Trial · NCT02459899

Dose-ranging Study in Patients With Type 1 Diabetes Mellitus

NCT02459899, Phase 2, Completed, Lexicon Pharmaceuticals; results first posted 2019-10-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Dose-ranging Study in Patients With Type 1 Diabetes Mellitus. Trials, record NCT02459899. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02459899

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Trial

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

Title: Dose-ranging Study in Patients With Type 1 Diabetes Mellitus
NCT number: NCT02459899
Status: Completed
Phases: Phase 2
Enrollment: 141 participants, actual
Lead sponsor: Lexicon Pharmaceuticals
Conditions: Type 1 Diabetes Mellitus
Interventions: Placebo, Sotagliflozin
First posted: 2015-06-02
Last updated: 2020-02-12
Results first posted: 2019-10-30

Source ClinicalTrials.gov

Registered outcomes6

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 to Week 12	Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-baseline Least Square (LS) mean values were obtained from mixed-effects model repeated measures (MMRM) model with treatment, randomization strata of insulin delivery method (continuous subcutaneous insulin infusion \[CSII\] or multiple daily injection \[MDI\]), 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 to Week 12 in 2-Hour Postprandial Glucose (PPG) Following the Standardized Mixed Meal	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. Post-Baseline LS mean was obtained from analysis of covariance (ANCOVA) model with treatment, randomization strata of insulin delivery method (CSII, MDI) as fixed categorical effects, and baseline postprandial glucose as a covariate.
Secondary	Absolute Change From Baseline in Body Weight to Week 12	Baseline to Week 12	Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-Baseline LS mean was obtained from MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline weight-by-time interaction as a covariate.
Secondary	Percent Change From Baseline in Body Weight to Week 12	Baseline to Week 12	Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-Baseline LS mean was obtained from MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline weight-by-time interaction as a covariate.
Secondary	Change From Baseline to Week 12 in 24-Hour Urinary Glucose Excretion	Baseline, Week 12	Urine was collected over 24 hours to measure Urinary Glucose Excretion at baseline, and at the end of the 12-week treatment. Post-Baseline LS mean was obtained from ANCOVA model with treatment, randomization strata of insulin delivery method (CSII, MDI) as fixed categorical effects, and Baseline urinary glucose excretion as a covariate.
Secondary	Change From Baseline to Week 12 in Fasting Plasma Glucose	Baseline to Week 12	Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-Baseline LS mean was obtained from MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline fasting plasma glucose-by-time interaction as a covariate.

Source ClinicalTrials.gov

Outcomes6

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 to Week 12	Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.	percentage of A1C	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Week 12 in 2-Hour Postprandial Glucose (PPG) Following the Standardized Mixed Meal	Baseline, Week 12	Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.	milligrams per deciliter (mg/dL)	LEAST_SQUARES_MEAN
SECONDARY	Absolute Change From Baseline in Body Weight to Week 12	Baseline to Week 12	Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.	kilograms	LEAST_SQUARES_MEAN
SECONDARY	Percent Change From Baseline in Body Weight to Week 12	Baseline to Week 12	Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.	percent change	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Week 12 in 24-Hour Urinary Glucose Excretion	Baseline, Week 12	Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.	grams per day	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Week 12 in Fasting Plasma Glucose	Baseline to Week 12	Analysis included participants from the mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.	mg/dL	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group24

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

Outcome	Group	Value	Spread	Units
Change From Baseline in Hemoglobin A1C (A1C) at Week 12	Placebo	-0.35	Standard Error 0.096	percentage of A1C
Change From Baseline in Hemoglobin A1C (A1C) at Week 12	Sotagliflozin 75 mg	-0.60	Standard Error 0.100	percentage of A1C
Change From Baseline in Hemoglobin A1C (A1C) at Week 12	Sotagliflozin 200 mg	-0.84	Standard Error 0.095	percentage of A1C
Change From Baseline in Hemoglobin A1C (A1C) at Week 12	Sotagliflozin 400 mg	-0.73	Standard Error 0.096	percentage of A1C
Change From Baseline to Week 12 in 2-Hour Postprandial Glucose (PPG) Following the Standardized Mixed Meal	Placebo	-0.2	Standard Error 12.51	milligrams per deciliter (mg/dL)
Change From Baseline to Week 12 in 2-Hour Postprandial Glucose (PPG) Following the Standardized Mixed Meal	Sotagliflozin 75 mg	-20.5	Standard Error 13.66	milligrams per deciliter (mg/dL)
Change From Baseline to Week 12 in 2-Hour Postprandial Glucose (PPG) Following the Standardized Mixed Meal	Sotagliflozin 200 mg	-27.6	Standard Error 14.16	milligrams per deciliter (mg/dL)
Change From Baseline to Week 12 in 2-Hour Postprandial Glucose (PPG) Following the Standardized Mixed Meal	Sotagliflozin 400 mg	-49.7	Standard Error 12.51	milligrams per deciliter (mg/dL)
Absolute Change From Baseline in Body Weight to Week 12	Placebo	1.13	Standard Error 0.425	kilograms
Absolute Change From Baseline in Body Weight to Week 12	Sotagliflozin 75 mg	-0.16	Standard Error 0.441	kilograms

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	36
Overall Study	STARTED	Sotagliflozin 75 mg	35
Overall Study	STARTED	Sotagliflozin 200 mg	35
Overall Study	STARTED	Sotagliflozin 400 mg	35
Overall Study	COMPLETED	Placebo	33
Overall Study	COMPLETED	Sotagliflozin 75 mg	29
Overall Study	COMPLETED	Sotagliflozin 200 mg	35
Overall Study	COMPLETED	Sotagliflozin 400 mg	33
Overall Study	NOT COMPLETED	Placebo	3
Overall Study	NOT COMPLETED	Sotagliflozin 75 mg	6

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events48

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	Abdominal discomfort	Gastrointestinal disorders	Placebo	0	36	0
other	Abdominal discomfort	Gastrointestinal disorders	Sotagliflozin 75 mg	0	35	0
other	Abdominal discomfort	Gastrointestinal disorders	Sotagliflozin 200 mg	0	35	0
other	Abdominal discomfort	Gastrointestinal disorders	Sotagliflozin 400 mg	2	35	2
other	Asthma	Respiratory, thoracic and mediastinal disorders	Placebo	0	36	0
other	Asthma	Respiratory, thoracic and mediastinal disorders	Sotagliflozin 75 mg	0	35	0
other	Asthma	Respiratory, thoracic and mediastinal disorders	Sotagliflozin 200 mg	2	35	2
other	Asthma	Respiratory, thoracic and mediastinal disorders	Sotagliflozin 400 mg	0	35	0
other	Constipation	Gastrointestinal disorders	Placebo	2	36	2
other	Constipation	Gastrointestinal disorders	Sotagliflozin 75 mg	0	35	0

1 to 10 of 48Source ClinicalTrials.gov

See all 48 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	36
Total, all-cause mortality	Sotagliflozin 75 mg	0	35
Total, all-cause mortality	Sotagliflozin 200 mg	0	35
Total, all-cause mortality	Sotagliflozin 400 mg	0	35
Total, other adverse events	Placebo	10	36
Total, other adverse events	Sotagliflozin 75 mg	5	35
Total, other adverse events	Sotagliflozin 200 mg	6	35
Total, other adverse events	Sotagliflozin 400 mg	4	35
Total, serious adverse events	Placebo	1	36
Total, serious adverse events	Sotagliflozin 75 mg	1	35

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
31264767	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 comparisons0

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

None in this release.

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.

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