| Outcome Measures: |
Primary: Change in weekly average Pain Intensity-Numerical Rating Scale (PI-NRS), The PI-NRS measures the intensity of pain. It is a numerical scale ranging from 0 (indicating no pain) to 10 (representing the worst pain imaginable). Measured as score on a scale., From baseline (week 0) to end of treatment (week 32) | Secondary: Number of participants reaching ≥30 percentage (%) reduction in PI-NRS, The PI-NRS measures the intensity of pain. It is a numerical scale ranging from 0 (indicating no pain) to 10 (representing the worst pain imaginable). Measured as count of participants., From baseline (week 0) to end of treatment (week 32)|Time to achieve ≥30% reduction in weekly average PI-NRS, The PI-NRS measures the intensity of pain. It is a numerical scale ranging from 0 (indicating no pain) to 10 (representing the worst pain imaginable). Measured as days., From baseline (week 0) to end of treatment (week 32)|Number of participants reaching ≥50 % reduction in PI-NRS, The PI-NRS measures the intensity of pain. It is a numerical scale ranging from 0 (indicating no pain) to 10 (representing the worst pain imaginable). Measured as count of participants., From baseline (week 0) to end of treatment (week 32)|Time to achieve ≥50% reduction in weekly average PI-NRS, The PI-NRS measures the intensity of pain. It is a numerical scale ranging from 0 (indicating no pain) to 10 (representing the worst pain imaginable). Measured as days., From baseline (week 0) to end of treatment (week 32)|Change in Brief Pain Inventory-Short Form (BPI-SF), The BPI-SF measures the severity of pain and the impact of pain on daily functions. It consists of two sections: Pain Severity and Pain Interference. Pain Severity is calculated as the average of four domains: Worst Pain, Least Pain, Average Pain, and Current Pain. Pain Interference is calculated as the average of seven domains: General Activity, Mood, Walking Ability, Normal Work, Relations with Other People, Sleep, and Enjoyment of Life. Each domain is measured on a scale from 0 to 10. Higher scores indicate more severe pain and greater interference with daily life. Measured as score on a scale., From baseline (week 0) to end of treatment (week 32)|Change in Chronic Pain Sleep Inventory 3-item (CPSI 3), The CPSI-3 measures the impact of chronic pain on sleep quality. It consists of 3 items and each item is rated on a scale where 0 represents 'never' and 100 represents 'always'. Higher scores indicate more frequent sleep disturbances and, consequently, a worse outcome in terms of sleep quality due to chronic pain. Measured as score on a scale., From baseline (week 0) to end of treatment (week 32)|Change in Michigan Neuropathy Screening Instrument (MNSI), The MNSI is a specialised tool designed to screen for the presence of diabetic neuropathy. It consists of 2 parts: a 15-item questionnaire that assesses symptoms related to foot sensation, including pain, numbness, and temperature sensitivity. Each item can be answered 'yes' (1 point) or 'no (0 points). Higher scores indicate more neuropathic symptoms and patients with a total score \>4 points are considered to have neuropathy. a physical examination conducted by a health professional. Higher scores indicate more neuropathic symptoms and a physical assessment score ≥2.5 indicates a diagnosis of clinical neuropathy with a sensitivity and specificity of 61% and 95%, respectively. Measured as score on a scale., From baseline (week 0) to end of treatment (week 32)|Change in systolic blood pressure, Measured as millimeters of mercury (mmHg)., From baseline (week 0) to end of treatment (week 32)|Change in diastolic blood pressure, Measured as mmHg., From baseline (week 0) to end of treatment (week 32)|Change in glycated haemoglobin (HbA1c), Measured as percentage of HbA1c., From baseline (week 0) to end of treatment (week 32)|Change in Fasting Plasma Glucose (FPG), Measured as millimole per liter (mmol/L)., From baseline (week 0) to end of treatment (week 32)|Relative change in body weight, Measured as percentage change., From baseline (week 0) to end of treatment (week 32)|Change in waist circumference, Measured as centimeter (cm)., From baseline (week 0) to end of treatment (week 32)|Ratio to Baseline in Lipids: Total Cholesterol, Measured as ratio., From baseline (week 0) to end of treatment (week 32)|Ratio to Baseline in Lipids: High-density lipoprotein (HDL) cholesterol, Measured as ratio., From baseline (week 0) to end of treatment (week 32)|Ratio to Baseline in Lipids: Low-density lipoprotein (LDL) cholesterol, Measured as ratio., From baseline (week 0) to end of treatment (week 32)|Ratio to Baseline in Lipids: Very low-density lipoprotein (VLDL) cholesterol, Measured