18 and older, any sex, with Diabetic Peripheral Neuropathy or Diabetes. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline to Week 6 in ADPS as Measured by the Numerical Rating ScalePrimary· Baseline (Week 2 of the Run-in period) to Week 6
ADPS is based on question 5 of Brief Pain Inventory (BPI)-short form for Diabetic Peripheral Neuropathy (BPI-DPN) and is assessed on an 11-point numerical rating scale. Participants were asked to rate their average pain over the past 24 hours, by answering the question 5 "Please rate your pain due to your diabetes by indicating the one number that best describes your pain on the average." on a scale of 0 to 10: 0=no pain, and 10=pain as bad as you can imagine. Higher ADPS scores indicate higher pain intensity. Negative change from baseline indicates improvement.
Group
Value
95% CI
Placebo
-0.72
-1.08 – -0.36
LX9211 100 mg/10 mg
-1.39
-1.77 – -1.01
LX9211 200 mg/20 mg
-1.27
-1.66 – -0.88
Percentage of Participants With ≥30% Reduction in Pain Intensity in ADPS From Baseline to Week 6Secondary· Baseline (Week 2 of the Run-in period) to Week 6
ADPS is based on question 5 of BPI-DPN and assessed on an 11-point numerical rating scale. Participants were asked to rate their average pain over the past 24 hours, by answering the question 5 "Please rate your pain due to your diabetes by indicating the one number that best describes your pain on the average." on a scale of 0 to 10 where 0 = No Pain and 10 = pain as bad as you can imagine. If % change from Baseline ≤ (-30) then participant was considered a Responder and if missing % change from Baseline or \>(-30) participant is considered a Non-responder. Percentage of participants who were
Group
Value
95% CI
Placebo
17.8
LX9211 100 mg/10 mg
27.4
LX9211 200 mg/20 mg
17.0
Percentage of Participants With ≥50% Reduction in Pain Intensity in ADPS From Baseline at Week 6Secondary· Baseline (Week 2 of the Run-in period) to Week 6
ADPS is based on question 5 of BPI-DPN and assessed on an 11-point numerical rating scale. Participants were asked to rate their average pain over the past 24 hours, by answering the question 5 "Please rate your pain due to your diabetes by indicating the one number that best describes your pain on the average." on a scale of 0 to 10 where 0 = No Pain and 10 = pain as bad as you can imagine. If % change from Baseline ≤ (-50) then participant is considered a Responder and if missing % change from Baseline or \>(-50) then participant is considered a Non-responder. Percentage of participants who
Group
Value
95% CI
Placebo
10.3
LX9211 100 mg/10 mg
15.1
LX9211 200 mg/20 mg
9.4
Change From Baseline to Week 6 in Severity of Pain and Interference of Pain With Sleep and Other Aspects of the Participant's Life Based on the BPI-DPNSecondary· Baseline (Week 2 of the Run-in period) to Week 6
BPI-DPN: questionnaire that assesses severity of pain \& its impact on functioning in participants with DPN. It consists of 4 questions that measure pain at its "worst,"least","average","now"(current pain) on 11-point numerical scale 0=no pain;10=worst pain.Score range:0-10 for each of these pain questions, higher scores=greater pain severity. Other 7 questions of BPI evaluate level of interference of pain on daily functioning (general activity,walking,work ability,mood,enjoyment of life,relations,sleep) on 11-point numerical scale, 0=does not interfere;10=completely interferes.Score range:0-1
Pain at its Worst
Group
Value
95% CI
Placebo
-0.69
-1.11 – -0.26
LX9211 100 mg/10 mg
-1.42
-1.87 – -0.97
LX9211 200 mg/20 mg
-1.38
-1.81 – -0.96
Pain at its Least
Group
Value
95% CI
Placebo
-0.69
-1.13 – -0.26
LX9211 100 mg/10 mg
-1.43
-1.89 – -0.98
LX9211 200 mg/20 mg
-1.38
-1.81 – -0.95
Pain Right Now
Group
Value
95% CI
Placebo
-0.55
-1.00 – -0.10
LX9211 100 mg/10 mg
-1.42
-1.89 – -0.95
LX9211 200 mg/20 mg
-1.03
-1.47 – -0.59
Interference Score Averaged Over Questions 9A - G
Group
Value
95% CI
Placebo
-0.74
-1.17 – -0.30
LX9211 100 mg/10 mg
-1.00
-1.46 – -0.53
LX9211 200 mg/20 mg
-0.97
-1.41 – -0.53
