A Study Of The Analgesic (Pain-Relief) Effects Of Tanezumab In Adult Patients With Diabetic Peripheral Neuropathy

A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PARALLEL GROUP, PROOF OF CONCEPT STUDY OF THE ANALGESIC EFFECTS OF TANEZUMAB IN ADULT PATIENTS WITH DIABETIC PERIPHERAL NEUROPATHY

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01087203

Enrollment

Registered

2010-03-16

Start date

2010-03-30

Completion date

2011-07-06

Last updated

2021-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Peripheral Neuropathy

Keywords

diabetic peripheral neuropathy, tanezumab, diabetic neuropathies, diabetic polyneuropathy, diabetic neuropathy painful

Brief summary

The purpose of this study is to determine the effectiveness and safety of the investigational drug, tanezumab, in adult patients with painful diabetic peripheral neuropathy.

Detailed description

This study was terminated on 18 November 2010 following a US FDA clinical hold for the tanezumab diabetic peripheral neuropathy clinical study which halted dosing and enrollment of patients on 19 July 2010 for potential safety issues.

Interventions

BIOLOGICALTanezumab

20 mg subcutaneous injection every 8 weeks x 2 doses (at Baseline and week 8)

BIOLOGICALplacebo

Placebo to match tanezumab 20 mg subcutaneous injection every 8 weeks x 2 doses (at Baseline and week 8)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

Inclusion criteria

* Diagnosis of diabetes mellitus (high blood sugar) with HbA1c levels of ≤11% at Screening, and on a stable anti-diabetic medication regimen for the 30 days prior to randomization. * Diagnosis of diabetic peripheral neuropathy pain in the legs or feet with decreased sensation in the feet or decreased/absent ankle jerk/ reflexes. * Presence of ongoing pain due to diabetic peripheral neuropathy for at least 3 months. * A pain score of greater than or equal to (≥) 4 for from diabetic peripheral neuropathy on the Numerical Rating Scale (NRS), a 11-point scale with 0 meaning no pain and 10 meaning worst pain at Screening. * Be willing to stop all pain medications for diabetic peripheral neuropathy except for the limited use of acetaminophen (Tylenol) or ibuprofen-like (Motrin) medications between Screening and Baseline and not use prohibited pain medications throughout the duration of the study except as permitted by the study guidelines.

Exclusion criteria

* Painful neuropathies other than diabetic peripheral neuropathy. * Other types of diabetic neuropathies. * Patients with a past history of carpal tunnel syndrome (CTS) with signs or symptoms of CTS in the one year prior to Screening are not eligible for participation. * Patients with fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to severe pain. * Patients with a present (current) history of sciatica are not eligible for participation. * The presence of pain conditions that cannot be distinguished from diabetic peripheral neuropathy such as peripheral vascular disease. * Amputations dues to diabetes. * Patient with any clinically significant medical condition or laboratory abnormalities. * History, diagnosis, or signs and symptoms of clinically significant neurological diseases (such as Alzheimer's disease, head trauma, epilepsy or stroke). * History, diagnosis, or signs and symptoms of clinically significant psychiatric diseases (such as bipoar disorder or schizophrenia). * History of known alcohol, analgesic or drug abuse within 2 years of Screening. * Pregnant women, lactating mothers, women suspected of being pregnant, and women who wish to be pregnant during the course of clinical study.

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16	Baseline, Week 16	Participants assessed their DPN pain during the past 24 hours using 11-point Numeric Rating Scale (NRS) with score range of 0 (no pain) to 10 ( worst possible pain). Baseline score was calculated as the mean of the average pain scores over the 3 days in the initial pain assessment period. The Week 16 value was the average DPN Pain score calculated for the 7 days prior to and including Day 113 (Week 16).

