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Pilot Study of ONO-5129 in Patients With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT00335712
Recruitment Status : Completed
First Posted : June 12, 2006
Last Update Posted : June 13, 2012
Sponsor:
Information provided by (Responsible Party):
Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc )

Brief Summary:
The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of ONO-5129 in patients with type 2 diabetes mellitus.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: ONO-5129 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase II Study of ONO-5129 in Patients With Type 2 Diabetes Mellitus
Study Start Date : June 2006

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Fasting Blood Glucose at week 8

Secondary Outcome Measures :
  1. Other glycemic control parameters (e.g., HbA1c, glycoalbumin)


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Fasting Blood Glucose 126-250mg/dL
  2. HbA1c 6.5-11%

Exclusion Criteria:

  1. Previous treatment with antidiabetic agents equal to or less than 2-3 months prior to randomization
  2. History of myocardial infarction, coronary artery surgery
  3. Other eligibility criteria as specified in the study protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00335712


Locations
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Japan
Kanto Region
Kanto, Japan
Kyusyu Region
Kyusyu, Japan
Sponsors and Collaborators
Ono Pharma USA Inc
Investigators
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Study Director: Project Leader, Development Planning Ono Pharmaceutical Co. Ltd

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Responsible Party: Ono Pharma USA Inc
ClinicalTrials.gov Identifier: NCT00335712     History of Changes
Other Study ID Numbers: ONO-5129-03
First Posted: June 12, 2006    Key Record Dates
Last Update Posted: June 13, 2012
Last Verified: June 2012

Keywords provided by Ono Pharmaceutical Co. Ltd ( Ono Pharma USA Inc ):
ONO-5129
type 2 diabetes mellitus

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases