Type 2 Diabetes Mellitus
Conditions
Brief summary
The purpose of this study is to investigate the safety and effectiveness of the study drug known as LY3053102 in participants with Type 2 diabetes mellitus. The study drug will be given in different doses as an injection under the skin. The study is expected to last up to 6 months for each participant. Participants may remain on stable-dose metformin as prescribed by their personal physician.
Interventions
DRUGLY3053102
Administered SC
DRUGExenatide ER
Administered SC
DRUGPlacebo
Administered SC
DRUGMetformin
Administered orally (PO)
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with type 2 diabetes mellitus for at least 6 months before entering the trial based on the disease diagnostic criteria (World Health Organization \[WHO\]) classification managed with diet or exercise alone or with a stable dose of metformin of at least 1000 mg/day for at least 60 days before screening or on metformin and an eligible second oral anti-hyperglycemic medication after a 60-day washout of the second oral anti-hyperglycemic medication * Women not of childbearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause * Have a hemoglobin A1c value of ≥7.0% and ≤10.5%, if on diet and exercise or diet, exercise, and metformin (stable dose of at least 1000 mg/day for at least 60 days), or have a hemoglobin A1c value of ≥7.0% and ≤9.5%, and are on an appropriate diet and exercise regimen, a stable dose of metformin and willing to discontinue a second oral anti-hyperglycemic medication * Have a body mass index ≥23 and ≤45 kilograms per square meter (kg/m\^2)
Exclusion criteria
* Have used insulin for diabetic control for more than 6 consecutive days within 1 year prior to screening * Have used thiazolidinediones within 3 months, or any other drugs for treatment of hyperglycemia (except metformin) within 2 months, prior to the first week of the study * Have hepatitis B and/or positive hepatitis B surface antigen. hepatitis C or human immunodeficiency virus (HIV) and/or positive HIV antibodies * Have known or suspected cardiac autonomic neuropathy (for example, resting tachycardia or orthostatic hypotension), based on clinical signs, symptoms, or appropriate diagnostic testing * Have cardiac disease with functional status that is New York Heart Association Class II, III, or IV or in the last 6 months have had any of the following: a history of myocardial infarction , unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack, or cerebrovascular accident (for example, stroke) * Have poorly controlled hypertension, malignant hypertension, renal artery stenosis, and/or evidence of labile blood pressure including symptomatic postural hypotension. Doses of antihypertensive medications must be stable for 30 days prior to the first week of the study * Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or an alanine transaminase or aspartate aminotransferase levels \>2 times the upper limit of the reference range * Have evidence of hypothyroidism or hyperthyroidism based on clinical evaluation and/or an abnormal thyroid-stimulating hormone which, in the opinion of the investigator, would pose a risk to participant safety. Participants on a stable dose of thyroid replacement therapy may be eligible if they meet the other criteria * Have clinically significant peripheral vascular disease, or clinical evidence of active diabetic proliferative retinopathy, (known significant autonomic neuropathy) as evidenced by urinary retention, orthostatic hypotension, diabetic diarrhea or gastroparesis * Have an active or untreated malignancy or have been in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years * Have impaired renal function * Have fasting triglycerides \>500 milligrams per deciliter (mg/dL) at screening * Have experienced a keto-acidotic episode requiring hospitalization in the last 6 months * Have an electrocardiogram (ECG) considered to be indicative of cardiac disease * Have personal or family history of long QT syndrome, family history of sudden death in a first-degree relative before age 40, or personal history of unexplained syncope within the last year. Use of prescription or over-the-counter medications known to prolong the QT or QTc interval * Have a history of bone disease (including osteoporosis or unhealed fractures), evidence of osteoporosis (femoral neck or lumbar spine T-score \<-2.5) determined by dual X-ray absorptometry (DXA) scan at screening, evidence of osteopenia (T-score between -1.0 and -2.5 at the femoral neck or lumbar spine) with a high risk of fracture based on risk factors or current active treatment of periodontal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) at 12-Week Endpoint | 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) means were calculated using mixed model repeated measures (MMRM) analysis adjusting for metformin use, washout of second oral anti-hyperglycemic medication (OAM), treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants That Require Rescue Therapy | Baseline through Week 12 | Percentage of participants that required \>=1 rescue (blood glucose lowering) medications. |
| Change From Baseline in Body Weight at 12-Week Endpoint | Baseline, Week 12 | LS means were calculated using MMRM analysis adjusting for baseline HbA1c category, metformin use, washout of second OAM, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy). |
| Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint | Baseline, Week 12 | 7-Point Self-Monitored Blood Glucose profiles are measures of blood glucose concentration taken 7 times a day at morning pre-prandial, morning 2 hours postprandial, midday pre-prandial, midday 2 hours postprandial, evening pre-prandial, evening 2 hour postprandial, and bedtime. LS means were calculated using MMRM analysis adjusting for baseline HbA1c category, metformin use, washout of second OAM, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy). |
