Clinical Trial Details
| Trial ID: | L4263 |
| Source ID: | NCT02384941 |
| Associated Drug: | Placebo |
| 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: | inTandem1 |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT02384941/results |
| Conditions: | Type 1 Diabetes Mellitus |
| Interventions: | DRUG: Placebo|DRUG: Sotagliflozin |
| 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 lower 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) Upto Week 24, Blood samples were collected for the assessment of Hemoglobin A1C to determine the participants with A1C value \<7.0%. A central blinded adjudication process determined 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|Absolute 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 per 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 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 at Week 24 compared to baseline., Baseline to Week 24|Change From Baseline in Diabetes Total Treatment Satisfaction Scores as Measured by Total Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) Scores at Week 24, DTSQs is a diabetes-specific measure used to evaluate overall treatment satisfaction and perception of hyperglycemia and hypoglycemia events. It consists of 8 items and the response categories for all items were on a 7-point likert scale.The DTSQs response options ranged from 0 (very dissatisfied) to 6 (very satisfied). Responses to item 1, 4, 5, 6, 7 and 8 were summarized to determine the total treatment satisfaction score which ranged from 0 (very dissatisfied) to 36 (very satisfied), with a higher score corresponding to higher satisfaction . 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 Diabetes Distress Scores as Measured by 2-item Diabetes Distress Screening Scale (DDS2) Scores at Week 24, The DDS2 is a 2-item diabetes distress screening instrument where respondents rated, on a 6-point scale, 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 (not a problem) to 12 (very serious problem), with higher score corresponding to higher distress. 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: | 793 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT |
| Start Date: | 2015-03 |
| Completion Date: | 2017-02 |
| Results First Posted: | 2019-11-25 |
| Last Update Posted: | 2020-02-12 |
| Locations: | Lexicon Investigational Site, Birmingham, Alabama, 35294, United States|Lexicon Investigational Site, Little Rock, Arkansas, 72205, United States|Lexicon Investigational Site, Escondido, California, 92025, United States|Lexicon Investigational Site, Greenbrae, California, 94904, United States|Lexicon Investigational Site, Huntington Beach, California, 92648, United States|Lexicon Investigational Site, La Jolla, California, 92037, United States|Lexicon Investigational Site, Los Angeles, California, 90057-3550, United States|Lexicon Investigational Site, Orange, California, 92868, United States|Lexicon Investigational Site, Palm Springs, California, 92262, United States|Lexicon Investigational Site, San Mateo, California, 94401, United States|Lexicon Investigational Site, Tarzana, California, 91356, United States|Lexicon Investigational Site, Tustin, California, 92780, United States|Lexicon Investigational Site, Walnut Creek, California, 94598, United States|Lexicon Investigational Site, Aurora, Colorado, 70045, United States|Lexicon Investigational Site, Longmont, Colorado, 80501, United States|Lexicon Investigational Site, Fleming Island, Florida, 32003, United States|Lexicon Investigational Site, Jacksonville, Florida, 32204, United States|Lexicon Investigational Site, Jacksonville, Florida, 32216, United States|Lexicon Investigational Site, New Port Richey, Florida, 34652, United States|Lexicon Investigational Site, Ormond Beach, Florida, 32174, United States|Lexicon Investigational Site, West Palm Beach, Florida, 33401, United States|Lexicon Investigational Site, Atlanta, Georgia, 30318, United States|Lexicon Investigational Site, Lawrenceville, Georgia, 30046, United States|Lexicon Investigational Site, Roswell, Georgia, 30076, United States|Lexicon Investigational Site, Honolulu, Hawaii, 96814, United States|Lexicon Investigational Site, Crystal Lake, Illinois, 60012, United States|Lexicon Investigational Site, Elgin, Illinois, 60123, United States|Lexicon Investigational Site, Springfield, Illinois, 62711, United States|Lexicon Investigational Site, Topeka, Kansas, 66606, United States|Lexicon Investigational Site, Lexington, Kentucky, 40503, United States|Lexicon Investigational Site, Bangor, Maine, 04401, United States|Lexicon Investigational Site, Baltimore, Maryland, 21204, United States|Lexicon Investigational Site, Boston, Massachusetts, 02215, United States|Lexicon Investigational Site, Detroit, Michigan, 46214, United States|Lexicon Investigational Site, Chesterfield, Missouri, 63017, United States|Lexicon Investigational Site, Saint Louis, Missouri, 63110, United States|Lexicon Investigational Site, Omaha, Nebraska, 68131, United States|Lexicon Investigational Site, Henderson, Nevada, 89052, United States|Lexicon Investigational Site, Las Vegas, Nevada, 89148, United States|Lexicon Investigational Site, Albany, New York, 12206, United States|Lexicon Investigational Site, New York, New York, 10029, United States|Lexicon Investigational Site, Asheville, North Carolina, 28803, United States|Lexicon Investigational Site, Chapel Hill, North Carolina, 27517, United States|Lexicon Investigational Site, Morehead City, North Carolina, 28557, United States|Lexicon Investigational Site, Columbus, Ohio, 43201, United States|Lexicon Investigational Site, Oklahoma City, Oklahoma, 73112, United States|Lexicon Investigational Site, Portland, Oregon, 97239, United States|Lexicon Investigational Site, Greer, South Carolina, 29651, United States|Lexicon Investigational Site, Rapid City, South Dakota, 57701, United States|Lexicon Investigational Site, Chattanooga, Tennessee, 37404, United States|Lexicon Investigational Site, Chattanooga, Tennessee, 37411, United States|Lexicon Investigational Site, Memphis, Tennessee, 38119, United States|Lexicon Investigational Site, Austin, Texas, 78749, United States|Lexicon Investigational Site, Dallas, Texas, 75230, United States|Lexicon Investigational Site, Dallas, Texas, 75231, United States|Lexicon Investigational Site, Dallas, Texas, 75246, United States|Lexicon Investigational Site, Houston, Texas, 77079, United States|Lexicon Investigational Site, Houston, Texas, 77095, United States|Lexicon Investigational Site, San Antonio, Texas, 78258, United States|Lexicon Investigational Site, Schertz, Texas, 78154, United States|Lexicon Investigational Site, Chesapeake, Virginia, 23321, United States|Lexicon Investigational Site, Renton, Washington, 98057, United States|Lexicon Investigational Site, Seattle, Washington, 98105, United States|Lexicon Investigational Site, Calgary, Alberta, T2H 2G4, Canada|Lexicon Investigational Site, Vancouver, British Columbia, V5Z 1M9, Canada|Lexicon Investigational Site, Winnipeg, Manitoba, R3C 0N2, Canada|Lexicon Investigational Site, Halifax, Nova Scotia, B3H 1V7, Canada|Lexicon Investigational Site, Barrie, Ontario, L4M 7G1, Canada|Lexicon Investigational Site, Hamilton, Ontario, L8N 3Z5, Canada|Lexicon Investigational Site, London, Ontario, N6A 4V2, Canada|Lexicon Investigational Site, Ottawa, Ontario, K1H 7W9, Canada|Lexicon Investigational Site, Thornhill, Ontario, L4J 8L7, Canada|Lexicon Investigational Site, Toronto, Ontario, M4G 3E8, Canada|Lexicon Investigational Site, Montreal, Quebec, H2W 1R7, Canada|Lexicon Investigational Site, St. Laurent, Quebec, H4T 1Z9, Canada |
| URL: | https://clinicaltrials.gov/show/NCT02384941 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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