Secondary

Measure	Time frame	Description
Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 1, 2, 4, 6, 8, and 12	Baseline, Week 1, 2, 4, 6, 8, 12	Participant rated their DPN pain using 11-point NRS with score ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicated greater level of pain. Change: score at observation minus score at baseline.
Number of Participants With Cumulative Reduction From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16	Week 16	Participant rated their DPN pain using 11-point NRS with score ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicated greater level of pain.
Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 1, 2, 4, 6, 8, 12, 16	Participant rated their DPN pain using 11-point NRS with score ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicated greater level of pain. Change: score at observation minus score at baseline.
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst and Average Pain Score at Week 8 and 16	Baseline, Week 8, 16	BPI-sf (Brief Pain Inventory-short form) is a participant-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24-hour period prior to evaluation. It consists of 5 questions. Questions 1-4 measure the magnitude of pain at its worst and least (in the last 24 hours), average, and right now. Responses are provided by the participant on an 11-point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Question 5 consists of 7 item subsets (A to G) which measure the level of interference of pain on daily functions. Responses are given on an 11-point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). The instrument is scored by item and by dimension, with lower scores indicating less pain or pain interference.
Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score at Week 8 and 16: Last Observation Carried Forward (LOCF)	Baseline, Week 8, 16	Participant rated questionnaire to evaluate different symptoms of neuropathic pain (burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]) during past 24-hour period and included 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.
Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16	Baseline, Week 8, 16	BPI-sf (Brief Pain Inventory-short form) is a participant-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24-hour period prior to evaluation. It consisted of 5 questions. Questions 1-4 measure the magnitude of pain at its worst and least (in the last 24 hours), average, and right now. Responses were provided by the participant on an 11-point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Question 5 consisted of 7 item subsets (A to G) as being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). The instrument was scored by item and by dimension, with lower scores indicated less pain or pain interference.
Change From Baseline in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy (DPN) at Week 4, 8, 12 and 16	Baseline, Week 4, 8, 12, 16	The PGA is a global evaluation that utilizes a 5-point Likert scale with a score of 1 being the best (very good: Asymptomatic and no limitation of normal activities) and a score of 5 being the worst (very poor: Very severe symptoms which are intolerable and inability to carry out all normal activities).
Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy	Week 4, 8, 12, 16	The PGA is a global evaluation that utilizes a 5-point Likert scale with a score of 1 being the best (very good: Asymptomatic and no limitation of normal activities) and a score of 5 being the worst (very poor: Very severe symptoms which are intolerable and inability to carry out all normal activities).
Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility at Week 16	Baseline, Week 16	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Scoring formula developed by Euro Quality of life group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicated a better health state.
Time to Discontinuation Due to Lack of Efficacy	Baseline up to Week 16	—
Number of Participants Who Used Rescue Medication	Week 1, 2, 4, 6, 8, 12, 16	Participants who did not experience adequate pain relief for DPN pain during the treatment period took acetaminophen 3000 mg/day up to 3 days/week as rescue medication.
Days Per Week of Rescue Medication Usage	Week 1, 2, 4, 6, 8, 12, 16	Participants who did not experience adequate pain relief for DPN pain during the treatment period took acetaminophen 3000 mg/day up to 3 days/week as rescue medication.
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	Baseline up to 112 days after last dose of study treatment (up to 169 days)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Number of Participants With Clinically Significant Laboratory Values	Baseline up to Week 24	Criteria:Hemoglobin(Hgb),hematocrit,red blood cell(RBC)count:less than(\<)0.8\lower limit of normal(LLN), mean cell Hgb,mean corpuscular volume,mean corpuscular Hgb concentration,mean platelet volume:\<0.9\LLNor\>1.1\upper limit of normal(ULN),platelet:\<0.5\LLN \>1.75\* ULN, lymphocyte,neutrophil:\<0.8\LLN or\>1.2\ULN,basophil, eosinophil,monocyte:\>1.2\ULN;bilirubin(total, direct,)\>1.5\ULN, aspartate and alanine aminotransferase,alkaline phosphatase:\> 3.0\ULN;gamma GT\>3.0;cholestrol,triglycerides:\>1.3\ULN; total protein, albumin:\<0.8\LLN or\>1.2\ULN ;blood urea nitrogen,creatinine:\>1.3\ULN,uric acid\>1.2\ULN;sodium \<0.95\LLNor\>1.05\ULN,potassium,chloride,calcium,bicarbonate, magnesium:\<0.9\LLN or \>1.1\ULN;phosphate\<0.8\LLN or\>1.2\ULN;glucose \<0.6\LLNor\>1.5\ULN,glycosylated Hgb\>1.3\ULN,creatine kinase \>2.0\ULN;urine(specific gravity\<1.003or\>1.030;pH \<4.8or\>8;glucose,ketone,proteins,blood/Hgb,bilirubin,nitrite\>=1;WBC, RBC≥20/HPF;hyaline cast≥1;epithelial cell\>=6;bacteria \>1);serum pregnancy \>=1.
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities	Baseline up to Week 24	Following parameters were analyzed for ECG abnormality: PR interval, QRS interval, QT interval, QT interval corrected using the Fridericia's formula (QTcF), QT interval corrected using the Bazett's formula (QTcB), RR interval and heart rate (HR). Number of participants with clinically significant abnormal ECG findings reported as adverse events were presented.
Number of Participants With Clinically Significant Change From Baseline Physical Examination	Baseline up to Week 24	Physical examination included examination of following sites in addition to general examination: abdomen, ears, extremities, eyes, head, heart, musculoskeletal, neck, nose, skin, throat, lungs and thyroid.
Number of Participants With Clinically Significant Vital Signs Abnormalities	Baseline up to Week 24	Following parameters were analyzed for examination of vital signs: body temperature, blood pressure, pulse rate and respiratory rate. Number of participants with clinically significant abnormality in vital signs reported as adverse events were presented.
Number of Participants With Anti Drug Antibody (ADA) for Tanezumab	Baseline, Week 8, 16, 24	Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA).
Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Baseline, Weeks 2, 4, 8, 12, 16 and 24	Neurologic examination assessed strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense and pin prick) of index fingers and great toes in order to complete the NIS. The NIS consists of 74 items (37 items assessed on the right side and 37 items assessed on the left side). Each item was rated on a scale of either 0 to 4 or 0 to 2 points, which were summed to calculate a total score. The NIS total score ranges from 0 to 244, where higher scores represent greater impairment.
Change From Baseline Neuropathy Symptoms and Change (NSC) Score at Week 16: Last Observation Carried Forward (LOCF)	Baseline, Week 16	The NSC (Neuropathy symptoms and change) is a standardized instrument and has been used to evaluate participants for number of symptoms of peripheral neuropathy. The NSC score included 38 (muscle weakness, Q1-19; sensation, Q20-29; and autonomic symptoms, Q30-38) symptom questions where the participants indicated experiencing the number of symptoms (to any severity). The score ranged from 0 to 38, with higher scores indicated more symptoms. The change score is the participant's comparison of the symptoms at last evaluation to the symptoms at onset. A change from baseline \> 0 indicated increased neuropathy.
Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Baseline, Week 16	QST was performed on dorsum of foot and anterior thigh (at midpoint of a line from inguinal crease to midpoint of patella) to assess and quantify sensory function in lower extremity. Parameters were selected to assess small fiber function such as cooling detection threshold (mainly small diameter myelinated fibers, A delta), heat pain detection threshold (A delta and C fiber functions), and large fiber function via vibration detection threshold. normal deviate scores derived from a normal distribution of a reference population. A standard deviate score of 0 corresponds to 50th percentile of control population. Standard deviate score 1.96 corresponds to 95th percentile of normal distribution and -1.96 corresponds to 5th percentile of normal distribution. A normal deviate score indicated how many standard deviations higher (in case of positive normal deviate score) or lower (in case of negative normal deviate score) participant's value was relative to mean of reference population.
Change From Baseline in the Average Density of Protein Gene Product (PGP) 9.5-Positive Intraepidermal Nerve Fiber (IENF) at Week 16: LOCF	Baseline, Week 16	IENF density was quantified in 3 millimeter (mm) immunostained skin punch biopsies containing epidermis and superficial dermis to evaluate the amount and morphological appearance of small diameter nerve fibers, both somatic and autonomic, in sensory neuropathies. IENF density was assessed from skin biopsies taken from the distal calves and distal thigh.
Plasma Tanezumab Concentration	Baseline(Day 1), Week 2, 4, 8, 12, 16, 24	—
Serum Nerve Growth Factor (NGF)	Day 1, Week 8, 16, 24	Serum samples were analyzed for determining total NGF concentration. Total NGF was analyzed using a validated, sensitive and specific immunoaffinity enrichment liquid chromatography tandem mass spectrometric (IA/LC/MS/MS) method.
Amount of Rescue Medication Taken	Week 1, 2, 4, 6, 8, 12, 16	Participants who did not experience adequate pain relief for DPN pain during the treatment period took acetaminophen 3000 mg/day up to 3 days/week as rescue medication.

Other

Measure	Time frame	Description
Number of Participants With Subcutaneous Doses of Study Medication	Day 1 up to Week 8	Number of participants are reported based on the maximum number of Subcutaneous doses of either tanezumab or placebo received.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Placebo Placebo matched to tanezumab (RN624 or PF-04383119) subcutaneous injection on Day 1 and Week 8.	35
Tanezumab Tanezumab (RN624 or PF-04383119) 20 milligram (mg) subcutaneous injection on Day 1 and Week 8.	38
Total	73

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lack of Efficacy	1	2
Overall Study	Lost to Follow-up	2	0
Overall Study	Study terminated by sponsor	27	27
Overall Study	Withdrawal by Subject	2	6

Baseline characteristics

Characteristic	Placebo	Tanezumab	Total
Age, Continuous	59.6 Years STANDARD_DEVIATION 11.6	61.6 Years STANDARD_DEVIATION 8.9	60.7 Years STANDARD_DEVIATION 10.2
Sex: Female, Male Female	15 Participants	11 Participants	26 Participants
Sex: Female, Male Male	20 Participants	27 Participants	47 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	19 / 35	24 / 38
serious Total, serious adverse events	0 / 35	1 / 38

Outcome results

Primary

Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16

Participants assessed their DPN pain during the past 24 hours using 11-point Numeric Rating Scale (NRS) with score range of 0 (no pain) to 10 ( worst possible pain). Baseline score was calculated as the mean of the average pain scores over the 3 days in the initial pain assessment period. The Week 16 value was the average DPN Pain score calculated for the 7 days prior to and including Day 113 (Week 16).

Time frame: Baseline, Week 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of study medication. Last Observation Carried Forward (LOCF) method of imputation was used.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16	Baseline	6.91 Units on a scale	Standard Deviation 1.5
Placebo	Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16	Change at Week 16	-1.04 Units on a scale	Standard Deviation 1.92
Tanezumab	Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16	Baseline	6.59 Units on a scale	Standard Deviation 1.4
Tanezumab	Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16	Change at Week 16	-2.10 Units on a scale	Standard Deviation 3.14

Comparison: Analysis of Covariance (ANCOVA) model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.p-value: 0.02595% CI: [-2.28, -0.16]ANCOVA

Secondary

Amount of Rescue Medication Taken

Participants who did not experience adequate pain relief for DPN pain during the treatment period took acetaminophen 3000 mg/day up to 3 days/week as rescue medication.

