Safety and Efficacy of IV Infusion of Investigational Agent (TZP-101) in Patients With Diabetic Gastroparesis

This study has been completed.
Information provided by:
Tranzyme, Inc. Identifier:
First received: March 13, 2008
Last updated: March 19, 2008
Last verified: March 2008

The purpose of this study is to determine whether TZP-101 is safe in people with diabetes. Also to determine if TZP-101 is effective in increasing the gastric emptying rate in diabetic patients.

Condition Intervention Phase
Diabetes Mellitus
Drug: 5% dextrose in water
Drug: TZP-101
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Double-Blind, Placebo Controlled, Crossover Single Dose Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Effect on Gastric Emptying of TZP-101 IV Infusion in Diabetic Gastroparesis Patients

Resource links provided by NLM:

Further study details as provided by Tranzyme, Inc.:

Primary Outcome Measures:
  • 12-lead ECG data [ Time Frame: 8 assessments including baseline (prior to start of infusion of study drug) until 24 four hours after start of infusion. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Scintigraphy to measure rate of gastric emptying after ingestion of a radio-labeled meal [ Time Frame: Measurements at: 30, 60, 120, 180, 210, and 240 minutes after the meal is eaten ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: August 2006
Study Completion Date: March 2008
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: 5% dextrose in water
60 ml IV infusion over 30 minutes
Other Name: D5W
Experimental: 2
Drug: TZP-101
1 infusion: IV 2ml/min for 30 minutes for 1 day of either 160, 320 or 600 micrograms/kg


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject has type 1 or type 2 diabetes mellitus
  • Subject has documented diagnosis of gastroparesis by:
  • Delayed gastric emptying (gastric retention ≥60% at 2h and ≥10% at 4 h; based on scintigraphy -4h standardized radionuclide solid meal)
  • A minimum 3 month history of chronic upper abdominal discomfort (two or more: chronic postprandial fullness, bloating, epigastric discomfort, early satiety, belching after meal, postprandial nausea, vomiting)
  • Subject has normal upper endoscopy
  • If female, must be permanently sterilized or postmenopausa.

Exclusion Criteria:

  • Patient has received any investigational drug within the preceding 30 days
  • Patient is taking unstable doses of medication that affects gastric motility
  • Patient has co-morbid condition
  • Patient has a positive laboratory test result for hepatitis B, hepatitis C, HIV, or controlled substances.
  • Patient has a history of a psychiatric disorder (including drug or alcohol addiction) requiring care by a psychiatrist or psychologist within the preceding 12 months.
  • Patient has a recent,adult history of clinically significanthypersensitivity reaction(s) to any drug.
  • Patient has known history of alcoholism
  Contacts and Locations
Please refer to this study by its identifier: NCT00639808

Aarhus Hospital
Aarhus, Denmark
Hvidore Hospital
Copenhagen, Denmark
Karolinska University Hospital
Stockholm, Sweden
Sponsors and Collaborators
Tranzyme, Inc.
  More Information

No publications provided

Responsible Party: Gordana Kosutic, MD; VP Clinical & Regulatory Affairs, Tranzyme, Inc. Identifier: NCT00639808     History of Changes
Other Study ID Numbers: TZP-101-CL-002, EudraCT 2006-002730-38
Study First Received: March 13, 2008
Last Updated: March 19, 2008
Health Authority: United States: Food and Drug Administration
Denmark: Danish Medicines Agency

Keywords provided by Tranzyme, Inc.:
delayed gastric emptying
symptomatic gastroparesis
diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Neurologic Manifestations
Signs and Symptoms processed this record on April 16, 2014