Clinical trial NCT01571297 (phase 2, status: completed)
Conditions: diabetes mellitus, diabetes mellitus complications, gastroparesis
ICD codes: P70.2, O24.92, Z83.3, E10.65, E10.9, E11.65, E11.9, E10.9, E11.9, E13.9, E10.8, E11.8, E13.8, E08.9, K31.84
Drugs: rm-131, placebo
SMILES: NC(=O)C1(CCNCC1)NC(=O)[C@H](CC1=CC=CC=C1)NC(=O)[C@@H](CC1=CNC2=CC=CC=C12)NC(=O)[C@@H](CC1=CSC2=CC=CC=C12)NC(=O)C1CCNCC1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Able to provide written informed consent prior to any study procedures and be willing
             and able to comply with study procedures.

          -  Type 1 or Type 2 diabetes mellitus with HbA1c ≤11% at screening.

          -  Diabetic gastroparesis defined as at least 3 months history of symptoms suggestive of
             gastroparesis on an ongoing basis.

          -  Average Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) > 2.6 during Visit
             2.

          -  History of nausea and/or vomiting/emesis at least once a week during the 2 weeks prior
             to Visit 1.

          -  Delayed gastric emptying confirmed at screening by abnormal gastric emptying breath
             test (GEBT), defined as half-emptying time (t½) > 79 minutes.

          -  Stable concomitant medications defined as no changes in regimen for at least 2 weeks
             prior to Visit 2.

          -  No use of metoclopramide, erythromycin or anti-emetics for at least 2 weeks prior to
             Visit 2.

          -  Body mass index > 18 kg/m2.

          -  Female patients must have negative serum or urine pregnancy tests and must not be
             lactating. For females able to bear children, a hormonal (i.e., oral, implantable, or
             injectable) and single-barrier method, or a double-barrier method of birth control
             must be used throughout the study. Female patients unable to bear children must have
             this documented in the electronic case report form (eCRF) (i.e., tubal ligation,
             hysterectomy, or post-menopausal [defined as a minimum of one year since the last
             menstrual period]). Post-menopausal status will be confirmed by FSH.

        Exclusion Criteria:

          -  Currently receiving parenteral feeding; presence of a nasogastric or other enteral
             tube for feeding or decompression.

          -  History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker
             placement, vagotomy, bariatric procedure.

          -  History of pyloric injection of botulinum toxin within 6 months of screening.

          -  Persistent daily vomiting.

          -  Patients with clinical suspicion of upper gastrointestinal obstruction must have been
             evaluated per standard of care, and obstruction ruled out before screening.

          -  Currently taking opiates.

          -  Currently taking GLP-1 and amylin analogs.

          -  Allergic or intolerant of egg, wheat, milk or algae, as these are components of the
             GEBT study meal.

          -  History of anorexia nervosa, binge-eating or bulimia within 5 years.

          -  ALT or AST > 2 X upper limit of normal during screening.

          -  History of intestinal malabsorption or pancreatic exocrine disease.

          -  Requires hemodialysis or has end-stage renal disease.

          -  History of human immunodeficiency virus (HIV) infection.

          -  Clinically significant neurologic or psychiatric disorders which are likely to impact
             compliance with protocol requirements.

          -  Poor venous access or inability to tolerate venipuncture.

          -  Participation in a clinical study within the 30 days prior to dosing in the present
             study.

          -  Any other reason, which in the opinion of the Investigator, including renal, hepatic
             or cardiopulmonary disease, or significant acute ECG abnormalities that would confound
             proper interpretation of the study or expose a patient to unacceptable risk.