Trial · NCT02383940

Efficacy and Safety of Sotagliflozin in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C

NCT02383940, Phase 2, Completed, Lexicon Pharmaceuticals; results first posted 2019-10-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Sotagliflozin in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C. Trials, record NCT02383940. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02383940

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety of Sotagliflozin in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C
NCT number: NCT02383940
Status: Completed
Phases: Phase 2
Enrollment: 87 participants, actual
Lead sponsor: Lexicon Pharmaceuticals
Conditions: Type 1 Diabetes Mellitus
Interventions: Sotagliflozin, Placebo
First posted: 2015-03-10
Last updated: 2020-02-12
Results first posted: 2019-10-30

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Hemoglobin A1C (A1C) at Week 12	Baseline, 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.
Secondary	Change From Baseline in Total Daily Bolus Insulin Dose and Total Daily Basal Insulin Dose at Week 12	Baseline, 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.
Secondary	Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Standardized Mixed Meal at Week 12	Baseline, 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.
Secondary	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	Baseline, 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.
Secondary	Change From Baseline in Number of Hypoglycemic Events/Day (<=70 mg/dL) by Self-Monitored Blood Glucose (SMBG) at Week 12	Baseline, 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.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Hemoglobin A1C (A1C) at Week 12	Baseline, Week 12	Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.	percentage of A1C	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Total Daily Bolus Insulin Dose and Total Daily Basal Insulin Dose at Week 12	Baseline, Week 12	Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.	International Units per day (IU/day)	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Standardized Mixed Meal at Week 12	Baseline, Week 12	Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.	milligrams per deciliter (mg/dL)	LEAST_SQUARES_MEAN
SECONDARY	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	Baseline, Week 12	Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.	mg/dL*minutes/1000	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Number of Hypoglycemic Events/Day (<=70 mg/dL) by Self-Monitored Blood Glucose (SMBG) at Week 12	Baseline, Week 12	Analysis was performed on mITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.	events/day	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Hemoglobin A1C (A1C) at Week 12	Placebo		-0.99	Standard Error 0.149	percentage of A1C
Change From Baseline in Hemoglobin A1C (A1C) at Week 12	Sotagliflozin 400 mg		-1.33	Standard Error 0.143	percentage of A1C
Change From Baseline in Total Daily Bolus Insulin Dose and Total Daily Basal Insulin Dose at Week 12	Placebo	Total Daily Bolus Insulin Dose	-2.96	Standard Error 1.945	International Units per day (IU/day)
Change From Baseline in Total Daily Bolus Insulin Dose and Total Daily Basal Insulin Dose at Week 12	Sotagliflozin 400 mg	Total Daily Bolus Insulin Dose	-4.89	Standard Error 1.832	International Units per day (IU/day)
Change From Baseline in Total Daily Bolus Insulin Dose and Total Daily Basal Insulin Dose at Week 12	Placebo	Total Daily Basal Insulin Dose	3.26	Standard Error 1.262	International Units per day (IU/day)
Change From Baseline in Total Daily Bolus Insulin Dose and Total Daily Basal Insulin Dose at Week 12	Sotagliflozin 400 mg	Total Daily Basal Insulin Dose	2.03	Standard Error 1.211	International Units per day (IU/day)
Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Standardized Mixed Meal at Week 12	Placebo		0.2	Standard Error 12.24	milligrams per deciliter (mg/dL)
Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Standardized Mixed Meal at Week 12	Sotagliflozin 400 mg		-56.4	Standard Error 11.61	milligrams per deciliter (mg/dL)
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	Placebo	Glycemic Instability by Hyperglycemia	-5.035	Standard Error 7.9092	mg/dL*minutes/1000
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	Sotagliflozin 400 mg	Glycemic Instability by Hyperglycemia	-27.338	Standard Error 8.0100	mg/dL*minutes/1000

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	44
Overall Study	STARTED	Sotagliflozin 400 mg	43
Overall Study	Treated	Placebo	42
Overall Study	Treated	Sotagliflozin 400 mg	43
Overall Study	COMPLETED	Placebo	35
Overall Study	COMPLETED	Sotagliflozin 400 mg	40
Overall Study	NOT COMPLETED	Placebo	9
Overall Study	NOT COMPLETED	Sotagliflozin 400 mg	3

Source ClinicalTrials.gov

Adverse events28

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Back pain	Musculoskeletal and connective tissue disorders	Placebo	0	42	0
other	Back pain	Musculoskeletal and connective tissue disorders	Sotagliflozin 400 mg	3	43	3
other	Blood ketone body increased	Investigations	Placebo	3	42	3
other	Blood ketone body increased	Investigations	Sotagliflozin 400 mg	8	43	17
other	Cough	Respiratory, thoracic and mediastinal disorders	Placebo	1	42	1
other	Cough	Respiratory, thoracic and mediastinal disorders	Sotagliflozin 400 mg	3	43	3
other	Nasopharyngitis	Infections and infestations	Placebo	4	42	4
other	Nasopharyngitis	Infections and infestations	Sotagliflozin 400 mg	5	43	6
other	Nausea	Gastrointestinal disorders	Placebo	3	42	4
other	Nausea	Gastrointestinal disorders	Sotagliflozin 400 mg	1	43	1

1 to 10 of 28Source ClinicalTrials.gov

See all 28 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	42
Total, all-cause mortality	Sotagliflozin 400 mg	0	43
Total, other adverse events	Placebo	16	42
Total, other adverse events	Sotagliflozin 400 mg	21	43
Total, serious adverse events	Placebo	3	42
Total, serious adverse events	Sotagliflozin 400 mg	2	43

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32640846	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Sotagliflozin 400 mg vs Placebo: deaths from any cause	Trial comparisons
Sotagliflozin 400 mg vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02383940

GET https://conductscience.org/api/trials/v1/NCT02383940/events?page=2

API reference For AI assistants