| Change From Baseline in Lipids at 12-Week Endpoint | Baseline, Week 12 | Lipids includes: High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C), Triglycerides, and Cholesterol. LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy). |
| Percentage of Participants With Anti-Drug Antibodies to LY3053102 | Baseline through Study Completion (Up to 6 Months) | Percentage of participants with anti-LY3053102 antibody titre changes from baseline to the maximum postbaseline value. |
| Percentage of Participants Achieving HbA1c <7.0% or HbA1c ≤6.5% at 12-Week Endpoint | Week 12 | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. |
| Change From Baseline in Bone Metabolism at 12-Week Endpoint (Osteocalcin and Bone-Specific Alkaline Phosphatase [Bone-Specific ALP]) | Baseline, Week 12 | LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy). |
| Change From Baseline in Bone Metabolism at 12-Week Endpoint (Beta-Crosslaps and Procollagen 1 N-Terminal Propeptide [P1NP]) | Baseline, Week 12 | LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy). |
| Change From Baseline in Bone Mineral Density Markers at 12-Week Endpoint | Baseline, Week 12 | LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy). |
| Pharmacokinetics: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State (AUC [τ,ss]) of LY3053102 | Predose, 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 hours post-dose | AUC (τ,ss) = area under the concentration versus time curve during one dosing interval at steady state, where the dosing interval (τ) = 168 hours. |
| Percentage of Participants With Hypoglycemia | Baseline through Week 12 | Hypoglycemia was defined as any event meeting the criteria for documented symptomatic hypoglycemia, asymptomatic hypoglycemia, or probable symptomatic hypoglycemia. |
Countries
United States
Participant flow
Pre-assignment details
The study was planned in 2 stages; Stage 1 evaluated up to 5 escalating parallel-dose groups. Stage 2, which was to evaluate participants stratified by Hemoglobin A1c (HbA1c), metformin therapy, and washout of a second oral anti-hyperglycemic medication (OAM) was not conducted because of inadequate efficacy at well-tolerated doses in Stage 1.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo administered SC QW for 12 weeks | 10 |
| 7 mg LY3053102 7 mg LY3053102 administered SC QW for 12 weeks | 8 |
| 15 mg LY3053102 15 mg LY3053102 administered SC QW for 12 weeks | 8 |
| 50 mg LY3053102 50 mg LY3053102 administered SC QW for 12 weeks | 7 |
| 100 mg LY3053102 100 mg LY3053102 administered SC QW for 12 weeks | 8 |
| 200 mg LY3053102 200 mg LY3053102 administered SC QW for 12 weeks | 8 |
| 2 mg Exenatide ER 2 mg Exenatide ER administered SC QW for 12 weeks | 10 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Overall Study | Early Termination Criteria Met | 0 | 0 | 1 | 0 | 0 | 1 | 0 |
| Overall Study | Lack of Efficacy | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 1 | 1 | 1 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 0 | 1 | 2 |
| Overall Study | Randomized in Error | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | 200 mg LY3053102 | 2 mg Exenatide ER | Total | 15 mg LY3053102 | 7 mg LY3053102 | Placebo | 100 mg LY3053102 | 50 mg LY3053102 |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 54.6 Years STANDARD_DEVIATION 8.3 | 52.8 Years STANDARD_DEVIATION 9.1 | 55.3 Years STANDARD_DEVIATION 8.5 | 59.9 Years STANDARD_DEVIATION 5.8 | 57.3 Years STANDARD_DEVIATION 4.9 | 55.9 Years STANDARD_DEVIATION 8.9 | 50.8 Years STANDARD_DEVIATION 13 | 56.3 Years STANDARD_DEVIATION 6 |
| Baseline Fasting Plasma Glucose | 185.9 milligram/deciliter (mg/dL) STANDARD_DEVIATION 50.6 | 150.6 milligram/deciliter (mg/dL) STANDARD_DEVIATION 46.8 | 174.9 milligram/deciliter (mg/dL) STANDARD_DEVIATION 46.5 | 176.6 milligram/deciliter (mg/dL) STANDARD_DEVIATION 58 | 178.6 milligram/deciliter (mg/dL) STANDARD_DEVIATION 44.3 | 180.6 milligram/deciliter (mg/dL) STANDARD_DEVIATION 45.3 | 183.3 milligram/deciliter (mg/dL) STANDARD_DEVIATION 46.2 | 173.3 milligram/deciliter (mg/dL) STANDARD_DEVIATION 39.6 |
| Baseline Hemoglobin A1c (HbA1c) | 8.10 Percent of HbA1c STANDARD_DEVIATION 0.63 | 8.50 Percent of HbA1c STANDARD_DEVIATION 1.03 | 8.42 Percent of HbA1c STANDARD_DEVIATION 1.02 | 7.93 Percent of HbA1c STANDARD_DEVIATION 0.81 | 8.33 Percent of HbA1c STANDARD_DEVIATION 1.17 | 8.39 Percent of HbA1c STANDARD_DEVIATION 0.8 | 9.40 Percent of HbA1c STANDARD_DEVIATION 1.43 | 8.30 Percent of HbA1c STANDARD_DEVIATION 0.74 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 2 Participants | 35 Participants | 3 Participants | 4 Participants | 7 Participants | 6 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 8 Participants | 24 Participants | 5 Participants | 4 Participants | 3 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 11 Participants | 4 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 4 Participants | 44 Participants | 4 Participants | 7 Participants | 10 Participants | 6 Participants | 5 Participants |
| Region of Enrollment United States | 8 Participants | 10 Participants | 59 Participants | 8 Participants | 8 Participants | 10 Participants | 8 Participants | 7 Participants |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 24 Participants | 4 Participants | 3 Participants | 5 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Male | 4 Participants | 8 Participants | 35 Participants | 4 Participants | 5 Participants | 5 Participants | 4 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 10 | 4 / 8 | 4 / 8 | 4 / 7 | 7 / 8 | 7 / 8 | 8 / 10 |
| serious Total, serious adverse events | 1 / 10 | 0 / 8 | 0 / 8 | 0 / 7 | 1 / 8 | 0 / 8 | 0 / 10 |
Outcome results
Primary
Change From Baseline in Hemoglobin A1c (HbA1c) at 12-Week Endpoint
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) means were calculated using mixed model repeated measures (MMRM) analysis adjusting for metformin use, washout of second oral anti-hyperglycemic medication (OAM), treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect.
