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A Study for Participants With Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00871572
Recruitment Status : Completed
First Posted : March 30, 2009
Results First Posted : April 24, 2018
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: LY2409021 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of LY2409021 in Patients With Type 2 Diabetes Mellitus
Study Start Date : March 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
4 capsules by mouth once daily for 12 weeks
Experimental: LY2409021 10 milligrams (mg) Drug: LY2409021
4 capsules by mouth taken once daily for 12 weeks
Experimental: LY2409021 30 mg Drug: LY2409021
4 capsules by mouth taken once daily for 12 weeks
Experimental: LY2409021 60 mg Drug: LY2409021
4 capsules by mouth taken once daily for 12 weeks



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change From Baseline Values for Fasting Blood Glucose (FBG) [ Time Frame: Baseline, Week 12 ]
    LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.

  2. Change From Baseline for Glucose Area Under the Curve (AUC) From Oral Glucose Tolerance Test (OGTT) [ Time Frame: Baseline, Week 12 ]
    LS mean was calculated using analysis of covariance (ANCOVA) model that included terms for treatment group, baseline value and metformin use.

  3. Change From Baseline to Endpoint for Fasting Triglycerides [ Time Frame: Baseline, Week 12 ]
    LS mean was calculated using ANCOVA model that included terms for treatment group, baseline value and metformin use.

  4. Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R) [ Time Frame: Baseline, Week 12 ]
    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.

  5. 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 ]
    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.

  6. Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles [ Time Frame: Baseline, Week 12 ]
    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.

  7. Change From Baseline Values for Fasting Insulin [ Time Frame: Baseline, Week 12 ]
    LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.

  8. Change From Baseline Values for Fasting Glucagon [ Time Frame: Baseline, Week 12 ]
    LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.

  9. Change From Baseline Values for Fasting Glucagon-Like Peptide 1 (GLP-1) [ Time Frame: Baseline, Week 12 ]
    LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.

  10. Change From Baseline for Insulin AUC From OGTT [ Time Frame: Baseline, Week 12 ]
    LS mean was calculated using an ANCOVA that included terms for treatment group, baseline value and metformin use.

  11. Change From Baseline for C-Peptide AUC From OGTT [ Time Frame: Baseline, Week 12 ]
    LS mean was calculated using an ANCOVA model that included terms for treatment group, baseline value and metformin use.

  12. Change From Baseline to Endpoint for Low Density Lipoprotein (LDL) [ Time Frame: Baseline, Week 12 ]
    Fasting LDL LS mean was calculated using ANCOVA that included terms for baseline and treatment.

  13. Change From Baseline to Endpoint for High Density Lipoprotein (HDL) [ Time Frame: Baseline, Week 12 ]
    Fasting HDL LS mean was calculated using ANCOVA that included terms for baseline and treatment.

  14. Change From Baseline to Endpoint for Non-HDL Cholesterol [ Time Frame: Baseline, Week 12 ]
    Fasting non-HDL cholesterol LS mean was calculated using ANCOVA that included terms for baseline and treatment.

  15. Change From Baseline to Endpoint for Total Cholesterol [ Time Frame: Baseline, Week 12 ]
    Fasting total cholesterol LS mean was calculated using ANCOVA that included terms for baseline and treatment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00871572


Locations
United States, California
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.
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.
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.
Westlake Village, California, United States, 91361
United States, Florida
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.
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.
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.
New Port Richey, Florida, United States, 34652
United States, Idaho
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.
Idaho Falls, Idaho, United States, 83404
United States, Kansas
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.
Topeka, Kansas, United States, 66606
United States, Kentucky
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.
Madisonville, Kentucky, United States, 42431
United States, Nevada
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.
Las Vegas, Nevada, United States, 89101
United States, South Dakota
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.
Rapid City, South Dakota, United States, 57702
United States, Texas
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.
San Antonio, Texas, United States, 78229
United States, Virginia
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.
Norfolk, Virginia, United States, 23502
Germany
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.
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.
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.
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.
Saarlouis, Germany, 66740
Lithuania
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.
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.
Vilnius, Lithuania, LT-08661
Sponsors and Collaborators
Eli Lilly and Company
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00871572     History of Changes
Other Study ID Numbers: 11095
I1R-MC-GLBE ( Other Identifier: Eli Lilly and Company )
First Posted: March 30, 2009    Key Record Dates
Results First Posted: April 24, 2018
Last Update Posted: April 24, 2018
Last Verified: March 2018

Keywords provided by Eli Lilly and Company:
Diabetes Mellitus, Type 2

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases