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| ID | Type | Description | Link |
|---|---|---|---|
| B2201004 | Other Identifier | Alias Study Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OAP-189 | Placebo Comparator |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OAP-189 | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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). | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration Versus Time Summary of Metformin Following Single Dose of OAP-189 | 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 (2 hours before dosing), 1, 2, 3, 4, 6 hours post-dose on Day 14 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Profil Institute for Clincal Research | Chula Vista | California | 91911 | United States | ||
| Cetero Research - Miami |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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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All participants received the background metformin immediate release tablets, during the 4 weeks run-in period. Compliant participants were then randomized to study treatments for a maximum period of 31 days.
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| ID | Title | Description |
|---|---|---|
| FG000 | OAP-189 0.2 mg IR | Participants received OAP-189 0.2 milligram (mg), immediate release (IR) infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization). |
| FG001 | OAP-189 0.4 mg IR | Participants received OAP-189 0.4 mg, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization). |
| FG002 | OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg | Participants received OAP-189 0.9 mg, modified release (MR) infusion (with 0.05:1 zinc to peptide [Z/P] ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.2 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization). |
| FG003 | OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg | Participants received OAP-189 1.2 mg, MR infusion (with 0.1:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization). |
| FG004 | OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg | Participants received OAP-189 1.2 mg, MR infusion (with 0.25:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization). |
| FG005 | Placebo IR | Participants received placebo matched to OAP-189, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization). |
| FG006 | Placebo MR | Participants received placebo matched to OAP-189, MR infusion subcutaneously once daily from Day 1 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population included all randomly assigned participants who received at least 1 dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | OAP-189 0.2 mg IR | Participants received OAP-189 0.2 milligram (mg), immediate release (IR) infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Safety population included all randomly assigned participants who received at least 1 dose of study medication. | Posted | Number | participants | Baseline up to 17 days after last dose of study drug (Day 31) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OAP-189 0.2 mg IR | Participants received OAP-189 0.2 mg, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v14.0 | Non-systematic Assessment |
Data for fasting Insulin level abnormalities and capillary glucose level abnormalities was not reported due to change in planned analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
| placebo comparator | Drug | 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 |
|
| 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. | 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. | 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. | 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. | 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. | 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. | Baseline, Day 15 |
| Plasma Concentration Versus Time Summary of Metformin Following Multiple Dose of OAP-189 | 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 (2 hours before dosing), 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24 hours post-dose on Day 7 |
| Plasma Concentration Versus Time Summary of Single Dose of OAP-189 | Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ = 0.500 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 (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 |
| Plasma Concentration Versus Time Summary of Multiple Dose of OAP-189 | Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.500 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 (2 hours before dosing), 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24 hours post-dose on Day 7 |
| Miami Gardens |
| Florida |
| 33169 |
| United States |
| Discontinuation of study by sponsor |
|
| Withdrawal by Subject |
|
| OAP-189 0.4 mg IR |
Participants received OAP-189 0.4 mg, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization). |
| BG002 | OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg | Participants received OAP-189 0.9 mg, modified release (MR) infusion (with 0.05:1 zinc to peptide [Z/P] ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.2 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization). |
| BG003 | OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg | Participants received OAP-189 1.2 mg, MR infusion (with 0.1:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization). |
| BG004 | OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg | Participants received OAP-189 1.2 mg, MR infusion (with 0.25:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization). |
| BG005 | Placebo IR | Participants received placebo matched to OAP-189, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization). |
| BG006 | Placebo MR | Participants received placebo matched to OAP-189, MR infusion subcutaneously once daily from Day 1 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization). |