Time frame: Baseline, Week 12
Population: All randomized participants who received at least 1 dose of study drug, and who had baseline and post-baseline data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Hemoglobin A1c (HbA1c) at 12-Week Endpoint | -0.49 Percent of HbA1c | Standard Error 0.33 |
| 7 mg LY3053102 | Change From Baseline in Hemoglobin A1c (HbA1c) at 12-Week Endpoint | -0.70 Percent of HbA1c | Standard Error 0.4 |
| 15 mg LY3053102 | Change From Baseline in Hemoglobin A1c (HbA1c) at 12-Week Endpoint | -0.75 Percent of HbA1c | Standard Error 0.44 |
| 50 mg LY3053102 | Change From Baseline in Hemoglobin A1c (HbA1c) at 12-Week Endpoint | -0.22 Percent of HbA1c | Standard Error 0.43 |
| 100 mg LY3053102 | Change From Baseline in Hemoglobin A1c (HbA1c) at 12-Week Endpoint | -0.48 Percent of HbA1c | Standard Error 0.4 |
| 200 mg LY3053102 | Change From Baseline in Hemoglobin A1c (HbA1c) at 12-Week Endpoint | -0.52 Percent of HbA1c | Standard Error 0.47 |
| 2 mg Exenatide ER | Change From Baseline in Hemoglobin A1c (HbA1c) at 12-Week Endpoint | -1.43 Percent of HbA1c | Standard Error 0.36 |
Secondary
Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint
7-Point Self-Monitored Blood Glucose profiles are measures of blood glucose concentration taken 7 times a day at morning pre-prandial, morning 2 hours postprandial, midday pre-prandial, midday 2 hours postprandial, evening pre-prandial, evening 2 hour postprandial, and bedtime. LS means were calculated using MMRM analysis adjusting for baseline HbA1c category, metformin use, washout of second OAM, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy).
Time frame: Baseline, Week 12
Population: All randomized participants who received at least 1 dose of study drug, and who had baseline and post-baseline data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint | Morning Meal (Post- minus Pre-prandial) | -23.4 milligram/deciliter (mg/dL) | Standard Error 15.8 |
| Placebo | Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint | Midday Meal (Post- minus Pre-prandial) | -1.1 milligram/deciliter (mg/dL) | Standard Error 22.4 |
| Placebo | Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint | Evening Meal (Post- minus Pre-prandial) | -18.8 milligram/deciliter (mg/dL) | Standard Error 20.8 |
| Placebo | Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint | Bedtime | 3.9 milligram/deciliter (mg/dL) | Standard Error 19.1 |
| 7 mg LY3053102 | Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint | Bedtime | 18.8 milligram/deciliter (mg/dL) | Standard Error 23.3 |
| 7 mg LY3053102 | Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint | Evening Meal (Post- minus Pre-prandial) | -11.1 milligram/deciliter (mg/dL) | Standard Error 25.8 |
| 7 mg LY3053102 | Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint | Morning Meal (Post- minus Pre-prandial) | -18.7 milligram/deciliter (mg/dL) | Standard Error 19.4 |
| 7 mg LY3053102 | Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint | Midday Meal (Post- minus Pre-prandial) | -31.3 milligram/deciliter (mg/dL) | Standard Error 27.5 |
| 15 mg LY3053102 | Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint | Evening Meal (Post- minus Pre-prandial) | -46.5 milligram/deciliter (mg/dL) | Standard Error 27.5 |
| 15 mg LY3053102 | Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint | Midday Meal (Post- minus Pre-prandial) | -55.0 milligram/deciliter (mg/dL) | Standard Error 29.2 |
| 15 mg LY3053102 | Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint | Morning Meal (Post- minus Pre-prandial) | -57.7 milligram/deciliter (mg/dL) | Standard Error 21.6 |
| 15 mg LY3053102 | Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint | Bedtime | -44.5 milligram/deciliter (mg/dL) | Standard Error 28.1 |
| 50 mg LY3053102 | Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint | Morning Meal (Post- minus Pre-prandial) | -34.9 milligram/deciliter (mg/dL) | Standard Error 21.9 |
| 50 mg LY3053102 | Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint | Midday Meal (Post- minus Pre-prandial) | -24.7 milligram/deciliter (mg/dL) | Standard Error 29.2 |
| 50 mg LY3053102 | Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint | Evening Meal (Post- minus Pre-prandial) | -25.9 milligram/deciliter (mg/dL) | Standard Error 27.9 |
| 50 mg LY3053102 | Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint | Bedtime | -10.1 milligram/deciliter (mg/dL) | Standard Error 25.7 |
| 100 mg LY3053102 | Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint | Morning Meal (Post- minus Pre-prandial) | 4.7 milligram/deciliter (mg/dL) | Standard Error 18.3 |
| 100 mg LY3053102 | Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint | Bedtime | 4.9 milligram/deciliter (mg/dL) | Standard Error 22.1 |
