Diabetes MellitusPhase 13283K1-1008-USNCT00970593

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

A Phase 1 study testing OAP-189 in people with Diabetes Mellitus, run by Pfizer at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Diabetes Mellitus
What is being tested?: OAP-189
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 92 participants
Where: 2 sitesUnited States
Study dates: 2 Sep 2009to 25 Jul 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

2 sites in 1 country.

United States2 sites

Profil Institute for Clincal Research
Chula Vista, California, 91911
Cetero Research - Miami
Miami Gardens, Florida, 33169

Other trials in United States

About this study

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.

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.

Conditions: Diabetes Mellitus
Being tested: OAP-189, placebo comparator
Medical subject headings: Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OAP-189Drug
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)
placebo comparatorDrug
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 groups in NCT00970593
Study group	Role	What they receive
OAP-189	Placebo comparator	Not described Receives: Drug: OAP-189
2	Placebo comparator	Not described Receives: Drug: placebo comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Clinically Significant Physical Examination Abnormalities
Physical examination included examination of skin, head, eyes, ears, nose, throat (HEENT), heart, lungs, abdomen, extremities, neurological function, back and lymph nodes. Clinically significant physical examination abnormalities were considered as adverse events based on investigator's discretion.
Measured: Baseline up to 17 days after last dose of study drug (Day 31)
Number of Participants With Clinically Significant Vital Signs Abnormalities
Criteria for clinically significant vital sign abnormalities: sitting systolic blood pressure (SBP) of (greater than equal to) >=160 millimeter of mercury (mmHg), (less than equal to) <=90 mmHg, >=20 mmHg increase and decrease from baseline; sitting diastolic blood pressure (DBP) of >=100 mmHg, <=50 mmHg, >=15 mmHg increase and decrease from baseline; heart rate of >=120 beats per minute (bpm), <=45 bpm, (greater than) >15 bpm increase and decrease from baseline, orthostatic SBP: decrease of >=20 mm Hg from sitting value, orthostatic DBP: decrease of >=20 mm Hg from sitting value, orthostatic heart rate: increase of >=30 bpm from sitting value, oral temperature of (less than) <35 or >38.3 degree celsius, respiratory rate of <10 or >25 breaths per minute, weight: maximum increase or decrease of >=7 percent (%) from baseline.
Measured: Baseline up to 17 days after last dose of study drug (Day 31)
Number of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities
Criteria for clinically significant ECG abnormalities: PR interval >=220 millisecond (msec) or a change of >=20 msec from baseline values, QRS interval >=120 msec, QTc interval >450 msec (in males) and >470 msec (in females).
Measured: Baseline up to 17 days after last dose of study drug (Day 31)
Number of Participants With Clinically Significant Laboratory Abnormalities
Hematocrit, haemoglobin: decrease of >=0.05 L/L and >=20 g/L from baseline respectively, WBC count:<3*10^9 /L, neutrophils: <1.5*10^9 /L, platelet count: <100*10^9 /L, eosinophil: <0.5*10^9 /L; prothrombin time, partial thromboplastin time >1.5*upper limit of normal (ULN); sodium:>5 mmol/L above ULN or below lower limit of normal(LLN), potassium >0.5 mmol/L above ULN or below LLN, creatinine >1.36*ULN, blood urea nitrogen >1.5*ULN, glucose (fasting) >0.83 mmol/L above ULN or below LLN, glucose (non-fasting) >5 mmol/L above ULN or >0.56 below LLN, calcium, magnesium: Change of >=0.25 and >=0.21 mmol/L from baseline respectively, phosphorus >0.162 mmol/L above ULN or below LLN, total protein, albumin, uric acid: change of >=20g/L, >=10 g/L, >0.119 mmol/L from baseline respectively, creatinine kinase >3*ULN, total cholesterol >7.77 mmol/L, triglycerides >3.39 mmol/L: AST, ALT, total bilirubin >2*ULN, alkaline phosphatase >1.5*ULN, alpha-glumatyl transferase, lactate dehydrogenase >3*ULN.
Measured: Baseline up to 17 days after last dose of study drug (Day 31)
Number of Participants With Injection Site Reactions
Injection site reactions included irritation, erythema, pain, hematoma, inflammation.
Measured: Baseline up to 17 days after last dose of study drug (Day 31)
Number of Participants With Clinically Significant Fasting Glucose Level Abnormalities
Criteria: Blood glucose levels >15 milligram per deciliter (mg/dL) above ULN or >15 mg/dL below LLN.
Measured: Baseline up to 17 days after last dose of study drug (Day 31)
Number of Participants With Hypoglycaemia
Hypoglycaemia is a condition characterized by abnormally low blood glucose (blood sugar) levels, usually <=50 mg/dL.
Measured: Baseline up to 17 days after last dose of study drug (Day 31)
Number of Participants With Drug-Induced Liver Injury
Criteria for drug induced liver injury: Levels of aspartate transaminase (AST) or alanine transaminase (ALT) should be >= 3 times ULN concurrent with a total bilirubin of >=2 times ULN with no evidence of hemolysis and an alkaline phosphatase should be <=2 times ULN.
Measured: Baseline up to 17 days after last dose of study drug (Day 31)
Change From Baseline in Predose Fasting Glucose Levels at Day 8
Fasting glucose levels were determined before administration of OAP-189 using a glucometer.
Measured: Baseline, Day 8
Change From Baseline in Predose Fasting Glucose Levels at Day 15
Fasting glucose levels were determined before administration of OAP-189 using a glucometer.
Measured: Baseline, Day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Sep 200925 Jul 2011