Time frame: Week 1, 2, 4, 6, 8, 12, 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of study medication. LOCF method of imputation was used. 'Overall Number of Participants Analyzed'=participants evaluable for this measure. Here, 'Number Analyzed' signifies those participants who were evaluable for this measure at given time point for each arm, respectively.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Amount of Rescue Medication Taken	Week 4	1354.17 mg/week	Standard Deviation 1997.17
Placebo	Amount of Rescue Medication Taken	Week 8	1354.17 mg/week	Standard Deviation 1997.17
Placebo	Amount of Rescue Medication Taken	Week 2	2020.83 mg/week	Standard Deviation 2939.53
Placebo	Amount of Rescue Medication Taken	Week 12	1416.67 mg/week	Standard Deviation 2009.04
Placebo	Amount of Rescue Medication Taken	Week 6	1395.83 mg/week	Standard Deviation 1978.03
Placebo	Amount of Rescue Medication Taken	Week 16	1416.67 mg/week	Standard Deviation 2009.04
Placebo	Amount of Rescue Medication Taken	Week 1	2666.67 mg/week	Standard Deviation 4090.46
Tanezumab	Amount of Rescue Medication Taken	Week 16	1160.71 mg/week	Standard Deviation 2419.27
Tanezumab	Amount of Rescue Medication Taken	Week 1	2759.26 mg/week	Standard Deviation 3716.83
Tanezumab	Amount of Rescue Medication Taken	Week 2	2178.57 mg/week	Standard Deviation 3174.59
Tanezumab	Amount of Rescue Medication Taken	Week 4	1464.29 mg/week	Standard Deviation 2567.35
Tanezumab	Amount of Rescue Medication Taken	Week 6	1250.00 mg/week	Standard Deviation 2420.97
Tanezumab	Amount of Rescue Medication Taken	Week 8	1160.71 mg/week	Standard Deviation 2419.27
Tanezumab	Amount of Rescue Medication Taken	Week 12	1160.71 mg/week	Standard Deviation 2419.27

Secondary

Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 1, 2, 4, 6, 8, and 12

Participant rated their DPN pain using 11-point NRS with score ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicated greater level of pain. Change: score at observation minus score at baseline.

Time frame: Baseline, Week 1, 2, 4, 6, 8, 12

Population: ITT analysis set included all randomized participants who received at least 1 dose of study medication. LOCF method of imputation was used.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 1, 2, 4, 6, 8, and 12	Change at Week 2	-1.00 Units on a scale	Standard Deviation 1.67
Placebo	Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 1, 2, 4, 6, 8, and 12	Change at Week 6	-0.95 Units on a scale	Standard Deviation 1.68
Placebo	Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 1, 2, 4, 6, 8, and 12	Change at Week 1	-0.76 Units on a scale	Standard Deviation 1.31
Placebo	Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 1, 2, 4, 6, 8, and 12	Change at Week 8	-0.98 Units on a scale	Standard Deviation 1.83
Placebo	Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 1, 2, 4, 6, 8, and 12	Change at Week 4	-0.95 Units on a scale	Standard Deviation 1.75
Placebo	Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 1, 2, 4, 6, 8, and 12	Change at Week 12	-1.00 Units on a scale	Standard Deviation 1.89
Placebo	Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 1, 2, 4, 6, 8, and 12	Baseline	6.91 Units on a scale	Standard Deviation 1.5
Tanezumab	Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 1, 2, 4, 6, 8, and 12	Change at Week 12	-2.14 Units on a scale	Standard Deviation 3.12
Tanezumab	Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 1, 2, 4, 6, 8, and 12	Baseline	6.59 Units on a scale	Standard Deviation 1.4
Tanezumab	Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 1, 2, 4, 6, 8, and 12	Change at Week 1	-0.97 Units on a scale	Standard Deviation 1.5
Tanezumab	Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 1, 2, 4, 6, 8, and 12	Change at Week 2	-1.31 Units on a scale	Standard Deviation 1.92
Tanezumab	Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 1, 2, 4, 6, 8, and 12	Change at Week 4	-1.78 Units on a scale	Standard Deviation 2.55
Tanezumab	Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 1, 2, 4, 6, 8, and 12	Change at Week 6	-2.04 Units on a scale	Standard Deviation 2.86
Tanezumab	Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 1, 2, 4, 6, 8, and 12	Change at Week 8	-2.16 Units on a scale	Standard Deviation 2.96

Comparison: Week 1: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.p-value: 0.33295% CI: [-0.92, 0.32]ANCOVA

Comparison: Week 2: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.p-value: 0.29795% CI: [-1.15, 0.36]ANCOVA

Comparison: Week 4: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.p-value: 0.02995% CI: [-1.81, -0.1]ANCOVA

Comparison: Week 6: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.p-value: 0.0195% CI: [-2.17, -0.3]ANCOVA

Comparison: Week 8: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.p-value: 0.00995% CI: [-2.3, -0.34]ANCOVA

Comparison: Week 12: ANCOVA model with treatment as main effect, baseline value as covariate, and study site as a random effect was used.p-value: 0.01595% CI: [-2.36, -0.27]ANCOVA

Secondary

Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16

BPI-sf (Brief Pain Inventory-short form) is a participant-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24-hour period prior to evaluation. It consisted of 5 questions. Questions 1-4 measure the magnitude of pain at its worst and least (in the last 24 hours), average, and right now. Responses were provided by the participant on an 11-point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Question 5 consisted of 7 item subsets (A to G) as being pain interference with general activity; mood; walking ability; normal work (outside home and housework); relations with other people; sleep and enjoyment of life. Responses were given on an 11-point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). The instrument was scored by item and by dimension, with lower scores indicated less pain or pain interference.

Time frame: Baseline, Week 8, 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of study medication. Here, 'Overall Number of Participants Analyzed= participants evaluable for this measure. 'Number Analyzed' =participants who were evaluable for this measure at given time point for each arm, respectively.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16	PI General Activity: Change at Week 8	-1.26 Units on scale	Standard Deviation 2.2
Placebo	Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16	PI Walking Ability: Change at Week 16	-2.00 Units on scale	Standard Deviation 1.41
Placebo	Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16	PII: Change at Week 8	-1.12 Units on scale	Standard Deviation 2.32
Placebo	Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16	PI Sleep: Baseline	5.70 Units on scale	Standard Deviation 2.78
Placebo	Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16	PI General Activity: Change at Week 16	-2.00 Units on scale	Standard Deviation 0
Placebo	Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16	PI Sleep: Change at Week 8	-0.87 Units on scale	Standard Deviation 2.69
Placebo	Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16	PI General Activity: Baseline	5.30 Units on scale	Standard Deviation 2.23
Placebo	Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16	PI Sleep: Change at Week 16	-1.00 Units on scale	Standard Deviation 0
Placebo	Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16	PI Walking Ability: Baseline	5.43 Units on scale	Standard Deviation 2.5
Placebo	Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16	PI Normal Work: Baseline	5.33 Units on scale	Standard Deviation 2.59
Placebo	Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16	PII: Change at Week 16	-1.64 Units on scale	Standard Deviation 0.51
Placebo	Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16	PI Normal Work: Change at Week 8	-1.04 Units on scale	Standard Deviation 2.53
Placebo	Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16	PI Walking Ability: Change at Week 8	-1.09 Units on scale	Standard Deviation 3.18
Placebo	Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16	PI Normal Work: Change at Week 16	-1.50 Units on scale	Standard Deviation 0.71
Placebo	Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16	Pain Interference Index (PII);Baseline	5.23 Units on scale	Standard Deviation 2.36
Tanezumab	Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16	PI Normal Work: Change at Week 16	-0.67 Units on scale	Standard Deviation 3.51
Tanezumab	Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16	Pain Interference Index (PII);Baseline	4.71 Units on scale	Standard Deviation 2.41
Tanezumab	Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16	PII: Change at Week 8	-1.75 Units on scale	Standard Deviation 3.15
Tanezumab	Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16	PII: Change at Week 16	-1.24 Units on scale	Standard Deviation 2.18
Tanezumab	Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16	PI General Activity: Baseline	4.49 Units on scale	Standard Deviation 3.02
Tanezumab	Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16	PI General Activity: Change at Week 8	-1.81 Units on scale	Standard Deviation 3.86
Tanezumab	Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16	PI General Activity: Change at Week 16	-1.33 Units on scale	Standard Deviation 3.51
Tanezumab	Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16	PI Walking Ability: Baseline	5.54 Units on scale	Standard Deviation 2.8
Tanezumab	Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16	PI Walking Ability: Change at Week 8	-2.25 Units on scale	Standard Deviation 3.21
Tanezumab	Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16	PI Walking Ability: Change at Week 16	-2.33 Units on scale	Standard Deviation 2.52
Tanezumab	Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16	PI Sleep: Baseline	5.95 Units on scale	Standard Deviation 2.59
Tanezumab	Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16	PI Sleep: Change at Week 8	-2.34 Units on scale	Standard Deviation 3.6
Tanezumab	Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16	PI Sleep: Change at Week 16	-2.00 Units on scale	Standard Deviation 1
Tanezumab	Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16	PI Normal Work: Baseline	4.78 Units on scale	Standard Deviation 2.89
Tanezumab	Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16	PI Normal Work: Change at Week 8	-1.44 Units on scale	Standard Deviation 3.86

