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 (LixiRam)
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ClinicalTrials.gov Identifier: NCT02941367 |
Recruitment Status :
Completed
First Posted : October 21, 2016
Last Update Posted : September 21, 2017
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 2 | Drug: Lixisenatide (AVE0010) Drug: Sulfonylurea Drug: metformin Drug: basal insulin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 184 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | February 23, 2017 |
Actual Primary Completion Date : | August 4, 2017 |
Actual Study Completion Date : | August 4, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Lyxumia
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.
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Drug: Lixisenatide (AVE0010)
Pharmaceutical form: solution for injection Route of administration: subcutaneous Other Name: Lyxumia Drug: metformin Pharmaceutical form: tablet Route of administration: oral Drug: basal insulin Pharmaceutical form: solution for injection Route of administration: subcutaneous |
Active Comparator: Sulfonylurea
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.
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Drug: Sulfonylurea
Pharmaceutical form: tablet Route of administration: oral Drug: metformin Pharmaceutical form: tablet Route of administration: oral Drug: basal insulin Pharmaceutical form: solution for injection Route of administration: subcutaneous |
- 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) ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria :
- 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.
Exclusion criteria:
- 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.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02941367
India | |
Investigational Site Number 356005 | |
Ahmedabad, India, 380007 | |
Investigational Site Number 356002 | |
Bangalore, India, 560043 | |
Investigational Site Number 356015 | |
Bangalore, India, 560055 | |
Investigational Site Number 356008 | |
Bangalore, India, 560060 | |
Investigational Site Number 356009 | |
Hyderabad, India, 500001 | |
Investigational Site Number 356018 | |
Hyderabad, India, 500004 | |
Investigational Site Number 356010 | |
Hyderabad, India, 500072 | |
Investigational Site Number 356003 | |
Hyderabad, India, 500095 | |
Investigational Site Number 356007 | |
Jaipur, India | |
Investigational Site Number 356019 | |
Madurai, India, 625020 | |
Investigational Site Number 356014 | |
Mumbai, India, 400007 | |
Investigational Site Number 356022 | |
Nagpur, India, 440010 | |
Israel | |
Investigational Site Number 376001 | |
Haifa, Israel, 31096 | |
Investigational Site Number 376002 | |
Safed, Israel, 13100 | |
Kuwait | |
Investigational Site Number 414001 | |
Kuwait, Kuwait | |
Turkey | |
Investigational Site Number 792002 | |
Zonguldak, Turkey |
Study Director: | Clinical Sciences & Operations | Sanofi |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT02941367 History of Changes |
Other Study ID Numbers: |
LPS14410 U1111-1172-3026 ( Other Identifier: UTN ) |
First Posted: | October 21, 2016 Key Record Dates |
Last Update Posted: | September 21, 2017 |
Last Verified: | September 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available we continue to protect the privacy of the participants in our clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Lixisenatide Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Insulin Insulin, Globin Zinc Metformin Hypoglycemic Agents Physiological Effects of Drugs |