Phase 1
Completed N=82
A 2-week Trial Of PF-04991532 In Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT01469065 ↗Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcomePrimary: Change From Baseline (Day -1) in Mean Daily Glucose at Day 14 — 228.67; 233.20; 219.13; 229.92 milligram/deciliter (mg/dL)
Summary
This will be a 2-week oral dose study of PF 04991532, performed in patients with type 2 diabetes. Safety, pharmacokinetics (how the drug is distributed in the body), and pharmacodynamics (how the drug works in the body) will be studied. Patients may be asked to wash off their diabetes medication for 4-6 prior to study drug administration, and they will remain in the clinical research unit for a total of 20 days for baseline tests, 2 weeks of dosing, and some follow up tests.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (Day -1) in Mean Daily Glucose at Day 14 |
228.67; 233.20; 219.13; 229.92; 218.20; 24.98 | — |
| SECONDARY Area Under the Curve From Time Zero to 24 Hours Postdose (AUC24) of PF-04991532 |
441.6; 1745; 3899; 6943; 487.4; 1892 | — |
| SECONDARY Area Under the Curve From Time Zero to 10 Hours Postdose (AUC10) of PF-04991532 |
372.1; 1447; 3329; 5661; 384.7; 1508 | — |
| SECONDARY Maximum Observed Plasma Concentration of PF-04991532 After Morning Dose Administration (Cmax(AM)) |
137.7; 486.6; 1285; 1951; 148.2; 469.8 | — |
| SECONDARY Maximum Observed Plasma Concentration of PF-04991532 After Evening Dose Administration (Cmax(PM)) |
97.10; 336.0; 932.0; 1645; 89.99; 360.7 | — |
| SECONDARY Minimum Observed Plasma Trough Concentration (Cmin) of PF-04991532 |
0.1691; 5.249; 11.32; 21.15 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04991532 After Morning Dose Administration (Tmax(AM)) |
1.00; 1.00; 1.83; 1.00; 1.00; 1.00 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04991532 After Evening Dose Administration (Tmax(PM)) |
11.0; 11.0; 11.0; 11.0; 11.0; 11.0 | — |
| SECONDARY Apparent Oral Clearance (CL/F) of PF-04991532 |
1886; 1434; 1282; 1440; 1710; 1322 | — |
| SECONDARY Observed Accumulation Ratio of Area Under the Curve From Time Zero to 10 Hours Postdose of PF-04991532 (Rac) |
1.095; 1.049; 0.9004; 1.017 | — |
| SECONDARY Observed Accumulation Ratio of Maximum Observed Plasma Concentration of PF-04991532 After Morning Dose Administration (Rac, Cmax(AM)) |
1.057; 0.9655; 0.7022; 0.8663 | — |
| SECONDARY Dose Normalized Area Under the Curve From Time Zero to 24 Hours Postdose (AUC24(dn)) of PF-04991532 |
4.416; 5.810; 6.497; 5.787; 4.874; 6.307 | — |
| SECONDARY Dose Normalized Maximum Plasma Concentration After Morning Dose Administration (Cmax(AM)(dn)) of PF-04991532 |
2.754; 3.245; 4.283; 3.252; 2.964; 3.132 | — |
| SECONDARY Change From Baseline (Day -2) in Mean Daily Glucose at Day 13 |
214.31; 230.70; 207.98; 219.59; 204.68; 18.78 | — |
| SECONDARY Change From Baseline in Area Under the Curve of Glucose From Time 2 to 6 Hours Post Morning Dose (Glucose AUC(2-6)) Following Mixed Meal Tolerance Test (MMTT) at Day 14 |
1091.23; 1126.34; 1029.76; 1085.84; 1050.69; 86.05 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) |
-4.19; -5.04; -4.33; 0.29; -5.55; -0.63 | — |
| SECONDARY Change From Baseline in Area Under the Curve of Insulin From Time 2 to 6 Hours Post Morning Dose (Insulin AUC(2-6)) Following Mixed Meal Tolerance Test (MMTT) at Day 14 |
149.12; 139.40; 166.87; 111.13; 276.61; -3.96 | — |
| SECONDARY Change From Baseline in Area Under the Curve of C-peptide From Time 2 to 6 Hours Post Morning Dose (C-peptide AUC(2-6)) Following Mixed Meal Tolerance Test (MMTT) at Day 14 |
15.79; 17.04; 17.20; 15.23; 19.21; 0.09 | — |
| SECONDARY Change From Baseline in Fasting Lipid Parameters at Day 14 and 16 |
-9.81; 12.79; 37.52; 18.24; 58.00; 0.06 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with type 2 diabetes mellitus who are taking either no medication for the treatment of diabetes (diet/exercise therapy only), or who are taking only a single oral anti-diabetic drug (OAD) that can be temporarily discontinued for approximately 8-10 weeks. For those taking a single OAD, treatment should be stable, where this is defined as no change in the treatment, including dose, over the past 3 months prior to Screening. OAD medications that are acceptable to be discontinued include: a sulfonylurea (SU), a meglitinide, a biguanide (eg, metformin), a dipeptidyl peptidase 4 inhibitor (DPP-4i), or an alpha glucosidase inhibitor.
- Body Mass Index (BMI) of 18.5 to 45.0 kg/m2; and a total body weight >50 kg (110 lbs).
- HbA1c >/=7% and /=6.5% and /=160 mm Hg (systolic) or >/=100 mm Hg (diastolic), following at least 5 minutes of rest.
- Pregnant or nursing females; females of childbearing potential.
Data sourced from ClinicalTrials.gov (NCT01469065). 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.