Type 2 Diabetes MellitusPhase 1NCT01555008
Study to Evaluate the Pharmacodynamic and Pharmacokinetic Effects of LX4211 in Subjects With Type 2 Diabetes and Renal Impairment
A Phase 1 study testing LX4211 in people with Type 2 Diabetes Mellitus and Renal Impairment, run by Lexicon Pharmaceuticals at 6 sites in United States.
Trial summary
This Phase 1 study is intended to assess the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability of LX4211 following once daily oral administration in subjects with type 2 diabetes mellitus (T2DM) and moderate to severe renal impairment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Renal Impairment
- What is being tested?
- LX4211
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2012to Aug 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 to ≤80 years of age
- History of T2DM for at least 6 months prior to screening
- Moderate to severe renal impairment and not actively on dialysis
- Willing and able to perform self-monitoring of blood glucose
- Willing and able to provide written informed consent
Who cannot join
- History of type 1 diabetes mellitus, diabetic ketoacidosis (within the previous 6 months), or diabetes resulting from pancreatic disorder or secondary diabetes (from acromegaly and/or Cushing's disease)
- Subjects who have received a renal allograft
- Subjects expecting to require dialysis or to undergo kidney transplantation within 3 months of study dosing
- Presence of active hepatic disease or clinically significant abnormal liver function tests at Screening or planned study Day -1
- Subjects with a history of heart attack, severe/unstable angina, or coronary revascularization procedure within 6 months prior to study Day -2
- History of clinically significant cardiac arrhythmias within 1 year prior to study Day -2
Show all 20Show fewer
- Subjects with congestive heart failure
- Subjects with uncontrolled Stage III hypertension
- History of 2 or more emergency room visits, doctors' visits, or hospitalizations due to hypoglycemia within the 6 months prior to planned study Day -2
- History of alcohol or illicit drug abuse within 1 year prior to Screening
- History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- Major surgery within 6 months prior to planned study Day -2
- History of any malignancy within the last 5 years
- Triglycerides >1000 mg/dL at Screening or planned study Day -1
- History of any serious adverse reaction or hypersensitivity to an SGLT inhibitor
- Use of corticosteroids within 2 weeks prior to study Day 1
- Use of any investigational drug within 30 days prior to study Day 1, or investigational protein or antibodies within 60 days of Day 1
- Positive urine pregnancy test at Screening
- Positive urine screen for illicit drug abuse at Screening
- Prior exposure to LX4211
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Lexicon Investigational Site
Anniston, Alabama, 36207
Lexicon Investigational Site
Chula Vista, California, 91911
Lexicon Investigational Site
Edgewater, Florida, 32132
Lexicon Investigational Site
Minneapolis, Minnesota, 55404
Lexicon Investigational Site
Renton, Washington, 98057
Lexicon Investigational Site
San Antonio, Texas, 78209
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Evaluate the Pharmacodynamic and Pharmacokinetic Effects of LX4211 in Subjects With Type 2 Diabetes Mellitus and Moderate to Severe Renal Impairment
This Phase 1 study is intended to assess the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability of LX4211 following once daily oral administration in subjects with type 2 diabetes mellitus (T2DM) and moderate to severe renal impairment.
- Conditions
- Type 2 Diabetes Mellitus, Renal Impairment
- Being tested
- LX4211, LX4211 Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LX4211Drug
Subjects will receive LX4211 once daily for 7 days
LX4211 PlaceboDrug
Subjects will receive LX4211 placebo once daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Not described Receives: Drug: LX4211 |
| LX4211 Placebo | Placebo comparator | Not described Receives: Drug: LX4211 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in postprandial glucose
Measured: baseline to 7 days
Secondary outcomes (4)
Number of subjects experiencing an adverse event
Measured: 7 days
Change from baseline in fasting plasma glucose
Measured: baseline to 7 days
Change from baseline in glucagon-like peptide 1 (Glp-1)
Measured: baseline to 7 days
Area Under Curve (AUC)
Measured: Days 1 and 7; predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lexicon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ike Ogbaa, M.D., Study director, Lexicon Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555008
- Sponsor's protocol ID
- LX4211.1-107-DM
- Other IDs
- LX4211.107
- Status last verified
- Sep 2013
- First submitted
- 7 Mar 2012
- Last updated
- 9 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
PubMed 38770818Zambrowicz B, Lapuerta P, Strumph P, Banks P, Wilson A, Ogbaa I, Sands A, Powell D. LX4211 therapy reduces postprandial glucose levels in patients with type 2 diabetes mellitus and renal impairment despite low urinary glucose excretion. Clin Ther. 2015 Jan 1;37(1):71-82.e12. doi: 10.1016/j.clinthera.2014.10.026. Epub 2014 Dec 17.
