Safety and Effectiveness of an Investigational Agent (GM-611) in Patients With Diabetic Gastroparesis

This study is intended to evaluate the potential to relieve the symptoms associated with gastroparesis during 12 weeks of treatment with oral tablets given twice a day of GM-611 5mg, 10mg or placebo to type I or II diabetics who require insulin.

Additionally the study will evaluate the safety and tolerability of GM-611 compared to placebo, the levels of GM-611 in the blood, and the possible effect of GM-611 on diabetic control.

Inclusion Criteria:

Major Inclusion Criteria – Others Stipulated within the Protocol

The study physician must assure you have/are:

• Must be at least 18 years of age and have diabetes mellitus requiring insulin, which may be in addition to oral anti-diabetic agents.
• At least a three month history of the symptoms of gastroparesis that may include: early satiety (feeling full soon after beginning a meal), persistent fullness (long after eating), abdominal distention or bloating, nausea and vomiting. - No evidence of mechanical gastric obstruction, or other gastric problems since the onset of gastroparesis symptoms.
• You may be required to under go a Gastric Emptying Test (GET) procedure.
• You must be willing and able to maintain a daily telephone diary and consent to participate in this study.

Exclusion Criteria:

Major Exclusion Criteria – Others Stipulated within the Protocol

The study physician must assure you do not have/are not:

• Prior history of gastric surgery, excluding reflux surgery.
• Inability to withdraw from current prokinetic agents (e.g., metoclopramide, erythromycin, others) prior to, and during the study.
• Unstable current medical or surgical condition, or a recent history of frequent hospitalizations.
• A history of: HIV, recurring infection affecting the gastrointestinal track, cirrhosis, acute or chronic liver disease, active pancreatitis, cholecystitis, psychosis, severe depression, Parkinson’s disease, myopathy, scleroderma, eating disorder, or organ transplant.
• Evidence or history of QT-prolongation, or use of drugs that are, or may be associated with QT-prolongation are prohibited.
• May not be pregnant, breast-feeding or not using approved methods of contraception.
• An allergy or intolerance to macrolide antibiotics (e.g., erythromycin).
• Use of any investigational drug within 30 days prior to screening.