NCT00871572CompletedPhase 2
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of LY2409021 in Patients With Type 2 Diabetes Mellitus
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 87
- Locations
- 1
- Primary Endpoint
- Mean Change in Glycosylated Hemoglobin A1c (HbA1c)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
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 LY
- •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.
Arms & Interventions
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
LY2409021 10 milligrams (mg)
Experimental
Intervention: LY2409021 (Drug)
LY2409021 30 mg
Experimental
Intervention: LY2409021 (Drug)
LY2409021 60 mg
Experimental
Intervention: LY2409021 (Drug)
Outcomes
Primary Outcomes
Mean Change in Glycosylated Hemoglobin A1c (HbA1c)
Time Frame: 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 Outcomes
- Change From Baseline to Endpoint for Fasting Triglycerides(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 Values for Fasting Insulin(Baseline, Week 12)
- Change From Baseline to Endpoint for Total Cholesterol(Baseline, Week 12)
- Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R)(Baseline, Week 12)
- Change From Baseline Values for Fasting Glucagon(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)
- Change From Baseline for Insulin AUC From OGTT(Baseline, Week 12)
- Change From Baseline to Endpoint for High Density Lipoprotein (HDL)(Baseline, Week 12)
- Change From Baseline Values for Fasting Blood Glucose (FBG)(Baseline, Week 12)
- Change From Baseline to Endpoint for Non-HDL Cholesterol(Baseline, Week 12)
- Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles(Baseline, Week 12)
- Change From Baseline Values for Fasting Glucagon-Like Peptide 1 (GLP-1)(Baseline, Week 12)
- Change From Baseline for C-Peptide AUC From OGTT(Baseline, Week 12)
- Change From Baseline to Endpoint for Low Density Lipoprotein (LDL)(Baseline, Week 12)
Investigators
Study Sites (1)
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