A Study for Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00871572
First received: March 26, 2009
Last updated: December 9, 2010
Last verified: December 2010
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 2
Drug: LY2409021
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of LY2409021 in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Mean change in hemoglobin A1c [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline values for fasting glucose [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline for glucose area under the curve from Oral Glucose Tolerance Test [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to endpoint for fasting triglycerides [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Total and sub-domain scores of Diabetes Symptom Checklist-Revised [ Time Frame: baseline, over 12 weeks ] [ Designated as safety issue: No ]
  • Differences between Perceptions about Medication-Diabetes scores between placebo and LY2409021 [ Time Frame: baseline, over 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline values for 7-point glucose profiles [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline values for fasting insulin [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline values for fasting glucagon [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline values for fasting GLP-1 [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline for insulin area under the curve from Oral Glucose Tolerance Test [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline for C-peptide area under the curve from Oral Glucose Tolerance Test [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to endpoint for low density lipoprotein [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to endpoint for high density lipoprotein [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to endpoint for non high density lipoprotein cholesterol [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to endpoint for total cholesterol [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 87
Study Start Date: March 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
4 capsules by mouth once daily for 12 weeks
Experimental: LY2409021 10mg 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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • Patients 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 Patients are male, Patients 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.
  • Patients must have an Hemoglobin A1c (HbA1c) test of 6.5% to 10%
  • Patients must have a body mass index (BMI) between 25 to 40 kg/m2.
  • Patients must be willing and able to test your blood sugar levels at home with a blood sugar meter.
  • Patients must complete a study diary as instructed by your study doctor and staff and return the study diary as instructed by the study doctor.
  • Patients 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 antiarrythmic 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 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 oz or 360 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.
  • Patients have a problem with your stomach such that it empties slowly (diabetic gastroparesis) or you have had gastric bypass (bariatric) surgery.
  • Patients have a personal or family history of pancreatic neoplasia.
  • Patients have abnormal lipids (for example triglycerides).
  • Patients 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.
  • Patients have an elevated or uncontrolled blood pressure.
  • Patients electrocardiogram (ECG, a test that measures the electrical activity of your heart) is outside the normal limits, as determined by the study doctor.
  • Patients have a problem with your kidneys or are on dialysis.
  • Patients have a problem with your pancreas.
  • Patients must not have nor had liver disease (for example, Hepatitis B or C).
  • Patients have cancer, except for skin cancer or have been in remission (the absence of disease activity) from cancer for less than 5 years.
  • Patients 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.
  • Patients previously completed or withdrew from this study or any other study investigating LY2409021.
  • Patients 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00871572     History of Changes
Other Study ID Numbers: 11095, I1R-MC-GLBE
Study First Received: March 26, 2009
Last Updated: December 9, 2010
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 29, 2014