Clinical trial NCT00970593: Study Evaluating Safety, Tolerability, And Action Of OAP-189 In Subjects With Type 2 Diabetes On Metformin
Official title: A RANDOMIZED, PARALLEL-GROUP, OPEN-LABEL, PLACEBO CONTROLLED STUDY OF THE EFFECT OF OAP-189 ON THE PHARMACOKINETICS AND PHARMACODYNAMICS OF METFORMIN IN DIABETIC SUBJECTS.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-09-02
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Clinically Significant Physical Examination Abnormalities
timeFrame: Baseline up to 17 days after last dose of study drug (Day 31)
measure: Number of Participants With Clinically Significant Vital Signs Abnormalities
timeFrame: Baseline up to 17 days after last dose of study drug (Day 31)
measure: Number of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities
timeFrame: Baseline up to 17 days after last dose of study drug (Day 31)
measure: Number of Participants With Clinically Significant Laboratory Abnormalities
timeFrame: Baseline up to 17 days after last dose of study drug (Day 31)
measure: Number of Participants With Injection Site Reactions
timeFrame: Baseline up to 17 days after last dose of study drug (Day 31)
measure: Number of Participants With Clinically Significant Fasting Glucose Level Abnormalities
timeFrame: Baseline up to 17 days after last dose of study drug (Day 31)
measure: Number of Participants With Hypoglycaemia
timeFrame: Baseline up to 17 days after last dose of study drug (Day 31)
measure: Number of Participants With Drug-Induced Liver Injury
timeFrame: Baseline up to 17 days after last dose of study drug (Day 31)
measure: Change From Baseline in Predose Fasting Glucose Levels at Day 8
timeFrame: Baseline, Day 8
measure: Change From Baseline in Predose Fasting Glucose Levels at Day 15
timeFrame: Baseline, Day 15
Secondary outcomes:
Other outcomes:
measure: Plasma Concentration Versus Time Summary of Metformin Following Single Dose of OAP-189
timeFrame: Pre-dose (2 hours before dosing), 1, 2, 3, 4, 6 hours post-dose on Day 14
measure: Plasma Concentration Versus Time Summary of Metformin Following Multiple Dose of OAP-189
timeFrame: Pre-dose (2 hours before dosing), 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24 hours post-dose on Day 7
measure: Plasma Concentration Versus Time Summary of Single Dose of OAP-189
timeFrame: Pre-dose (2 hours before dosing), 2, 4, 6 hours post-dose on Day 7; Pre-dose (2 hours before dosing), 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24, 48, 72 hours post-dose on Day 14
measure: Plasma Concentration Versus Time Summary of Multiple Dose of OAP-189
timeFrame: Pre-dose (2 hours before dosing), 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24 hours post-dose on Day 7
Locations:
city: Chula Vista
country: United States
facility: Profil Institute for Clincal Research
state: California
city: Miami Gardens
country: United States
facility: Cetero Research - Miami
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: