Diabetes Mellitus, Gastroparesis
Conditions
Keywords
gastroparesis, diabetes mellitus, delayed gastric emptying
Brief summary
The purpose of this study is to evaluate the effect of TZP-102 on gastric emptying rate, gastroparesis symptoms and health-related quality of life in diabetic patients with gastroparesis.
Interventions
DRUGTZP-102
DRUGPlacebo
Sponsors
Tranzyme, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 18 to 80 years of age, inclusive. * Type 1 or type 2 diabetes mellitus. * Female patients of childbearing potential must have a negative serum pregnancy test and use (and agree to continue to use throughout the study) an acceptable method of contraception. * HbA1c level less than/equal to 10.0 % at the Screening Visit. * Diagnosis of gastroparesis including (all three of the following requirements apply): i. Documented delayed gastric emptying; ii. A greater than 3 month history of symptoms of gastroparesis; iii. A GCSI Total Score greater than/equal to 2.66 at the Screening Visit and greater than/equal to 1.90 at the Day 1 visit. * Upper gastrointestinal obstruction ruled out by endoscopy or barium scan. * Concomitant medications must be stable for at least 2 weeks leading up to the Baseline Visit and be maintained during the study. * Body Mass Index (BMI) \< 35. * Delayed gastric emptying by breath test demonstrated at the Baseline Visit.
Exclusion criteria
* Persistent daily vomiting * Gastrectomy, obesity surgery, fundoplication, or vagotomy/pyloroplasty. * Pyloric Botox within 6 months prior to Screening Visit. * NG, PEG or PEJ feeding tube. * Required in-patient hospitalization for treatment of gastroparesis within 2 weeks prior to the Screening Visit. * Parenteral nutrition for treatment of gastroparesis within 2 months prior to the Screening Visit. * Active gastric pacemaker within 3 months prior to the Screening Visit. * Participation in an investigational study within 30 days prior to study entry. * Chronic severe diarrhea. * Diabetic ketoacidosis requiring hospitalization within 30 days prior to study entry. * History of any eating disorder within 2 years prior to study entry. * Significant chronic obstructive pulmonary disease or chronic asthma. * Patient is a heavy smoker, and/or unable or unwilling to abstain from smoking during each of the three study visits during which the gastric emptying breath tests will be performed. * History of risk factors for Torsades de Pointes. * Patient requires treatment with certain concomitant medications known to have a clinically recognized risk for Torsades de Pointes. * History of acute myocardial infarction (MI) or unstable angina within 12 months prior to study entry. * History of any psychiatric disorder or cognitive impairment that would interfere with participation in the study. * History of alcohol dependency within 2 years prior to study entry. * Taking opiates for abdominal pain. * History of HIV infection. * History of Hepatitis B or C currently exhibiting symptoms expected to worsen during course of study. * Requires dialysis or has severely impaired renal function. * Severe impairment of liver function. * Uncontrolled hypo- or hyperthyroidism. * History of adrenal insufficiency. * Pregnant or is breast-feeding. * Allergic to or intolerant of wheat, egg, soy or milk products. * Patient requires a gluten-free diet. * Any other medical condition or social circumstance that, in the investigator's opinion, makes it inappropriate for the patient to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change from baseline in gastric half-emptying time | study days 1 and 28 |
Secondary
| Measure | Time frame |
|---|---|
| change from baseline in gastroparesis symptoms and health-related quality of life | study days 8, 15 and 28 |
Countries
Denmark, Norway, Poland, Sweden, United Kingdom, United States
Outcome results
None listed