Status:
COMPLETED
A Study to Test the Combination of Two Different Kinds of Medications for the Treatment of Diabetes
Lead Sponsor:
Eli Lilly and Company
Collaborating Sponsors:
OPKO Health, Inc.
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
Test the safety, tolerability and improvement of blood sugar control with combination therapy in individuals with Type 2 Diabetes.
Eligibility Criteria
Inclusion
- Written informed consent
- Have type 2 diabetes mellitus (T2DM) for at least 6 months
- Currently treated with diet and exercise alone or in combination with stable metformin
- Glycosylated hemoglobin (HbA1c) 7.0% to 10.0%
- Ages 18 to 70 years
- Women not of childbearing potential
- Body mass index (BMI) between 25 and 40 kilograms per meters squared (kg/m\^2), and stable weight in the 3 months prior to screening.
Exclusion
- Use of diabetes medicine other than metformin in past 3 months
- Gastrointestinal disease or surgery or drugs that significantly impacts gastric filling, emptying or motility; ongoing cholelithiasis or cholecystitis.
- Chronic, daily proton pump inhibitors (PPIs) and histamine (H2) antagonists.
- Severe hypoglycemia or hyperglycemia
- Advanced microvascular diabetes complications
- Medications to promote weight loss.
- Breastfeeding women
- Cardiac autonomic neuropathy
- In the past 6 months have cardiac disease with functional status that is Class II-IV or a history of myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, transient ischemic attack, cerebrovascular accident (stroke), or decompensated congestive heart failure.
- History of a supraventricular or ventricular tachycardia, pacemaker implantation, or other cardiac arrhythmia: Poorly controlled hypertension, malignant hypertension, renal artery stenosis, and/or evidence of labile blood pressure including symptomatic postural hypotension.
- Electrocardiograms (ECG) abnormality or medication that impairs the ability to measure QT interval (QT), or correct the QT interval (QT) for rate.
- QT interval Bazett corrected (QTcB) \>450 milliseconds (msec) or PR interval (PR) \>220 milliseconds (msec)
- Personal or family history of long QT interval (QT) syndrome, sudden death, or unexplained syncope
- Clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine transaminase levels \> 2.5 times the upper limit of the reference range
- Hypertriglyceridemia \> 400 mg/deciliter (dL)
- Inadequately treated hypothyroidism or hyperthyroidism
- Peptic ulcer disease and/or gastrointestinal bleeding/perforation.
- Known pentagastrin hypersensitivity
- Impaired renal function
- Transplanted organ.
- Active, uncontrolled endocrine or autoimmune abnormality
- \> 2 weeks systemic glucocorticoid therapy
- Ongoing courses of non-steroidal anti-inflammatory drugs (NSAIDs), except for aspirin 81-325 milligrams (mg)
- Diagnosed malignancy or in remission for less than 5 years.
- Prior acute or chronic pancreatitis or elevated serum lipase or amylase
- Current central nervous system stimulant
- Other conditions that preclude the participant from participating, following or completing the protocol.
- Chronic infection
- Personnel affiliated with the study and their immediate families.
- Within 30 days of the initial dose of study drug, have participated in an interventional medical, surgical, or pharmaceutical study in which a medical or surgical treatment was given.
- Have previously completed or withdrawn from this study after providing informed consent.
- Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT00853151
Start Date
February 1 2009
End Date
May 1 2010
Last Update
April 13 2012
Active Locations (29)
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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.
Birmingham, Alabama, United States, 35242
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.
Anaheim, California, United States, 92801
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.
Artesia, California, United States, 90701
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.
Fresno, California, United States, 93720