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PF-04991532 · 7 trials · 6 indications
HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. The normal range for the HbA1c test is between 4 percent (%) and 5.6%. HbA1c levels between 5.7% and 6.4% indicate increased risk of diabetes and levels of 6.5% or higher indicate diabetes.
Mean daily glucose (MDG) was calculated based on the mean of 8 glucose measurements at pre-specified time points throughout the day on Day -1 and Day 14.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Matching placebo for PF-04991532 and Sitagliptin |
| 150 mg PF-04991532 | EXPERIMENTAL | - |
| 450 mg PF-04991532 | EXPERIMENTAL | - |
| 750 mg PF-04991532 | EXPERIMENTAL | - |
| Sitagliptin 100 mg | ACTIVE_COMPARATOR | - |
| 25 mg PF-04991532 | EXPERIMENTAL | - |
| 75 mg PF-04991532 | EXPERIMENTAL | - |
| 300 mg PF-04991532 | EXPERIMENTAL | - |
| PF-04991532 | EXPERIMENTAL | PF-04991532 experimental study medication |
| healthy controls | EXPERIMENTAL | healthy subjects (creatinine clearance \> 90 mL/min) |
| ESRD / severe renal insufficiency | EXPERIMENTAL | Severe (creatinine clearance 15 to 29 mL/min) OR ESRD (creatinine clearnace \<15 mL/min OR requiring dialysis) |
| Moderate renal impairment | EXPERIMENTAL | Moderate (creatinine clearance = 30 to 59 mL/min) |
| Mild renal impairment | EXPERIMENTAL | Mild (creatinine clearance = 60 to 89 mL/min) |
| Japanese cohort | EXPERIMENTAL | A total of 12 Japanese healthy subjects will be allocated to receive 3 ascending single doses (100 mg, 300 mg and 750 mg) of PF-04991532 or placebo through 3 dosing periods in a randomization ratio of 3:1. |
| Weterner Cohort | EXPERIMENTAL | 9 western healthy subjects will be enrolled to receive 2 single ascending doses (300 mg and 750 mg) of PF-04991532 through 2 dosing periods. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Tablets (n=6), 0 mg, once daily for 84 days |
| 150 mg PF-04991532 | DRUG | Tablets (n=1), 150 mg + tablets (n=5), 0 mg, all once daily for 84 days |
| 450 mg PF-04991532 | DRUG | Tablets (n=3), 150 mg + tablets (n=3), 0 mg, all once daily for 84 days |
| 750 mg PF-04991532 | DRUG | Tablets (n=5), 150 mg + tablets (n=1), 0 mg, all once daily for 84 days |
| Sitagliptin 100 mg | DRUG | Tablets (n=1), 100 mg strength + tablets (n=5), 0 mg, all once daily for 84 days |
| 25 mg PF-04991532 | DRUG | Tablets (n=1), 25 mg strength + tablets (n=3) 0 mg twice daily for 84 days |
| 75 mg PF-04991532 | DRUG | Tablets (n=3), 25 mg strength + tablets (n=1) 0 mg twice daily for 84 days |
| 300 mg PF-04991532 | DRUG | Tablets (n=2), 150 mg strength + tablets (n=2) 0 mg twice daily for 84 days |
| PF-04991532 | DRUG | Oral administration of PF-04991532; 25 mg given twice a day (BID) for 14 days |
| PF-0499132 | DRUG | Oral administration of PF-04991532; 300 mg given twice a day (BID) for 14 days |
Inclusion Criteria: Subjects with type 2 diabetes on stable doses of background medicines for management of diabetes; aged 18-70 years; body mass index between 22.5 and 45.5 kg/m2 Exclusion Criteria: Subjects with type 1 diabetes, heart attack or stroke in the past 6 months, uncontrolled blood pr...
PF-04991532 is an investigational oral small molecule developed by Pfizer for the treatment of type 2 diabetes mellitus. It has been studied in Phase 1 and Phase 2 clinical trials in adults with type 2 diabetes, as well as in healthy volunteers, to evaluate safety, tolerability, pharmacokinetics, and efficacy.
PF-04991532 targets glucokinase (GCK) and acts as a glucokinase activator. Glucokinase is an enzyme that plays a key role in glucose metabolism, and activating it is intended to enhance glucose utilization and lower blood glucose levels in patients with type 2 diabetes.
PF-04991532 is being developed by Pfizer, Inc. (ticker: PFE). Pfizer is the sponsor of the clinical trials evaluating the drug in type 2 diabetes and related metabolic conditions.
PF-04991532 has completed Phase 1 and Phase 2 clinical trials. It is an investigational drug and has not been approved by the FDA for any indication. All trials listed for PF-04991532 are completed, and no active trials are currently recruiting.
PF-04991532 has been studied in four completed trials: NCT01469065 (Phase 1, 82 patients with type 2 diabetes), NCT01369602 (Phase 1, 27 subjects with renal impairment or healthy), NCT01369277 (Phase 1, 22 healthy Japanese and Western subjects), and NCT01338870 (Phase 2, 301 subjects with type 2 diabetes).