Clinical Trial Details
| Trial ID: | L3834 |
| Source ID: | NCT02421510 |
| Associated Drug: | Sotagliflozin |
| Title: | Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy |
| Acronym: | inTandem2 |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT02421510/results |
| Conditions: | Type 1 Diabetes Mellitus |
| Interventions: | DRUG: Sotagliflozin|DRUG: Sotagliflozin|DRUG: Placebo |
| Outcome Measures: | Primary: Change From Baseline in A1C at Week 24, Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. Least square (LS) means were obtained from a mixed-effects model for repeated measures (MMRM) that included fixed, categorical effects of treatment, randomization strata of insulin delivery method (MDI, CSII), randomization strata of Week -2 A1C (\<= 8.5%, \>8.5%), time (study week), a treatment-by-time interaction, and baseline A1C-by-time interaction as a covariate. A negative change from baseline (a reduction of A1C value at Week 24) indicates an improvement., Baseline to Week 24 | Secondary: Percentage of Participants With A1C <7.0% at Week 24 and no Episode of Severe Hypoglycemia, and no Episode of Diabetic Ketoacidosis (DKA) From Baseline to Week 24, The composite endpoint included blood samples for the assessment of Hemoglobin A1C to determine the participants with a value \<7.0% and a central blinded adjudication process to determine whether participants experienced either DKA or severe hypoglycemia. Only positively adjudicated severe hypoglycemia and diabetic ketoacidosis were included in the analysis., Baseline to Week 24|Change From Baseline in Body Weight at Week 24, Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model. A negative change from baseline indicates a loss in body weight from baseline to Week 24., Baseline to Week 24|Change From Baseline in Mean Daily Bolus Insulin Dose at Week 24, The mean bolus insulin dose in international units/day (IU/day) for Week 24 was the average over the 3 to 5 days prior to the Week 24 visit. The Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model including all available post baseline values. A negative change from baseline indicated a reduction in the amount of bolus insulin used and a positive change from baseline indicated an increase in the amount of bolus insulin used between baseline and Week 24., Baseline to Week 24|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24, The Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model including all available post baseline values. A negative change from baseline indicates a lower glucose level at Week 24 compared to baseline and a positive change from baseline indicates an increase in glucose level at Week 24 compared to baseline., Baseline to Week 24|Change From Baseline in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score at Week 24, The DTSQ instrument contains 8 items assessing overall treatment satisfaction, treatment convenience and flexibility, satisfaction with understanding of diabetes, willingness to continue present treatment and to recommend it to others, and frequency of unacceptably high and unacceptably low blood glucose levels. 6 items (1, 4, 5, 6, 7 and 8) (excluding perceived hyperglycemia and hypoglycemia items) were scored using a 7- point scale where 0=very dissatisfied to 6= very satisfied for a total possible score of 0 (very dissatisfied) to 36 (very satisfied), where higher scores indicate higher satisfaction from treatment. Two items (Q2 and 3), which were not included, measured perceived hyperglycemia and hypoglycemia, respectively. The baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model including all available post baseline values. A positive change from baseline indicates improvement., Baseline to Week 24|Change From Baseline in 2-Item Diabetes Distress Screen 2 (DDS2) Score at Week 24, DDS2 is a 2-item diabetes distress screening instrument where participants rated the degree to which the following items caused distress: (1) feeling overwhelmed by the demands of living with diabetes, and (2) feeling that I am often failing with my diabetes regimen using a 6-point scale: where 1=no distress to 6=severe distress for a total possible score of 2 to 12. LS means were obtained from MMRM model including all available post baseline values. A negative change from baseline indicates improvement., Baseline to Week 24|Percent Change From Baseline in Body Weight at Week 24, Baseline value was defined as the last value collected prior to the first dose of double-blind study medication. LS means were obtained from MMRM model. A negative percent change from baseline indicates a loss in body weight from baseline to Week 24., Baseline to Week 24 |
| Sponsor/Collaborators: | Sponsor: Lexicon Pharmaceuticals | Collaborators: Sanofi |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 782 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2015-05 |
| Completion Date: | 2017-06-23 |
| Results First Posted: | 2019-10-30 |
| Last Update Posted: | 2020-02-12 |
