Type 2 Diabetes MellitusPhase 1NCT01441232
A Study to Evaluate the Pharmacodynamic Effects of Single-Dose Co-Administration of LX4211 With Januvia® in Type 2 Diabetics
A Phase 1 study testing LX4211 and Januvia® in people with Type 2 Diabetes Mellitus, run by Lexicon Pharmaceuticals at 1 site in United States.
Trial summary
This study is intended to evaluate the pharmacodynamics, safety, and tolerability of LX4211 when administered concurrently with sitagliptin (Januvia®) in patients 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 and Januvia®
- 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
- Oct 2011to Nov 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65 years of age
- History of Type 2 Diabetes Mellitus for at least 3 months prior to Screening, with HgbA1c values of 6.5 to 10.5% and C-peptide ≥1.0 ng/mL
- Body mass index (BMI) ≤45 kg/sq m
- Willing and able to self-monitor blood glucose
- Able to provide written informed consent
Who cannot join
- History of Type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketotic syndrome, or diabetes resulting from pancreatic disorder or secondary diabetes
- Current use of any blood glucose lowering agent other than metformin
- History of renal disease or clinically significant abnormal kidney function tests at Screening or Day -2
- Presence of active hepatic disease or clinically significant abnormal liver function tests at Screening or Day -2
- History of myocardial infarction, severe/unstable angina, or coronary revascularization procedure within 6 months of Day -2
- History of clinically significant cardiac arrhythmias within 1 year of Day -2
Show all 23Show fewer
- Congestive heart failure and/or New York Heart Association (NYHA) class III or IV symptoms of heart failure
- Subjects with uncontrolled Stage 3 hypertension
- History of 2 or more emergency room visits, doctor's visits, or hospitalizations due to hypoglycemia within 6 months of Day -2
- History of alcohol or drug abuse within 12 months of Screening
- History of bowel resection > 20 cm, any malabsorptive disorder, severe gastroparesis, and GI procedure for the purpose of weight loss that would slow gastric emptying
- History of HIV or hepatitis C
- Major surgery within 3 months of Day -2 or any planned surgery during the study
- History of any active infection within 2 weeks of Day -2
- History of pancreatitis
- History of any malignancy within the last 5 years which would affect the diagnosis or assessment of LX4211 or sitagliptin
- History of any serious adverse reaction or hypersensitivity to LX4211 or sitagliptin
- Presence of any clinically significant physical, laboratory, or ECG findings or any concurrent condition at Screening that may interfere with the study in the opinion of the investigator
- Triglycerides > 1000 mg/dL at Screening or Day -2
- Donation or loss of >400 mL of blood or blood product within 8 weeks prior to Day -2
- Use of any tobacco product for the duration of study participation
- Use of corticosteroids within 2 weeks of Day 1
- Use of digoxin or warfarin within 2 weeks 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, Open-label, 3-period, 3-treatment, Single Dose Crossover Study to Evaluate the Pharmacodynamic Effects of LX4211 When Administered Concurrently With JANUVIA® (Sitagliptin) in Subjects With Type 2 Diabetes Mellitus
This study is intended to evaluate the pharmacodynamics, safety, and tolerability of LX4211 when administered concurrently with sitagliptin (Januvia®) in patients with Type 2 Diabetes Mellitus.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- LX4211, Januvia®
- 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.
