Phase 2 N=172 Randomized Double-blind Treatment

Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06291874 As Oral Monotherapy To Treat Adults With Type 2 Diabetes Mellitus

Diabetes Mellitus, Type II

Bottom Line

View on ClinicalTrials.gov: NCT02175121 ↗

Enrolled (actual)

172

Serious AEs

0.6%

Results posted

Jun 2016

Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), or Serious Adverse Events (SAEs), or Hypoglycemic Adverse Events (HAE) or Withdrawals Due to Adverse Events (AEs) — 11; 7; 10; 11 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Placebo (Drug); PF-06291874 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Mar 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs), or Serious Adverse Events (SAEs), or Hypoglycemic Adverse Events (HAE) or Withdrawals Due to Adverse Events (AEs)	11; 7; 10; 11; 12; 0	—
PRIMARY Number of Participants With Laboratory Test Abnormalities	31; 31; 24; 32; 30	—
PRIMARY Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Criteria of Potential Clinical Concern	3; 0; 0; 0; 0; 1	—
PRIMARY Number of Participants With Electrocardiogram (ECG) Data Meeting Criteria of Potential Clinical Concern	0; 0; 0; 0; 0; 0	—
SECONDARY Change From Baseline in Mean Daily Glucose	6.63; -29.15; -32.29; -59.98; -55.99	<0.0001 sig
SECONDARY Change From Baseline in Fasting Plasma Glucose	-6.08; -21.76; -29.59; -45.59; -52.18; 6.11	0.0060 sig
SECONDARY Percent Change From Baseline in Triglycerides	0.52; 25.69; 26.95; 2.71; 21.52; 19.58	0.2063
SECONDARY Percent Change From Baseline in Total Cholesterol	4.04; 4.49; 7.94; 4.60; 12.98; 4.07	0.8516
SECONDARY Percent Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C)	6.24; 3.95; 8.12; 5.29; 14.24; 2.92	0.6182
SECONDARY Percent Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C)	6.99; 9.02; 11.27; 14.47; 19.75; 3.94	0.6553
SECONDARY Percent Change From Baseline in Non-HDL-C	3.29; 2.96; 7.52; 1.26; 12.32; 3.84	0.9750
SECONDARY Percent Change From Baseline in Oxidized LDL	2.84; 2.83; 6.54; 2.05; 11.93	—
SECONDARY Percent Change From Baseline in Large LDL Particles	3.49; 33.07; -2.40; -3.27; 21.49	—
SECONDARY Percent Change From Baseline in Medium Small LDL Particles	2.50; 8.19; 9.90; 8.32; 14.31	—
SECONDARY Percent Change From Baseline in Small LDL Particles	2.60; 7.58; 13.21; 3.67; 13.21	—
SECONDARY Percent Change From Baseline in Very Small LDL Particles	2.87; 8.39; 14.25; 2.61; 12.92	—
SECONDARY Percent Change From Baseline in Total LDL Particles	1.33; 0.62; 3.39; 1.95; 13.70	—
SECONDARY Percent Change From Baseline in LDL Size	-0.10; 0.16; -0.19; -0.26; 0.23	—
SECONDARY Percent Change From Baseline in Apolipoprotein B100	1.85; 2.94; 3.82; 2.04; 10.35	—
SECONDARY Percent Change From Baseline in Lipoprotein A	-4.38; -12.78; -13.48; -13.17; -15.15	—
SECONDARY Maximum Plasma Concentration (Cmax)	714.3; 1819; 3560; 8265	—
SECONDARY Time to Reach Cmax (Tmax)	6.00; 6.00; 6.00; 6.00	—
SECONDARY Area Under the Concentration-Time Profile From Zero to Time Tau (AUCtau) (Where Tau=24 Hours)	12760; 32370; 65230; 142900	—
SECONDARY Minimum Plasma Concentration (Cmin)	350.6; 666.4; 1257; 3247	—
SECONDARY Apparent Clearance (CL/F)	1.176; 1.082; 1.150; 1.050	—

Summary

This study is going to assess the safety and tolerability of PF-06291874 in adults with Type 2 Diabetes Mellitus as monotherapy, to evaluate the significance of overall glycemic control in these subjects.

Eligibility Criteria

Inclusion Criteria

Male subjects and non-childbearing potential female subjects between the ages of 18 and 70 years old.
Body Mass Index of 18.0 to 45.4 kg/m2; and a total body weight of >50 kg
HbA1c value at the screening visit meeting once of the following criteria:
Currently taking acceptable oral antiglycemic drug therapy within 6.5 to 9.5%
Not currently taking any oral antiglycemic drug therapy within 7 to 10.5%
Fasting plasma glucose concentrations 160 mm Hg and/or diastolic blood pressure >100 mm Hg after at least a 5 minute seated rest. If the blood pressure exceeds this limit, the blood pressure may be repeated 2 more times following approximately 2 minutes of rest between measurements and the median of the 3 values should be used to determine subject eligibility;
Male subjects with partners currently pregnant; or male subjects capable of conceiving children who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02175121). 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.