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Study to Evaluate Safety and PK/PD of DA-3091 in Healthy Male Subjects (SR-Exenatide)

This study has been completed.
Information provided by (Responsible Party):
Dong-A ST Co., Ltd. ( Dong-A Pharmaceutical Co., Ltd. ) Identifier:
First received: July 2, 2010
Last updated: August 12, 2013
Last verified: August 2013
This Phase I clinical study is to evaluate the safety and tolerance of DA-3091 and to characterize the pharmacokinetic/pharmacodynamic of DA-3091 in healthy male subjects

Condition Intervention Phase
Diabetes Mellitus
Drug: SR-exenatide
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Dose Block-randomized, Double-blind, Placebo-controlled, Dose-escalating, Phase I Study to Evaluate Safety and Pharmacokinetics/Pharmacodynamics of DA-3091 After Subcutaneous Injection in Healthy Male Subjects

Resource links provided by NLM:

Further study details as provided by Dong-A ST Co., Ltd. ( Dong-A Pharmaceutical Co., Ltd. ):

Primary Outcome Measures:
  • Assessment of safety [ Time Frame: 84 days ]
    1. Adverse Events
    2. Laboratory Results
    3. Vital sign, Physical Examination, EKG

Secondary Outcome Measures:
  • Pharmacokinetics and Pharmacodynamics [ Time Frame: PK : 84 days / PD : 42days ]
    PK : Cmax, Tmax, AUClast PD : Glucose, Insulin, Glucagon, C-peptide in blood sample

Enrollment: 31
Study Start Date: July 2010
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DA-3091
Drug: SR-exenatide
Emulsion 0.5mg,1mg,2mg,4mg dosage (Dose-escalation) Single injection
Other Name: DA-3091
Placebo Comparator: Placebo of DA-3091
Drug: SR-exenatide
Emulsion 0.5mg,1mg,2mg,4mg dosage (Dose-escalation) Single injection
Other Name: DA-3091

Detailed Description:
This is a phase I dose escalation study. To meet the clinical objectives, we are using a two-part approach. In part I, 4 subjects are injected 0.5mg dose of DA-3091 or placebo(Single/Subcutaneous Injection). After completion of part I study, we are reporting data about safety to IDMC. In part II, 8 subjects per group are injected 1mg, 2mg, 4mg of DA-3091 or placebo through dose escalating protocol. The ratio of DA-3091 and placebo is 3:1.

Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Age : 20 ~ 45 years old
  2. Healthy Male
  3. Body weight : ≥50kg and Ideal body weight ± 20%
  4. Informed consent

Exclusion Criteria:

  1. Clinically significant medical history
  2. Acute or Chronic pancreatitis
  3. Clinically significant hypersensitivity of Drugs
  4. Clinically significant cutaneous disorder
  5. History of administration of exenatide
  6. Disorder of blood pressure
  7. History of drug abuse
  Contacts and Locations
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Please refer to this study by its identifier: NCT01156779

Korea, Republic of
Clinical Trial center, Clinical Research institute, Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Dong-A Pharmaceutical Co., Ltd.
Principal Investigator: Kyung-Sang Yu, M.D., Ph.d Seoul National University Hospital
  More Information

Responsible Party: Dong-A Pharmaceutical Co., Ltd. Identifier: NCT01156779     History of Changes
Other Study ID Numbers: DA3091_DM_I
Study First Received: July 2, 2010
Last Updated: August 12, 2013

Keywords provided by Dong-A ST Co., Ltd. ( Dong-A Pharmaceutical Co., Ltd. ):

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on May 25, 2017