Phase 1 N=50 Randomized Triple-blind Other

A Trial To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Single Doses Of PF-04937319 In Subjects With Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus

Bottom Line

View on ClinicalTrials.gov: NCT01044537 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2017

Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) — 1; 4; 1; 3 participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Placebo (Drug); PF-04937319 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: May 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)	1; 4; 1; 3; 3; 3	—
PRIMARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	475.2; 1362; 4418; 10640; 10830; 19970	—
PRIMARY Maximum Observed Plasma Concentration (Cmax)	72.29; 124.9; 339.8; 756.6; 769.9; 1050	—
PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax)	2.48; 2.50; 3.00; 3.50; 6.00; 7.98	—
PRIMARY Apparent Oral Clearance (CL/F)	344.8; 360.9; 364.4; 464.2; 690.3; 481.8	—
PRIMARY Apparent Volume of Distribution (Vz/F)	154.0; 204.6; 254.4; 284.1; 379.2; 399.3	—
PRIMARY Plasma Decay Half-Life (t1/2)	5.203; 6.592; 8.632; 7.366; 6.410; 12.79	—
PRIMARY Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)	483.3; 1385; 4570; 10770; 11590; 22130	—
SECONDARY Change From Baseline in Ratio of C-peptide Area Under Curve (C-peptide AUC) to Glucose Area Under Curve (Glucose AUC) After a Mixed Meal Tolerance Test (MMTT) on Day 1	0.02; 0.03; 0.03; 0.03; 0.03; 0.03	—
SECONDARY Percent Change From Baseline in Post-Prandial Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) on Day 1	8.58; -15.22; 4.96; -11.72; -10.81; -23.21	—
SECONDARY Percent Change From Baseline in Post-Prandial Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) on Day 1	30.98; 10.72; 0.22; 2.03; 35.61; 9.30	—
SECONDARY Percent Change From Baseline in Post-Prandial C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) on Day 1	14.10; -0.63; 1.79; 8.23; 21.13; 12.51	—
SECONDARY Change From Baseline in Ratio of Insulin Delta C30 to Glucose Delta C30 After a Mixed Meal Tolerance Test (MMTT) on Day 1	0.70; 4.59; 1.92; 0.77; 0.73; 0.85	—
SECONDARY Change From Baseline in Ratio of C-peptide Delta C30 to Glucose Delta C30 After a Mixed Meal Tolerance Test (MMTT)	0.04; 0.16; 0.05; 0.03; 0.02; 0.05	—
SECONDARY Change From Baseline in Ratio of Insulin Area Under Curve (Insulin AUC) to Glucose Area Under Curve (Glucose AUC) After a Mixed Meal Tolerance Test (MMTT) on Day 1	0.24; 0.32; 0.48; 0.36; 0.29; 0.38	—

Summary

The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, and pharmacodynamics of PF-04937319 following single escalating oral doses in adult subjects with Type 2 Diabetes Mellitus (T2DM).

Eligibility Criteria

Inclusion Criteria

Patients with type 2 diabetes mellitus who are taking stable doses of metformin only. Subjects treated with a sulfonylurea (SU) or a dipeptidyl peptidase-IV inhibitor (DPP-IVi) in combination with metformin may be eligible if washed off the SU or DPP-IVi to metformin only for a minimum of 4 weeks before dosing.
Male and/or female subjects (females will be women of non childbearing potential) between the ages of 18 and 65 years, inclusive, with a body mass index (BMI) of 18.5 to 45.0 kg/m2 and C-peptide >0.8 ng/mL.
Screening and Day -2 troponin I concentration /=7% and /=7% and 450 msec at screening, ECG findings suggestive of asymptomatic myocardial ischemia, or supine blood pressure >/=160 mm Hg (systolic) or /=8 hours) blood glucose, /=270 mg/dL, confirmed by a single repeat if deemed necessary.

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Data sourced from ClinicalTrials.gov (NCT01044537). 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.