 | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Psychological-Fatigue | 2.07 units on a scale | Standard Deviation 0.5 |
| 60 mg LY2409021 | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Hyperglycemic | 2.37 units on a scale | Standard Deviation 0.563 |
| 60 mg LY2409021 | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Visual | 2.05 units on a scale | Standard Deviation 1.16 |
| 60 mg LY2409021 | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Neurological-Sensory | 2.11 units on a scale | Standard Deviation 0.893 |
| 60 mg LY2409021 | Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) | Cardiovascular | 1.69 units on a scale | Standard Deviation 0.586 |