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LIXILAN JP-O1: 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

Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT02749890
Collaborator
(none)
321
Enrollment
61
Locations
2
Arms
23.7
Actual Duration (Months)
5.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
  • 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 Design

Study Type:
Interventional
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 1, 2018
Actual Study Completion Date :
May 1, 2018

Arms and Interventions

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 Names:
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in HbA1c [Baseline, 26 weeks]

    Secondary Outcome Measures

    1. Percentage of patients reaching HbA1c <7% or ≤6.5% [26 weeks]

    2. Change from baseline in fasting plasma glucose [Baseline, 26 weeks]

    3. Change in from baseline in 7 point self-monitored plasma profiles [Baseline, 26 weeks]

    4. Percentage of patients reaching HbA1c <7% with no body weight gain [26 weeks]

    5. Change from baseline in body weight [Baseline, 26 weeks]

    6. Percentage of patients requiring a rescue therapy [26 weeks]

    7. Change in daily dose of insulin glargine for the combination group [Day 1, 26 weeks]

    8. Number of hypoglycemic events [26 weeks, 52 weeks]

    9. Number of adverse events [26 weeks, 52 weeks]

    10. Measurement of anti-lixisenatide antibodies from baseline [Baseline, 26 weeks, 52 weeks]

    11. Measurement of anti-insulin antibodies from baseline [Baseline, 26 weeks, 52 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigational Site Number 392002 Adachi-Ku Japan
    2 Investigational Site Number 392009 Arakawa-Ku Japan
    3 Investigational Site Number 392025 Atsugi-Shi Japan
    4 Investigational Site Number 392060 Bunkyo-Ku Japan
    5 Investigational Site Number 392024 Chiba-Shi Japan
    6 Investigational Site Number 392011 Chigasaki-Shi Japan
    7 Investigational Site Number 392013 Chiyoda-Ku Japan
    8 Investigational Site Number 392052 Chiyoda-Ku Japan
    9 Investigational Site Number 392003 Chuo-Ku Japan
    10 Investigational Site Number 392017 Chuo-Ku Japan
    11 Investigational Site Number 392008 Fujimi-Shi Japan
    12 Investigational Site Number 392054 Fukuoka-Shi Japan
    13 Investigational Site Number 392094 Fukuoka-Shi Japan
    14 Investigational Site Number 392059 Hachioji-Shi Japan
    15 Investigational Site Number 392083 Hakodate-Shi Japan
    16 Investigational Site Number 392048 Hamamatsu-Shi Japan
    17 Investigational Site Number 392079 Hiki-Gun Japan
    18 Investigational Site Number 392057 Iruma-Shi Japan
    19 Investigational Site Number 392022 Ise-Shi Japan
    20 Investigational Site Number 392023 Isehara-Shi Japan
    21 Investigational Site Number 392020 Izumisano-Shi Japan
    22 Investigational Site Number 392066 Kashiwa-Shi Japan
    23 Investigational Site Number 392006 Kasugai-Shi Japan
    24 Investigational Site Number 392053 Kawagoe-Shi Japan
    25 Investigational Site Number 392065 Kawagoe-Shi Japan
    26 Investigational Site Number 392007 Kawaguchi-Shi Japan
    27 Investigational Site Number 392062 Kawaguchi-Shi Japan
    28 Investigational Site Number 392077 Kawasaki-Shi Japan
    29 Investigational Site Number 392082 Kawasaki-Shi Japan
    30 Investigational Site Number 392031 Kitakyushu-Shi Japan
    31 Investigational Site Number 392041 Kitakyusyu-Shi Japan
    32 Investigational Site Number 392068 Kitakyusyu-Shi Japan
    33 Investigational Site Number 392044 Koga-Shi Japan
    34 Investigational Site Number 392001 Koriyama-Shi Japan
    35 Investigational Site Number 392032 Kurume-Shi Japan
    36 Investigational Site Number 392088 Maebashi-Shi Japan
    37 Investigational Site Number 392014 Mitaka-Shi Japan
    38 Investigational Site Number 392042 Mito-Shi Japan
    39 Investigational Site Number 392078 Mito-Shi Japan
    40 Investigational Site Number 392026 Nagoya-Shi Japan
    41 Investigational Site Number 392080 Okayama-Shi Japan
    42 Investigational Site Number 392040 Oyama-Shi Japan
    43 Investigational Site Number 392038 Sagamihara-Shi Japan
    44 Investigational Site Number 392069 Saijo-Shi Japan
    45 Investigational Site Number 392030 Saitama-Shi Japan
    46 Investigational Site Number 392047 Sapporo-Shi Japan
    47 Investigational Site Number 392015 Satsumasendai-Shi Japan
    48 Investigational Site Number 392004 Sendai-Shi Japan
    49 Investigational Site Number 392034 Shimotsuke-Shi Japan
    50 Investigational Site Number 392037 Shizuoka-Shi Japan
    51 Investigational Site Number 392081 Shizuoka-Shi Japan
    52 Investigational Site Number 392019 Shobara-Shi Japan
    53 Investigational Site Number 392018 Shunan-Shi Japan
    54 Investigational Site Number 392027 Suita-Shi Japan
    55 Investigational Site Number 392056 Taito-Ku Japan
    56 Investigational Site Number 392051 Takatsuki-Shi Japan
    57 Investigational Site Number 392061 Tokorozawa-Shi Japan
    58 Investigational Site Number 392029 Toyonaka-Shi Japan
    59 Investigational Site Number 392093 Ube-Shi Japan
    60 Investigational Site Number 392067 Yatsushiro-Shi Japan
    61 Investigational Site Number 392035 Zentsuji-Shi Japan

    Sponsors and Collaborators

    • Sanofi

    Investigators

    • Study Director: Clinical Sciences & Operations, Sanofi

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sanofi
    ClinicalTrials.gov Identifier:
    NCT02749890
    Other Study ID Numbers:
    • EFC14112
    • U1111-1176-8357
    First Posted:
    Apr 25, 2016
    Last Update Posted:
    Jun 16, 2020
    Last Verified:
    Jul 1, 2018
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 2
    Insulin Glargine
    Lixisenatide
    Hypoglycemic Agents

    Study Results

    No Results Posted as of Jun 16, 2020