Diabetes Mellitus, Type 2Phase 4LixiRamNCT02941367
Safety Assessment of Lyxumia (Lixisenatide) and Sulfonylurea as Add-on Treatment to Basal Insulin in Uncontrolled Patients With Type 2 Diabetes Mellitus Who Elect to Fast During Ramadan
A Phase 4 study testing Lixisenatide (AVE0010), Sulfonylurea and metformin in people with Diabetes Mellitus, Type 2, run by Sanofi at 16 sites in 4 countries.
Trial summary
Primary Objective: To compare the safety, in terms of percentage of patients with symptomatic documented hypoglycemia during Ramadan fast, of lixisenatide versus sulfonylurea (SU). Secondary Objectives: To assess effect of lixisenatide versus SU on: Changes in glycemic control; Changes in body weight. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Lixisenatide (AVE0010), Sulfonylurea and metformin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 16 sitesin 4 countries
- Study dates
- 23 Feb 2017to 4 Aug 2017
- Phase
- Phase 4
- 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 for at least 1 year at the time of the screening visit, insufficiently controlled with basal insulin + SU (≤50% max allowed dose) ±1 oral antidiabetic (OAD) drug.
- Patients who express the intention to fast during Ramadan.
- Signed informed consent.
Who cannot join
- At the time of screening age < legal age of majority.
- Glycated hemoglobin (HbA1c) at screening visit: <7.5% or >10%.
- Body mass index (BMI) <20kg/m^2.
- Treatment with basal insulin for less than 6 months prior to screening.
- Prior antidiabetic medication (basal insulin and OADs) not at stable dose (eg, same medication, frequency and <20% dose change) in the last 8 weeks prior to screening.
- Previous treatment with short or rapid acting insulin other than for short term use (≤10 days) in relation to hospitalization or an acute illness in the last 6 months prior to screening.
Show all 17Show fewer
- Any discontinuation from a glucagon like peptide-1 receptor agonist (GLP-1 RA) due to safety/tolerability issue or lack of efficacy.
- Patient not willing to perform self-monitored plasma glucose (SMPG) as required by protocol and to follow the instructions provided.
- Type 1, gestational or secondary diabetes.
- History of diabetic ketoacidosis.
- History of hypoglycemia unawareness.
- Any medical contraindication for sustained and safe fasting.
- Pregnant or breast-feeding women.
- Women of childbearing potential (WOCB) not protected by highly effective contraceptive method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy.
- Known hypersensitivity/intolerance to lixisenatide (Lyxumia) or any of its excipients.
- All contraindications of the comparator and protocol mandated background therapies or warning/precaution of use (when appropriate) as displayed in the respective National Product Labeling.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
16 sites in 4 countries.
16 sites in 4 countries
India12 sites
Investigational Site Number 356005
Ahmedabad, 380007
Investigational Site Number 356002
Bangalore, 560043
Investigational Site Number 356015
Bangalore, 560055
Investigational Site Number 356008
Bangalore, 560060
Investigational Site Number 356009
Hyderabad, 500001
Investigational Site Number 356018
Hyderabad, 500004
Investigational Site Number 356010
Hyderabad, 500072
Investigational Site Number 356003
Hyderabad, 500095
Investigational Site Number 356007
Jaipur
Investigational Site Number 356019
Madurai, 625020
Investigational Site Number 356014
Mumbai, 400007
Investigational Site Number 356022
Nagpur, 440010
Israel2 sites
Investigational Site Number 376001
Haifa, 31096
Investigational Site Number 376002
Safed, 13100
About this study
Official title: International, Randomized, Open Label Study to Compare the Safety and Efficacy of Lixisenatide vs. Sulfonylurea on Top of Basal Insulin Treatment in Type 2 Diabetes Mellitus Subjects Who Elect to Fast During Ramadan
Primary Objective:
To compare the safety, in terms of percentage of patients with symptomatic documented hypoglycemia during Ramadan fast, of lixisenatide versus sulfonylurea (SU).
Secondary Objectives:
- To assess effect of lixisenatide versus SU on:
- Changes in glycemic control;
- Changes in body weight.
- To assess overall safety of lixisenatide and SU.
Read the detailed description
The total study duration per patient will have a minimum 12 weeks and maximum 22 weeks (up to 2 weeks screening period + 8-12 weeks pre-Ramadan period + 29-30 days Ramadan + 0 4 weeks post-Ramadan period). This is a phase 3b study in Kingdom of Saudi Arabia and Bangladesh (instead of phase 4 for other countries).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Lixisenatide (AVE0010), Sulfonylurea, metformin, basal insulin
- 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.
