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Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (LixiLan) to Lixisenatide on Top of Oral Anti-diabetic Drugs (OADs) With Type 2 Diabetes in Japan (LIXILAN JP-O1)

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ClinicalTrials.gov Identifier: NCT02749890
Recruitment Status : Completed
First Posted : April 25, 2016
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

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

Secondary Objective:

To compare the overall efficacy and safety of LixiLan to lixisenatide (with or without OADs) over a 52 week treatment period in patients with type 2 diabetes mellitus.


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

Detailed Description:
Approximately 55 weeks: an up-to 2-week screening period, a 26-week randomized open-label treatment period, a 26-week safety extension treatment period and a 3-day post-treatment safety follow up period.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 321 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 Insulin Glargine/Lixisenatide Combination to Lixisenatide on Top of OADs in Japanese Patients With Type 2 DM With an Extension Period
Actual Study Start Date : May 9, 2016
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LixiLan

LixiLan (insulin glargine/lixisenatide fixed ratio combination) 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: lixisenatide

Lixisenatide (AVE0010) is injected subcutaneously (under the skin) once daily. It will be initiated with Dose 1 for 1 week and then continue with Dose 2 for 1 week followed by the maintenance dose of Dose 3 up to the end of treatment period.

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

Drug: Lixisenatide (AVE0010)

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 fasting plasma glucose [ Time Frame: Baseline, 26 weeks ]
  3. Change in from baseline in 7 point self-monitored plasma profiles [ Time Frame: Baseline, 26 weeks ]
  4. Percentage of patients reaching HbA1c <7% with no body weight gain [ Time Frame: 26 weeks ]
  5. Change from baseline in body weight [ Time Frame: Baseline, 26 weeks ]
  6. Percentage of patients requiring a rescue therapy [ Time Frame: 26 weeks ]
  7. Change in daily dose of insulin glargine for the combination group [ Time Frame: Day 1, 26 weeks ]
  8. Number of hypoglycemic events [ Time Frame: 26 weeks, 52 weeks ]
  9. Number of adverse events [ Time Frame: 26 weeks, 52 weeks ]
  10. Measurement of anti-lixisenatide antibodies from baseline [ Time Frame: Baseline, 26 weeks, 52 weeks ]
  11. Measurement of anti-insulin antibodies from baseline [ Time Frame: Baseline, 26 weeks, 52 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, alpha-glucosidase-inhibitor, sodium glucose co-transporter 2 inhibitor; sulfonylurea, rapid-acting insulin secretagogue, or dipeptidyl-peptidase-4 inhibitor.
  • Signed written informed consent.

Exclusion criteria:

  • At the screening visit: age <20 years.
  • At the screening visit: HbA1c <7.5% or >10%.
  • At the screening visit: fasting plasma glucose (FPG) >250 mg/dL (13.8 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 in the inclusion criteria during 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 screening visit, including:
  • Amylase and/or lipase >3 times the upper limit of the normal laboratory range (ULN),
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 ULN,
  • Calcitonin ≥20 pg/mL (5.9 pmol/L),
  • Positive serum pregnancy test.
  • Contraindication to use of lixisenatide according to the local labeling. History of hypersensitivity to any glucagon-like peptide-1 receptor agonist (GLP-1RA) or to metacresol.
  • Contraindication to use of insulin glargine according to the 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/1.73m^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): NCT02749890


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

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02749890     History of Changes
Other Study ID Numbers: EFC14112
U1111-1176-8357 ( Other Identifier: UTN )
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 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