A Phase 2 interventional study of Sotagliflozin and Placebo in Type 1 Diabetes Mellitus, sponsored by Lexicon Pharmaceuticals. Completed at 15 sites in United States. Open to participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2020-02-12.
Sponsored by Lexicon Pharmaceuticals · Phase 2, Interventional, and Treatment
This Phase 2 study was intended to demonstrate superiority of sotagliflozin versus placebo on Hemoglobin A1C (A1C) reduction at Week 12 in young adult participants with type 1 diabetes mellitus (T1DM) who have poor glycemic control on their current insulin regimen.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 87 is close to the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Lexicon Pharmaceuticals is the lead sponsor of 60 studies on the registry; none are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 15 (83%) have results posted.
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Exclusion Criteria:
Two placebo-matching sotagliflozin tablets, once daily, orally, before the first meal of the day for 12 weeks.
Drug: Placebo
Sotagliflozin 400 milligram (mg) (two 200 mg tablets), once daily, orally, before the first meal of the day for 12 weeks.
Drug: Sotagliflozin
Sotagliflozin 400 mg, once daily before the first meal of the day
Also known as: LX4211
Placebo, once daily before the first meal of the day
Change From Baseline in Hemoglobin A1C (A1C) at Week 12
Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Change was calculated by subtracting baseline value from Week 12 value. Least Square (LS) mean changes from baseline were obtained from mixed model repeated measures (MMRM) model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week-4 A1C (\<=10%, \>10%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C-by-time interaction as a covariate.
Time frame: Baseline, Week 12
Change From Baseline in Total Daily Bolus Insulin Dose and Total Daily Basal Insulin Dose at Week 12
The daily bolus and basal insulin doses were calculated as an average of the doses over 3 to 5 days before each visit (Baseline and Week 12). Change was calculated by subtracting baseline value from Week 12 value. LS mean changes from baseline were obtained from MMRM model.
Time frame: Baseline, Week 12
Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Standardized Mixed Meal at Week 12
A 2-hour PPG sample (plasma) was obtained 2-hours after a standardized Mixed Meal at Baseline (Day 1) and at the visit at Week 12. At Week 12, study drug was to be given within 15 minutes before liquid "Boost®," "Ensure®," or similar nutrition drink product; at baseline, study drug was to be given after the 2-hour post-Mixed Meal PPG sample. Change was calculated by subtracting baseline value from Week 12 value. LS mean changes from baseline were obtained from analysis of covariance (ANCOVA) model.
Time frame: Baseline, Week 12
Change From Baseline in Glycemic Instability by Hyperglycemia (Continuous Glucose Monitoring [CGM] Area Under the Curve [AUC] >150 mg/dL) and Hypoglycemia (CGM AUC <70 mg/dL) Over a 24-hour Period at Week 12
Glycemic instability (mg/dL\*minutes/1000) by hyperglycemia/hypoglycemia was measured by CGM AUC outside target range (as a daily average over the week prior to the visit \[Baseline and Week 12\]) over 24 hours, where outside target range was defined as CGM glucose AUC \>150 mg/dL (hyperglycemia) and CGM glucose AUC \<70 mg/dL (hypoglycemia). Change was calculated by subtracting baseline value from Week 12 value. LS mean changes from baseline were obtained from MMRM model.
Time frame: Baseline, Week 12
Change From Baseline in Number of Hypoglycemic Events/Day (<=70 mg/dL) by Self-Monitored Blood Glucose (SMBG) at Week 12
Hypoglycemic event by SMBG was defined as an event in which the fingerstick measurement was \<=70 mg/dL. The number of hypoglycemic events per day was calculated as a daily average number of episodes over the week prior to visit (Baseline and Week 12). Change was calculated by subtracting baseline value from Week 12 value. LS mean changes from baseline were obtained from MMRM model.
Time frame: Baseline, Week 12
The study was conducted at 15 sites in United States between 20 April 2015 and 23 September 2016.
| Milestone | Placebo | Sotagliflozin 400 mg |
|---|---|---|
| Started | 44 | 43 |
| Treated | 42 | 43 |
| Completed | 35 | 40 |
| Not completed | 9 | 3 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Lost to follow-up | 2 | 2 |
| Withdrew: Physician decision | 2 | 0 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Randomized but not treated | 2 | 0 |
| Withdrew: Other than specified above | 1 | 0 |
Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Change was calculated by subtracting baseline value from Week 12 value. Least Square (LS) mean changes from baseline were obtained from mixed model repeated measures (MMRM) model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week-4 A1C (\<=10%, \>10%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C-by-time interaction as a covariate.
| percentage of A1C | Placebo | Sotagliflozin 400 mg |
|---|---|---|
| Change From Baseline in Hemoglobin A1C (A1C) at Week 12 | -0.99 ± 0.149 | -1.33 ± 0.143 |
The daily bolus and basal insulin doses were calculated as an average of the doses over 3 to 5 days before each visit (Baseline and Week 12). Change was calculated by subtracting baseline value from Week 12 value. LS mean changes from baseline were obtained from MMRM model.
| International Units per day (IU/day) | Placebo | Sotagliflozin 400 mg |
|---|---|---|
| Total Daily Bolus Insulin Dose | -2.96 ± 1.945 | -4.89 ± 1.832 |
| Total Daily Basal Insulin Dose | 3.26 ± 1.262 | 2.03 ± 1.211 |
A 2-hour PPG sample (plasma) was obtained 2-hours after a standardized Mixed Meal at Baseline (Day 1) and at the visit at Week 12. At Week 12, study drug was to be given within 15 minutes before liquid "Boost®," "Ensure®," or similar nutrition drink product; at baseline, study drug was to be given after the 2-hour post-Mixed Meal PPG sample. Change was calculated by subtracting baseline value from Week 12 value. LS mean changes from baseline were obtained from analysis of covariance (ANCOVA) model.