General Activity
Group
Value
95% CI
Placebo
-0.77
-1.25 – -0.28
LX9211 100 mg/10 mg
-0.96
-1.48 – -0.44
LX9211 200 mg/20 mg
-0.82
-1.31 – -0.33
Mood
Group
Value
95% CI
Placebo
-0.71
-1.22 – -0.19
LX9211 100 mg/10 mg
-0.72
-1.27 – -0.16
LX9211 200 mg/20 mg
-0.65
-1.18 – -0.13
Walking Ability
Group
Value
95% CI
Placebo
-0.74
-1.24 – -0.24
LX9211 100 mg/10 mg
-1.36
-1.89 – -0.83
LX9211 200 mg/20 mg
-1.22
-1.73 – -0.72
Normal Work
Group
Value
95% CI
Placebo
-1.01
-1.50 – -0.53
LX9211 100 mg/10 mg
-1.07
-1.58 – -0.55
LX9211 200 mg/20 mg
-1.05
-1.54 – -0.56
Percentage of Participants Discontinuing Treatment Due to Lack of EfficacySecondary· Baseline (Week 2 of the Run-in period) to Week 6
Lack of efficacy was defined as an increase of 30% from baseline in ADPS based on question 5 of the BPI-DPN. Baseline was defined as the average of the Week 2 Run-in period data collected by participants in the daily pain diary of BPI-DPN. ADPS is based on question 5 of BPI-DPN and assessed on an 11-point numerical rating scale where 0 = No Pain to 10 = pain as bad as you can imagine, higher score indicates higher pain intensity.
Group
Value
95% CI
Placebo
0
LX9211 100 mg/10 mg
0
LX9211 200 mg/20 mg
0
Patient Global Impression of Change (PGIC) Scale Score at Week 6Secondary· Baseline (Week 2 of the Run-in period) to Week 6
PGIC is a 7-point rating scale that assesses participant's belief about the overall improvement experienced after the end of treatment, where 1= very much improved to 7 = very much worse. Higher score indicates worsening.
Group
Value
95% CI
Placebo
3.28
3.04 – 3.52
LX9211 100 mg/10 mg
2.93
2.69 – 3.17
LX9211 200 mg/20 mg
3.13
2.88 – 3.38
Time to Loss of Efficacy From Week 6 to Week 11 Among Participants Achieving a ≥30% Reduction in Pain Intensity at Week 6Secondary· Weeks 6 to 11
For participants who achieved ≥30% reduction in ADPS based on Question 5 of the BPI-DPN at Week 6, the time to loss of efficacy was defined as the time from the date of Week 6 visit to the date of termination of safety follow-up due to lack of efficacy. ADPS is based on question 5 of BPI-DPN and assessed on an 11-point numerical rating scale where, 0 = No Pain to 10 = pain as bad as you can imagine.
Group
Value
95% CI
Placebo
NA
NA – NA
LX9211 100 mg/10 mg
NA
NA – NA
LX9211 200 mg/20 mg
NA
NA – NA
Number of Participants With Treatment-emergent Adverse Events (TEAEs)Secondary· First dose of study drug after randomization up to the end of study (up to Week 11)
Adverse Events (AE) is defined as any sign, symptom, or diagnosis/disease that is unfavorable or unintended, that is new, or if pre-existing, worsens in participants administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. Treatment-emergent AEs are defined as any AEs that occur or worsen after the first dose of study medication.
Time frame: First dose of study drug after randomization up to the end of study (up to Week 11).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Evaluation of the efficacy of a low and high dose of LX9211 compared to placebo in reducing pain related to diabetic peripheral neuropathy (DPNP) over an 11 week assessment period.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04662281 — Efficacy and Safety of LX9211 in Participants With Postherpetic Neuralgia
· Phase 2
· completed
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Other Lexicon Pharmaceuticals trials
Trials by the same sponsor.
NCT06203002 — A Dose-ranging Study in Patients With Diabetic Peripheral Neuropathic Pain (DPNP)
· Phase 2
· completed
NCT04662281 — Efficacy and Safety of LX9211 in Participants With Postherpetic Neuralgia
· Phase 2
· completed
NCT03521934 — Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLO
· Phase 3
· terminated
NCT03386344 — Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Wh
· Phase 3
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· Phase 3
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Lexicon Pharmaceuticals
Last refreshed: 25 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04455633.