First posted2 Sep 2009 (estimated)
Study start2 Sep 2009
Primary completion25 Jul 2011
Study completion25 Jul 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes MellitusStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 92 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00970593
Sponsor's protocol ID: 3283K1-1008
Other IDs: B2201004
Acronym: 3283K1-1008-US
Status last verified: Oct 2020
First submitted: 1 Sep 2009
Last updated: 2 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
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Recruiting
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Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
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Recruiting
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All Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00970593
Acronym / sponsor ID: 3283K1-1008-US / 3283K1-1008
Conditions: Diabetes Mellitus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 92 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 2 Sep 2009 (actual)
Primary completion: 25 Jul 2011 (actual)
Study completion: 25 Jul 2011 (actual)
First posted: 2 Sep 2009 (estimated)
Results: Posted 2 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
OAP-189	Placebo comparator	Drug: OAP-189
2	Placebo comparator	Drug: placebo comparator

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OAP-189Group 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	OAP-189
placebo comparatorGroup 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	Drug	2

Primary outcome

Number of Participants With Clinically Significant Physical Examination Abnormalities
Time frame: Baseline up to 17 days after last dose of study drug (Day 31)
Physical examination included examination of skin, head, eyes, ears, nose, throat (HEENT), heart, lungs, abdomen, extremities, neurological function, back and lymph nodes. Clinically significant physical examination abnormalities were considered as adverse events based on investigator's discretion.
Number of Participants With Clinically Significant Vital Signs Abnormalities
Time frame: Baseline up to 17 days after last dose of study drug (Day 31)
Criteria for clinically significant vital sign abnormalities: sitting systolic blood pressure (SBP) of (greater than equal to) >=160 millimeter of mercury (mmHg), (less than equal to) <=90 mmHg, >=20 mmHg increase and decrease from baseline; sitting diastolic blood pressure (DBP) of >=100 mmHg, <=50 mmHg, >=15 mmHg increase and decrease from baseline; heart rate of >=120 beats per minute (bpm), <=45 bpm, (greater than) >15 bpm increase and decrease from baseline, orthostatic SBP: decrease of >=20 mm Hg from sitting value, orthostatic DBP: decrease of >=20 mm Hg from sitting value, orthostatic heart rate: increase of >=30 bpm from sitting value, oral temperature of (less than) <35 or >38.3 degree celsius, respiratory rate of <10 or >25 breaths per minute, weight: maximum increase or decrease of >=7 percent (%) from baseline.
Number of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities
Time frame: Baseline up to 17 days after last dose of study drug (Day 31)
Criteria for clinically significant ECG abnormalities: PR interval >=220 millisecond (msec) or a change of >=20 msec from baseline values, QRS interval >=120 msec, QTc interval >450 msec (in males) and >470 msec (in females).
Number of Participants With Clinically Significant Laboratory Abnormalities
Time frame: Baseline up to 17 days after last dose of study drug (Day 31)
Hematocrit, haemoglobin: decrease of >=0.05 L/L and >=20 g/L from baseline respectively, WBC count:<3*10^9 /L, neutrophils: <1.5*10^9 /L, platelet count: <100*10^9 /L, eosinophil: <0.5*10^9 /L; prothrombin time, partial thromboplastin time >1.5*upper limit of normal (ULN); sodium:>5 mmol/L above ULN or below lower limit of normal(LLN), potassium >0.5 mmol/L above ULN or below LLN, creatinine >1.36*ULN, blood urea nitrogen >1.5*ULN, glucose (fasting) >0.83 mmol/L above ULN or below LLN, glucose (non-fasting) >5 mmol/L above ULN or >0.56 below LLN, calcium, magnesium: Change of >=0.25 and >=0.21 mmol/L from baseline respectively, phosphorus >0.162 mmol/L above ULN or below LLN, total protein, albumin, uric acid: change of >=20g/L, >=10 g/L, >0.119 mmol/L from baseline respectively, creatinine kinase >3*ULN, total cholesterol >7.77 mmol/L, triglycerides >3.39 mmol/L: AST, ALT, total bilirubin >2*ULN, alkaline phosphatase >1.5*ULN, alpha-glumatyl transferase, lactate dehydrogenase >3*ULN.
Number of Participants With Injection Site Reactions
Time frame: Baseline up to 17 days after last dose of study drug (Day 31)
Injection site reactions included irritation, erythema, pain, hematoma, inflammation.
Number of Participants With Clinically Significant Fasting Glucose Level Abnormalities
Time frame: Baseline up to 17 days after last dose of study drug (Day 31)
Criteria: Blood glucose levels >15 milligram per deciliter (mg/dL) above ULN or >15 mg/dL below LLN.
Number of Participants With Hypoglycaemia
Time frame: Baseline up to 17 days after last dose of study drug (Day 31)
Hypoglycaemia is a condition characterized by abnormally low blood glucose (blood sugar) levels, usually <=50 mg/dL.
Number of Participants With Drug-Induced Liver Injury
Time frame: Baseline up to 17 days after last dose of study drug (Day 31)
Criteria for drug induced liver injury: Levels of aspartate transaminase (AST) or alanine transaminase (ALT) should be >= 3 times ULN concurrent with a total bilirubin of >=2 times ULN with no evidence of hemolysis and an alkaline phosphatase should be <=2 times ULN.
Change From Baseline in Predose Fasting Glucose Levels at Day 8
Time frame: Baseline, Day 8
Fasting glucose levels were determined before administration of OAP-189 using a glucometer.
Change From Baseline in Predose Fasting Glucose Levels at Day 15
Time frame: Baseline, Day 15
Fasting glucose levels were determined before administration of OAP-189 using a glucometer.

