Phase 2 Completed N=411 Randomized Quadruple-blind Treatment

A 16 Week Study to Evaluate the Efficacy and Safety of PF-06882961 in Adults With Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus

Source: ClinicalTrials.gov NCT03985293 ↗

Enrolled (actual)

411

Serious AEs

3.2%

Results posted

Jun 2022

Primary outcomePrimary: Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 16 — -0.02; -0.49; -0.91; -1.03 Percent — p=0.0071

Summary

This multicenter, randomized, double-blind, placebo controlled, parallel group study is being conducted to provide data on efficacy, safety, tolerability and pharmacokinetics (PK) of multiple dose levels of PF-06882961 in adults with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin and/or diet and exercise. In addition, the study is intended to enable selection of efficacious doses for future clinical development of PF-06882961.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 16	-0.02; -0.49; -0.91; -1.03; -0.96; -1.18	0.0071 sig
SECONDARY Percentage of Participants Achieving Less Than (<) 7% Glycated Hemoglobin (HbA1c) Levels	7.7; 30.8; 54.1; 58.2; 65.2; 60.5	—
SECONDARY Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 2	-0.09; -0.18; -0.31; -0.29; -0.33; -0.35	0.1578
SECONDARY Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 4	-0.08; -0.38; -0.51; -0.63; -0.58; -0.64	0.0013 sig
SECONDARY Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 6	-0.07; -0.47; -0.71; -0.84; -0.79; -0.84	0.0004 sig
SECONDARY Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 8	-0.13; -0.50; -0.78; -0.97; -0.92; -1.02	0.0054 sig
SECONDARY Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 12	-0.09; -0.53; -0.88; -1.06; -0.91; -1.11	0.0061 sig
SECONDARY Change From Baseline in Fasting Plasma Glucose at Week 2	-5.58; -22.72; -21.96; -27.79; -24.18; -30.92	0.0014 sig
SECONDARY Change From Baseline in Fasting Plasma Glucose at Week 4	-5.98; -17.77; -24.66; -33.42; -33.34; -34.06	0.0468 sig
SECONDARY Change From Baseline in Fasting Plasma Glucose at Week 6	-0.88; -16.78; -26.41; -30.89; -28.36; -32.65	0.0091 sig
SECONDARY Change From Baseline in Fasting Plasma Glucose at Week 8	-9.10; -12.73; -26.23; -29.74; -33.22; -34.31	0.5449
SECONDARY Change From Baseline in Fasting Plasma Glucose at Week 12	1.21; -6.49; -22.56; -32.01; -30.45; -32.38	0.2940
SECONDARY Change From Baseline in Fasting Plasma Glucose at Week 16	1.31; -12.81; -24.53; -30.47; -25.71; -31.93	0.0464 sig
SECONDARY Change From Baseline in Body Weight at Week 2	-0.15; -0.09; -0.12; -0.23; -0.57; -0.54	0.8011
SECONDARY Change From Baseline in Body Weight at Week 4	-0.25; -0.33; -0.08; -0.77; -1.05; -1.33	0.7898
SECONDARY Change From Baseline in Body Weight at Week 6	-0.09; -0.19; -0.32; -0.83; -1.69; -2.34	0.7985
SECONDARY Change From Baseline in Body Weight at Week 8	-0.36; -0.05; -0.27; -1.09; -1.97; -3.31	0.4692
SECONDARY Change From Baseline in Body Weight at Week 12	-0.24; -0.09; -0.00; -1.05; -2.52; -3.81	0.7758
SECONDARY Change From Baseline in Body Weight at Week 16	-0.43; 0.02; -0.06; -1.16; -2.48; -4.60	0.4325
SECONDARY Number of Participants With Treatment Emergent Adverse Events (Adverse Events [AEs] and Serious Adverse Events [SAEs])	32; 32; 31; 42; 43; 44	—
SECONDARY Number of Participants With Treatment Emergent Clinical Laboratory Abnormalities Without Regard to Baseline Abnormality	60; 57; 57; 57; 60; 64	—
SECONDARY Number of Participants With Treatment Emergent Vital Signs Abnormalities	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With Treatment Emergent ECG Abnormalities	0; 0; 0; 0; 0; 1	—

Eligibility Criteria

Inclusion Criteria

Patients with T2DM who are treated with metformin and/or diet and exercise
HbA1c greater than or equal to 7% and less than or equal to 10.5%
Total body weight >50 kg (110 lb) with BMI 24.5 to 45.4 kg/m^2

Exclusion Criteria

Any condition possibly affecting drug absorption
Diagnosis of Type 1 diabetes
History of myocardial infarction, unstable angina, arterial revascularization, stroke, heart failure, or transient ischemic attack within 6 months of screening
Any malignancy not considered cured
Personal or family history of MTC or MEN2, or participants with suspected MTC
Acute pancreatitis or history of chronic pancreatitis
Symptomatic gallbladder disease
Known medical history of active proliferative retinopathy and/or macular edema
Known medical history of active liver disease, including chronic active hepatitis B or C, or primary biliary cirrhosis
Known history of HIV
Supine blood pressure greater than or equal to 160 mmHg (systolic) or greater than or equal to 100 mmHg (diastolic)
Clinically relevant ECG abnormalities
Positive urine drug test

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Data sourced from ClinicalTrials.gov (NCT03985293). 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.