Phase 1
Completed N=92
Study Evaluating Safety, Tolerability, And Action Of OAP-189 In Subjects With Type 2 Diabetes On Metformin
Source: ClinicalTrials.gov NCT00970593 ↗Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: Number of Participants With Clinically Significant Physical Examination Abnormalities — 0; 0; 0; 0 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinically Significant Physical Examination Abnormalities |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Vital Signs Abnormalities |
1; 2; 1; 2; 4; 0 | — |
| PRIMARY Number of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities |
0; 0; 2; 4; 4; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Laboratory Abnormalities |
10; 15; 13; 9; 19; 5 | — |
| PRIMARY Number of Participants With Injection Site Reactions |
0; 0; 0; 0; 1; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Fasting Glucose Level Abnormalities |
10; 15; 13; 9; 19; 5 | — |
| PRIMARY Number of Participants With Hypoglycaemia |
0; 0; 0; 2; 1; 0 | — |
| PRIMARY Number of Participants With Drug-Induced Liver Injury |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Change From Baseline in Predose Fasting Glucose Levels at Day 8 |
10.02; 10.06; 9.27; 9.01; -1.37; -2.75 | — |
| PRIMARY Change From Baseline in Predose Fasting Glucose Levels at Day 15 |
-2.62; -3.87; -3.49; -0.33 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects must have been diagnosed with type 2 diabetes, with HbA1c level >=7.0% and =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.
Data sourced from ClinicalTrials.gov (NCT00970593). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.