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Study Evaluating Safety, Tolerability, And Action Of OAP-189 In Subjects With Type 2 Diabetes On Metformin (3283K1-1008-US)

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: September 1, 2009
Last updated: August 11, 2011
Last verified: August 2011
This is a study to evaluate the safety, tolerability, and activity of OAP-189 in subjects with type 2 diabetes who are taking metformin for their diabetes.

Condition Intervention Phase
Diabetes Mellitus Drug: OAP-189 Drug: placebo comparator Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study Of Multiple Doses Of OAP-189 To Determine The Safety, Tolerability, Pharmacodynamics, And Pharmacokinetics When Coadministered With Metformin In Type 2 Diabetic Subject

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety and tolerability as measured by adverse events (AEs), Laboratory test results, ECG results, glucose and insulin results [ Time Frame: 21 days ]

Secondary Outcome Measures:
  • The plasma concentration-time data of metformin after single and multiple dose administration of OAP and the plasma concentration-time data of OAP-189 after multiple dose administration of metformin will be characterized. [ Time Frame: 21 days ]

Estimated Enrollment: 88
Study Start Date: September 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: OAP-189 Drug: OAP-189
Group 1: OAP-189 BID (0.2 mg BID) x 7 days Group 2: OAP-189 (0.4 mg BID) x 7 days Group 3: OAP-189 QD (0.9 mg x 7 days followed by 1.2 mg x 7 days; MR formulation) Group 4: OAP-189 QD (1.2 mg x 7 days followed by 1.6 mg x 7 days; MR formulation) Group 5: OAP-189 QD (1.2 mg x 7 days followed by 1.6 mg x 7 days; different MR formulation) Group 6: OAP-189 QD (1.2 mg x 7 days followed by 1.6 mg x 7 days; different MR formulation)
Placebo Comparator: 2 Drug: placebo comparator
Group 1 & 2: PBO x 7 days BID Group 3: PBO QD x 14 days Group 4: PBO QD x 14 days Group 5: PBO QD x 14 days Group 6: PBO QD x 14 days


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects must have been diagnosed with type 2 diabetes, with HbA1c level >=7.0% and <=11.0% and a fasting glucose level <=280 mg/dL.
  • Men or women of nonchildbearing potential (WONCBP), aged 18 to 65 years inclusive on study day 1.
  • Body mass index in the range of 27 to 40kg/m² (inclusive) and body weight >=50 kg.
  • Subjects must be otherwise generally healthy, but may be enrolled with a stable chronic illness, if it is well controlled and does not interfere with the primary objective of the study.
  • Subjects must currently be treated for diabetes with metformin alone at a total daily dose of >=1gm (administered QD or BID) and that dose must have been stable for at least 4 weeks before study day 1.
  • Nonsmoker.

Exclusion Criteria:

  • Any significant disease with the exception of diabetes mellitus.
  • Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the investigational product.
  • Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day 1.
  • Any clinically important problems in physical examination results, vitals sign measurements, ECGs, or clinical laboratory test results.
  • Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies.
  • Positive findings of urine drug screen
  • Use of any investigational or non-permitted prescription drug within 30 days before investigational product administration.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00970593

United States, California
Pfizer Investigational Site
Chula Vista, California, United States, 91911
United States, Florida
Pfizer Investigational Site
Miami Gardens, Florida, United States, 33169
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc Identifier: NCT00970593     History of Changes
Other Study ID Numbers: 3283K1-1008
Study First Received: September 1, 2009
Last Updated: August 11, 2011

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on September 20, 2017