as ratio., From baseline (week 0) to end of treatment (week 32)|Ratio to Baseline in Lipids: Triglycerides, Measured as ratio., From baseline (week 0) to end of treatment (week 32)|Ratio to Baseline in Lipids: Free fatty acids, Measured as ratio., From baseline (week 0) to end of treatment (week 32)|Ratio to Baseline in Lipids: Non-HDL cholesterol, Measured as ratio., From baseline (week 0) to end of treatment (week 32)|Relative change in high sensitivity C-reactive protein (hsCRP), Measured as percentage change., From baseline (week 0) to end of treatment (week 32)|Number of treatment-emergent adverse events (TEAEs), Measured as count of events., From baseline (week 0) to end of study (week 38)|Number of treatment-emergent serious adverse events (TESAEs), Measured as count of events., From baseline (week 0) to end of study (week 38)|Number of severe hypoglycaemic episodes (level 3) (No specific glucose threshold), Severe hypoglycaemia is a severe event characterised by altered mental and/or physical status requiring assistance from another person to actively administer carbohydrates, glucagon, or take other corrective actions to treat hypoglycaemia. Measured as count of episodes., From baseline (week 0) to end of study (week 38)|Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL) confirmed by blood glucose meter)), Measured as count of episodes., From baseline (week 0) to end of study (week 38)
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| Locations: |
eStudySite, La Mesa, California, 91942, United States|Linda Vista Health Care Ctr, San Diego, California, 92111, United States|My Preferred Research, Miami, Florida, 33155, United States|New Horizon Research Center, Miami, Florida, 33165, United States|Renstar Medical Research, Ocala, Florida, 34471, United States|Foot & Ankle Center of Illinois, Springfield, Illinois, 62704, United States|Velocity Clinical Research Rockville, Rockville, Maryland, 20854, United States|Amicis Centers of Clinical Research, Saint Louis, Missouri, 63128, United States|Southgate Medical Group, LLP, West Seneca, New York, 14224, United States|Piedmont Healthcare/Research, Statesville, North Carolina, 28625, United States|Lillestol Research LLC, Fargo, North Dakota, 58104, United States|Oregon Health & Science University, Portland, Oregon, 97239, United States|Clinical Res Collaborative, Cumberland, Rhode Island, 02864, United States|Radiance Clinical Research, Lampasas, Texas, 76550, United States|DM Clinical Research, San Antonio, Texas, 78207, United States|Velocity Clinical Research Portsmouth, Suffolk, Virginia, 23435, United States|G.A. Research Associates Ltd., Moncton, New Brunswick, E1G 1A7, Canada|Premier Clinical Trial Research Network (PCTRN), Hamilton, Ontario, L8L 5G4, Canada|Diabetes Heart Research Centre, Toronto, Ontario, M6G 1M2, Canada|Ctr de Med Metab de Lanaudiere, Terrebonne, Quebec, J6X 4P7, Canada|Aarhus Universitetshospital, Steno Diabetes Center Aarhus, Aarhus N, 8200, Denmark|Steno Diabetes Center Nordjylland, Gistrup, 9260, Denmark|Steno Diabetes Center Cph_Steno Diabetes Center Cph, Herlev, 2730, Denmark|Kolding Sygehus Karkirurgi, Kolding, 6000, Denmark|Steno Diabetes Center Odense, Odense C, 5000, Denmark|Les Hopitaux de Chartres-Hopital Louis Pasteur, Le Coudray, 28630, France|Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu-1, Le Creusot, 71200, France|Aphp-Hopital La Pitie Salpetriere-1, Paris, 75013, France|Centre Hospitalier Universitaire de Bordeaux-Hopital Haut Leveque-1, Pessac, 33600, France|Centre de Recherche Clinique Portes Du Sud, Venissieux, 69200, France|Haukeland Universitetssykehus, Bergen, 5021, Norway|Sykehuset Innlandet HF Hamar, Hamar, 2318, Norway|Oslo universitetssykehus, Ullevål, Oslo, 0450, Norway|Stavanger Universitetssykehus, Helse Stavanger HF, Stavanger, NO-4011, Norway|Hospital Nisa Sevilla Aljarafe, Castilleja De La Cuesta. Sevilla, Andalucia, 41950, Spain|Hospital Germans Trias i Pujol, Badalona, Barcelona, 08916, Spain|Hospital Vall d'Hebron, Barcelona, 08035, Spain|Complejo Hospitalario Universitario A Coruña, La Coruña, 15006, Spain|Hospital Universitario de la Princesa, Madrid, 28006, Spain|Hospital Universitario Marqués de Valdecilla, Santander, 39008, Spain|Hospital Infanta Luisa, Sevilla, 41010, Spain|Tameside General Hospital, Ashton-Under-Lyne, Greater Manchester, OL6 9RW, United Kingdom|Ipswich Hospital_ESNEFT, Ipswich, IP4 5PD, United Kingdom|University Hospital Aintree, Liverpool, L9 7AL, United Kingdom|Kings College Hospital, London, SW9 8RR, United Kingdom|Manchester Royal Infirmary, Manchester, M13 9WL, United Kingdom|Royal Hallamshire Hospital, Sheffield, S10 2JF, United Kingdom
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