| 100 mg LY3053102 | Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint | Midday Meal (Post- minus Pre-prandial) | 2.5 milligram/deciliter (mg/dL) | Standard Error 25.8 |
| 100 mg LY3053102 | Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint | Evening Meal (Post- minus Pre-prandial) | -39.0 milligram/deciliter (mg/dL) | Standard Error 24.1 |
| 200 mg LY3053102 | Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint | Midday Meal (Post- minus Pre-prandial) | -24.6 milligram/deciliter (mg/dL) | Standard Error 32.3 |
| 200 mg LY3053102 | Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint | Morning Meal (Post- minus Pre-prandial) | -26.8 milligram/deciliter (mg/dL) | Standard Error 25.8 |
| 200 mg LY3053102 | Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint | Evening Meal (Post- minus Pre-prandial) | -61.3 milligram/deciliter (mg/dL) | Standard Error 31.4 |
| 200 mg LY3053102 | Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint | Bedtime | -13.0 milligram/deciliter (mg/dL) | Standard Error 30.8 |
| 2 mg Exenatide ER | Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint | Evening Meal (Post- minus Pre-prandial) | -4.9 milligram/deciliter (mg/dL) | Standard Error 24.2 |
| 2 mg Exenatide ER | Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint | Morning Meal (Post- minus Pre-prandial) | -47.9 milligram/deciliter (mg/dL) | Standard Error 19.4 |
| 2 mg Exenatide ER | Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint | Midday Meal (Post- minus Pre-prandial) | -31.3 milligram/deciliter (mg/dL) | Standard Error 24.9 |
| 2 mg Exenatide ER | Change From Baseline in 7-Point Blood Glucose Profile at 12-Week Endpoint | Bedtime | -53.6 milligram/deciliter (mg/dL) | Standard Error 23.5 |
Secondary
Change From Baseline in Body Weight at 12-Week Endpoint
LS means were calculated using MMRM analysis adjusting for baseline HbA1c category, metformin use, washout of second OAM, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy).
Time frame: Baseline, Week 12
Population: All randomized participants who received at least 1 dose of study drug, and who had baseline and post-baseline data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Body Weight at 12-Week Endpoint | 0.7 kilogram (kg) | Standard Error 1.1 |
| 7 mg LY3053102 | Change From Baseline in Body Weight at 12-Week Endpoint | 1.5 kilogram (kg) | Standard Error 1.3 |
| 15 mg LY3053102 | Change From Baseline in Body Weight at 12-Week Endpoint | 0.0 kilogram (kg) | Standard Error 1.4 |
| 50 mg LY3053102 | Change From Baseline in Body Weight at 12-Week Endpoint | 0.4 kilogram (kg) | Standard Error 1.4 |
| 100 mg LY3053102 | Change From Baseline in Body Weight at 12-Week Endpoint | -1.7 kilogram (kg) | Standard Error 1.3 |
| 200 mg LY3053102 | Change From Baseline in Body Weight at 12-Week Endpoint | -2.0 kilogram (kg) | Standard Error 1.4 |
| 2 mg Exenatide ER | Change From Baseline in Body Weight at 12-Week Endpoint | -0.1 kilogram (kg) | Standard Error 1.1 |
Secondary
Change From Baseline in Bone Metabolism at 12-Week Endpoint (Beta-Crosslaps and Procollagen 1 N-Terminal Propeptide [P1NP])
LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy).
Time frame: Baseline, Week 12
Population: All randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Bone Metabolism at 12-Week Endpoint (Beta-Crosslaps and Procollagen 1 N-Terminal Propeptide [P1NP]) | Beta-Crosslaps | -0.038 nanogram/milliliter (ng/mL) | Standard Error 0.042 |
| Placebo | Change From Baseline in Bone Metabolism at 12-Week Endpoint (Beta-Crosslaps and Procollagen 1 N-Terminal Propeptide [P1NP]) | P1NP | 5.0 nanogram/milliliter (ng/mL) | Standard Error 2.8 |
| 7 mg LY3053102 | Change From Baseline in Bone Metabolism at 12-Week Endpoint (Beta-Crosslaps and Procollagen 1 N-Terminal Propeptide [P1NP]) | Beta-Crosslaps | -0.033 nanogram/milliliter (ng/mL) | Standard Error 0.052 |
| 7 mg LY3053102 | Change From Baseline in Bone Metabolism at 12-Week Endpoint (Beta-Crosslaps and Procollagen 1 N-Terminal Propeptide [P1NP]) | P1NP | -0.3 nanogram/milliliter (ng/mL) | Standard Error 3.4 |
| 15 mg LY3053102 | Change From Baseline in Bone Metabolism at 12-Week Endpoint (Beta-Crosslaps and Procollagen 1 N-Terminal Propeptide [P1NP]) | Beta-Crosslaps | -0.023 nanogram/milliliter (ng/mL) | Standard Error 0.051 |
| 15 mg LY3053102 | Change From Baseline in Bone Metabolism at 12-Week Endpoint (Beta-Crosslaps and Procollagen 1 N-Terminal Propeptide [P1NP]) | P1NP | 0.9 nanogram/milliliter (ng/mL) | Standard Error 3.5 |
| 50 mg LY3053102 | Change From Baseline in Bone Metabolism at 12-Week Endpoint (Beta-Crosslaps and Procollagen 1 N-Terminal Propeptide [P1NP]) | Beta-Crosslaps | 0.001 nanogram/milliliter (ng/mL) | Standard Error 0.053 |
| 50 mg LY3053102 | Change From Baseline in Bone Metabolism at 12-Week Endpoint (Beta-Crosslaps and Procollagen 1 N-Terminal Propeptide [P1NP]) | P1NP | 1.9 nanogram/milliliter (ng/mL) | Standard Error 3.5 |