Secondary

Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst and Average Pain Score at Week 8 and 16

BPI-sf (Brief Pain Inventory-short form) is a participant-administered questionnaire developed to assess the severity of pain and the impact of pain on daily functions during the 24-hour period prior to evaluation. It consists of 5 questions. Questions 1-4 measure the magnitude of pain at its worst and least (in the last 24 hours), average, and right now. Responses are provided by the participant on an 11-point numeric rating scale with anchors at 0 (No Pain) and 10 (Pain as bad as you can imagine). Question 5 consists of 7 item subsets (A to G) which measure the level of interference of pain on daily functions. Responses are given on an 11-point numeric rating scale with anchors at 0 (Does not interfere) and 10 (Completely interferes). The instrument is scored by item and by dimension, with lower scores indicating less pain or pain interference.

Time frame: Baseline, Week 8, 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of study medication. LOCF method of imputation was used. Here, Overall Number of Participants Analyzed signifies participants evaluable for this measure.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst and Average Pain Score at Week 8 and 16	Worst Pain: Baseline	7.33 Units on a scale	Standard Deviation 1.24
Placebo	Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst and Average Pain Score at Week 8 and 16	Worst Pain: Change at Week 8	-1.13 Units on a scale	Standard Deviation 1.7
Placebo	Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst and Average Pain Score at Week 8 and 16	Worst Pain: Change at Week 16	-1.10 Units on a scale	Standard Deviation 1.65
Placebo	Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst and Average Pain Score at Week 8 and 16	Average Pain: Baseline	6.17 Units on a scale	Standard Deviation 1.21
Placebo	Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst and Average Pain Score at Week 8 and 16	Average Pain: Change at Week 8	-0.77 Units on a scale	Standard Deviation 1.43
Placebo	Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst and Average Pain Score at Week 8 and 16	Average Pain: Change at Week 16	-0.73 Units on a scale	Standard Deviation 1.36
Tanezumab	Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst and Average Pain Score at Week 8 and 16	Average Pain: Change at Week 8	-1.65 Units on a scale	Standard Deviation 2.14
Tanezumab	Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst and Average Pain Score at Week 8 and 16	Worst Pain: Baseline	6.92 Units on a scale	Standard Deviation 1.38
Tanezumab	Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst and Average Pain Score at Week 8 and 16	Average Pain: Baseline	5.62 Units on a scale	Standard Deviation 1.4
Tanezumab	Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst and Average Pain Score at Week 8 and 16	Worst Pain: Change at Week 8	-2.38 Units on a scale	Standard Deviation 3.06
Tanezumab	Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst and Average Pain Score at Week 8 and 16	Average Pain: Change at Week 16	-1.59 Units on a scale	Standard Deviation 2.15
Tanezumab	Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst and Average Pain Score at Week 8 and 16	Worst Pain: Change at Week 16	-2.32 Units on a scale	Standard Deviation 3.06

Secondary

Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility at Week 16

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Scoring formula developed by Euro Quality of life group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicated a better health state.

Time frame: Baseline, Week 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of study medication. 'Overall Number of Participants Analyzed'=participants evaluable for this measure. Here, 'Number Analyzed' signifies those participants who were evaluable for this measure at given time point for each arm, respectively.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility at Week 16	Baseline	0.54 Units on a scale	Standard Deviation 0.29
Placebo	Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility at Week 16	Change at Week 16	0.00 Units on a scale	Standard Deviation 0.05
Tanezumab	Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility at Week 16	Baseline	0.62 Units on a scale	Standard Deviation 0.22
Tanezumab	Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility at Week 16	Change at Week 16	-0.06 Units on a scale	Standard Deviation 0.11

Secondary

Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score at Week 8 and 16: Last Observation Carried Forward (LOCF)

Participant rated questionnaire to evaluate different symptoms of neuropathic pain (burning \[superficial\] spontaneous pain, pressing \[deep\] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia \[P/D\]) during past 24-hour period and included 10 descriptors quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.

Time frame: Baseline, Week 8, 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of study medication. Here, 'Overall Number of Participants Analyzed'= participants evaluable for this measure. 'Number Analyzed' = participants who were evaluable for this measure at given time point for each arm, respectively. LOCF method of imputation was used.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score at Week 8 and 16: Last Observation Carried Forward (LOCF)	Baseline	0.50 Units on a scale	Standard Deviation 0.21
Placebo	Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score at Week 8 and 16: Last Observation Carried Forward (LOCF)	Change at Week 8	-0.15 Units on a scale	Standard Deviation 0.21
Placebo	Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score at Week 8 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16	-0.13 Units on a scale	Standard Deviation 0.18
Tanezumab	Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score at Week 8 and 16: Last Observation Carried Forward (LOCF)	Baseline	0.45 Units on a scale	Standard Deviation 0.18
Tanezumab	Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score at Week 8 and 16: Last Observation Carried Forward (LOCF)	Change at Week 8	-0.20 Units on a scale	Standard Deviation 0.21
Tanezumab	Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score at Week 8 and 16: Last Observation Carried Forward (LOCF)	Change at Week 16	-0.17 Units on a scale	Standard Deviation 0.22

Secondary

Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)

Neurologic examination assessed strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense and pin prick) of index fingers and great toes in order to complete the NIS. The NIS consists of 74 items (37 items assessed on the right side and 37 items assessed on the left side). Each item was rated on a scale of either 0 to 4 or 0 to 2 points, which were summed to calculate a total score. The NIS total score ranges from 0 to 244, where higher scores represent greater impairment.

Time frame: Baseline, Weeks 2, 4, 8, 12, 16 and 24

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 4	-1.30 Units on a scale	Standard Deviation 4.02
Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 12	-2.27 Units on a scale	Standard Deviation 3.87
Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 2	-1.90 Units on a scale	Standard Deviation 3.13
Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 16	-1.58 Units on a scale	Standard Deviation 3.83
Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 8	-1.63 Units on a scale	Standard Deviation 3.37
Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 24	-1.18 Units on a scale	Standard Deviation 3.77
Placebo	Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Baseline	16.42 Units on a scale	Standard Deviation 10.42
Tanezumab	Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 24	-0.51 Units on a scale	Standard Deviation 6.31
Tanezumab	Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Baseline	15.86 Units on a scale	Standard Deviation 10.77
Tanezumab	Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 2	-1.40 Units on a scale	Standard Deviation 4.93
Tanezumab	Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 4	-0.35 Units on a scale	Standard Deviation 7.12
Tanezumab	Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 8	-0.24 Units on a scale	Standard Deviation 5.4
Tanezumab	Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 12	-1.19 Units on a scale	Standard Deviation 6.13
Tanezumab	Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)	Change at Week 16	-0.51 Units on a scale	Standard Deviation 6.31

Secondary

Change From Baseline in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy (DPN) at Week 4, 8, 12 and 16

The PGA is a global evaluation that utilizes a 5-point Likert scale with a score of 1 being the best (very good: Asymptomatic and no limitation of normal activities) and a score of 5 being the worst (very poor: Very severe symptoms which are intolerable and inability to carry out all normal activities).

