Trial · NCT01376557

Safety and Efficacy of LX4211 With Metformin in Type 2 Diabetes Patients With Inadequate Glycemic Control on Metformin

NCT01376557, Phase 2, Completed, Lexicon Pharmaceuticals; results first posted 2014-10-31

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of LX4211 With Metformin in Type 2 Diabetes Patients With Inadequate Glycemic Control on Metformin. Trials, record NCT01376557. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01376557

On this page

Trial

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

Title: Safety and Efficacy of LX4211 With Metformin in Type 2 Diabetes Patients With Inadequate Glycemic Control on Metformin
NCT number: NCT01376557
Status: Completed
Phases: Phase 2
Enrollment: 299 participants, actual
Lead sponsor: Lexicon Pharmaceuticals
Conditions: Type 2 Diabetes Mellitus
Interventions: 75 mg LX4211, 200 mg LX4211, 400 mg LX4211, 200 mg LX4211, Placebo
First posted: 2011-06-20
Last updated: 2014-10-31
Results first posted: 2014-10-31

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame
Primary	Change From Baseline in HbA1c to Week 12	12 weeks
Secondary	Number of Participants Achieving a HbA1c Value of <7% at Week 12	12 weeks
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12	12 weeks
Secondary	Change From Baseline in Body Weight at Week 12	12 weeks
Secondary	Change From Baseline in Systolic Blood Pressure (SPB) at Week 12	12 weeks
Secondary	Change From Baseline in Triglycerides at Week 12	12 weeks

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 HbA1c to Week 12	12 weeks	ITT	% change	MEAN
SECONDARY	Number of Participants Achieving a HbA1c Value of <7% at Week 12	12 weeks	ITT	participants	NUMBER
SECONDARY	Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12	12 weeks	ITT	mg/dL	MEAN
SECONDARY	Change From Baseline in Body Weight at Week 12	12 weeks	ITT	kg	MEAN
SECONDARY	Change From Baseline in Systolic Blood Pressure (SPB) at Week 12	12 weeks	ITT	mm Hg	MEAN
SECONDARY	Change From Baseline in Triglycerides at Week 12	12 weeks	ITT	mg/dL	MEAN

Source ClinicalTrials.gov

Results by group30

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

Outcome	Group	Value	Spread	Units
Change From Baseline in HbA1c to Week 12	75 mg LX4211 qd	-0.42	Standard Deviation 0.637	% change
Change From Baseline in HbA1c to Week 12	200 mg LX4211 qd	-0.52	Standard Deviation 0.780	% change
Change From Baseline in HbA1c to Week 12	400 mg LX4211 qd	-0.92	Standard Deviation 0.873	% change
Change From Baseline in HbA1c to Week 12	200 mg LX4211 Bid	-0.80	Standard Deviation 0.932	% change
Change From Baseline in HbA1c to Week 12	Placebo qd	-0.09	Standard Deviation 0.770	% change
Number of Participants Achieving a HbA1c Value of <7% at Week 12	75 mg LX4211 qd	16		participants
Number of Participants Achieving a HbA1c Value of <7% at Week 12	200 mg LX4211 qd	15		participants
Number of Participants Achieving a HbA1c Value of <7% at Week 12	400 mg LX4211 qd	22		participants
Number of Participants Achieving a HbA1c Value of <7% at Week 12	200 mg LX4211 Bid	17		participants
Number of Participants Achieving a HbA1c Value of <7% at Week 12	Placebo qd	14		participants

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow15

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

Period	Milestone	Group	Participants
Overall Study	STARTED	75 mg LX4211 qd	59
Overall Study	STARTED	200 mg LX4211 qd	60
Overall Study	STARTED	400 mg LX4211 qd	60
Overall Study	STARTED	200 mg LX4211 Bid	60
Overall Study	STARTED	Placebo qd	60
Overall Study	COMPLETED	75 mg LX4211 qd	51
Overall Study	COMPLETED	200 mg LX4211 qd	54
Overall Study	COMPLETED	400 mg LX4211 qd	55
Overall Study	COMPLETED	200 mg LX4211 Bid	54
Overall Study	COMPLETED	Placebo qd	53

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events100

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
other	Diarrhoea	Gastrointestinal disorders	75 mg LX4211 qd	2	57
other	Diarrhoea	Gastrointestinal disorders	200 mg LX4211 qd	6	60
other	Diarrhoea	Gastrointestinal disorders	400 mg LX4211 qd	5	59
other	Diarrhoea	Gastrointestinal disorders	200 mg LX4211 Bid	4	60
other	Diarrhoea	Gastrointestinal disorders	Placebo qd	4	60
other	Nausea	Gastrointestinal disorders	75 mg LX4211 qd	5	57
other	Nausea	Gastrointestinal disorders	200 mg LX4211 qd	3	60
other	Nausea	Gastrointestinal disorders	400 mg LX4211 qd	6	59
other	Nausea	Gastrointestinal disorders	200 mg LX4211 Bid	2	60
other	Nausea	Gastrointestinal disorders	Placebo qd	3	60

1 to 10 of 100Source ClinicalTrials.gov

See all 100 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	75 mg LX4211 qd
Total, all-cause mortality	200 mg LX4211 qd
Total, all-cause mortality	400 mg LX4211 qd
Total, all-cause mortality	200 mg LX4211 Bid
Total, all-cause mortality	Placebo qd
Total, other adverse events	75 mg LX4211 qd	31	57
Total, other adverse events	200 mg LX4211 qd	34	60
Total, other adverse events	400 mg LX4211 qd	26	59
Total, other adverse events	200 mg LX4211 Bid	26	60
Total, other adverse events	Placebo qd	27	60

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25216510	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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