| 100 mg LY3053102 | Change From Baseline in Bone Metabolism at 12-Week Endpoint (Beta-Crosslaps and Procollagen 1 N-Terminal Propeptide [P1NP]) | Beta-Crosslaps | 0.004 nanogram/milliliter (ng/mL) | Standard Error 0.048 |
| 100 mg LY3053102 | Change From Baseline in Bone Metabolism at 12-Week Endpoint (Beta-Crosslaps and Procollagen 1 N-Terminal Propeptide [P1NP]) | P1NP | -6.8 nanogram/milliliter (ng/mL) | Standard Error 3.2 |
| 200 mg LY3053102 | Change From Baseline in Bone Metabolism at 12-Week Endpoint (Beta-Crosslaps and Procollagen 1 N-Terminal Propeptide [P1NP]) | Beta-Crosslaps | 0.031 nanogram/milliliter (ng/mL) | Standard Error 0.054 |
| 200 mg LY3053102 | Change From Baseline in Bone Metabolism at 12-Week Endpoint (Beta-Crosslaps and Procollagen 1 N-Terminal Propeptide [P1NP]) | P1NP | -0.2 nanogram/milliliter (ng/mL) | Standard Error 3.8 |
| 2 mg Exenatide ER | Change From Baseline in Bone Metabolism at 12-Week Endpoint (Beta-Crosslaps and Procollagen 1 N-Terminal Propeptide [P1NP]) | Beta-Crosslaps | -0.010 nanogram/milliliter (ng/mL) | Standard Error 0.04 |
| 2 mg Exenatide ER | Change From Baseline in Bone Metabolism at 12-Week Endpoint (Beta-Crosslaps and Procollagen 1 N-Terminal Propeptide [P1NP]) | P1NP | 2.3 nanogram/milliliter (ng/mL) | Standard Error 2.9 |
Secondary
Change From Baseline in Bone Metabolism at 12-Week Endpoint (Osteocalcin and Bone-Specific Alkaline Phosphatase [Bone-Specific ALP])
LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy).
Time frame: Baseline, Week 12
Population: All randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Bone Metabolism at 12-Week Endpoint (Osteocalcin and Bone-Specific Alkaline Phosphatase [Bone-Specific ALP]) | Osteocalcin | 1.2 microgram/liter (ug/L) | Standard Error 1.1 |
| Placebo | Change From Baseline in Bone Metabolism at 12-Week Endpoint (Osteocalcin and Bone-Specific Alkaline Phosphatase [Bone-Specific ALP]) | Bone-Specific ALP | 0.4 microgram/liter (ug/L) | Standard Error 0.8 |
| 7 mg LY3053102 | Change From Baseline in Bone Metabolism at 12-Week Endpoint (Osteocalcin and Bone-Specific Alkaline Phosphatase [Bone-Specific ALP]) | Osteocalcin | -0.7 microgram/liter (ug/L) | Standard Error 1.3 |
| 7 mg LY3053102 | Change From Baseline in Bone Metabolism at 12-Week Endpoint (Osteocalcin and Bone-Specific Alkaline Phosphatase [Bone-Specific ALP]) | Bone-Specific ALP | -0.1 microgram/liter (ug/L) | Standard Error 0.9 |
| 15 mg LY3053102 | Change From Baseline in Bone Metabolism at 12-Week Endpoint (Osteocalcin and Bone-Specific Alkaline Phosphatase [Bone-Specific ALP]) | Osteocalcin | -1.7 microgram/liter (ug/L) | Standard Error 1.3 |
| 15 mg LY3053102 | Change From Baseline in Bone Metabolism at 12-Week Endpoint (Osteocalcin and Bone-Specific Alkaline Phosphatase [Bone-Specific ALP]) | Bone-Specific ALP | -0.2 microgram/liter (ug/L) | Standard Error 1 |
| 50 mg LY3053102 | Change From Baseline in Bone Metabolism at 12-Week Endpoint (Osteocalcin and Bone-Specific Alkaline Phosphatase [Bone-Specific ALP]) | Osteocalcin | 0.0 microgram/liter (ug/L) | Standard Error 1.4 |
| 50 mg LY3053102 | Change From Baseline in Bone Metabolism at 12-Week Endpoint (Osteocalcin and Bone-Specific Alkaline Phosphatase [Bone-Specific ALP]) | Bone-Specific ALP | -1.9 microgram/liter (ug/L) | Standard Error 1 |
| 100 mg LY3053102 | Change From Baseline in Bone Metabolism at 12-Week Endpoint (Osteocalcin and Bone-Specific Alkaline Phosphatase [Bone-Specific ALP]) | Osteocalcin | -2.6 microgram/liter (ug/L) | Standard Error 1.2 |
| 100 mg LY3053102 | Change From Baseline in Bone Metabolism at 12-Week Endpoint (Osteocalcin and Bone-Specific Alkaline Phosphatase [Bone-Specific ALP]) | Bone-Specific ALP | -1.9 microgram/liter (ug/L) | Standard Error 0.9 |
| 200 mg LY3053102 | Change From Baseline in Bone Metabolism at 12-Week Endpoint (Osteocalcin and Bone-Specific Alkaline Phosphatase [Bone-Specific ALP]) | Osteocalcin | -0.2 microgram/liter (ug/L) | Standard Error 1.4 |
| 200 mg LY3053102 | Change From Baseline in Bone Metabolism at 12-Week Endpoint (Osteocalcin and Bone-Specific Alkaline Phosphatase [Bone-Specific ALP]) | Bone-Specific ALP | -0.3 microgram/liter (ug/L) | Standard Error 1 |
| 2 mg Exenatide ER | Change From Baseline in Bone Metabolism at 12-Week Endpoint (Osteocalcin and Bone-Specific Alkaline Phosphatase [Bone-Specific ALP]) | Osteocalcin | 0.3 microgram/liter (ug/L) | Standard Error 1 |
| 2 mg Exenatide ER | Change From Baseline in Bone Metabolism at 12-Week Endpoint (Osteocalcin and Bone-Specific Alkaline Phosphatase [Bone-Specific ALP]) | Bone-Specific ALP | -2.3 microgram/liter (ug/L) | Standard Error 0.7 |
Secondary
Change From Baseline in Bone Mineral Density Markers at 12-Week Endpoint
LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy).
