Status:
COMPLETED
Evaluation of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Patients With Type 2 Diabetes Insufficiently Controlled With Oral Antidiabetic Drug(s)
Lead Sponsor:
Sanofi
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Primary Objectives: The co-primary objective of this study is: * To demonstrate the superiority of iGlarLixi (fixed ratio combination of insulin glargine and lixisenatide) versus lixisenatide on gly...
Detailed Description
The maximum study duration per patient will be approximately 31 weeks: an up-to 6-week screening and run-in period (with an up-to 2-week screening phase and a 4-week run-in phase), followed by a 24-we...
Eligibility Criteria
Inclusion
- Inclusion criteria :
- Patients with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year before the screening visit (V1), treated for at least 3 months prior to the screening visit (V1) with metformin alone or metformin and a second oral antidiabetic treatment that can be a sulfonylurea (SU), a glinide, an alpha-glucosidase inhibitor (alpha-GI), a dipeptidyl peptidase-4 (DPP-4) inhibitor or a sodium-glucose co transporter 2 (SGLT-2) inhibitor and who are not adequately controlled with this treatment.
- Signed written informed consent.
- Exclusion criteria:
- Age \< legal age of majority at the screening visit (V1).
- Body mass index (BMI) \>40 kg/m² at screening.
- Glycated hemoglobin A1c (HbA1c) at screening visit:
- \<7.5% or \>11% for patients previously treated with metformin alone;
- \<7.0% or \>10% for patients previously treated with metformin and a second oral antidiabetic treatment.
- History of hypoglycemia unawareness.
- History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening.
- Use of oral or injectable glucose-lowering agents other than those stated in the inclusion criteria within 3 months prior to screening.
- Previous treatment with insulin (except for short-term treatment due to intercurrent illness at the discretion of the Investigator) within 1 year prior to screening.
- History of discontinuation of a previous treatment with glucagon-like-peptide-1 receptor agonists (GLP-1 RAs) due to safety/tolerability reasons or lack of efficacy.
- Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 1 week or more within 3 months prior to screening.
- Use of weight loss drugs within 3 months prior to screening.
- Use of any investigational drug other than specified in this protocol within 1 month or 5 half-lives, whichever is longer, prior to screening.
- Within 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization.
- Planned coronary, carotid, or peripheral artery revascularization procedures to be performed during the study period.
- Known history of drug or alcohol abuse within 6 months prior to screening.
- Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic blood pressure \>180 mmHg or diastolic blood pressure \>95 mmHg.
- Laboratory findings at screening visit (V1):
- Amylase and/or lipase \>3 times the upper limit of normal (ULN) laboratory range.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 ULN.
- Total bilirubin \>1.5 ULN (except in case of Gilbert's syndrome).
- Calcitonin ≥20 pg/mL (5.9 pmol/L).
- Hemoglobin \<10.5 g/dL and/or neutrophils \<1500/mm3 and/or platelets \<100 000/mm3.
- Positive urine pregnancy test in female of childbearing potential.
- Patient who has a severe renal function impairment with an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2 or end-stage renal disease.
- History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy has been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy.
- Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (eg, multiple endocrine neoplasia syndromes).
- Use of SU, glinide, alpha-GI, DPP-4 inhibitor, and SGLT-2 inhibitor after start of run-in (from V2 \[Week -4\]).
- HbA1c at V4 (Week -1) : \<7.0% or \>10%.
- Fasting plasma glucose \>250 mg/dL (13.9 mmol/L) at V4 (Week-1) (can be repeated once to confirm).
- Metformin maximal tolerated dose \<1500 mg/day.
- Amylase and/or lipase \>3 ULN at V4 (Week-1).
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
February 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2021
Estimated Enrollment :
878 Patients enrolled
Trial Details
Trial ID
NCT03798054
Start Date
February 15 2019
End Date
March 1 2021
Last Update
July 19 2022
Active Locations (79)
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1
Investigational Site Number 1560001
Beijing, China, 1000029
2
Investigational Site Number 1560006
Beijing, China, 101200
3
Investigational Site Number 1560049
Beijing, China, 102218
4
Investigational Site Number 1560039
Cangzhou, China, 061000