Time frame: Baseline, Week 4, 8, 12, 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of study medication. Here, 'Overall Number Analyzed' signifies those participants who were evaluable for this measure. LOCF method of imputation was used.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy (DPN) at Week 4, 8, 12 and 16	Change at Week 4	-0.47 Units on a scale	Standard Deviation 0.86
Placebo	Change From Baseline in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy (DPN) at Week 4, 8, 12 and 16	Change at Week 12	-0.63 Units on a scale	Standard Deviation 0.76
Placebo	Change From Baseline in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy (DPN) at Week 4, 8, 12 and 16	Change at Week 8	-0.63 Units on a scale	Standard Deviation 0.76
Placebo	Change From Baseline in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy (DPN) at Week 4, 8, 12 and 16	Change at Week 16	-0.63 Units on a scale	Standard Deviation 0.76
Placebo	Change From Baseline in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy (DPN) at Week 4, 8, 12 and 16	Baseline	3.17 Units on a scale	Standard Deviation 0.65
Tanezumab	Change From Baseline in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy (DPN) at Week 4, 8, 12 and 16	Change at Week 16	-0.59 Units on a scale	Standard Deviation 0.9
Tanezumab	Change From Baseline in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy (DPN) at Week 4, 8, 12 and 16	Baseline	2.89 Units on a scale	Standard Deviation 0.61
Tanezumab	Change From Baseline in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy (DPN) at Week 4, 8, 12 and 16	Change at Week 4	-0.54 Units on a scale	Standard Deviation 0.84
Tanezumab	Change From Baseline in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy (DPN) at Week 4, 8, 12 and 16	Change at Week 8	-0.57 Units on a scale	Standard Deviation 0.93
Tanezumab	Change From Baseline in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy (DPN) at Week 4, 8, 12 and 16	Change at Week 12	-0.62 Units on a scale	Standard Deviation 0.89

Secondary

Change From Baseline in Quantitative Sensory Testing (QST) at Week 16

QST was performed on dorsum of foot and anterior thigh (at midpoint of a line from inguinal crease to midpoint of patella) to assess and quantify sensory function in lower extremity. Parameters were selected to assess small fiber function such as cooling detection threshold (mainly small diameter myelinated fibers, A delta), heat pain detection threshold (A delta and C fiber functions), and large fiber function via vibration detection threshold. normal deviate scores derived from a normal distribution of a reference population. A standard deviate score of 0 corresponds to 50th percentile of control population. Standard deviate score 1.96 corresponds to 95th percentile of normal distribution and -1.96 corresponds to 5th percentile of normal distribution. A normal deviate score indicated how many standard deviations higher (in case of positive normal deviate score) or lower (in case of negative normal deviate score) participant's value was relative to mean of reference population.

Time frame: Baseline, Week 16

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Baseline: VDT Left Foot	1.64 Normal deviate score	Standard Deviation 1.14
Placebo	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Baseline: CDT Left Foot	1.72 Normal deviate score	Standard Deviation 0.87
Placebo	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Baseline: HPDT 0.5 Left Foot	0.07 Normal deviate score	Standard Deviation 1.88
Placebo	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Baseline: HPDT 5.0 Left Foot	0.40 Normal deviate score	Standard Deviation 2.23
Placebo	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Baseline: HPDT 5.0-0.5 Left Foot	0.64 Normal deviate score	Standard Deviation 1.39
Placebo	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Baseline: VDT Left Thigh	1.31 Normal deviate score	Standard Deviation 1.16
Placebo	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Baseline: CDT Left Thigh	1.52 Normal deviate score	Standard Deviation 1.09
Placebo	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Baseline: HPDT 0.5 Left Thigh	-0.82 Normal deviate score	Standard Deviation 1.5
Placebo	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Baseline: HPDT 5.0 Left Thigh	-0.55 Normal deviate score	Standard Deviation 1.7
Placebo	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Baseline: HPDT 5.0-0.5 Left Thigh	0.71 Normal deviate score	Standard Deviation 1.32
Placebo	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Change at Week 16: VDT Left Foot	-0.07 Normal deviate score	Standard Deviation 0.66
Placebo	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Change at Week 16: CDT Left Foot	0.02 Normal deviate score	Standard Deviation 0.5
Placebo	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Change at Week 16: HPDT 0.5 Left Foot	-0.27 Normal deviate score	Standard Deviation 1.52
Placebo	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Change at Week 16: HPDT 5.0 Left Foot	0.26 Normal deviate score	Standard Deviation 1.53
Placebo	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Change at Week 16:HPDT 5.0-0.5 Left Foot	0.38 Normal deviate score	Standard Deviation 1.27
Placebo	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Change at Week 16: VDT Left Thigh	-0.11 Normal deviate score	Standard Deviation 0.88
Placebo	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Change at Week 16: CDT Left Thigh	0.19 Normal deviate score	Standard Deviation 0.95
Placebo	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Change at Week 16: HPDT 0.5 Left Thigh	-0.23 Normal deviate score	Standard Deviation 1.36
Placebo	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Change at Week 16: HPDT 5.0 Left	-0.11 Normal deviate score	Standard Deviation 1.26
Placebo	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Change at Week 16:HPDT 5.0-0.5 Left Thigh	0.23 Normal deviate score	Standard Deviation 1.57
Tanezumab	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Change at Week 16: HPDT 0.5 Left Thigh	-0.27 Normal deviate score	Standard Deviation 1.4
Tanezumab	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Baseline: VDT Left Foot	1.47 Normal deviate score	Standard Deviation 1.22
Tanezumab	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Change at Week 16: VDT Left Foot	-0.01 Normal deviate score	Standard Deviation 0.9
Tanezumab	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Baseline: CDT Left Foot	1.54 Normal deviate score	Standard Deviation 1.18
Tanezumab	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Change at Week 16: VDT Left Thigh	-0.06 Normal deviate score	Standard Deviation 0.87
Tanezumab	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Baseline: HPDT 0.5 Left Foot	0.38 Normal deviate score	Standard Deviation 2.21
Tanezumab	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Change at Week 16: CDT Left Foot	-0.16 Normal deviate score	Standard Deviation 0.81
Tanezumab	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Baseline: HPDT 5.0 Left Foot	1.06 Normal deviate score	Standard Deviation 2
Tanezumab	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Change at Week 16:HPDT 5.0-0.5 Left Thigh	0.22 Normal deviate score	Standard Deviation 1.38
Tanezumab	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Baseline: HPDT 5.0-0.5 Left Foot	0.80 Normal deviate score	Standard Deviation 1.38
Tanezumab	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Change at Week 16: HPDT 0.5 Left Foot	-0.04 Normal deviate score	Standard Deviation 1.54
Tanezumab	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Baseline: VDT Left Thigh	1.07 Normal deviate score	Standard Deviation 1.28
Tanezumab	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Change at Week 16: CDT Left Thigh	0.09 Normal deviate score	Standard Deviation 0.87
Tanezumab	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Baseline: CDT Left Thigh	1.76 Normal deviate score	Standard Deviation 1.05
Tanezumab	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Change at Week 16: HPDT 5.0 Left Foot	0.09 Normal deviate score	Standard Deviation 1.2
Tanezumab	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Baseline: HPDT 0.5 Left Thigh	-0.48 Normal deviate score	Standard Deviation 1.17
Tanezumab	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Change at Week 16: HPDT 5.0 Left	-0.05 Normal deviate score	Standard Deviation 1.57
Tanezumab	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Baseline: HPDT 5.0 Left Thigh	-0.04 Normal deviate score	Standard Deviation 1.41
Tanezumab	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Change at Week 16:HPDT 5.0-0.5 Left Foot	0.21 Normal deviate score	Standard Deviation 1.48
Tanezumab	Change From Baseline in Quantitative Sensory Testing (QST) at Week 16	Baseline: HPDT 5.0-0.5 Left Thigh	0.71 Normal deviate score	Standard Deviation 1.42

Secondary

Change From Baseline in the Average Density of Protein Gene Product (PGP) 9.5-Positive Intraepidermal Nerve Fiber (IENF) at Week 16: LOCF

IENF density was quantified in 3 millimeter (mm) immunostained skin punch biopsies containing epidermis and superficial dermis to evaluate the amount and morphological appearance of small diameter nerve fibers, both somatic and autonomic, in sensory neuropathies. IENF density was assessed from skin biopsies taken from the distal calves and distal thigh.