Time frame: Baseline, Week 12
Population: All randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Bone Mineral Density Markers at 12-Week Endpoint | Total Hip | 0.2 milligram/square centimeter (mg/cm2) | Standard Error 1 |
| Placebo | Change From Baseline in Bone Mineral Density Markers at 12-Week Endpoint | Neck of Femur | 0.2 milligram/square centimeter (mg/cm2) | Standard Error 1.6 |
| Placebo | Change From Baseline in Bone Mineral Density Markers at 12-Week Endpoint | L1-L4 Intervertebral Space | 1.4 milligram/square centimeter (mg/cm2) | Standard Error 1.6 |
| 7 mg LY3053102 | Change From Baseline in Bone Mineral Density Markers at 12-Week Endpoint | Neck of Femur | -0.6 milligram/square centimeter (mg/cm2) | Standard Error 1.9 |
| 7 mg LY3053102 | Change From Baseline in Bone Mineral Density Markers at 12-Week Endpoint | L1-L4 Intervertebral Space | -0.4 milligram/square centimeter (mg/cm2) | Standard Error 1.9 |
| 7 mg LY3053102 | Change From Baseline in Bone Mineral Density Markers at 12-Week Endpoint | Total Hip | -0.6 milligram/square centimeter (mg/cm2) | Standard Error 1.2 |
| 15 mg LY3053102 | Change From Baseline in Bone Mineral Density Markers at 12-Week Endpoint | Total Hip | -0.7 milligram/square centimeter (mg/cm2) | Standard Error 1.2 |
| 15 mg LY3053102 | Change From Baseline in Bone Mineral Density Markers at 12-Week Endpoint | L1-L4 Intervertebral Space | 1.2 milligram/square centimeter (mg/cm2) | Standard Error 2 |
| 15 mg LY3053102 | Change From Baseline in Bone Mineral Density Markers at 12-Week Endpoint | Neck of Femur | -0.4 milligram/square centimeter (mg/cm2) | Standard Error 2 |
| 50 mg LY3053102 | Change From Baseline in Bone Mineral Density Markers at 12-Week Endpoint | Neck of Femur | -0.8 milligram/square centimeter (mg/cm2) | Standard Error 2 |
| 50 mg LY3053102 | Change From Baseline in Bone Mineral Density Markers at 12-Week Endpoint | L1-L4 Intervertebral Space | 1.0 milligram/square centimeter (mg/cm2) | Standard Error 2.1 |
| 50 mg LY3053102 | Change From Baseline in Bone Mineral Density Markers at 12-Week Endpoint | Total Hip | -1.0 milligram/square centimeter (mg/cm2) | Standard Error 1.2 |
| 100 mg LY3053102 | Change From Baseline in Bone Mineral Density Markers at 12-Week Endpoint | Neck of Femur | -0.3 milligram/square centimeter (mg/cm2) | Standard Error 1.8 |
| 100 mg LY3053102 | Change From Baseline in Bone Mineral Density Markers at 12-Week Endpoint | L1-L4 Intervertebral Space | 2.0 milligram/square centimeter (mg/cm2) | Standard Error 1.8 |
| 100 mg LY3053102 | Change From Baseline in Bone Mineral Density Markers at 12-Week Endpoint | Total Hip | 0.1 milligram/square centimeter (mg/cm2) | Standard Error 1.1 |
| 200 mg LY3053102 | Change From Baseline in Bone Mineral Density Markers at 12-Week Endpoint | L1-L4 Intervertebral Space | 1.6 milligram/square centimeter (mg/cm2) | Standard Error 2.1 |
| 200 mg LY3053102 | Change From Baseline in Bone Mineral Density Markers at 12-Week Endpoint | Total Hip | -0.7 milligram/square centimeter (mg/cm2) | Standard Error 1.3 |
| 200 mg LY3053102 | Change From Baseline in Bone Mineral Density Markers at 12-Week Endpoint | Neck of Femur | -1.2 milligram/square centimeter (mg/cm2) | Standard Error 2.1 |
| 2 mg Exenatide ER | Change From Baseline in Bone Mineral Density Markers at 12-Week Endpoint | Total Hip | -1.0 milligram/square centimeter (mg/cm2) | Standard Error 0.8 |
| 2 mg Exenatide ER | Change From Baseline in Bone Mineral Density Markers at 12-Week Endpoint | Neck of Femur | -2.1 milligram/square centimeter (mg/cm2) | Standard Error 1.4 |
| 2 mg Exenatide ER | Change From Baseline in Bone Mineral Density Markers at 12-Week Endpoint | L1-L4 Intervertebral Space | 1.8 milligram/square centimeter (mg/cm2) | Standard Error 1.4 |
Secondary
Change From Baseline in Lipids at 12-Week Endpoint
Lipids includes: High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C), Triglycerides, and Cholesterol. LS means were calculated using MMRM analysis adjusting for metformin use, washout of second OAM, baseline HbA1c category, treatment, visit, and treatment-by-visit interaction as fixed effects, baseline as a covariate, and participant as a random effect (excludes data after rescue therapy).