Results and safety

Results posted to the registry on 2 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OAP-189 0.2 mg IR	11	10
OAP-189 0.4 mg IR	15	14
OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg	13	7
OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	12	12
OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	20	20
Placebo IR	5	5
Placebo MR	16	14

Primary outcome: Number of Participants With Clinically Significant Physical Examination Abnormalities

Time frame: Baseline up to 17 days after last dose of study drug (Day 31). Number. Unit: participants

Measure	OAP-189 0.2 mg IR n = 11	OAP-189 0.4 mg IR n = 15	OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg n = 13	OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg n = 12	OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg n = 20	Placebo IR n = 5	Placebo MR n = 16
Value	0	0	0	0	0	0	0

Population analysed: Safety population included all randomly assigned participants who received at least 1 dose of study medication.

Primary outcome: Number of Participants With Clinically Significant Vital Signs Abnormalities

Time frame: Baseline up to 17 days after last dose of study drug (Day 31). Number. Unit: participants

Measure	OAP-189 0.2 mg IR n = 11	OAP-189 0.4 mg IR n = 15	OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg n = 13	OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg n = 12	OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg n = 20	Placebo IR n = 5	Placebo MR n = 16
Value	1	2	1	2	4	0	1

Population analysed: Safety population included all randomly assigned participants who received at least 1 dose of study medication.

Primary outcome: Number of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities

Time frame: Baseline up to 17 days after last dose of study drug (Day 31). Number. Unit: participants

Measure	OAP-189 0.2 mg IR n = 11	OAP-189 0.4 mg IR n = 15	OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg n = 8	OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg n = 12	OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg n = 20	Placebo IR n = 5	Placebo MR n = 14
Value	0	0	2	4	4	0	7

Population analysed: Safety population included all randomly assigned participants who received at least 1 dose of study medication. Here, 'N' (Number of Participants analyzed) signifies those participants who were evaluable for this measure.

Primary outcome: Number of Participants With Clinically Significant Laboratory Abnormalities

Time frame: Baseline up to 17 days after last dose of study drug (Day 31). Number. Unit: participants

Measure	OAP-189 0.2 mg IR n = 11	OAP-189 0.4 mg IR n = 15	OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg n = 13	OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg n = 12	OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg n = 20	Placebo IR n = 5	Placebo MR n = 16
Value	10	15	13	9	19	5	15

Population analysed: Safety population included all randomly assigned participants who received at least 1 dose of study medication.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
OAP-189 0.2 mg IR	0 of 11 (0%)	6 of 11 (54.5%)	Not reported
OAP-189 0.4 mg IR	0 of 15 (0%)	11 of 15 (73.3%)	Not reported
OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg	0 of 13 (0%)	13 of 13 (100%)	Not reported
OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	0 of 12 (0%)	10 of 12 (83.3%)	Not reported
OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	0 of 20 (0%)	16 of 20 (80%)	Not reported
Placebo IR	0 of 5 (0%)	1 of 5 (20%)	Not reported
Placebo MR	0 of 16 (0%)	11 of 16 (68.8%)	Not reported

Limitations and caveats (from the sponsor): Data for fasting Insulin level abnormalities and capillary glucose level abnormalities was not reported due to change in planned analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing OAP-189 in people with Diabetes Mellitus, run by Pfizer at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Clinically Significant Physical Examination Abnormalities (time frame: Baseline up to 17 days after last dose of study drug (Day 31)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00970593.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2020.