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Study Evaluating Safety, Tolerability, And Action Of OAP-189 In Subjects With Type 2 Diabetes On Metformin

Last updated on December 5, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Chula Vista, California, 91911 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects must have been diagnosed with type 2 diabetes, with HbA1c level >=7.0% and

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00970593
Pfizer
Completed
Study Evaluating Safety, Tolerability, And Action Of OAP-189 In Subjects With Type 2 Diabetes On Metformin

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Descriptive Information
Brief Title  ICMJE Study Evaluating Safety, Tolerability, And Action Of OAP-189 In Subjects With Type 2 Diabetes On Metformin
Official Title  ICMJE 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
Brief SummaryThis 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus
Intervention  ICMJE
  • 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)
  • 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
Study Arms  ICMJE
  • Placebo Comparator: OAP-189
    Intervention: Drug: OAP-189
  • Placebo Comparator: 2
    Intervention: Drug: placebo comparator
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: May 9, 2011)
88
Original Estimated Enrollment  ICMJE
 (submitted: September 1, 2009)
28
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion DateJuly 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00970593
Other Study ID Numbers  ICMJE 3283K1-1008
B2201004
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateAugust 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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