Type 2 Diabetes MellitusPhase 1NCT01292993
A Study to Evaluate the Interaction of LX4211 and Metformin in Healthy Subjects
A Phase 1 study testing 400 mg LX4211 and 1000 mg metformin in people with Type 2 Diabetes Mellitus, run by Lexicon Pharmaceuticals at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of LX4211 and metformin on each other when given at the same time as single doses to healthy human subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- 400 mg LX4211 and 1000 mg metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Mar 2011
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults ≥18 to ≤55 years of age. Females must be of non-childbearing potential.
- Body mass index (BMI)≥18 to ≤35 kg/sq m
- Able to provide written consent
- Vital signs within sponsor-defined ranges
Who cannot join
- Use of any medication, including any prescription, over-the-counter, herbal tea, or other supplements within 5 days of dosing
- No investigational agent or study treatment within 30 days prior to Day 1.
- No protein or antibody-based therapeutic agents within 3 months prior to screening
- Use of any tobacco product
- History of bariatric surgery or any gastrointestinal surgery that may induce malabsorption
- History of any major surgery within 6 months prior to screening
Show all 13Show fewer
- History of any serious adverse reaction or hypersensitivity to metformin or LX4211.
- History of renal disease or significantly abnormal kidney function test
- History of hepatic disease or significantly abnormal liver function test
- History of any active infection within 30 days prior to Day 1
- History of any surgical or medical condition or clinically significant laboratory or physical finding
- Positive urine glucose at Screening
- Use of drugs or alcohol
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, 3-Period, 3-Treatment, Single-dose Crossover Study to Evaluate the Pharmacokinetic Interaction of LX4211 and Metformin in Healthy Subjects
The purpose of this study is to determine the effects of LX4211 and metformin on each other when given at the same time as single doses to healthy human subjects.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- 400 mg LX4211, 1000 mg metformin
- 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.
400 mg LX4211Drug
400 mg of LX4211 given as a solid oral dose form
1000 mg metforminDrug
1000 mg metformin given as a solid oral dose form
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | 400 mg LX4211 Receives: Drug: 400 mg LX4211 |
| Treatment B | Experimental | 1000 mg metformin Receives: Drug: 1000 mg metformin |
| Treatment C | Experimental | 400 mg LX4211 + 1000 mg metformin Receives: Drug: 400 mg LX4211; Drug: 1000 mg metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of LX4211 and metformin after concurrent single-dose administration
Measured: Up to 43 days, including screening
Secondary outcomes (7)
Urinary glucose excretion
Measured: Up to 43 days, including screening
Fasting plasma glucose
Measured: Up to 43 days, including screening
Postprandial glucose
Measured: Up to 43 days, including screening
Insulin
Measured: Up to 43 days, including screening
Peptide YY
Measured: Up to 43 days, including screening
Glucagon-like peptide (GLP-1)
Measured: Up to 43 days, including screening
Glucose-dependent insulinotropic peptide
Measured: Up to 43 days, including screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lexicon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ikenna Ogbaa, MD, Study director, Lexicon Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292993
- Sponsor's protocol ID
- LX4211.1-103-DDI
- Other IDs
- LX4211.103
- Status last verified
- Mar 2011
- First submitted
- 8 Feb 2011
- Last updated
- 30 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
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, 3-Period, 3-Treatment, Single-dose Crossover Study to Evaluate the Pharmacokinetic Interaction of LX4211 and Metformin in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01292993
- Acronym / sponsor ID
- LX4211.1-103-DDI
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Lexicon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Mar 2011 (actual)
- First posted
- 10 Feb 2011 (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.
The purpose of this study is to determine the effects of LX4211 and metformin on each other when given at the same time as single doses to healthy human subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: 400 mg LX4211400 mg LX4211 |
| Treatment B | Experimental | Drug: 1000 mg metformin1000 mg metformin |
| Treatment C | Experimental | Drug: 400 mg LX4211, Drug: 1000 mg metformin400 mg LX4211 + 1000 mg metformin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults ≥18 to ≤55 years of age. Females must be of non-childbearing potential.
- Body mass index (BMI)≥18 to ≤35 kg/sq m
- Able to provide written consent
- Vital signs within sponsor-defined ranges
Key exclusion criteria (13 listed)
- Use of any medication, including any prescription, over-the-counter, herbal tea, or other supplements within 5 days of dosing
- No investigational agent or study treatment within 30 days prior to Day 1.
- No protein or antibody-based therapeutic agents within 3 months prior to screening
- Use of any tobacco product
- History of bariatric surgery or any gastrointestinal surgery that may induce malabsorption
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 |
|---|---|---|
| 400 mg LX4211400 mg of LX4211 given as a solid oral dose form | Drug | Treatment A, Treatment C |
| 1000 mg metformin1000 mg metformin given as a solid oral dose form | Drug | Treatment B, Treatment C |
Primary outcome
Plasma concentration of LX4211 and metformin after concurrent single-dose administration
Time frame: Up to 43 days, including screening
7 secondary outcomes
Urinary glucose excretion
Time frame: Up to 43 days, including screening
Fasting plasma glucose
Time frame: Up to 43 days, including screening
Postprandial glucose
Time frame: Up to 43 days, including screening
Insulin
Time frame: Up to 43 days, including screening
Peptide YY
Time frame: Up to 43 days, including screening
Glucagon-like peptide (GLP-1)
Time frame: Up to 43 days, including screening
Glucose-dependent insulinotropic peptide
Time frame: Up to 43 days, including screening
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.
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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.
Ikenna Ogbaa, MD 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 400 mg LX4211 and 1000 mg metformin 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 4 inclusion and 13 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?
Plasma concentration of LX4211 and metformin after concurrent single-dose administration (time frame: Up to 43 days, including screening). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.