A Study for Participants With Type 2 Diabetes Mellitus

Lilly

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo; Drug: LY2409021

Study type: Interventional

Funder types: Industry

Identifiers

NCT00871572

I1R-MC-GLBE (Other Identifier)

11095 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 87 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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87 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

LY2409021 10 milligrams (mg)

Experimental group

Treatment:

Drug: LY2409021

LY2409021 30 mg

Experimental group

Treatment:

Drug: LY2409021

LY2409021 60 mg

Experimental group

Treatment:

Drug: LY2409021