| BG007 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | OAP-189 0.4 mg IR | Participants received OAP-189 0.4 mg, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization). |
| OG002 | OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg | Participants received OAP-189 0.9 mg, MR infusion (with 0.05:1 zinc to peptide [Z/P] ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.2 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization). |
| OG003 | OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg | Participants received OAP-189 1.2 mg, MR infusion (with 0.1:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization). |
| OG004 | OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg | Participants received OAP-189 1.2 mg, MR infusion (with 0.25:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization). |
| OG005 | Placebo IR | Participants received placebo matched to OAP-189, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization). |
| OG006 | Placebo MR | Participants received placebo matched to OAP-189, MR infusion subcutaneously once daily from Day 1 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization). |
|
|
| Primary | 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. | Safety population included all randomly assigned participants who received at least 1 dose of study medication. | Posted | Number | participants | Baseline up to 17 days after last dose of study drug (Day 31) |
|
|
|
| Primary | 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). | 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. | Posted | Number | participants | Baseline up to 17 days after last dose of study drug (Day 31) |
|
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| Primary | 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. | Safety population included all randomly assigned participants who received at least 1 dose of study medication. | Posted | Number | participants | Baseline up to 17 days after last dose of study drug (Day 31) |
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| Primary | Number of Participants With Injection Site Reactions | Injection site reactions included irritation, erythema, pain, hematoma, inflammation. | Safety population included all randomly assigned participants who received at least 1 dose of study medication. | Posted | Number | participants | Baseline up to 17 days after last dose of study drug (Day 31) |
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|
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| Primary | 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. | Safety population included all randomly assigned participants who received at least 1 dose of study medication. | Posted | Number | participants | Baseline up to 17 days after last dose of study drug (Day 31) |
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| Primary | Number of Participants With Hypoglycaemia | Hypoglycaemia is a condition characterized by abnormally low blood glucose (blood sugar) levels, usually <=50 mg/dL. | Safety population included all randomly assigned participants who received at least 1 dose of study medication. | Posted | Number | participants | Baseline up to 17 days after last dose of study drug (Day 31) |
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|
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| Primary | 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. | Safety population included all randomly assigned participants who received at least 1 dose of study medication. | Posted | Number | participants | Baseline up to 17 days after last dose of study drug (Day 31) |
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| Primary | Change From Baseline in Predose Fasting Glucose Levels at Day 8 | Fasting glucose levels were determined before administration of OAP-189 using a glucometer. | Safety population included all randomly assigned participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable at specified time points. This outcome measure was not to be analyzed in participants of OAP-189 0.2, 0.4 mg IR and Placebo IR as pre-specified in the protocol. | Posted | Mean | Standard Deviation | millimole per liter | Baseline, Day 8 |
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| Primary | Change From Baseline in Predose Fasting Glucose Levels at Day 15 | Fasting glucose levels were determined before administration of OAP-189 using a glucometer. | Safety population included all randomly assigned participants who received at least 1 dose of study medication. Here, 'N' signifies those participants who were evaluable for this measure. This outcome measure was not to be analyzed in participants of OAP-189 0.2, 0.4 mg IR and Placebo IR as pre-specified in protocol. | Posted | Mean | Standard Deviation | millimole per liter | Baseline, Day 15 |
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| Other Pre-specified | Plasma Concentration Versus Time Summary of Metformin Following Single Dose of OAP-189 | 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. | Pharmacokinetic (PK) analysis set. Here, 'N' (Number of Participants analyzed) signifies those participants who were evaluable for this measure. This outcome measure was not to be analyzed in participants of OAP-189 0.2, 0.4 mg IR, Placebo IR, OAP-189 MR (0.25:1 Z/P ratio) 1.2 mg followed by 1.6 mg and Placebo MR as pre-specified in protocol. | Posted | Mean | Standard Deviation | nanogram per milliliter | Pre-dose (2 hours before dosing), 1, 2, 3, 4, 6 hours post-dose on Day 14 |
|
|
|
| Other Pre-specified | Plasma Concentration Versus Time Summary of Metformin Following Multiple Dose of OAP-189 | 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. | PK analysis set. Here, 'N' = participants evaluable for this measure. This outcome was not to be analyzed in participants of Placebo IR, OAP-189 MR (0.05:1 Z/P ratio) 0.9 mg followed by 1.2 mg, OAP-189 MR (0.1:1 Z/P ratio) 1.2 mg followed by 1.6 mg, OAP-189 MR (0.25:1 Z/P ratio) 1.2 mg followed by 1.6 mg and Placebo MR as pre-specified in protocol. | Posted | Mean | Standard Deviation | nanogram per milliliter | Pre-dose (2 hours before dosing), 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24 hours post-dose on Day 7 |
