Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

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.
Baseline, Week 12

Secondary Outcomes (15)

Change From Baseline Values for Fasting Blood Glucose (FBG)
Baseline, Week 12
Change From Baseline for Glucose Area Under the Curve (AUC) From Oral Glucose Tolerance Test (OGTT)
Baseline, Week 12
Change From Baseline to Endpoint for Fasting Triglycerides
Baseline, Week 12
Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R)
Baseline, Week 12
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
+10 more secondary outcomes

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

LY2409021 10 milligrams (mg)

EXPERIMENTAL

Drug: LY2409021

LY2409021 30 mg

EXPERIMENTAL

Drug: LY2409021

LY2409021 60 mg

EXPERIMENTAL

Drug: LY2409021

Interventions

LY2409021DRUG

4 capsules by mouth taken once daily for 12 weeks

LY2409021 10 milligrams (mg)LY2409021 30 mgLY2409021 60 mg

PlaceboDRUG

4 capsules by mouth once daily for 12 weeks

Placebo

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.
+8 more criteria

Contact the study team to confirm eligibility.