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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 17, 2017

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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Study Evaluating Safety, Tolerability, And Action Of OAP-189 In Subjects With Type 2 Diabetes On Metformin
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetes Mellitus
  • 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
  • Placebo Comparator: OAP-189
    Intervention: Drug: OAP-189
  • Placebo Comparator: 2
    Intervention: Drug: placebo comparator
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
July 2011
July 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00970593
3283K1-1008
B2201004
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 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 thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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