Trial · NCT00962065

Study of LX4211 in Subjects With Type 2 Diabetes Mellitus

NCT00962065, Phase 2, Completed, Lexicon Pharmaceuticals; results first posted 2011-03-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of LX4211 in Subjects With Type 2 Diabetes Mellitus. Trials, record NCT00962065. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00962065

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Trial

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

Title: Study of LX4211 in Subjects With Type 2 Diabetes Mellitus
NCT number: NCT00962065
Status: Completed
Phases: Phase 2
Enrollment: 36 participants, actual
Lead sponsor: Lexicon Pharmaceuticals
Conditions: Type 2 Diabetes Mellitus
Interventions: LX4211 Low Dose, LX4211 High Dose, Placebo
First posted: 2009-08-19
Last updated: 2011-03-03
Results first posted: 2011-03-03

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 at Day 28 in 24-hour Urinary Glucose Excretion	Baseline to Day 28	To assess 24-hour urinary glucose excretion, urine was collected over a 24-hour period and evaluated for glucose concentration.
Secondary	Change From Baseline at Day 29 in Fasting Plasma Glucose	Baseline to Day 29
Secondary	Change From Baseline at Day 28 in Plasma HbA1c	Baseline to Day 28
Secondary	Change From Baseline at Day 28 in Plasma Fructosamine Level	Baseline to Day 28
Secondary	Change From Baseline at Day 28 in Mean Arterial Pressure	Baseline to Day 28
Secondary	Change From Baseline at Day 28 in Triglycerides	Baseline to Day 28

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Change From Baseline at Day 28 in 24-hour Urinary Glucose Excretion	Baseline to Day 28	grams	MEAN
SECONDARY	Change From Baseline at Day 29 in Fasting Plasma Glucose	Baseline to Day 29	mg/dL	MEAN
SECONDARY	Change From Baseline at Day 28 in Plasma HbA1c	Baseline to Day 28	Percent	MEAN
SECONDARY	Change From Baseline at Day 28 in Plasma Fructosamine Level	Baseline to Day 28	µmol/L	MEAN
SECONDARY	Change From Baseline at Day 28 in Mean Arterial Pressure	Baseline to Day 28	mm Hg	MEAN
SECONDARY	Change From Baseline at Day 28 in Triglycerides	Baseline to Day 28	mg/dL	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 at Day 28 in 24-hour Urinary Glucose Excretion	Low Dose	35.729	95% Confidence Interval 26.207 to 45.252	grams
Change From Baseline at Day 28 in 24-hour Urinary Glucose Excretion	High Dose	47.085	95% Confidence Interval 37.562 to 56.608	grams
Change From Baseline at Day 28 in 24-hour Urinary Glucose Excretion	Placebo	-0.965	95% Confidence Interval -10.768 to 8.838	grams
Change From Baseline at Day 29 in Fasting Plasma Glucose	Low Dose	-52.3	95% Confidence Interval -67.7 to -36.9	mg/dL
Change From Baseline at Day 29 in Fasting Plasma Glucose	High Dose	-67.8	95% Confidence Interval -83.2 to -52.4	mg/dL
Change From Baseline at Day 29 in Fasting Plasma Glucose	Placebo	-12.3	95% Confidence Interval -28.0 to 3.4	mg/dL
Change From Baseline at Day 28 in Plasma HbA1c	Low Dose	-1.15	95% Confidence Interval -1.58 to -0.72	Percent
Change From Baseline at Day 28 in Plasma HbA1c	High Dose	-1.25	95% Confidence Interval -1.68 to -0.82	Percent
Change From Baseline at Day 28 in Plasma HbA1c	Placebo	-0.49	95% Confidence Interval -0.93 to -0.05	Percent
Change From Baseline at Day 28 in Plasma Fructosamine Level	Low Dose	-24.5	95% Confidence Interval -39.5 to -9.5	µmol/L

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Low Dose	12
Overall Study	STARTED	High Dose	12
Overall Study	STARTED	Placebo	12
Overall Study	COMPLETED	Low Dose	12
Overall Study	COMPLETED	High Dose	12
Overall Study	COMPLETED	Placebo	12
Overall Study	NOT COMPLETED	Low Dose	0
Overall Study	NOT COMPLETED	High Dose	0
Overall Study	NOT COMPLETED	Placebo	0

Source ClinicalTrials.gov

Adverse events147

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	Headache	Nervous system disorders	Low Dose	5	12	10
other	Headache	Nervous system disorders	High Dose	1	12	15
other	Headache	Nervous system disorders	Placebo	2	12	3
other	Constipation	Gastrointestinal disorders	Low Dose	3	12	3
other	Constipation	Gastrointestinal disorders	High Dose	2	12	2
other	Constipation	Gastrointestinal disorders	Placebo	2	12	2
other	Dizziness	Nervous system disorders	Low Dose	3	12	3
other	Dizziness	Nervous system disorders	High Dose	0	12	0
other	Dizziness	Nervous system disorders	Placebo	2	12	2
other	Nausea	Gastrointestinal disorders	Low Dose	2	12	4

1 to 10 of 147Source ClinicalTrials.gov

See all 147 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Low Dose
Total, all-cause mortality	High Dose
Total, all-cause mortality	Placebo
Total, other adverse events	Low Dose	9	12
Total, other adverse events	High Dose	8	12
Total, other adverse events	Placebo	8	12
Total, serious adverse events	Low Dose	0	12
Total, serious adverse events	High Dose	0	12
Total, serious adverse events	Placebo	0	12

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22739142	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.

GET https://conductscience.org/api/trials/v1/NCT00962065

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