Type 2 Diabetes MellitusPhase 2NCT00962065

Study of LX4211 in Subjects With Type 2 Diabetes Mellitus

A Phase 2 study testing LX4211 Low Dose and LX4211 High Dose in people with Type 2 Diabetes Mellitus, run by Lexicon Pharmaceuticals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of LX4211 versus a placebo control in subjects with type 2 diabetes mellitus. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: LX4211 Low Dose and LX4211 High Dose
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 36 participants
Where: 1 siteUnited States
Study dates: Aug 2009to Dec 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males and females (non-childbearing potential), aged 18-65 years
Diagnosis of Type 2 diabetes mellitus for at least 6 months prior to screening
Fasting plasma glucose ≤ 240 mg/dL prior to metformin washout
Body mass index < 42 kg/m^2
HbA1c value of 7 to 11%
C-peptide ≥ 1.0 ng/mL
Ability to provide written informed consent

Who cannot join

History of Type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketotic syndrome, incontinence, or nocturia
Use of any blood glucose lowering agent other than metformin
Prior exposure to insulin, thiazide, or loop diuretics within 4 weeks prior to screening
Laboratory or electrocardiogram abnormalities deemed significant by the Sponsor or the Investigator
Positive test result for glutamic acid decarboxylase (GAD) antibody
Surgery within 6 months of screening

Show all 9Show fewer

Exposure to any investigational agent or participation in any investigational trial within 30 days prior to Day 1
Hypersensitivity to an SGLT2 inhibitor
History of drug or alcohol abuse within the last 12 months

Trial locations and contacts

1 site in 1 country.

United States1 site

Lexicon Investigational Site
San Antonio, Texas, 78209

Other trials in United States

About this study

Official title: A Phase 2, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Determine the Safety and Efficacy of Orally Administered LX4211 in Subjects With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the safety, tolerability, and efficacy of LX4211 versus a placebo control in subjects with type 2 diabetes mellitus.

Conditions: Type 2 Diabetes Mellitus
Being tested: LX4211 Low Dose, LX4211 High Dose, Placebo
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LX4211 Low DoseDrug
A low dose of LX4211; daily oral intake for 28 days
LX4211 High DoseDrug
A high dose of LX4211; daily oral intake for 28 days
PlaceboDrug
Matching placebo dosing with daily oral intake for 28 days

Study groups in NCT00962065
Study group	Role	What they receive
Low Dose	Experimental	A low dose of LX4211; daily oral intake for 28 days Receives: Drug: LX4211 Low Dose
High Dose	Experimental	A high dose of LX4211; daily oral intake for 28 days Receives: Drug: LX4211 High Dose
Placebo	Placebo comparator	Matching placebo dosing with daily oral intake for 28 days Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline at Day 28 in 24-hour Urinary Glucose Excretion
To assess 24-hour urinary glucose excretion, urine was collected over a 24-hour period and evaluated for glucose concentration.
Measured: Baseline to Day 28

Secondary outcomes (5)

Change From Baseline at Day 29 in Fasting Plasma Glucose
Measured: Baseline to Day 29
Change From Baseline at Day 28 in Plasma HbA1c
Measured: Baseline to Day 28
Change From Baseline at Day 28 in Plasma Fructosamine Level
Measured: Baseline to Day 28
Change From Baseline at Day 28 in Mean Arterial Pressure
Measured: Baseline to Day 28
Change From Baseline at Day 28 in Triglycerides
Measured: Baseline to Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2009Dec 2009

First posted19 Aug 2009 (estimated)
Study startAug 2009
Primary completionDec 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00962065
Sponsor's protocol ID: LX4211.1-201-DM
Other IDs: LX4211.201
Status last verified: Feb 2011
First submitted: 10 Aug 2009
Last updated: 3 Mar 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Zambrowicz B, Freiman J, Brown PM, Frazier KS, Turnage A, Bronner J, Ruff D, Shadoan M, Banks P, Mseeh F, Rawlins DB, Goodwin NC, Mabon R, Harrison BA, Wilson A, Sands A, Powell DR. LX4211, a dual SGLT1/SGLT2 inhibitor, improved glycemic control in patients with type 2 diabetes in a randomized, placebo-controlled trial. Clin Pharmacol Ther. 2012 Aug;92(2):158-69. doi: 10.1038/clpt.2012.58. Epub 2012 Jul 4.
PubMed 22739142

