- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00871572
A Study for Participants With Type 2 Diabetes Mellitus
March 24, 2018 updated by: Eli Lilly and Company
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of LY2409021 in Patients With Type 2 Diabetes Mellitus
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
87
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aschaffenburg, Germany, 63739
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Mainz, Germany, 55116
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Munchen, Germany, 80336
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Saarlouis, Germany, 66740
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kaunas, Lithuania, LT-51270
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Vilnius, Lithuania, LT-08661
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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California
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Buena Park, California, United States, 90620
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Huntington Park, California, United States, 90255
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Westlake Village, California, United States, 91361
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Florida
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Fort Lauderdale, Florida, United States, 33306
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Jupiter, Florida, United States, 33458
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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New Port Richey, Florida, United States, 34652
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Idaho
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Idaho Falls, Idaho, United States, 83404
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kansas
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Topeka, Kansas, United States, 66606
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Kentucky
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Madisonville, Kentucky, United States, 42431
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Nevada
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Las Vegas, Nevada, United States, 89101
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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South Dakota
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Rapid City, South Dakota, United States, 57702
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Texas
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San Antonio, Texas, United States, 78229
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Virginia
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Norfolk, Virginia, United States, 23502
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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PLACEBO_COMPARATOR: Placebo
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4 capsules by mouth once daily for 12 weeks
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EXPERIMENTAL: LY2409021 10 milligrams (mg)
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4 capsules by mouth taken once daily for 12 weeks
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EXPERIMENTAL: LY2409021 30 mg
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4 capsules by mouth taken once daily for 12 weeks
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EXPERIMENTAL: LY2409021 60 mg
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4 capsules by mouth taken once daily for 12 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Mean Change in Glycosylated Hemoglobin A1c (HbA1c)
Time Frame: Baseline, Week 12
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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.
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Baseline, Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline Values for Fasting Blood Glucose (FBG)
Time Frame: Baseline, Week 12
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LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.
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Baseline, Week 12
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Change From Baseline for Glucose Area Under the Curve (AUC) From Oral Glucose Tolerance Test (OGTT)
Time Frame: Baseline, Week 12
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LS mean was calculated using analysis of covariance (ANCOVA) model that included terms for treatment group, baseline value and metformin use.
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Baseline, Week 12
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Change From Baseline to Endpoint for Fasting Triglycerides
Time Frame: Baseline, Week 12
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LS mean was calculated using ANCOVA model that included terms for treatment group, baseline value and metformin use.
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Baseline, Week 12
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Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R)
Time Frame: Baseline, Week 12
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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.
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Baseline, Week 12
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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)
Time Frame: Baseline, Week 12
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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.
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Baseline, Week 12
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Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles
Time Frame: Baseline, Week 12
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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.
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Baseline, Week 12
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Change From Baseline Values for Fasting Insulin
Time Frame: Baseline, Week 12
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LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.
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Baseline, Week 12
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Change From Baseline Values for Fasting Glucagon
Time Frame: Baseline, Week 12
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LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.
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Baseline, Week 12
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Change From Baseline Values for Fasting Glucagon-Like Peptide 1 (GLP-1)
Time Frame: Baseline, Week 12
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LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.
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Baseline, Week 12
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Change From Baseline for Insulin AUC From OGTT
Time Frame: Baseline, Week 12
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LS mean was calculated using an ANCOVA that included terms for treatment group, baseline value and metformin use.
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Baseline, Week 12
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Change From Baseline for C-Peptide AUC From OGTT
Time Frame: Baseline, Week 12
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LS mean was calculated using an ANCOVA model that included terms for treatment group, baseline value and metformin use.
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Baseline, Week 12
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Change From Baseline to Endpoint for Low Density Lipoprotein (LDL)
Time Frame: Baseline, Week 12
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Fasting LDL LS mean was calculated using ANCOVA that included terms for baseline and treatment.
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Baseline, Week 12
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Change From Baseline to Endpoint for High Density Lipoprotein (HDL)
Time Frame: Baseline, Week 12
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Fasting HDL LS mean was calculated using ANCOVA that included terms for baseline and treatment.
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Baseline, Week 12
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Change From Baseline to Endpoint for Non-HDL Cholesterol
Time Frame: Baseline, Week 12
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Fasting non-HDL cholesterol LS mean was calculated using ANCOVA that included terms for baseline and treatment.
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Baseline, Week 12
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Change From Baseline to Endpoint for Total Cholesterol
Time Frame: Baseline, Week 12
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Fasting total cholesterol LS mean was calculated using ANCOVA that included terms for baseline and treatment.
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Baseline, Week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (ACTUAL)
February 1, 2010
Study Completion (ACTUAL)
February 1, 2010
Study Registration Dates
First Submitted
March 26, 2009
First Submitted That Met QC Criteria
March 27, 2009
First Posted (ESTIMATE)
March 30, 2009
Study Record Updates
Last Update Posted (ACTUAL)
April 24, 2018
Last Update Submitted That Met QC Criteria
March 24, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11095 (Registry Identifier: DAIDS ES Registry Number)
- I1R-MC-GLBE (OTHER: Eli Lilly and Company)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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