| Locations: | Lexicon Investigational Site, Linz, 4021, Austria|Lexicon Investigational Site, Vienna, 1010, Austria|Lexicon Investigational Site, Vienna, 1030, Austria|Lexicon Investigational Site, Vienna, 1130, Austria|Lexicon Investigational Site, Vienna, 1160, Austria|Lexicon Investigational Site, Antwerp, 2018, Belgium|Lexicon Investigational Site, Brussels, 1090, Belgium|Lexicon Investigational Site, Edegem, 2650, Belgium|Lexicon Investigational Site, Leuven, 3000, Belgium|Lexicon Investigational Site, Sint Niklaas, 9100, Belgium|Lexicon Investigational Site, Lovech, 5500, Bulgaria|Lexicon Investigational Site, Plovdiv, 4002, Bulgaria|Lexicon Investigational Site, Ruse, 7002, Bulgaria|Lexicon Investigational Site, Smolyan, 4700, Bulgaria|Lexicon Investigational Site, Sofia, 1750, Bulgaria|Lexicon Investigational Site, Varna, 9000, Bulgaria|Lexicon Investigational Site, Beziers, 34500, France|Lexicon Investigational Site, Dijon cedex, 21079, France|Lexicon Investigational Site, Nantes, 44000, France|Lexicon Investigational Site, Nantes, 44093, France|Lexicon Investigational Site, Nîmes, 30029, France|Lexicon Investigational Site, Duesseldorf, 40210, Germany|Lexicon Investigational Site, Hamburg, 21073, Germany|Lexicon Investigational Site, Hamburg, 22607, Germany|Lexicon Investigational Site, Hannover, 30173, Germany|Lexicon Investigational Site, Mainz, 55116, Germany|Lexicon Investigational Site, Muenster, 48145, Germany|Lexicon Investigational Site, Neuwied, 56564, Germany|Lexicon Investigational Site, Budapest, 1027, Hungary|Lexicon Investigational Site, Budapest, 1042, Hungary|Lexicon Investigational Site, Budapest, 1097, Hungary|Lexicon Investigational Site, Budapest, 1106, Hungary|Lexicon Investigational Site, Budapest, 1134, Hungary|Lexicon Investigational Site, Gyula, 5700, Hungary|Lexicon Investigational Site, Hodmezovasarhely, 6800, Hungary|Lexicon Investigational Site, Zalaegerszeg, 8900, Hungary|Lexicon Investigational Site, Haifa, 31096, Israel|Lexicon Investigational Site, Holon, 58100, Israel|Lexicon Investigational Site, Jerusalem, 91120, Israel|Lexicon Investigational Site, Petah Tikva, 49202, Israel|Lexicon Investigational Site, Tel Aviv, 61480, Israel|Lexicon Investigational Site, Tel Hashomer, 52621, Israel|Lexicon Investigational Site, Zerifin, 70300, Israel|Lexicon Investigational Site, Catania, 95123, Italy|Lexicon Investigational Site, Milano, 20132, Italy|Lexicon Investigational Site, Palermo, 90127, Italy|Lexicon Investigational Site, Perugia, 06126, Italy|Lexicon Investigational Site, Pisa, 56124, Italy|Lexicon Investigational Site, Roma, 00128, Italy|Lexicon Investigational Site, Jonava, LT-55201, Lithuania|Lexicon Investigational Site, Kaunas, LT-49449, Lithuania|Lexicon Investigational Site, Kaunas, LT-50161, Lithuania|Lexicon Investigational Site, Dordrecht, 3318, Netherlands|Lexicon Investigational Site, Katowice, 40-060, Poland|Lexicon Investigational Site, Kraków, 30-015, Poland|Lexicon Investigational Site, Lodz, 90-242, Poland|Lexicon Investigational Site, Lublin, 20-538, Poland|Lexicon Investigational Site, Poznan, 61-655, Poland|Lexicon Investigational Site, Szczecin, 70-506, Poland|Lexicon Investigational Site, Warsaw, 04-736, Poland|Lexicon Investigational Site, Warszawa, 01-518, Poland|Lexicon Investigational Site, Warszawa, 02-507, Poland|Lexicon Investigational Site, Bacau, 600238, Romania|Lexicon Investigational Site, Bucuresti, 010507, Romania|Lexicon Investigational Site, Bucuresti, 013764, Romania|Lexicon Investigational Site, Buzau, 120203, Romania|Lexicon Investigational Site, Galati, 800098, Romania|Lexicon Investigational Site, Oradea, 410159, Romania|Lexicon Investigational Site, Sibiu, 550371, Romania|Lexicon Investigational Site, Targu-Mures, 540142, Romania|Lexicon Investigational Site, Bratislava, 821 02, Slovakia|Lexicon Investigational Site, Bratislava, 851 01, Slovakia|Lexicon Investigational Site, Kosice, 040 01, Slovakia|Lexicon Investigational Site, Nove Zamky, 940 01, Slovakia|Lexicon Investigational Site, Sturovo, 943 01, Slovakia|Lexicon Investigational Site, Vrutky, 038 61, Slovakia|Lexicon Investigational Site, Barcelona, 08035, Spain|Lexicon Investigational Site, Barcelona, 08036, Spain|Lexicon Investigational Site, Granada, 18012, Spain|Lexicon Investigational Site, Malaga, 29006, Spain|Lexicon Investigational Site, Sevilla, 41003, Spain|Lexicon Investigational Site, Sevilla, 41009, Spain|Lexicon Investigational Site, Sevilla, 41010, Spain|Lexicon Investigational Site, Sevilla, 41014, Spain|Lexicon Investigational Site, Valencia, 46014, Spain|Lexicon Investigational Site, Härnösand, 871 82, Sweden|Lexicon Investigational Site, Kristianstad, 291 85, Sweden|Lexicon Investigational Site, Stockholm, 112 21, Sweden|Lexicon Investigational Site, St. Gallen, 9007, Switzerland|Lexicon Investigational Site, Birmingham, B15 2TH, United Kingdom|Lexicon Investigational Site, Blackburn, BB2 3HH, United Kingdom|Lexicon Investigational Site, Bristol, BS10 5NB, United Kingdom|Lexicon Investigational Site, Glasgow, G4 0SF, United Kingdom|Lexicon Investigational Site, Leeds, LS2 9JT, United Kingdom|Lexicon Investigational Site, Leicester, LE5 4PW, United Kingdom|Lexicon Investigational Site, Sheffield, S5 7AU, United Kingdom |
| URL: | https://clinicaltrials.gov/show/NCT02421510 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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