A Study to Test the Combination of Two Different Kinds of Medications for the Treatment of Diabetes

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Test the safety, tolerability and improvement of blood sugar control with combination therapy in individuals with Type 2 Diabetes.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborators: OPKO Health, Inc.; Transition Therapeutics

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.