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Efficacy and Safety of LixiLan Versus Insulin Glargine Alone Both With Metformin in Japanese With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Drugs (LIXILAN JP-L)

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Sanofi

Status and phase

Completed
Phase 3

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Insulin glargine/Lixisenatide (HOE901/AVE0010)
Drug: Insulin glargine U100 (HOE901)
Drug: Metformin

Study type

Interventional

Funder types

Industry

Identifiers

NCT02752412
U1111-1176-8378 (Other Identifier)
EFC14113

Details and patient eligibility

About

Primary Objective:

To compare LixiLan to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to week 26 in patients with type 2 diabetes mellitus.

Secondary Objective:

To compare overall efficacy and safety of LixiLan to insulin glargine over 26 weeks in patients with type 2 diabetes mellitus.

Full description

The maximum study duration per patient will be approximately 41 weeks: an up to 14-week screening period (consisting of an up to 2-week screening phase and a 12-week run-in phase), a 26-week randomized treatment period, and a 3-day post-treatment safety follow-up period.

Enrollment

513 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria :

  • Patient with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year before the screening visit (V1).
  • Patient treated with a stable, once a day basal insulin regimen (ie, type of insulin and time/frequency of the injection), for at least 3 months before the screening visit.
  • The total daily basal insulin dose should be stable (± 20%) and <15 U/day for at least 1 month before the screening visit.
  • Patient receiving 1 or 2 oral anti-diabetic drugs (OADs): the OAD dose(s) must be stable during the 3 months before the screening visit. The OADs can be 1 to 2 out of:
  • Metformin;
  • Sulfonylurea (SU);
  • Glinide;
  • Dipeptidyl-peptidase-4 (DPP-4) inhibitor;
  • Sodium glucose co-transporter 2 (SGLT2) inhibitor;
  • Alpha glucosidase inhibitor (alpha-GI).
  • Signed written informed consent.

Exclusion criteria:

  • Age <20 years at screening visit.
  • HbA1c at screening visit <7.5% or >9.5%.
  • Fasting plasma glucose (FPG) >180 mg/dL (10.0 mmol/L) at screening visit.
  • Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.
  • Use of oral or injectable glucose-lowering agents other than those stated in the inclusion criteria in the 3 months before screening visit.
  • Previous use of insulin regimen other than basal insulin, eg, prandial or pre-mixed insulin.

Note: Short-term treatment (≤10 days) due to intercurrent illness including gestational diabetes is allowed at the discretion of the Investigator.

  • Use of thiazolidinedione (TZD) within 6 months prior to screening visit.
  • History of discontinuation of a previous treatment with a glucagon-like peptide-1(GLP-1) receptor agonist due to safety/ tolerability issues or lack of efficacy.
  • Laboratory findings at the screening visit; including:
  • Amylase and/or lipase >3 times the upper limit of the normal (ULN) laboratory range;
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 ULN;
  • Calcitonin ≥20 pg/mL (5.9 pmol/L);
  • Positive serum pregnancy test.
  • Any contraindication to metformin use according to local labeling.
  • History of hypersensitivity to any GLP-1 receptor agonist or to metacresol.
  • Contraindication to use of insulin glargine or lixisenatide according to local labeling. History of hypersensitivity to insulin glargine or to any of the excipients.
  • Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposes to MTC (eg, multiple endocrine neoplasia syndromes).
  • History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy has now been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy, stomach/gastric surgery.
  • Exclusion criteria for randomization at the end of the run-in phase:
  • HbA1c <7.5% or >9.5% at visit 6 (Week -1).
  • Mean fasting self monitored plasma glucose (SMPG) >160 mg/dL (8.9 mmol/L), calculated from all available (minimum of 4 self-measurements) values during the 7 days prior to randomization.

Note:fasting SMPG on the day of randomization can be included if assessed before randomization.

  • Average insulin glargine daily dose ≥15 U/day or <5U/day calculated for the last 3 days before Visit 7.
  • Metformin total daily dose <750 mg/day.
  • Amylase and/or lipase >3 ULN at Visit 6 (Week -1).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

513 participants in 2 patient groups

LixiLan
Experimental group
Description:
LixiLan (insulin glargine/lixisenatide fixed ratio combination) is injected subcutaneously (under the skin) once daily. Dose is individually adjusted. Metformin will be continued.
Treatment:
Drug: Metformin
Drug: Insulin glargine/Lixisenatide (HOE901/AVE0010)
insulin glargine
Active Comparator group
Description:
Insulin glargine U100 (Lantus) will be injected subcutaneously (under skin) once daily. Dose will be individually adjusted. Metformin will be continued.
Treatment:
Drug: Metformin
Drug: Insulin glargine U100 (HOE901)

Trial contacts and locations

122

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Data sourced from clinicaltrials.gov

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