LX4211Drug
400 mg of LX4211 administered as two 200 mg tablets
Januvia®Drug
100 mg Januvia® (sitagliptin) administered as one 100 mg sitagliptin tablet
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Not described Receives: Drug: LX4211 |
| Treatment C | Experimental | Not described Receives: Drug: LX4211; Drug: Januvia® |
| Treatment B | Active comparator | Not described Receives: Drug: Januvia® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in gut hormones
Measured: Days 1, 8, and 15
Secondary outcomes (5)
Change from baseline in fasting plasma glucose
Measured: Days 1, 8, and 15
Change from baseline in postprandial glucose
Measured: Days 1, 8, and 15
Change from baseline in insulin
Measured: Days 1, 8, and 15
Change from baseline in peptide YY
Measured: Days 1, 8, and 15
Change from baseline in urinary glucose excretion
Measured: Days 1, 8, and 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionNov 2011
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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lexicon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ikenna Ogbaa, MD, Study director, Lexicon Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01441232
- Sponsor's protocol ID
- LX4211.1-105-DM
- Other IDs
- LX4211.105
- Status last verified
- Jan 2012
- First submitted
- 23 Sep 2011
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Zambrowicz B, Ding ZM, Ogbaa I, Frazier K, Banks P, Turnage A, Freiman J, Smith M, Ruff D, Sands A, Powell D. Effects of LX4211, a dual SGLT1/SGLT2 inhibitor, plus sitagliptin on postprandial active GLP-1 and glycemic control in type 2 diabetes. Clin Ther. 2013 Mar;35(3):273-285.e7. doi: 10.1016/j.clinthera.2013.01.010. Epub 2013 Feb 21.
PubMed 23433601
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, 3-period, 3-treatment, Single Dose Crossover Study to Evaluate the Pharmacodynamic Effects of LX4211 When Administered Concurrently With JANUVIA® (Sitagliptin) in Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01441232
- Acronym / sponsor ID
- LX4211.1-105-DM
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Lexicon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Nov 2011 (actual)
- First posted
- 27 Sep 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.
This study is intended to evaluate the pharmacodynamics, safety, and tolerability of LX4211 when administered concurrently with sitagliptin (Januvia®) in patients 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 |
|---|---|---|
| Treatment A | Experimental | Drug: LX4211 |
| Treatment C | Experimental | Drug: LX4211, Drug: Januvia® |
| Treatment B | Active comparator | Drug: Januvia® |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 to 65 years of age
- History of Type 2 Diabetes Mellitus for at least 3 months prior to Screening, with HgbA1c values of 6.5 to 10.5% and C-peptide ≥1.0 ng/mL
- Body mass index (BMI) ≤45 kg/sq m
- Willing and able to self-monitor blood glucose
- Able to provide written informed consent
Key exclusion criteria (23 listed)
- History of Type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketotic syndrome, or diabetes resulting from pancreatic disorder or secondary diabetes
- Current use of any blood glucose lowering agent other than metformin
- History of renal disease or clinically significant abnormal kidney function tests at Screening or Day -2
- Presence of active hepatic disease or clinically significant abnormal liver function tests at Screening or Day -2
- History of myocardial infarction, severe/unstable angina, or coronary revascularization procedure within 6 months of 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 |
|---|---|---|
| LX4211400 mg of LX4211 administered as two 200 mg tablets | Drug | Treatment A, Treatment C |
| Januvia®100 mg Januvia® (sitagliptin) administered as one 100 mg sitagliptin tablet | Drug | Treatment B, Treatment C |
Primary outcome
Change from baseline in gut hormones
Time frame: Days 1, 8, and 15
5 secondary outcomes
Change from baseline in fasting plasma glucose
Time frame: Days 1, 8, and 15
Change from baseline in postprandial glucose
Time frame: Days 1, 8, and 15
Change from baseline in insulin
Time frame: Days 1, 8, and 15
Change from baseline in peptide YY
Time frame: Days 1, 8, and 15
Change from baseline in urinary glucose excretion
Time frame: Days 1, 8, and 15
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 31 Jan 2012.
- Derived from this study: PubMed 23433601Zambrowicz B, Ding ZM, Ogbaa I, Frazier K, Banks P, Turnage A, Freiman J, Smith M, Ruff D, Sands A, Powell D. Effects of LX4211, a dual SGLT1/SGLT2 inhibitor, plus sitagliptin on postprandial active GLP-1 and glycemic control in type 2 diabetes. Clin Ther. 2013 Mar;35(3):273-285.e7. doi: 10.1016/j.clinthera.2013.01.010. Epub 2013 Feb 21.
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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 LX4211 and Januvia® 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 5 inclusion and 23 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 31 Jan 2012. 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?
Change from baseline in gut hormones (time frame: Days 1, 8, and 15). 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 NCT01441232, 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 31 Jan 2012.