Diabetes MellitusPhase 2NCT01910194
Impact of Combined of Lantus(Insulin Glargine) and Lyxumia (Lixisenatide) on Insulin Secretion and Gastric Emptying
A Phase 2 study testing Luyxumia versus Lantus in people with Diabetes Mellitus, run by Profil Institut für Stoffwechselforschung GmbH at 2 sites in Germany.
Trial summary
Impact of combined Lantus (insulin glargine) and Lyxumia(lixisenatide) on insulin secretion and gastric emptying Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Luyxumia versus Lantus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesGermany
- Study dates
- Dec 2013to Oct 2014
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes mellitus diagnosed at least one year before the screening visit not previously treated with glitazones, insulin or GLP-1 agonists
- Inadequately controlled diabetes mellitus
Who cannot join
- Subjects with type 1 diabetes, maturity onset diabetes of the young (MODY) or secondary forms of diabetes such as due to pancreatitis
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
St. Josef-Hospital, University Hospital, Ruhr
Bochum, 44791
Profil Institut für Stoffwechselforschung GmbH
Neuss, 41460
About this study
Official title: A Bicentric Open-label, Randomized, Two-parallel-group Study Investigating the Impact of Combined Lantus Insulin Glargine) and Lyxumia(Lixisenatide) on Insulin Secretion and Gastric Emptying in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled on Diet and Oral Antidiabetic Medication
Impact of combined Lantus (insulin glargine) and Lyxumia(lixisenatide) on insulin secretion and gastric emptying
Read the detailed description
Impact of combined Lantus (insulin glargine) and Lyxumia(lixisenatide) on insulin secretion and gastric emptying
- Conditions
- Diabetes Mellitus
- Being tested
- Luyxumia versus Lantus
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Luyxumia versus LantusDrug
| Study group | Role | What they receive |
|---|---|---|
| Lyxumia | Other | 4 weeks Luxumia plus another 4 weeks combination Receives: Drug: Luyxumia versus Lantus |
| Lantus | Other | 4 weeks Lantus plus another 4 weeks combination Receives: Drug: Luyxumia versus Lantus |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCISEC(0-10min)
Measured: Within 0 to 10 min after iv glucose challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2013 (estimated)
- Study startDec 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Profil Institut für Stoffwechselforschung GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01910194
- Sponsor's protocol ID
- LanLyx
- Status last verified
- Jan 2015
- First submitted
- 25 Jul 2013
- Last updated
- 22 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bicentric Open-label, Randomized, Two-parallel-group Study Investigating the Impact of Combined Lantus Insulin Glargine) and Lyxumia(Lixisenatide) on Insulin Secretion and Gastric Emptying in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled on Diet and Oral Antidiabetic Medication
- ClinicalTrials.gov ID
- NCT01910194
- Acronym / sponsor ID
- LanLyx
- Conditions
- Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Profil Institut für Stoffwechselforschung GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- Dec 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 29 Jul 2013 (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.
Impact of combined Lantus (insulin glargine) and Lyxumia(lixisenatide) on insulin secretion and gastric emptying
Detailed description
Impact of combined Lantus (insulin glargine) and Lyxumia(lixisenatide) on insulin secretion and gastric emptying
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lyxumia | Other | Drug: Luyxumia versus Lantus4 weeks Luxumia plus another 4 weeks combination |
| Lantus | Other | Drug: Luyxumia versus Lantus4 weeks Lantus plus another 4 weeks combination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with type 2 diabetes mellitus diagnosed at least one year before the screening visit not previously treated with glitazones, insulin or GLP-1 agonists
- Inadequately controlled diabetes mellitus
Key exclusion criteria (1 listed)
- Subjects with type 1 diabetes, maturity onset diabetes of the young (MODY) or secondary forms of diabetes such as due to pancreatitis
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 |
|---|---|---|
| Luyxumia versus Lantus | Drug | Lantus, Lyxumia |
Primary outcome
AUCISEC(0-10min)
Time frame: Within 0 to 10 min after iv glucose challenge
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 22 Jan 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Luyxumia versus Lantus in people with Diabetes Mellitus, run by Profil Institut für Stoffwechselforschung GmbH at 2 sites in Germany.
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 2 inclusion and 1 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 22 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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 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?
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?
AUCISEC(0-10min) (time frame: Within 0 to 10 min after iv glucose challenge). 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 22 Jan 2015.