Lixisenatide (AVE0010)Drug
Also called Lyxumia
Pharmaceutical form: solution for injection
Route of administration: subcutaneous
SulfonylureaDrug
Pharmaceutical form: tablet
Route of administration: oral
metforminDrug
Pharmaceutical form: tablet
Route of administration: oral
basal insulinDrug
Pharmaceutical form: solution for injection
Route of administration: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Lyxumia | Experimental | Patients will receive Lyxumia once daily as investigational medicinal product (IMP) on top of patient's previous basal insulin with/without metformin. Non-IMPs will be administrated as per Investigator's indications according to local labeling, guidelines, and clinical judgment. Receives: Drug: Lixisenatide (AVE0010); Drug: metformin; Drug: basal insulin |
| Sulfonylurea | Active comparator | Patients will continue the treatment with previous Sulfonylurea as IMP on top of patient's previous basal insulin with/without metformin. The IMP and non-IMPs will be administrated as per Investigator's indications according to local labeling, guidelines, and clinical judgment. Receives: Drug: Sulfonylurea; Drug: metformin; Drug: basal insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with at least 1 documented symptomatic hypoglycemia event (plasma glucose ≤70 mg/dL; 3.9 mmol/L)
Measured: Approximately 30 days (from start to end of Ramadan holy month)
Secondary outcomes (6)
Mean change in HbA1c
Measured: Baseline, 0-4 weeks pre- and 0-4 weeks post-Ramadan
Mean change in body weight
Measured: Baseline, 0-4 weeks pre- and 0-4 weeks post-Ramadan
Percentage of patients with 2-hour post prandial glucose (2hPPG) <180 mg/dL (10 mmol/L)
Measured: Last 14 days of Ramadan month
Percentage of patients with HbA1C <7%
Measured: At 0-4 weeks pre- and 0-4 weeks post-Ramadan
Percentage of patients with fasting plasma glucose (FPG) <130 mg/dL (7.22 mmol/L)
Measured: At pre-Ramadan visit
Percentage of patients with HbA1c <7%, no weight gain and no documented symptomatic hypoglycemia (plasma glucose ≤70 mg/dL; 3.9 mmol/L)
Measured: At 0-4 weeks pre- and 0-4 weeks post-Ramadan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study start23 Feb 2017
- Primary completion4 Aug 2017
- Study completion4 Aug 2017
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 Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941367
- Sponsor's protocol ID
- LPS14410
- Other IDs
- U1111-1172-3026
- Acronym
- LixiRam
- Status last verified
- Apr 2022
- First submitted
- 12 Oct 2016
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Publications
Lee SWH, Chen WS, Sellappans R, Md Sharif SB, Metzendorf MI, Lai NM. Interventions for people with type 2 diabetes mellitus fasting during Ramadan. Cochrane Database Syst Rev. 2023 Jul 12;7(7):CD013178. doi: 10.1002/14651858.CD013178.pub2.
PubMed 37435938Sahay R, Hafidh K, Djaballah K, Coudert M, Azar S, Shehadeh N, Hanif W, Hassanein M. Safety of lixisenatide plus basal insulin treatment regimen in Indian people with type 2 diabetes mellitus during Ramadan fast: A post hoc analysis of the LixiRam randomized trial. Diabetes Res Clin Pract. 2020 May;163:108148. doi: 10.1016/j.diabres.2020.108148. Epub 2020 Apr 14.
PubMed 32302665
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International, Randomized, Open Label Study to Compare the Safety and Efficacy of Lixisenatide vs. Sulfonylurea on Top of Basal Insulin Treatment in Type 2 Diabetes Mellitus Subjects Who Elect to Fast During Ramadan
- ClinicalTrials.gov ID
- NCT02941367
- Acronym / sponsor ID
- LixiRam / LPS14410
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2017 (actual)
- Primary completion
- 4 Aug 2017 (actual)
- Study completion
- 4 Aug 2017 (actual)
- First posted
- 21 Oct 2016 (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.
Primary Objective:
To compare the safety, in terms of percentage of patients with symptomatic documented hypoglycemia during Ramadan fast, of lixisenatide versus sulfonylurea (SU).
Secondary Objectives:
- To assess effect of lixisenatide versus SU on:
- Changes in glycemic control;
- Changes in body weight.
- To assess overall safety of lixisenatide and SU.