Time frame: Baseline, Week 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of study medication. LOCF method of imputation was used.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline in the Average Density of Protein Gene Product (PGP) 9.5-Positive Intraepidermal Nerve Fiber (IENF) at Week 16: LOCF	Change at Week 16: Distal Calves	0.40 Fibers/mm	Standard Error 0.22
Placebo	Change From Baseline in the Average Density of Protein Gene Product (PGP) 9.5-Positive Intraepidermal Nerve Fiber (IENF) at Week 16: LOCF	Change at Week 16: Distal Thighs	0.40 Fibers/mm	Standard Error 0.45
Tanezumab	Change From Baseline in the Average Density of Protein Gene Product (PGP) 9.5-Positive Intraepidermal Nerve Fiber (IENF) at Week 16: LOCF	Change at Week 16: Distal Calves	-0.15 Fibers/mm	Standard Error 0.21
Tanezumab	Change From Baseline in the Average Density of Protein Gene Product (PGP) 9.5-Positive Intraepidermal Nerve Fiber (IENF) at Week 16: LOCF	Change at Week 16: Distal Thighs	-0.30 Fibers/mm	Standard Error 0.45

Secondary

Change From Baseline Neuropathy Symptoms and Change (NSC) Score at Week 16: Last Observation Carried Forward (LOCF)

The NSC (Neuropathy symptoms and change) is a standardized instrument and has been used to evaluate participants for number of symptoms of peripheral neuropathy. The NSC score included 38 (muscle weakness, Q1-19; sensation, Q20-29; and autonomic symptoms, Q30-38) symptom questions where the participants indicated experiencing the number of symptoms (to any severity). The score ranged from 0 to 38, with higher scores indicated more symptoms. The change score is the participant's comparison of the symptoms at last evaluation to the symptoms at onset. A change from baseline \> 0 indicated increased neuropathy.

Time frame: Baseline, Week 16

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline Neuropathy Symptoms and Change (NSC) Score at Week 16: Last Observation Carried Forward (LOCF)	Baseline	6.97 Units on a scale	Standard Deviation 4.04
Placebo	Change From Baseline Neuropathy Symptoms and Change (NSC) Score at Week 16: Last Observation Carried Forward (LOCF)	Change at Week 16	-1.07 Units on a scale	Standard Deviation 1.84
Tanezumab	Change From Baseline Neuropathy Symptoms and Change (NSC) Score at Week 16: Last Observation Carried Forward (LOCF)	Baseline	7.57 Units on a scale	Standard Deviation 3.49
Tanezumab	Change From Baseline Neuropathy Symptoms and Change (NSC) Score at Week 16: Last Observation Carried Forward (LOCF)	Change at Week 16	-1.56 Units on a scale	Standard Deviation 2.85

Secondary

Days Per Week of Rescue Medication Usage

Participants who did not experience adequate pain relief for DPN pain during the treatment period took acetaminophen 3000 mg/day up to 3 days/week as rescue medication.

Time frame: Week 1, 2, 4, 6, 8, 12, 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of study medication. LOCF method of imputation was used. Here, 'Overall Number of Participants Analyzed'=participants evaluable for this measure. 'Number Analyzed' signifies those participants who were evaluable for this measure at given time point for each arm, respectively.

Arm	Measure	Group	Value (MEDIAN)
Placebo	Days Per Week of Rescue Medication Usage	Week 12	1 Days per week
Placebo	Days Per Week of Rescue Medication Usage	Week 4	1 Days per week
Placebo	Days Per Week of Rescue Medication Usage	Week 16	1 Days per week
Placebo	Days Per Week of Rescue Medication Usage	Week 8	1 Days per week
Placebo	Days Per Week of Rescue Medication Usage	Week 2	1 Days per week
Tanezumab	Days Per Week of Rescue Medication Usage	Week 16	0 Days per week
Tanezumab	Days Per Week of Rescue Medication Usage	Week 12	0 Days per week
Tanezumab	Days Per Week of Rescue Medication Usage	Week 2	1 Days per week
Tanezumab	Days Per Week of Rescue Medication Usage	Week 4	0 Days per week
Tanezumab	Days Per Week of Rescue Medication Usage	Week 8	0 Days per week
Unknown	Days Per Week of Rescue Medication Usage	Week 6	— Days per week
Unknown	Days Per Week of Rescue Medication Usage	Week 1	— Days per week

Secondary

Number of Participants Who Used Rescue Medication

Participants who did not experience adequate pain relief for DPN pain during the treatment period took acetaminophen 3000 mg/day up to 3 days/week as rescue medication.

Time frame: Week 1, 2, 4, 6, 8, 12, 16

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants Who Used Rescue Medication	Week 4	12 Participants
Placebo	Number of Participants Who Used Rescue Medication	Week 8	12 Participants
Placebo	Number of Participants Who Used Rescue Medication	Week 2	13 Participants
Placebo	Number of Participants Who Used Rescue Medication	Week 12	12 Participants
Placebo	Number of Participants Who Used Rescue Medication	Week 6	13 Participants
Placebo	Number of Participants Who Used Rescue Medication	Week 16	12 Participants
Placebo	Number of Participants Who Used Rescue Medication	Week 1	14 Participants
Tanezumab	Number of Participants Who Used Rescue Medication	Week 16	12 Participants
Tanezumab	Number of Participants Who Used Rescue Medication	Week 1	20 Participants
Tanezumab	Number of Participants Who Used Rescue Medication	Week 2	17 Participants
Tanezumab	Number of Participants Who Used Rescue Medication	Week 4	13 Participants
Tanezumab	Number of Participants Who Used Rescue Medication	Week 6	13 Participants
Tanezumab	Number of Participants Who Used Rescue Medication	Week 8	12 Participants
Tanezumab	Number of Participants Who Used Rescue Medication	Week 12	12 Participants

Secondary

Number of Participants With Anti Drug Antibody (ADA) for Tanezumab

Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA).

Time frame: Baseline, Week 8, 16, 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of study medication. Here, 'Number Analyzed' signifies those participants who were evaluable for this measure at given time points for Tanezumab 20 mg group.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants With Anti Drug Antibody (ADA) for Tanezumab	Week 16	1 Participants
Placebo	Number of Participants With Anti Drug Antibody (ADA) for Tanezumab	Baseline	0 Participants
Placebo	Number of Participants With Anti Drug Antibody (ADA) for Tanezumab	Week 8	0 Participants
Placebo	Number of Participants With Anti Drug Antibody (ADA) for Tanezumab	Week 24	0 Participants

Secondary

Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)

