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

Study Overview
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Brief Summary
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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.

Official Title
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A 12-Week Study Conducted at Multiple Centers, Blinded to Both the Patient and Doctor, Evaluating for Safety and Effectiveness Two Dosages of an Investigational Agent (GM-611) Versus a Placebo, That Are Randomly Assigned to Patients With Diabetic Gastroparesis

Conditions
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Gastroparesis

Intervention / Treatment
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* Drug: GM-611


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GM-611|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GM-611, Diabetic gastroparesis, Bloating, Delayed gastric emptying, Mitemcinal