Clinical trial NCT00871572: A Study for Participants With Type 2 Diabetes Mellitus
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of LY2409021 in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2009-03-30
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Mean Change in Glycosylated Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline Values for Fasting Blood Glucose (FBG)
timeFrame: Baseline, Week 12
measure: Change From Baseline for Glucose Area Under the Curve (AUC) From Oral Glucose Tolerance Test (OGTT)
timeFrame: Baseline, Week 12
measure: Change From Baseline to Endpoint for Fasting Triglycerides
timeFrame: Baseline, Week 12
measure: Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R)
timeFrame: Baseline, Week 12
measure: 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)
timeFrame: Baseline, Week 12
measure: Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles
timeFrame: Baseline, Week 12
measure: Change From Baseline Values for Fasting Insulin
timeFrame: Baseline, Week 12
measure: Change From Baseline Values for Fasting Glucagon
timeFrame: Baseline, Week 12
measure: Change From Baseline Values for Fasting Glucagon-Like Peptide 1 (GLP-1)
timeFrame: Baseline, Week 12
measure: Change From Baseline for Insulin AUC From OGTT
timeFrame: Baseline, Week 12
measure: Change From Baseline for C-Peptide AUC From OGTT
timeFrame: Baseline, Week 12
measure: Change From Baseline to Endpoint for Low Density Lipoprotein (LDL)
timeFrame: Baseline, Week 12
measure: Change From Baseline to Endpoint for High Density Lipoprotein (HDL)
timeFrame: Baseline, Week 12
measure: Change From Baseline to Endpoint for Non-HDL Cholesterol
timeFrame: Baseline, Week 12
measure: Change From Baseline to Endpoint for Total Cholesterol
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Buena Park
country: United States
facility: 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.
state: California
city: Huntington Park
country: United States
facility: 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.
state: California
city: Westlake Village
country: United States
facility: 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.
state: California
city: Fort Lauderdale
country: United States
facility: 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.
state: Florida
city: Jupiter
country: United States
facility: 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.
state: Florida
city: New Port Richey
country: United States
facility: 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.
state: Florida
city: Idaho Falls
country: United States
facility: 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.
state: Idaho
city: Topeka
country: United States
facility: 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.
state: Kansas
city: Madisonville
country: United States
facility: 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.
state: Kentucky
city: Las Vegas
country: United States
facility: 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.
state: Nevada
city: Rapid City
country: United States
facility: 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.
state: South Dakota
city: San Antonio
country: United States
facility: 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.
state: Texas
city: Norfolk
country: United States
facility: 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.
state: Virginia
city: Aschaffenburg
country: Germany
facility: 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.
city: Mainz
country: Germany
facility: 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.
city: Munchen
country: Germany
facility: 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.
city: Saarlouis
country: Germany
facility: 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.
city: Kaunas
country: Lithuania
facility: 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.
city: Vilnius
country: Lithuania
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: Kazda CM, Ding Y, Kelly RP, Garhyan P, Shi C, Lim CN, Fu H, Watson DE, Lewin AJ, Landschulz WH, Deeg MA, Moller DE, Hardy TA. Evaluation of Efficacy and Safety of the Glucagon Receptor Antagonist LY2409021 in Patients With Type 2 Diabetes: 12- and 24-Week Phase 2 Studies. Diabetes Care. 2016 Jul;39(7):1241-9. doi: 10.2337/dc15-1643. Epub 2015 Dec 17.