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

Pfizer logo

Pfizer

Status and phase

Completed
Phase 1

Conditions

Diabetes Mellitus

Treatments

Drug: OAP-189
Drug: placebo comparator

Study type

Interventional

Funder types

Industry

Identifiers

NCT00970593
3283K1-1008
B2201004 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

92 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

92 participants in 2 patient groups, including a placebo group

OAP-189
Placebo Comparator group
Treatment:
Drug: OAP-189
2
Placebo Comparator group
Treatment:
Drug: placebo comparator

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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