Type 2 Diabetes MellitusPhase 1NCT01188863
Study of Two Oral Formulations of LX4211 in Patients With Type 2 Diabetes Mellitus
A Phase 1 study testing 300 mg LX4211 (150 mg tablets), 300 mg LX4211 (50 mg tablets) and 300 mg LX4211 (liquid) in people with Type 2 Diabetes Mellitus, run by Lexicon Pharmaceuticals at 1 site in United States.
Trial summary
This protocol is intended to compare the effects of both a solid (tablet) and liquid oral dosage form of LX4211 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?
- 300 mg LX4211 (150 mg tablets), 300 mg LX4211 (50 mg tablets) and 300 mg LX4211 (liquid)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Oct 2010
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65 years of age
- Males and females of non-childbearing potential
- Diagnosis of type 2 diabetes mellitus for at least 6 months prior to screening
- Fasting plasma glucose ≤240 mg/dL
- Body mass index <42 kg/sq m
- HbA1c of 7-11%
- C-peptide of ≥1.0 ng/mL
- Ability to provide written informed consent
Who cannot join
- History of type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketonic syndrome, incontinence, or nocturia
- Current use of any blood glucose-lowering agent other than metformin
- Exposure to insulin, thiazide, or loop diuretics within 4 weeks prior to screening
- History of HIV, Hepatitis B, or Hepatitis C
- Surgery within 6 months of screening
- Donation or loss of >400 mL of blood or blood product within 8 weeks prior to start of study
Show all 9Show fewer
- Use of proteins or antibodies within 12 weeks prior to screening. (Flu shots are allowed.)
- Exposure to any investigational agent or participation in an investigational trial within 30 days of the start of the study
- History of drug or alcohol abuse within 12 months prior to screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lexicon Investigational Site
San Antonio, Texas, 78209
About this study
Official title: A Phase 1, Randomized, Open-Label, Three-Way Crossover Study of Two Oral Formulations of LX4211 in Subjects With Type 2 Diabetes Mellitus
This protocol is intended to compare the effects of both a solid (tablet) and liquid oral dosage form of LX4211 in subjects with type 2 diabetes mellitus.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- 300 mg LX4211 (150 mg tablets), 300 mg LX4211 (50 mg tablets), 300 mg LX4211 (liquid)
- 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.
300 mg LX4211 (150 mg tablets)Drug
Single oral dose of two 150 mg tablets LX4211
300 mg LX4211 (50 mg tablets)Drug
Single oral dose of six 50 mg tablets LX4211
300 mg LX4211 (liquid)Drug
Single 30 mL dose of liquid oral solution LX4211 (10 mg/mL)
| Study group | Role | What they receive |
|---|---|---|
| Solid Oral Dose - 150 mg tablets | Experimental | Not described Receives: Drug: 300 mg LX4211 (150 mg tablets) |
| Solid Oral Dose - 50 mg tablets | Experimental | Not described Receives: Drug: 300 mg LX4211 (50 mg tablets) |
| Liquid Oral Dose | Experimental | Not described Receives: Drug: 300 mg LX4211 (liquid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration
Measured: Pharmacokinetics samples collected on day of dosing and 24 and 48 hours post-dose (Follow-up).
Time at which maximum observed plasma concentration occurs
Measured: Pharmacokinetics samples collected on day of dosing and 24 and 48 hours post-dose (Follow-up).
Half-life of the drug in plasma
Measured: Pharmacokinetics samples collected on day of dosing and 24 and 48 hours post-dose (Follow-up).
Secondary outcomes (5)
Plasma glucose
Measured: Samples collected on initial visit; Day -15 and Day -5 (Washout); numerous timepoints on Day -1 (Washout) and day of dosing; 24 hours post-dose (Follow-up); and upon discharge.
Urinary glucose excretion
Measured: Samples collected on Day -1 (Washout), day of dosing, and 24 and 48 hours post-dose (Follow-up).
Insulin
Measured: Samples collected on initial visit; Day -15 and Day -5 (Washout); numerous timepoints on Day -1 (Washout) and day of dosing; 24 hours post-dose (Follow-up); and upon discharge.
Peptide YY
Measured: Samples collected on initial visit; Day -15 and Day -5 (Washout); numerous timepoints on Day -1 (Washout) and day of dosing; 24 hours post-dose (Follow-up); and upon discharge.
