NCT00970593 (3283K1-1008-US) is a Phase 1 clinical trial of OAP-189 in Diabetes Mellitus, sponsored by Pfizer.

Who is sponsoring NCT00970593?

NCT00970593 is sponsored by Pfizer.

What drugs are being tested in NCT00970593?

Interventions in NCT00970593: OAP-189, placebo comparator.

What condition does NCT00970593 study?

NCT00970593 studies Diabetes Mellitus.

Is NCT00970593 still recruiting?

NCT00970593 is currently completed. Last updated 2 November 2020.

Are results published for NCT00970593?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-11-02 · How we verify

NCT00970593: 3283K1-1008-US

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Results posted Last updated 2 November 2020

What this trial tests

Phase 1 trial testing OAP-189 in Diabetes Mellitus in 92 participants. Completed in 25 July 2011.

Timeline

2 September 2009

Primary endpoint
25 July 2011

25 July 2011

Quick facts

Lead sponsor	Pfizer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	92
Start date	2 September 2009
Primary completion	25 July 2011
Estimated completion	25 July 2011
Sites	2 locations across United States

Drugs / interventions tested

OAP-189 — full drug profile →
placebo comparator

Conditions studied

Diabetes Mellitus — all drugs for Diabetes Mellitus →

Sponsor

Pfizer — full company profile →

Who can join

Adults 18 to 65, any sex, with Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Clinically Significant Physical Examination Abnormalities Primary · 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.

Group	Value	95% CI
OAP-189 0.2 mg IR	0
OAP-189 0.4 mg IR	0
OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg	0
OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	0
OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	0
Placebo IR	0
Placebo MR	0

Number of Participants With Clinically Significant Vital Signs Abnormalities Primary · 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, o

Group	Value	95% CI
OAP-189 0.2 mg IR	1
OAP-189 0.4 mg IR	2
OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg	1
OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	2
OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	4
Placebo IR	0
Placebo MR	1

Number of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities Primary · 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).

Group	Value	95% CI
OAP-189 0.2 mg IR	0
OAP-189 0.4 mg IR	0
OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg	2
OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	4
OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	4
Placebo IR	0
Placebo MR	7

Number of Participants With Clinically Significant Laboratory Abnormalities Primary · 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: Ch

Group	Value	95% CI
OAP-189 0.2 mg IR	10
OAP-189 0.4 mg IR	15
OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg	13
OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	9
OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	19
Placebo IR	5
Placebo MR	15

Number of Participants With Injection Site Reactions Primary · Baseline up to 17 days after last dose of study drug (Day 31)

Injection site reactions included irritation, erythema, pain, hematoma, inflammation.

Irritation

Group	Value	95% CI
OAP-189 0.2 mg IR	0
OAP-189 0.4 mg IR	0
OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg	0
OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	0
OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	1
Placebo IR	0
Placebo MR	1

Erythema

Group	Value	95% CI
OAP-189 0.2 mg IR	0
OAP-189 0.4 mg IR	0
OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg	0
OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	0
OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	1
Placebo IR	0
Placebo MR	1

Pain

Group	Value	95% CI
OAP-189 0.2 mg IR	0
OAP-189 0.4 mg IR	0
OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg	0
OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	2
OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	1
Placebo IR	0
Placebo MR	0

Hematoma

Group	Value	95% CI
OAP-189 0.2 mg IR	0
OAP-189 0.4 mg IR	0
OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg	0
OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	0
OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	3
Placebo IR	0
Placebo MR	1

Inflammation

Group	Value	95% CI
OAP-189 0.2 mg IR	0
OAP-189 0.4 mg IR	0
OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg	0
OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	0
OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	0
Placebo IR	0
Placebo MR	1

Number of Participants With Clinically Significant Fasting Glucose Level Abnormalities Primary · 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.

Group	Value	95% CI
OAP-189 0.2 mg IR	10
OAP-189 0.4 mg IR	15
OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg	13
OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	9
OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	19
Placebo IR	5
Placebo MR	15

Number of Participants With Hypoglycaemia Primary · 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.

Group	Value	95% CI
OAP-189 0.2 mg IR	0
OAP-189 0.4 mg IR	0
OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg	0
OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	2
OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	1
Placebo IR	0
Placebo MR	0

Number of Participants With Drug-Induced Liver Injury Primary · 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.

Group	Value	95% CI
OAP-189 0.2 mg IR	0
OAP-189 0.4 mg IR	0
OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg	0
OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	0
OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	0
Placebo IR	0
Placebo MR	0

Change From Baseline in Predose Fasting Glucose Levels at Day 8 Primary · Baseline, Day 8

Fasting glucose levels were determined before administration of OAP-189 using a glucometer.

Baseline

Group	Value	95% CI
OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg	10.02	± 2.373
OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	10.06	± 2.583
OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	9.27	± 2.148
Placebo MR	9.01	± 1.769

Change at Day 8

Group	Value	95% CI
OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg	-1.37	± 2.222
OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	-2.75	± 1.663
OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	-2.47	± 1.400
Placebo MR	-0.25	± 1.166

Change From Baseline in Predose Fasting Glucose Levels at Day 15 Primary · Baseline, Day 15

Fasting glucose levels were determined before administration of OAP-189 using a glucometer.