Time frame: Baseline, Week 12
Population: All randomized participants who received at least 1 dose of study drug, and who had baseline and post-baseline data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Lipids at 12-Week Endpoint | HDL-C | 1.0 mg/dL | Standard Error 2.2 |
| Placebo | Change From Baseline in Lipids at 12-Week Endpoint | LDL-C | 12.1 mg/dL | Standard Error 10.4 |
| 7 mg LY3053102 | Change From Baseline in Lipids at 12-Week Endpoint | HDL-C | 6.0 mg/dL | Standard Error 2.6 |
| 7 mg LY3053102 | Change From Baseline in Lipids at 12-Week Endpoint | LDL-C | 6.8 mg/dL | Standard Error 12 |
| 15 mg LY3053102 | Change From Baseline in Lipids at 12-Week Endpoint | HDL-C | 9.3 mg/dL | Standard Error 2.9 |
| 15 mg LY3053102 | Change From Baseline in Lipids at 12-Week Endpoint | LDL-C | -25.6 mg/dL | Standard Error 13.8 |
| 50 mg LY3053102 | Change From Baseline in Lipids at 12-Week Endpoint | HDL-C | 6.4 mg/dL | Standard Error 2.9 |
| 50 mg LY3053102 | Change From Baseline in Lipids at 12-Week Endpoint | LDL-C | -6.5 mg/dL | Standard Error 13.5 |
| 100 mg LY3053102 | Change From Baseline in Lipids at 12-Week Endpoint | HDL-C | 6.0 mg/dL | Standard Error 2.6 |
| 100 mg LY3053102 | Change From Baseline in Lipids at 12-Week Endpoint | LDL-C | -2.2 mg/dL | Standard Error 12 |
| 200 mg LY3053102 | Change From Baseline in Lipids at 12-Week Endpoint | HDL-C | 11.4 mg/dL | Standard Error 3.1 |
| 200 mg LY3053102 | Change From Baseline in Lipids at 12-Week Endpoint | LDL-C | -7.3 mg/dL | Standard Error 14.5 |
| 2 mg Exenatide ER | Change From Baseline in Lipids at 12-Week Endpoint | HDL-C | -2.3 mg/dL | Standard Error 2.2 |
| 2 mg Exenatide ER | Change From Baseline in Lipids at 12-Week Endpoint | LDL-C | -19.9 mg/dL | Standard Error 11.3 |
Secondary
Percentage of Participants Achieving HbA1c <7.0% or HbA1c ≤6.5% at 12-Week Endpoint
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.
Time frame: Week 12
Population: All randomized participants who received at least 1 dose of study drug, and who had baseline and post-baseline data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving HbA1c <7.0% or HbA1c ≤6.5% at 12-Week Endpoint | HbA1c <7.0% | 0.0 Percentage of Participants |
| Placebo | Percentage of Participants Achieving HbA1c <7.0% or HbA1c ≤6.5% at 12-Week Endpoint | HbA1c ≤6.5% | 0.0 Percentage of Participants |
| 7 mg LY3053102 | Percentage of Participants Achieving HbA1c <7.0% or HbA1c ≤6.5% at 12-Week Endpoint | HbA1c <7.0% | 14.3 Percentage of Participants |
| 7 mg LY3053102 | Percentage of Participants Achieving HbA1c <7.0% or HbA1c ≤6.5% at 12-Week Endpoint | HbA1c ≤6.5% | 0.0 Percentage of Participants |
| 15 mg LY3053102 | Percentage of Participants Achieving HbA1c <7.0% or HbA1c ≤6.5% at 12-Week Endpoint | HbA1c <7.0% | 40.0 Percentage of Participants |
| 15 mg LY3053102 | Percentage of Participants Achieving HbA1c <7.0% or HbA1c ≤6.5% at 12-Week Endpoint | HbA1c ≤6.5% | 0.0 Percentage of Participants |
| 50 mg LY3053102 | Percentage of Participants Achieving HbA1c <7.0% or HbA1c ≤6.5% at 12-Week Endpoint | HbA1c <7.0% | 20.0 Percentage of Participants |
| 50 mg LY3053102 | Percentage of Participants Achieving HbA1c <7.0% or HbA1c ≤6.5% at 12-Week Endpoint | HbA1c ≤6.5% | 0.0 Percentage of Participants |
| 100 mg LY3053102 | Percentage of Participants Achieving HbA1c <7.0% or HbA1c ≤6.5% at 12-Week Endpoint | HbA1c <7.0% | 0.0 Percentage of Participants |
| 100 mg LY3053102 | Percentage of Participants Achieving HbA1c <7.0% or HbA1c ≤6.5% at 12-Week Endpoint | HbA1c ≤6.5% | 0.0 Percentage of Participants |
| 200 mg LY3053102 | Percentage of Participants Achieving HbA1c <7.0% or HbA1c ≤6.5% at 12-Week Endpoint | HbA1c <7.0% | 0.0 Percentage of Participants |
| 200 mg LY3053102 | Percentage of Participants Achieving HbA1c <7.0% or HbA1c ≤6.5% at 12-Week Endpoint | HbA1c ≤6.5% | 0.0 Percentage of Participants |
| 2 mg Exenatide ER | Percentage of Participants Achieving HbA1c <7.0% or HbA1c ≤6.5% at 12-Week Endpoint | HbA1c <7.0% | 83.3 Percentage of Participants |
| 2 mg Exenatide ER | Percentage of Participants Achieving HbA1c <7.0% or HbA1c ≤6.5% at 12-Week Endpoint | HbA1c ≤6.5% | 66.7 Percentage of Participants |
Secondary
Percentage of Participants That Require Rescue Therapy
Percentage of participants that required \>=1 rescue (blood glucose lowering) medications.