Glucagon-like Peptide 1
Measured: Samples collected on initial visit; Day -15 and Day -5 (Washout); numerous timepoints on Day -1 (Washout) and day of dosing; 24 hours post-dose (Follow-up); and upon discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lexicon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Joel P. Freiman, MD, MPH, Study director, Lexicon Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188863
- Sponsor's protocol ID
- LX4211.1-102-DM
- Other IDs
- LX4211.102
- Status last verified
- Mar 2011
- First submitted
- 24 Aug 2010
- Last updated
- 30 Mar 2011
- Results posted
- No
- 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-Label, Three-Way Crossover Study of Two Oral Formulations of LX4211 in Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01188863
- Acronym / sponsor ID
- LX4211.1-102-DM
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Lexicon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Oct 2010 (actual)
- First posted
- 26 Aug 2010 (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 protocol is intended to compare the effects of both a solid (tablet) and liquid oral dosage form of LX4211 in subjects with type 2 diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Solid Oral Dose - 150 mg tablets | Experimental | Drug: 300 mg LX4211 (150 mg tablets) |
| Solid Oral Dose - 50 mg tablets | Experimental | Drug: 300 mg LX4211 (50 mg tablets) |
| Liquid Oral Dose | Experimental | Drug: 300 mg LX4211 (liquid) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged 18 to 65 years of age
- Males and females of non-childbearing potential
- Diagnosis of type 2 diabetes mellitus for at least 6 months prior to screening
- Fasting plasma glucose ≤240 mg/dL
- Body mass index <42 kg/sq m
Key exclusion criteria (9 listed)
- History of type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketonic syndrome, incontinence, or nocturia
- Current use of any blood glucose-lowering agent other than metformin
- Exposure to insulin, thiazide, or loop diuretics within 4 weeks prior to screening
- History of HIV, Hepatitis B, or Hepatitis C
- Surgery within 6 months of screening
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 |
|---|---|---|
| 300 mg LX4211 (150 mg tablets)Single oral dose of two 150 mg tablets LX4211 | Drug | Solid Oral Dose - 150 mg tablets |
| 300 mg LX4211 (50 mg tablets)Single oral dose of six 50 mg tablets LX4211 | Drug | Solid Oral Dose - 50 mg tablets |
| 300 mg LX4211 (liquid)Single 30 mL dose of liquid oral solution LX4211 (10 mg/mL) | Drug | Liquid Oral Dose |
Primary outcome
Maximum observed plasma concentration
Time frame: Pharmacokinetics samples collected on day of dosing and 24 and 48 hours post-dose (Follow-up).
Time at which maximum observed plasma concentration occurs
Time frame: Pharmacokinetics samples collected on day of dosing and 24 and 48 hours post-dose (Follow-up).
Half-life of the drug in plasma
Time frame: Pharmacokinetics samples collected on day of dosing and 24 and 48 hours post-dose (Follow-up).
5 secondary outcomes
Plasma glucose
Time frame: Samples collected on initial visit; Day -15 and Day -5 (Washout); numerous timepoints on Day -1 (Washout) and day of dosing; 24 hours post-dose (Follow-up); and upon discharge.
Urinary glucose excretion
Time frame: Samples collected on Day -1 (Washout), day of dosing, and 24 and 48 hours post-dose (Follow-up).
Insulin
Time frame: Samples collected on initial visit; Day -15 and Day -5 (Washout); numerous timepoints on Day -1 (Washout) and day of dosing; 24 hours post-dose (Follow-up); and upon discharge.
Peptide YY
Time frame: Samples collected on initial visit; Day -15 and Day -5 (Washout); numerous timepoints on Day -1 (Washout) and day of dosing; 24 hours post-dose (Follow-up); and upon discharge.
Glucagon-like Peptide 1
Time frame: Samples collected on initial visit; Day -15 and Day -5 (Washout); numerous timepoints on Day -1 (Washout) and day of dosing; 24 hours post-dose (Follow-up); and upon discharge.
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 30 Mar 2011.
- 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.
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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 1 study testing 300 mg LX4211 (150 mg tablets), 300 mg LX4211 (50 mg tablets) and 300 mg LX4211 (liquid) 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 8 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 30 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. 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?
Maximum observed plasma concentration (time frame: Pharmacokinetics samples collected on day of dosing and 24 and 48 hours post-dose (Follow-up).). The study lists 3 primary outcomes in all. 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 NCT01188863, 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 30 Mar 2011.