Group	Value	95% CI
OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg	-2.62	± 0.998
OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	-3.87	± 1.783
OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	-3.49	± 1.643
Placebo MR	-0.33	± 1.273

Plasma Concentration Versus Time Summary of Metformin Following Single Dose of OAP-189 Secondary · Pre-dose (2 hours before dosing), 1, 2, 3, 4, 6 hours post-dose on Day 14

Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =2 nanogram per millliter) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0.

Pre-dose

Group	Value	95% CI
OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg	318.7	± 140.36
OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	455.6	± 246.43

1 hour post dose

Group	Value	95% CI
OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg	899.1	± 344.02
OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	990.9	± 453.01

2 hour post dose

Group	Value	95% CI
OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg	885.4	± 364.20
OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	1112	± 652.61

3 hour post dose

Group	Value	95% CI
OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg	881.4	± 357.83
OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	1063	± 613.86

4 hour post dose

Group	Value	95% CI
OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg	912.3	± 381.22
OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	943.7	± 474.35

6 hour post dose

Group	Value	95% CI
OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg	869.7	± 215.27
OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg	804.8	± 349.20

Plasma Concentration Versus Time Summary of Metformin Following Multiple Dose of OAP-189 Secondary · Pre-dose (2 hours before dosing), 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24 hours post-dose on Day 7

Pre-dose

Group	Value	95% CI
OAP-189 0.2 mg IR	544.7	± 334.72
OAP-189 0.4 mg IR	558.9	± 386.19

1 hour post dose

Group	Value	95% CI
OAP-189 0.2 mg IR	998.8	± 360.42
OAP-189 0.4 mg IR	1276	± 858.80

2 hour post dose

Group	Value	95% CI
OAP-189 0.2 mg IR	980.7	± 336.37
OAP-189 0.4 mg IR	1084	± 582.26

3 hour post dose

Group	Value	95% CI
OAP-189 0.2 mg IR	995.8	± 342.21
OAP-189 0.4 mg IR	985.5	± 424.50

4 hour post dose

Group	Value	95% CI
OAP-189 0.2 mg IR	938.3	± 355.38
OAP-189 0.4 mg IR	974.7	± 504.81

6 hour post dose

Group	Value	95% CI
OAP-189 0.2 mg IR	804.6	± 343.23
OAP-189 0.4 mg IR	854.0	± 415.21

8 hour post dose

Group	Value	95% CI
OAP-189 0.2 mg IR	617.0	± 265.18
OAP-189 0.4 mg IR	735.4	± 350.03

10 hour post dose

Group	Value	95% CI
OAP-189 0.2 mg IR	462.4	± 194.50
OAP-189 0.4 mg IR	658.1	± 457.83

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

OAP-189 0.2 mg IR

Serious: 0/11 (0%)

Deaths: —

OAP-189 0.4 mg IR

Serious: 0/15 (0%)

Deaths: —

OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg

Serious: 0/13 (0%)

Deaths: —

OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg

Serious: 0/12 (0%)

Deaths: —

OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg

Serious: 0/20 (0%)

Deaths: —

Placebo IR

Serious: 0/5 (0%)

Deaths: —

Placebo MR

Serious: 0/16 (0%)

Deaths: —

Other adverse events (58 terms — click to expand)

Reaction	System	OAP-189 0.2 mg IR	OAP-189 0.4 mg IR	OAP-189 MR (0.05:1 Z/P Rat…	OAP-189 MR (0.1:1 Z/P Rati…	OAP-189 MR (0.25:1 Z/P Rat…	Placebo IR	Placebo MR
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—	—	—	—	—
Injection site haematoma	General disorders	—	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Ecchymosis	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—
Tinnitus	Ear and labyrinth disorders	—	—	—	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—
Injection site pain	General disorders	—	—	—	—	—	—	—
Injection site reaction	General disorders	—	—	—	—	—	—	—
Hypoglycaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Erythema	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—
Ear pain	Ear and labyrinth disorders	—	—	—	—	—	—	—
Vision blurred	Eye disorders	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—
Eructation	Gastrointestinal disorders	—	—	—	—	—	—	—
Hyperchlorhydria	Gastrointestinal disorders	—	—	—	—	—	—	—
Lip dry	Gastrointestinal disorders	—	—	—	—	—	—	—
Vomiting projectile	Gastrointestinal disorders	—	—	—	—	—	—	—
Application site irritation	General disorders	—	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—
Inflammation	General disorders	—	—	—	—	—	—	—
Infusion site inflammation	General disorders	—	—	—	—	—	—	—
Injection site erythema	General disorders	—	—	—	—	—	—	—
Non-cardiac chest pain	General disorders	—	—	—	—	—	—	—
Pain	General disorders	—	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT00970593 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00970593 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 2 November 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00970593.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT00970593: 3283K1-1008-US

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Diabetes Mellitus

Other Pfizer trials

Verify against primary sources