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Trial record 2 of 8 for:    LixiLan

Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (LixiLan) to Insulin Glargine Alone on Top of Oral Anti-diabetic Drugs (OADs) With Type 2 Diabetes in Japan (LIXILAN JP-O2)

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ClinicalTrials.gov Identifier: NCT02752828
Recruitment Status : Completed
First Posted : April 27, 2016
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

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

Secondary Objective:

To compare the overall efficacy and safety of LixiLan to insulin glargine (with or without OADs) over a 26 Week treatment period in patients with type 2 Diabetes.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Insulin glargine/lixisenatide (HOE901/AVE0010) Drug: Insulin glargine (HOE901) Drug: Oral anti-diabetic drugs Phase 3

Detailed Description:
The maximum study duration per patient will be approximately 29 weeks: an up to 2-week screening period, a 26-week randomized open-label treatment period and a 3-day post-treatment safety follow up period.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 521 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Active-controlled, Open Label, 2-treatment Arm, and Multicenter Study Comparing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Combination to Insulin Glargine on Top of OADs in Japanese Patients With Type 2 Diabetes Mellitus (T2DM)
Study Start Date : May 23, 2016
Actual Primary Completion Date : March 12, 2018
Actual Study Completion Date : March 12, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LixiLan

LixiLan (insulin glargine/lixisenatide) is injected subcutaneously (under the skin) once daily. Dose is individually adjusted.

Background therapy with OADs (except dipeptidyl-peptidase-4 inhibitor) should be continued during the treatment period.

Drug: Insulin glargine/lixisenatide (HOE901/AVE0010)

Pharmaceutical form: solution

Route of administration: subcutaneous

Other Name: LixiLan

Drug: Oral anti-diabetic drugs

Pharmaceutical form: tablet

Route of administration: oral


Active Comparator: insulin glargine

Insulin glargine (HOE901) is injected subcutaneously (under the skin) once daily. Dose is individually adjusted.

Background therapy with OADs (except dipeptidyl-peptidase-4 inhibitor) should be continued during the treatment period.

Drug: Insulin glargine (HOE901)

Pharmaceutical form: solution

Route of administration: subcutaneous


Drug: Oral anti-diabetic drugs

Pharmaceutical form: tablet

Route of administration: oral





Primary Outcome Measures :
  1. Change from baseline in HbA1c [ Time Frame: Baseline, 26 weeks ]

Secondary Outcome Measures :
  1. Percentage of patients reaching HbA1c <7% or ≤6.5% [ Time Frame: 26 weeks ]
  2. Change from baseline in 2-hour postprandial glucose (PPG) during standardized meal test [ Time Frame: Baseline, 26 weeks ]
  3. Change from baseline in 7 point self monitored plasma glucose (SMPG) profiles during standardized meal test [ Time Frame: Baseline, 26 weeks ]
  4. Change from baseline in body weight [ Time Frame: Baseline, 26 weeks ]
  5. Percentage of patients reaching HbA1c <7% with no body weight gain and with no documented (PG ≤70 mg/dL [3.9 mmol/L]) symptomatic hypoglycemia [ Time Frame: 26 weeks ]
  6. Percentage of patients reaching HbA1c <7% at Week 26 with no documented (PG ≤70 mg/dL [3.9 mmol/L]) symptomatic hypoglycemia [ Time Frame: 26 weeks ]
  7. Percentage of patients requiring a rescue therapy [ Time Frame: 26 weeks ]
  8. Number of adverse events [ Time Frame: 26 weeks ]
  9. Number of hypoglycemic events [ Time Frame: 26 weeks ]
  10. Measurement of anti-lixisenatide antibodies from baseline [ Time Frame: Baseline, 26 weeks ]
  11. Measurement of anti-insulin antibodies from baseline [ Time Frame: Baseline, 26 weeks ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Patient with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year before the screening visit, receiving 1 or 2 OADs that can be Biguanide,Thiazolidinedione (TZD), -Alpha-glucosidase-inhibitor (alpha-GI),Sodium glucose co-transporter 2 (SGLT2) inhibitor,Sulfonylurea (SU),Rapid-acting insulin secretagogue (Glinide),diphenyl-peptidase -4 inhibitor (DPP-4 inhibitor).
  • Signed written informed consent.

Exclusion criteria:

  • At the screening visit: Age <20 years.
  • At the screening visit: HbA1c <7.5% or >9.5%.
  • At the screening visit: fasting plasma glucose (FPG) >180 mg/dL (10.0 mmol/L).
  • Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.
  • Use of oral or injectable glucose-lowering agents other than those stated during the inclusion criteria in the 3 months before the screening visit.
  • Previous treatment with insulin (except for short-term treatment due to intercurrent illness including gestational diabetes at the discretion of the trial physician).
  • Laboratory findings at the time of screening:
  • 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 in female of childbearing potential.
  • Contraindication to use of lixisenatide according to the local labeling. History of hypersensitivity to any Glucagon-Like Peptide-1 Receptor Agonists or to metacresol.
  • Contraindication to use of insulin glargine according to local labeling. History of hypersensitivity to insulin glargine or to any of the excipients.
  • Patient who has a severe renal function impairment with estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2 or end-stage renal disease for patient not treated with metformin.
  • 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 been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy, stomach/gastric surgery.

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


Information from the National Library of Medicine

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): NCT02752828


  Show 113 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02752828     History of Changes
Other Study ID Numbers: EFC14114
U1111-1176-8450 ( Other Identifier: UTN )
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Lixisenatide
Insulin
Insulin Glargine
Hypoglycemic Agents
Dipeptidyl-Peptidase IV Inhibitors
Physiological Effects of Drugs
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action