| milligrams per deciliter (mg/dL) | Placebo | Sotagliflozin 400 mg |
|---|---|---|
| Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Standardized Mixed Meal at Week 12 | 0.2 ± 12.24 | -56.4 ± 11.61 |
Glycemic instability (mg/dL\*minutes/1000) by hyperglycemia/hypoglycemia was measured by CGM AUC outside target range (as a daily average over the week prior to the visit \[Baseline and Week 12\]) over 24 hours, where outside target range was defined as CGM glucose AUC \>150 mg/dL (hyperglycemia) and CGM glucose AUC \<70 mg/dL (hypoglycemia). Change was calculated by subtracting baseline value from Week 12 value. LS mean changes from baseline were obtained from MMRM model.
| mg/dL*minutes/1000 | Placebo | Sotagliflozin 400 mg |
|---|---|---|
| Glycemic Instability by Hyperglycemia | -5.035 ± 7.9092 | -27.338 ± 8.0100 |
| Glycemic Instability by Hypoglycemia | 0.221 ± 0.2508 | 0.428 ± 0.2528 |
Hypoglycemic event by SMBG was defined as an event in which the fingerstick measurement was \<=70 mg/dL. The number of hypoglycemic events per day was calculated as a daily average number of episodes over the week prior to visit (Baseline and Week 12). Change was calculated by subtracting baseline value from Week 12 value. LS mean changes from baseline were obtained from MMRM model.
| events/day | Placebo | Sotagliflozin 400 mg |
|---|---|---|
| Change From Baseline in Number of Hypoglycemic Events/Day (<=70 mg/dL) by Self-Monitored Blood Glucose (SMBG) at Week 12 | -0.042 ± 0.0408 | -0.001 ± 0.0379 |
Collected over All Adverse Events (AEs) were collected from Baseline (Day 1) until the end of study (up to Week 12).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/42 (0%) | 3/42 (7.1%) | 16/42 (38.1%) |
| Sotagliflozin 400 mg | 0/43 (0%) | 2/43 (4.7%) | 21/43 (48.8%) |
| Event | Placebo | Sotagliflozin 400 mg |
|---|---|---|
| Diabetic ketoacidosisMetabolism and nutrition disorders | 2/42 | 1/43 |
| VomitingGastrointestinal disorders | 1/42 | 0/43 |
| Femoral neck fractureInjury, poisoning and procedural complications | 1/42 | 0/43 |
| Hypoglycaemic unconsciousnessNervous system disorders | 1/42 | 0/43 |
| PneumoniaInfections and infestations | 0/42 | 1/43 |
| HypoglycaemiaMetabolism and nutrition disorders | 0/42 | 1/43 |
| Event | Placebo | Sotagliflozin 400 mg |
|---|---|---|
| Blood ketone body increasedInvestigations | 3/42 | 8/43 |
| NasopharyngitisInfections and infestations | 4/42 | 5/43 |
| NauseaGastrointestinal disorders | 3/42 | 1/43 |
| Upper respiratory tract infectionInfections and infestations | 3/42 | 2/43 |
| VomitingGastrointestinal disorders | 3/42 | 2/43 |
| Back painMusculoskeletal and connective tissue disorders | 0/42 | 3/43 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/42 | 3/43 |
| Urinary tract infectionInfections and infestations | 1/42 | 3/43 |
Analysis was performed on modified intent-to treat (mITT) population which included all randomly assigned participants who received at least 1 dose of study drug.
| Age, Continuous(years) | Placebo | Sotagliflozin 400 mg | Total |
|---|---|---|---|
| Mean | 21.7 ± 3.55 | 22.8 ± 4.01 | 22.3 ± 3.81 |
| Sex: Female, Male(Participants) | Placebo | Sotagliflozin 400 mg | Total |
|---|---|---|---|
| Female | 23 | 22 | 45 |
| Male | 19 | 21 | 40 |
| Race (NIH/OMB)(Participants) | Placebo | Sotagliflozin 400 mg | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 2 | 8 |
| White | 34 | 41 | 75 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Body weight(kilogram (kg)) | Placebo | Sotagliflozin 400 mg | Total |
|---|---|---|---|
| Mean | 77.27 ± 14.570 | 83.74 ± 20.439 | 80.54 ± 17.975 |
| Body Mass Index (BMI)(kilograms per square meter (kg/m^2)) | Placebo | Sotagliflozin 400 mg | Total |
|---|---|---|---|
| Mean | 26.73 ± 4.993 | 29.39 ± 7.214 | 28.07 ± 6.324 |
| Duration of diabetes(years) | Placebo | Sotagliflozin 400 mg | Total |
|---|---|---|---|
| Mean | 11.9 ± 5.38 | 11.9 ± 6.16 | 11.9 ± 5.75 |
| Insulin Delivery Method(Participants) | Placebo | Sotagliflozin 400 mg | Total |
|---|---|---|---|
| Continuous Subcutaneous Insulin Infusion (CSII) | 23 | 23 | 46 |
| Multiple Daily Injections (MDI) | 19 | 20 | 39 |
| Hemoglobin A1C Level in Participants(Participants) | Placebo | Sotagliflozin 400 mg | Total |
|---|---|---|---|
| <=10 percent (%) | 19 | 18 | 37 |
| >10 % | 23 | 25 | 48 |
1 further baseline measures are reported on the registry.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Lexicon Pharmaceuticals