PubMed 25529979
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Evaluate the Pharmacodynamic and Pharmacokinetic Effects of LX4211 in Subjects With Type 2 Diabetes Mellitus and Moderate to Severe Renal Impairment
- ClinicalTrials.gov ID
- NCT01555008
- Acronym / sponsor ID
- LX4211.1-107-DM
- Conditions
- Type 2 Diabetes Mellitus, Renal Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Lexicon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Aug 2013 (actual)
- First posted
- 15 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 1 study is intended to assess the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability of LX4211 following once daily oral administration in subjects with type 2 diabetes mellitus (T2DM) and moderate to severe renal impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: LX4211 |
| LX4211 Placebo | Placebo comparator | Drug: LX4211 Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults ≥18 to ≤80 years of age
- History of T2DM for at least 6 months prior to screening
- Moderate to severe renal impairment and not actively on dialysis
- Willing and able to perform self-monitoring of blood glucose
- Willing and able to provide written informed consent
Key exclusion criteria (20 listed)
- History of type 1 diabetes mellitus, diabetic ketoacidosis (within the previous 6 months), or diabetes resulting from pancreatic disorder or secondary diabetes (from acromegaly and/or Cushing's disease)
- Subjects who have received a renal allograft
- Subjects expecting to require dialysis or to undergo kidney transplantation within 3 months of study dosing
- Presence of active hepatic disease or clinically significant abnormal liver function tests at Screening or planned study Day -1
- Subjects with a history of heart attack, severe/unstable angina, or coronary revascularization procedure within 6 months prior to study Day -2
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 |
|---|---|---|
| LX4211Subjects will receive LX4211 once daily for 7 days | Drug | Treatment A |
| LX4211 PlaceboSubjects will receive LX4211 placebo once daily for 7 days | Drug | LX4211 Placebo |
Primary outcome
Change from baseline in postprandial glucose
Time frame: baseline to 7 days
4 secondary outcomes
Number of subjects experiencing an adverse event
Time frame: 7 days
Change from baseline in fasting plasma glucose
Time frame: baseline to 7 days
Change from baseline in glucagon-like peptide 1 (Glp-1)
Time frame: baseline to 7 days
Area Under Curve (AUC)
Time frame: Days 1 and 7; predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, and 48 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2013.
- Derived from this study: PubMed 38770818Natale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
- Derived from this study: PubMed 25529979Zambrowicz B, Lapuerta P, Strumph P, Banks P, Wilson A, Ogbaa I, Sands A, Powell D. LX4211 therapy reduces postprandial glucose levels in patients with type 2 diabetes mellitus and renal impairment despite low urinary glucose excretion. Clin Ther. 2015 Jan 1;37(1):71-82.e12. doi: 10.1016/j.clinthera.2014.10.026. Epub 2014 Dec 17.
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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.
Ike Ogbaa, M.D. study director
Lexicon Pharmaceuticals, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LX4211 in people with Type 2 Diabetes Mellitus and Renal Impairment, run by Lexicon Pharmaceuticals at 6 sites 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 5 inclusion and 20 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 9 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in postprandial glucose (time frame: baseline to 7 days). 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 NCT01555008, which also lists 2 linked publications.
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 9 Sep 2013.