Detailed description
The total study duration per patient will have a minimum 12 weeks and maximum 22 weeks (up to 2 weeks screening period + 8-12 weeks pre-Ramadan period + 29-30 days Ramadan + 0 4 weeks post-Ramadan period). This is a phase 3b study in Kingdom of Saudi Arabia and Bangladesh (instead of phase 4 for other countries).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lyxumia | Experimental | Drug: Lixisenatide (AVE0010), Drug: metformin, Drug: basal insulinPatients will receive Lyxumia once daily as investigational medicinal product (IMP) on top of patient's previous basal insulin with/without metformin. Non-IMPs will be administrated as per Investigator's indications according to local labeling, guidelines, and clinical judgment. |
| Sulfonylurea | Active comparator | Drug: Sulfonylurea, Drug: metformin, Drug: basal insulinPatients will continue the treatment with previous Sulfonylurea as IMP on top of patient's previous basal insulin with/without metformin. The IMP and non-IMPs will be administrated as per Investigator's indications according to local labeling, guidelines, and clinical judgment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with type 2 diabetes mellitus, diagnosed for at least 1 year at the time of the screening visit, insufficiently controlled with basal insulin + SU (≤50% max allowed dose) ±1 oral antidiabetic (OAD) drug.
- Patients who express the intention to fast during Ramadan.
- Signed informed consent.
Key exclusion criteria (17 listed)
- At the time of screening age < legal age of majority.
- Glycated hemoglobin (HbA1c) at screening visit: <7.5% or >10%.
- Body mass index (BMI) <20kg/m^2.
- Treatment with basal insulin for less than 6 months prior to screening.
- Prior antidiabetic medication (basal insulin and OADs) not at stable dose (eg, same medication, frequency and <20% dose change) in the last 8 weeks prior to 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 |
|---|---|---|
| Lixisenatide (AVE0010)Also: LyxumiaPharmaceutical form: solution for injection Route of administration: subcutaneous | Drug | Lyxumia |
| SulfonylureaPharmaceutical form: tablet Route of administration: oral | Drug | Sulfonylurea |
| metforminPharmaceutical form: tablet Route of administration: oral | Drug | Lyxumia, Sulfonylurea |
| basal insulinPharmaceutical form: solution for injection Route of administration: subcutaneous | Drug | Lyxumia, Sulfonylurea |
Primary outcome
Percentage of patients with at least 1 documented symptomatic hypoglycemia event (plasma glucose ≤70 mg/dL; 3.9 mmol/L)
Time frame: Approximately 30 days (from start to end of Ramadan holy month)
6 secondary outcomes
Mean change in HbA1c
Time frame: Baseline, 0-4 weeks pre- and 0-4 weeks post-Ramadan
Mean change in body weight
Time frame: Baseline, 0-4 weeks pre- and 0-4 weeks post-Ramadan
Percentage of patients with 2-hour post prandial glucose (2hPPG) <180 mg/dL (10 mmol/L)
Time frame: Last 14 days of Ramadan month
Percentage of patients with HbA1C <7%
Time frame: At 0-4 weeks pre- and 0-4 weeks post-Ramadan
Percentage of patients with fasting plasma glucose (FPG) <130 mg/dL (7.22 mmol/L)
Time frame: At pre-Ramadan visit
Percentage of patients with HbA1c <7%, no weight gain and no documented symptomatic hypoglycemia (plasma glucose ≤70 mg/dL; 3.9 mmol/L)
Time frame: At 0-4 weeks pre- and 0-4 weeks post-Ramadan
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 25 Apr 2022.
- Derived from this study: PubMed 37435938Lee SWH, Chen WS, Sellappans R, Md Sharif SB, Metzendorf MI, Lai NM. Interventions for people with type 2 diabetes mellitus fasting during Ramadan. Cochrane Database Syst Rev. 2023 Jul 12;7(7):CD013178. doi: 10.1002/14651858.CD013178.pub2.
- Derived from this study: PubMed 32302665Sahay R, Hafidh K, Djaballah K, Coudert M, Azar S, Shehadeh N, Hanif W, Hassanein M. Safety of lixisenatide plus basal insulin treatment regimen in Indian people with type 2 diabetes mellitus during Ramadan fast: A post hoc analysis of the LixiRam randomized trial. Diabetes Res Clin Pract. 2020 May;163:108148. doi: 10.1016/j.diabres.2020.108148. Epub 2020 Apr 14.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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.
Clinical Sciences & Operations study director
Sanofi
16 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lixisenatide (AVE0010), Sulfonylurea and metformin in people with Diabetes Mellitus, Type 2, run by Sanofi at 16 sites in 4 countries.
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 3 inclusion and 17 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 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in India, Israel, Kuwait, Turkey (Türkiye). 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Percentage of patients with at least 1 documented symptomatic hypoglycemia event (plasma glucose ≤70 mg/dL; 3.9 mmol/L) (time frame: Approximately 30 days (from start to end of Ramadan holy month)). 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 NCT02941367, 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 25 Apr 2022.