Time frame: Baseline through Week 12
Population: All randomized participants who took at least 1 dose of study drug, and who had a baseline and a post-baseline measurement for the time point.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants That Require Rescue Therapy | 0.0 Percentage of Participants |
| 7 mg LY3053102 | Percentage of Participants That Require Rescue Therapy | 0.0 Percentage of Participants |
| 15 mg LY3053102 | Percentage of Participants That Require Rescue Therapy | 12.5 Percentage of Participants |
| 50 mg LY3053102 | Percentage of Participants That Require Rescue Therapy | 14.3 Percentage of Participants |
| 100 mg LY3053102 | Percentage of Participants That Require Rescue Therapy | 0.0 Percentage of Participants |
| 200 mg LY3053102 | Percentage of Participants That Require Rescue Therapy | 0.0 Percentage of Participants |
| 2 mg Exenatide ER | Percentage of Participants That Require Rescue Therapy | 0.0 Percentage of Participants |
Secondary
Percentage of Participants With Anti-Drug Antibodies to LY3053102
Percentage of participants with anti-LY3053102 antibody titre changes from baseline to the maximum postbaseline value.
Time frame: Baseline through Study Completion (Up to 6 Months)
Population: All randomized participants who received at least 1 dose of study drug and had evaluable immunogenicity.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Anti-Drug Antibodies to LY3053102 | 0 Percentage of Participants |
| 7 mg LY3053102 | Percentage of Participants With Anti-Drug Antibodies to LY3053102 | 1 Percentage of Participants |
| 15 mg LY3053102 | Percentage of Participants With Anti-Drug Antibodies to LY3053102 | 1 Percentage of Participants |
| 50 mg LY3053102 | Percentage of Participants With Anti-Drug Antibodies to LY3053102 | 0 Percentage of Participants |
| 100 mg LY3053102 | Percentage of Participants With Anti-Drug Antibodies to LY3053102 | 2 Percentage of Participants |
| 200 mg LY3053102 | Percentage of Participants With Anti-Drug Antibodies to LY3053102 | 2 Percentage of Participants |
| 2 mg Exenatide ER | Percentage of Participants With Anti-Drug Antibodies to LY3053102 | 2 Percentage of Participants |
Secondary
Percentage of Participants With Hypoglycemia
Hypoglycemia was defined as any event meeting the criteria for documented symptomatic hypoglycemia, asymptomatic hypoglycemia, or probable symptomatic hypoglycemia.
Time frame: Baseline through Week 12
Population: All randomized participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Hypoglycemia | 10.0 Percentage of Participants |
| 7 mg LY3053102 | Percentage of Participants With Hypoglycemia | 12.5 Percentage of Participants |
| 15 mg LY3053102 | Percentage of Participants With Hypoglycemia | 0.0 Percentage of Participants |
| 50 mg LY3053102 | Percentage of Participants With Hypoglycemia | 0.0 Percentage of Participants |
| 100 mg LY3053102 | Percentage of Participants With Hypoglycemia | 12.5 Percentage of Participants |
| 200 mg LY3053102 | Percentage of Participants With Hypoglycemia | 12.5 Percentage of Participants |
| 2 mg Exenatide ER | Percentage of Participants With Hypoglycemia | 20.0 Percentage of Participants |
Secondary
Pharmacokinetics: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State (AUC [τ,ss]) of LY3053102
AUC (τ,ss) = area under the concentration versus time curve during one dosing interval at steady state, where the dosing interval (τ) = 168 hours.
Time frame: Predose, 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 168 hours post-dose
Population: All randomized participants who received at least 1 dose of study drug and had evaluable pharmacokinetics
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Pharmacokinetics: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State (AUC [τ,ss]) of LY3053102 | 22.6 microgram•hour/milliliter (µg•h/mL) | Geometric Coefficient of Variation 32.1 |
| 7 mg LY3053102 | Pharmacokinetics: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State (AUC [τ,ss]) of LY3053102 | 76.8 microgram•hour/milliliter (µg•h/mL) | Geometric Coefficient of Variation 25.6 |
| 15 mg LY3053102 | Pharmacokinetics: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State (AUC [τ,ss]) of LY3053102 | 190.0 microgram•hour/milliliter (µg•h/mL) | Geometric Coefficient of Variation 47.3 |
| 50 mg LY3053102 | Pharmacokinetics: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State (AUC [τ,ss]) of LY3053102 | 350.0 microgram•hour/milliliter (µg•h/mL) | Geometric Coefficient of Variation 36.3 |
| 100 mg LY3053102 | Pharmacokinetics: Area Under the Concentration Versus Time Curve During One Dosing Interval at Steady State (AUC [τ,ss]) of LY3053102 | 917.0 microgram•hour/milliliter (µg•h/mL) | Geometric Coefficient of Variation 35.1 |