Time frame: Week 1, 2, 4, 6, 8, 12, 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of study medication. LOCF method of imputation was used.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 16: >= 70% Reduction	2 Participants
Placebo	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 1: >= 30% Reduction	4 Participants
Placebo	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 1: >= 50% Reduction	2 Participants
Placebo	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 1: >= 70% Reduction	0 Participants
Placebo	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 1: >= 90% Reduction	0 Participants
Placebo	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 2: >= 30% Reduction	6 Participants
Placebo	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 2: >= 50% Reduction	3 Participants
Placebo	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 2: >= 70% Reduction	2 Participants
Placebo	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 2: >= 90% Reduction	1 Participants
Placebo	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 4: >= 30% Reduction	6 Participants
Placebo	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 4: >= 50% Reduction	3 Participants
Placebo	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 4: >= 70% Reduction	2 Participants
Placebo	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 4: >= 90% Reduction	1 Participants
Placebo	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 6: >= 30% Reduction	6 Participants
Placebo	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 6: >= 50% Reduction	2 Participants
Placebo	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 6: >= 70% Reduction	2 Participants
Placebo	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 6: >= 90% Reduction	1 Participants
Placebo	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 8: >= 30% Reduction	6 Participants
Placebo	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 8: >= 50% Reduction	4 Participants
Placebo	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 8: >= 70% Reduction	2 Participants
Placebo	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 8: >= 90% Reduction	1 Participants
Placebo	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 12: >= 30% Reduction	7 Participants
Placebo	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 12: >= 50% Reduction	4 Participants
Placebo	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 12: >= 70% Reduction	2 Participants
Placebo	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 12: >= 90% Reduction	1 Participants
Placebo	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 16: >= 30% Reduction	7 Participants
Placebo	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 16: >= 50% Reduction	5 Participants
Placebo	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 16: >= 90% Reduction	1 Participants
Tanezumab	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 6: >= 50% Reduction	10 Participants
Tanezumab	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 16: >= 30% Reduction	15 Participants
Tanezumab	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 1: >= 30% Reduction	8 Participants
Tanezumab	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 6: >= 70% Reduction	7 Participants
Tanezumab	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 1: >= 50% Reduction	3 Participants
Tanezumab	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 12: >= 50% Reduction	12 Participants
Tanezumab	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 1: >= 70% Reduction	1 Participants
Tanezumab	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 6: >= 90% Reduction	3 Participants
Tanezumab	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 1: >= 90% Reduction	0 Participants
Tanezumab	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 16: >= 90% Reduction	4 Participants
Tanezumab	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 2: >= 30% Reduction	12 Participants
Tanezumab	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 8: >= 30% Reduction	15 Participants
Tanezumab	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 2: >= 50% Reduction	7 Participants
Tanezumab	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 12: >= 70% Reduction	11 Participants
Tanezumab	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 2: >= 70% Reduction	1 Participants
Tanezumab	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 8: >= 50% Reduction	12 Participants
Tanezumab	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 2: >= 90% Reduction	0 Participants
Tanezumab	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 16: >= 50% Reduction	12 Participants
Tanezumab	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 4: >= 30% Reduction	15 Participants
Tanezumab	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 8: >= 70% Reduction	8 Participants
Tanezumab	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 4: >= 50% Reduction	9 Participants
Tanezumab	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 12: >= 90% Reduction	4 Participants
Tanezumab	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 4: >= 70% Reduction	5 Participants
Tanezumab	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 8: >= 90% Reduction	5 Participants
Tanezumab	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 4: >= 90% Reduction	1 Participants
Tanezumab	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 16: >= 70% Reduction	11 Participants
Tanezumab	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 6: >= 30% Reduction	15 Participants
Tanezumab	Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)	Week 12: >= 30% Reduction	15 Participants

Secondary

Number of Participants With Clinically Significant Change From Baseline Physical Examination

Physical examination included examination of following sites in addition to general examination: abdomen, ears, extremities, eyes, head, heart, musculoskeletal, neck, nose, skin, throat, lungs and thyroid.

Time frame: Baseline up to Week 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of study medication.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants With Clinically Significant Change From Baseline Physical Examination	0 Participants
Tanezumab	Number of Participants With Clinically Significant Change From Baseline Physical Examination	2 Participants

Secondary

Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities

Following parameters were analyzed for ECG abnormality: PR interval, QRS interval, QT interval, QT interval corrected using the Fridericia's formula (QTcF), QT interval corrected using the Bazett's formula (QTcB), RR interval and heart rate (HR). Number of participants with clinically significant abnormal ECG findings reported as adverse events were presented.

Time frame: Baseline up to Week 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of study medication.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities	1 Participants
Tanezumab	Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities	4 Participants

Secondary

Number of Participants With Clinically Significant Laboratory Values

Criteria:Hemoglobin(Hgb),hematocrit,red blood cell(RBC)count:less than(\<)0.8\*lower limit of normal(LLN), mean cell Hgb,mean corpuscular volume,mean corpuscular Hgb concentration,mean platelet volume:\<0.9\*LLNor\>1.1\*upper limit of normal(ULN),platelet:\<0.5\*LLN \>1.75\* ULN, lymphocyte,neutrophil:\<0.8\*LLN or\>1.2\*ULN,basophil, eosinophil,monocyte:\>1.2\*ULN;bilirubin(total, direct,)\>1.5\*ULN, aspartate and alanine aminotransferase,alkaline phosphatase:\> 3.0\*ULN;gamma GT\>3.0;cholestrol,triglycerides:\>1.3\*ULN; total protein, albumin:\<0.8\*LLN or\>1.2\*ULN ;blood urea nitrogen,creatinine:\>1.3\*ULN,uric acid\>1.2\*ULN;sodium \<0.95\*LLNor\>1.05\*ULN,potassium,chloride,calcium,bicarbonate, magnesium:\<0.9\*LLN or \>1.1\*ULN;phosphate\<0.8\*LLN or\>1.2\*ULN;glucose \<0.6\*LLNor\>1.5\*ULN,glycosylated Hgb\>1.3\*ULN,creatine kinase \>2.0\*ULN;urine(specific gravity\<1.003or\>1.030;pH \<4.8or\>8;glucose,ketone,proteins,blood/Hgb,bilirubin,nitrite\>=1;WBC, RBC≥20/HPF;hyaline cast≥1;epithelial cell\>=6;bacteria \>1);serum pregnancy \>=1.

Time frame: Baseline up to Week 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of study medication. Here, 'Overall Number of Participants Analyzed'= total number of participants with at least one observation of the given laboratory test while on study treatment or during lag time.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants With Clinically Significant Laboratory Values	33 Participants
Tanezumab	Number of Participants With Clinically Significant Laboratory Values	32 Participants

Secondary

Number of Participants With Clinically Significant Vital Signs Abnormalities

Following parameters were analyzed for examination of vital signs: body temperature, blood pressure, pulse rate and respiratory rate. Number of participants with clinically significant abnormality in vital signs reported as adverse events were presented.

Time frame: Baseline up to Week 24

Population: ITT analysis set included all randomized participants who received at least 1 dose of study medication.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants With Clinically Significant Vital Signs Abnormalities	1 Participants
Tanezumab	Number of Participants With Clinically Significant Vital Signs Abnormalities	0 Participants

Secondary

Number of Participants With Cumulative Reduction From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16

Participant rated their DPN pain using 11-point NRS with score ranging from 0 (no pain) to 10 (worst possible pain) during past 24-hour period. Higher score indicated greater level of pain.