|
|
|
| Other Pre-specified | Plasma Concentration Versus Time Summary of Single Dose of OAP-189 | Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ = 0.500 nanogram per millliter) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0. | PK analysis set. Here, 'n' signifies those participants who were evaluable at specified time points. This outcome measure was not to be analyzed in participants of OAP-189 0.2, 0.4 mg IR, Placebo IR and MR as pre-specified in protocol. | Posted | Mean | Standard Deviation | nanogram per milliliter | 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 |
|
|
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| Other Pre-specified | Plasma Concentration Versus Time Summary of Multiple Dose of OAP-189 | Concentration versus time summary was calculated by setting concentration values below the lower limit of quantification (LLOQ =0.500 nanogram per millliter) to zero. Summary statistics were not to be presented if number of observations above lower limit of quantification (NALQ) =0. | PK analysis set. Here, 'N' = participants evaluable for this measure. This outcome was not to be analyzed in participants of Placebo IR, OAP-189 MR (0.05:1 Z/P ratio) 0.9 mg followed by 1.2 mg, OAP-189 MR (0.1:1 Z/P ratio) 1.2 mg followed by 1.6 mg, OAP-189 MR (0.25:1 Z/P ratio) 1.2 mg followed by 1.6 mg and Placebo MR as pre-specified in protocol. | Posted | Mean | Standard Deviation | nanogram per milliliter | Pre-dose (2 hours before dosing), 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24 hours post-dose on Day 7 |
|
|
|
| 0 |
| 11 |
| 6 |
| 11 |
| EG001 | OAP-189 0.4 mg IR | Participants received OAP-189 0.4 mg, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization). | 0 | 15 | 11 | 15 |
| EG002 | OAP-189 MR (0.05:1 Z/P Ratio) 0.9 mg Followed by 1.2 mg | Participants received OAP-189 0.9 mg, MR infusion (with 0.05:1 zinc to peptide [Z/P] ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.2 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization). | 0 | 13 | 13 | 13 |
| EG003 | OAP-189 MR (0.1:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg | Participants received OAP-189 1.2 mg, MR infusion (with 0.1:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization). | 0 | 12 | 10 | 12 |
| EG004 | OAP-189 MR (0.25:1 Z/P Ratio) 1.2 mg Followed by 1.6 mg | Participants received OAP-189 1.2 mg, MR infusion (with 0.25:1 Z/P ratio) subcutaneously once daily from Day 1 to Day 7 followed by OAP-189 1.6 mg, MR infusion subcutaneously once daily from Day 8 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization). | 0 | 20 | 16 | 20 |
| EG005 | Placebo IR | Participants received placebo matched to OAP-189, IR infusion subcutaneously twice daily from Day 1 to Day 7 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization). | 0 | 5 | 1 | 5 |
| EG006 | Placebo MR | Participants received placebo matched to OAP-189, MR infusion subcutaneously once daily from Day 1 to Day 14 along with background metformin 850 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization). | 0 | 16 | 11 | 16 |
| Ear pain | Ear and labyrinth disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Hyperchlorhydria | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Lip dry | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Vomiting projectile | Gastrointestinal disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Application site irritation | General disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Chills | General disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Inflammation | General disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Infusion site inflammation | General disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Injection site erythema | General disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Injection site haematoma | General disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Injection site pain | General disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Injection site reaction | General disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Pain | General disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Sluggishness | General disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Otitis externa | Infections and infestations | MedDRA v14.0 | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA v14.0 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Polydipsia | Metabolism and nutrition disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
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| Umbilical erythema | Skin and subcutaneous tissue disorders | MedDRA v14.0 | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Erythema |
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| Pain |
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| Hematoma |
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| Inflammation |
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| Change at Day 8 |
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| LS mean difference |
| -1.90 |
| Standard Error of the Mean |
| 0.543 |
| 2-Sided |
| 95 |
| -2.98 |
| -0.83 |
| Superiority or Other (legacy) |
| The Mixed model used fixed effects of treatment, study day and treatment by study day interaction. | LS mean difference | -2.15 | Standard Error of the Mean | 0.458 | 2-Sided | 95 | -3.06 | -1.24 | Superiority or Other (legacy) |
| LS mean difference |
| -3.18 |
| Standard Error of the Mean |
| 0.495 |
| 2-Sided |
| 95 |
| -4.16 |
| -2.20 |
| Superiority or Other (legacy) |
| The Mixed model used fixed effects of treatment, study day and treatment by study day interaction. | LS mean difference | -3.14 | Standard Error of the Mean | 0.437 | 2-Sided | 95 | -4.01 | -2.28 | Superiority or Other (legacy) |
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