Status:
COMPLETED
Effects of LY2189265 on Glycemic Control in Participants With Type 2 Diabetes
Lead Sponsor:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a study to demonstrate that different doses of once-weekly LY2189265 injected subcutaneously will have dose proportional effect on hemoglobin A1c (HbA1c) at 12 weeks in participants with type ...
Detailed Description
Participants in the trial will be randomized to one of the LY2189265 doses (4 doses are planned, range 0.1-1.5 milligram \[mg\]) or placebo. The main purpose is to assess dose-dependent effect of this...
Eligibility Criteria
Inclusion
- Diabetes mellitus, type 2
- Treatment regimens: diet and exercise only or are taking metformin as monotherapy and are willing to discontinue this medication
- Have completed at least 8 weeks of wash-out prior to randomization (if on metformin therapy at screening)
- Have a qualifying glycosylated hemoglobin (HbA1c) value, as determined by the central laboratory: at screening (for diet and exercise only ≥7.0% to ≤9.5%; for metformin monotherapy \>6.5% to ≤9.0%) and at time of randomization for all participants ≥6.5% to ≤9.5%
- Females of childbearing potential must test negative for pregnancy and agree to use a reliable birth control method
- Have a body mass index (BMI) between 23 and 40 kilograms/meter squared (kg/m\^2), inclusive, for participants who are native to, and reside in, South and/or East Asia; all other participants must have a BMI between 25 and 40 kg/m\^2, inclusive.
- Stable weight for 3 months prior to screening
Exclusion
- Diabetes mellitus, type 1
- Taking any glucose-lowering oral agents other than metformin within 3 months prior to screening
- Use of glucagon-like peptide-1 (GLP-1) analog (for example, exenatide) within 6 months prior to screening or being treated within insulin (with the exception of short-term management of acute conditions that occurred more than 3 months immediately prior to screening)
- Use of medications (prescription or over-the counter) to promote weight loss
- Chronic (\>2 weeks) use of systemic glucocorticoid therapy
- Gastric emptying abnormality, history of bariatric surgery or chronic use of drugs that affect gastrointestinal motility
- Use of central nervous system (CNS) stimulant (for example, Ritalin-sustained release \[SR\])
- Cardiovascular event within 6 months prior to screening
- Poorly controlled hypertension (determined by a mean seated systolic blood pressure (BP) ≥160 millimeters of mercury (mmHg) or mean seated diastolic BP ≥95 mmHg at screening or randomization)
- Electrocardiogram (ECG) reading considered outside the normal limits by the investigator and relevant for interpretation or indicating cardiac disease
- Liver disease, hepatitis, chronic hepatitis, or alanine transaminase levels \>3.0 times upper limit of normal
- Clinical signs or symptoms of pancreatitis or history of chronic or acute pancreatitis at time of screening
- Amylase ≥3 times the upper limit of normal and/or lipase ≥2 times upper limit of normal which are determined by central labs at the time of screening
- Serum creatinine ≥1.5 milligrams per deciliter (mg/dL) for men or ≥1.4 mg/dL for women or a creatinine clearance \<60 milliliter (mL)/minute which are determined by central labs at the time of screening
- Uncontrolled diabetes (defined as 2 or more episode of hyperosmolar state requiring hospitalization in the 6 months prior to screening)
- Significant active, uncontrolled endocrine or autoimmune abnormality
- History of a transplanted organ (corneal transplants are allowed)
- Active or untreated malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years
- Have any other condition, in the opinion of the investigator, that may preclude the participant from following or completing the protocol
- Investigator site personnel directly affiliated with this study and/or their immediate families (spouse, parent, child, or sibling, whether biological or legally adopted)
- Sponsor employees
- Received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
- Participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to entry into the study
- Have previously completed or withdrawn from this study after providing informed consent
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
167 Patients enrolled
Trial Details
Trial ID
NCT00791479
Start Date
December 1 2008
End Date
January 1 2010
Last Update
December 10 2014
Active Locations (46)
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1
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.
Concord, California, United States, 94520
2
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.
Lancaster, California, United States, 93534
3
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.
Mission Hills, California, United States, 91345
4
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.
Palm Springs, California, United States, 92262