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Determine the Safety and Efficacy of Orally Administered LX4211 in Subjects With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT00962065
Acronym / sponsor ID: LX4211.1-201-DM
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Lexicon PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Aug 2009
Primary completion: Dec 2009 (actual)
First posted: 19 Aug 2009 (estimated)
Results: Posted 3 Mar 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the safety, tolerability, and efficacy of LX4211 versus a placebo control in subjects with type 2 diabetes mellitus.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Low Dose	Experimental	Drug: LX4211 Low DoseA low dose of LX4211; daily oral intake for 28 days
High Dose	Experimental	Drug: LX4211 High DoseA high dose of LX4211; daily oral intake for 28 days
Placebo	Placebo comparator	Drug: PlaceboMatching placebo dosing with daily oral intake for 28 days

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Males and females (non-childbearing potential), aged 18-65 years
Diagnosis of Type 2 diabetes mellitus for at least 6 months prior to screening
Fasting plasma glucose ≤ 240 mg/dL prior to metformin washout
Body mass index < 42 kg/m^2
HbA1c value of 7 to 11%

Key exclusion criteria (9 listed)

History of Type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketotic syndrome, incontinence, or nocturia
Use of any blood glucose lowering agent other than metformin
Prior exposure to insulin, thiazide, or loop diuretics within 4 weeks prior to screening
Laboratory or electrocardiogram abnormalities deemed significant by the Sponsor or the Investigator
Positive test result for glutamic acid decarboxylase (GAD) antibody

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LX4211 Low DoseA low dose of LX4211; daily oral intake for 28 days	Drug	Low Dose
LX4211 High DoseA high dose of LX4211; daily oral intake for 28 days	Drug	High Dose
PlaceboMatching placebo dosing with daily oral intake for 28 days	Drug	Placebo

Primary outcome

Change From Baseline at Day 28 in 24-hour Urinary Glucose Excretion
Time frame: Baseline to Day 28
To assess 24-hour urinary glucose excretion, urine was collected over a 24-hour period and evaluated for glucose concentration.

5 secondary outcomes

Change From Baseline at Day 29 in Fasting Plasma Glucose
Time frame: Baseline to Day 29
Change From Baseline at Day 28 in Plasma HbA1c
Time frame: Baseline to Day 28
Change From Baseline at Day 28 in Plasma Fructosamine Level
Time frame: Baseline to Day 28
Change From Baseline at Day 28 in Mean Arterial Pressure
Time frame: Baseline to Day 28
Change From Baseline at Day 28 in Triglycerides
Time frame: Baseline to Day 28

Results and safety

Results posted to the registry on 3 Mar 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Low Dose	12	12
High Dose	12	12
Placebo	12	12

Primary outcome: Change From Baseline at Day 28 in 24-hour Urinary Glucose Excretion

Time frame: Baseline to Day 28. Mean (95% Confidence Interval). Unit: grams

Measure	Low Dose n = 12	High Dose n = 12	Placebo n = 12
Value	35.729 (26.207 to 45.252)	47.085 (37.562 to 56.608)	-0.965 (-10.768 to 8.838)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were followed during the treatment period.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low Dose	0 of 12 (0%)	9 of 12 (75%)	Not reported
High Dose	0 of 12 (0%)	8 of 12 (66.7%)	Not reported
Placebo	0 of 12 (0%)	8 of 12 (66.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22739142Zambrowicz B, Freiman J, Brown PM, Frazier KS, Turnage A, Bronner J, Ruff D, Shadoan M, Banks P, Mseeh F, Rawlins DB, Goodwin NC, Mabon R, Harrison BA, Wilson A, Sands A, Powell DR. LX4211, a dual SGLT1/SGLT2 inhibitor, improved glycemic control in patients with type 2 diabetes in a randomized, placebo-controlled trial. Clin Pharmacol Ther. 2012 Aug;92(2):158-69. doi: 10.1038/clpt.2012.58. Epub 2012 Jul 4.

Related trials for Type 2 Diabetes Mellitus

Not yet recruitingPhase 3
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Active, not recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joel P. Freiman, MD, MPH study director

Lexicon Pharmaceuticals, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LX4211 Low Dose and LX4211 High Dose in people with Type 2 Diabetes Mellitus, run by Lexicon Pharmaceuticals at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline at Day 28 in 24-hour Urinary Glucose Excretion (time frame: Baseline to Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00962065, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2011.