Time frame: Week 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of study medication. LOCF method of imputation was used.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants With Cumulative Reduction From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16	>= 30%	7 Participants
Placebo	Number of Participants With Cumulative Reduction From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16	>= 60%	3 Participants
Placebo	Number of Participants With Cumulative Reduction From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16	>= 20%	10 Participants
Placebo	Number of Participants With Cumulative Reduction From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16	>= 70%	2 Participants
Placebo	Number of Participants With Cumulative Reduction From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16	>= 40%	5 Participants
Placebo	Number of Participants With Cumulative Reduction From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16	>= 80%	1 Participants
Placebo	Number of Participants With Cumulative Reduction From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16	Greater than equal to (>=) 10%	18 Participants
Placebo	Number of Participants With Cumulative Reduction From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16	>= 90%	1 Participants
Placebo	Number of Participants With Cumulative Reduction From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16	>= 50%	5 Participants
Placebo	Number of Participants With Cumulative Reduction From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16	= 100%	1 Participants
Placebo	Number of Participants With Cumulative Reduction From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16	Greater than (>) 0%	23 Participants
Tanezumab	Number of Participants With Cumulative Reduction From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16	= 100%	4 Participants
Tanezumab	Number of Participants With Cumulative Reduction From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16	Greater than (>) 0%	24 Participants
Tanezumab	Number of Participants With Cumulative Reduction From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16	Greater than equal to (>=) 10%	20 Participants
Tanezumab	Number of Participants With Cumulative Reduction From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16	>= 20%	20 Participants
Tanezumab	Number of Participants With Cumulative Reduction From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16	>= 30%	15 Participants
Tanezumab	Number of Participants With Cumulative Reduction From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16	>= 40%	14 Participants
Tanezumab	Number of Participants With Cumulative Reduction From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16	>= 50%	12 Participants
Tanezumab	Number of Participants With Cumulative Reduction From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16	>= 60%	11 Participants
Tanezumab	Number of Participants With Cumulative Reduction From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16	>= 70%	11 Participants
Tanezumab	Number of Participants With Cumulative Reduction From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16	>= 80%	9 Participants
Tanezumab	Number of Participants With Cumulative Reduction From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16	>= 90%	4 Participants

Secondary

Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy

Time frame: Week 4, 8, 12, 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of study medication. LOCF method of imputation was used.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy	Week 4	1 Participants
Placebo	Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy	Week 8	2 Participants
Placebo	Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy	Week 12	2 Participants
Placebo	Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy	Week 16	2 Participants
Tanezumab	Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy	Week 16	5 Participants
Tanezumab	Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy	Week 4	6 Participants
Tanezumab	Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy	Week 12	5 Participants
Tanezumab	Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy	Week 8	5 Participants

Secondary

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

Time frame: Baseline up to 112 days after last dose of study treatment (up to 169 days)

Population: ITT analysis set included all randomized participants who received at least 1 dose of study medication.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	AEs	19 Participants
Placebo	Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	SAEs	0 Participants
Tanezumab	Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	AEs	24 Participants
Tanezumab	Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	SAEs	1 Participants

Secondary

Plasma Tanezumab Concentration

Time frame: Baseline(Day 1), Week 2, 4, 8, 12, 16, 24

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Plasma Tanezumab Concentration	Day 1	13.66 nanogram per milliliter (ng/mL)	Standard Deviation 59.71
Placebo	Plasma Tanezumab Concentration	Week 2	1752 nanogram per milliliter (ng/mL)	Standard Deviation 610.54
Placebo	Plasma Tanezumab Concentration	Week 4	1316 nanogram per milliliter (ng/mL)	Standard Deviation 438.16
Placebo	Plasma Tanezumab Concentration	Week 8	591.9 nanogram per milliliter (ng/mL)	Standard Deviation 232.07
Placebo	Plasma Tanezumab Concentration	Week 12	475.9 nanogram per milliliter (ng/mL)	Standard Deviation 430.22
Placebo	Plasma Tanezumab Concentration	Week 16	265.6 nanogram per milliliter (ng/mL)	Standard Deviation 282.5
Placebo	Plasma Tanezumab Concentration	Week 24	97.77 nanogram per milliliter (ng/mL)	Standard Deviation 59.975

Secondary

Serum Nerve Growth Factor (NGF)

Serum samples were analyzed for determining total NGF concentration. Total NGF was analyzed using a validated, sensitive and specific immunoaffinity enrichment liquid chromatography tandem mass spectrometric (IA/LC/MS/MS) method.

Time frame: Day 1, Week 8, 16, 24

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Serum Nerve Growth Factor (NGF)	Day 1	48.10 picogram per milliliter (pg/mL)	Standard Deviation 11.04
Placebo	Serum Nerve Growth Factor (NGF)	Week 8	50.15 picogram per milliliter (pg/mL)	Standard Deviation 11.21
Placebo	Serum Nerve Growth Factor (NGF)	Week 16	46.12 picogram per milliliter (pg/mL)	Standard Deviation 10.65
Placebo	Serum Nerve Growth Factor (NGF)	Week 24	38.69 picogram per milliliter (pg/mL)	Standard Deviation 4.47
Tanezumab	Serum Nerve Growth Factor (NGF)	Week 24	2689.0 picogram per milliliter (pg/mL)	Standard Deviation 316.8
Tanezumab	Serum Nerve Growth Factor (NGF)	Day 1	45.54 picogram per milliliter (pg/mL)	Standard Deviation 12.25
Tanezumab	Serum Nerve Growth Factor (NGF)	Week 16	2811.3 picogram per milliliter (pg/mL)	Standard Deviation 1284
Tanezumab	Serum Nerve Growth Factor (NGF)	Week 8	4193.9 picogram per milliliter (pg/mL)	Standard Deviation 1304

Secondary

Time to Discontinuation Due to Lack of Efficacy

Time frame: Baseline up to Week 16

Population: ITT analysis set included all randomized participants who received at least 1 dose of study medication.

Arm	Measure	Value (MEDIAN)
Placebo	Time to Discontinuation Due to Lack of Efficacy	5.0 Days
Tanezumab	Time to Discontinuation Due to Lack of Efficacy	21.0 Days

Other Pre-specified

Number of Participants With Subcutaneous Doses of Study Medication

Number of participants are reported based on the maximum number of Subcutaneous doses of either tanezumab or placebo received.

Time frame: Day 1 up to Week 8

Population: ITT analysis set included all randomized participants who received at least 1 dose of study medication.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants With Subcutaneous Doses of Study Medication	1 dose	32 Participants
Placebo	Number of Participants With Subcutaneous Doses of Study Medication	2 doses	3 Participants
Tanezumab	Number of Participants With Subcutaneous Doses of Study Medication	1 dose	35 Participants
Tanezumab	Number of Participants With Subcutaneous Doses of Study Medication	2 doses	3 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

A Study Of The Analgesic (Pain-Relief) Effects Of Tanezumab In Adult Patients With Diabetic Peripheral Neuropathy

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Brief summary

Detailed description

Related papers

Interventions

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Study design

Eligibility

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Design outcomes

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Secondary

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Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16

Amount of Rescue Medication Taken

Change From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 1, 2, 4, 6, 8, and 12

Change From Baseline in BPI-sf Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and Week 16

Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Worst and Average Pain Score at Week 8 and 16

Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility at Week 16

Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score at Week 8 and 16: Last Observation Carried Forward (LOCF)

Change From Baseline in Neuropathy Impairment Score (NIS) at Weeks 2, 4, 8, 12, 16 and 24: Last Observation Carried Forward (LOCF)

Change From Baseline in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy (DPN) at Week 4, 8, 12 and 16

Change From Baseline in Quantitative Sensory Testing (QST) at Week 16

Change From Baseline in the Average Density of Protein Gene Product (PGP) 9.5-Positive Intraepidermal Nerve Fiber (IENF) at Week 16: LOCF

Change From Baseline Neuropathy Symptoms and Change (NSC) Score at Week 16: Last Observation Carried Forward (LOCF)

Days Per Week of Rescue Medication Usage

Number of Participants Who Used Rescue Medication

Number of Participants With Anti Drug Antibody (ADA) for Tanezumab

Number of Participants With at Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average DPN Pain Score: Last Observation Carried Forward (LOCF)

Number of Participants With Clinically Significant Change From Baseline Physical Examination

Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities

Number of Participants With Clinically Significant Laboratory Values

Number of Participants With Clinically Significant Vital Signs Abnormalities

Number of Participants With Cumulative Reduction From Baseline in Average Diabetic Peripheral Neuropathy (DPN) Pain Score at Week 16

Number of Participants With Improvement of at Least 2 Points in Patient's Global Assessment (PGA) of Diabetic Peripheral Neuropathy

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Plasma Tanezumab Concentration

Serum Nerve Growth Factor (NGF)

Time to Discontinuation Due to Lack of Efficacy

Number of Participants With Subcutaneous Doses of Study Medication