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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00970593
Recruitment Status : Completed
First Posted : September 2, 2009
Last Update Posted : August 12, 2011
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Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus Drug: OAP-189 Drug: placebo comparator Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
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
Study Start Date : September 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Metformin

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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.

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 identifier (NCT number): 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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc Identifier: NCT00970593     History of Changes
Other Study ID Numbers: 3283K1-1008
First Posted: September 2, 2009    Key Record Dates
Last Update Posted: August 12, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs