search
Back to results

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)

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Insulin glargine/lixisenatide (HOE901/AVE0010)
Insulin glargine (HOE901)
Oral anti-diabetic drugs
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 392002
  • Investigational Site Number 392132
  • Investigational Site Number 392009
  • Investigational Site Number 392025
  • Investigational Site Number 392024
  • Investigational Site Number 392151
  • Investigational Site Number 392011
  • Investigational Site Number 392013
  • Investigational Site Number 392052
  • Investigational Site Number 392003
  • Investigational Site Number 392017
  • Investigational Site Number 392055
  • Investigational Site Number 392155
  • Investigational Site Number 392008
  • Investigational Site Number 392143
  • Investigational Site Number 392054
  • Investigational Site Number 392094
  • Investigational Site Number 392147
  • Investigational Site Number 392100
  • Investigational Site Number 392059
  • Investigational Site Number 392083
  • Investigational Site Number 392048
  • Investigational Site Number 392102
  • Investigational Site Number 392079
  • Investigational Site Number 392112
  • Investigational Site Number 392109
  • Investigational Site Number 392057
  • Investigational Site Number 392022
  • Investigational Site Number 392020
  • Investigational Site Number 392139
  • Investigational Site Number 392136
  • Investigational Site Number 392066
  • Investigational Site Number 392045
  • Investigational Site Number 392006
  • Investigational Site Number 392053
  • Investigational Site Number 392065
  • Investigational Site Number 392007
  • Investigational Site Number 392062
  • Investigational Site Number 392077
  • Investigational Site Number 392082
  • Investigational Site Number 392091
  • Investigational Site Number 392142
  • Investigational Site Number 392133
  • Investigational Site Number 392129
  • Investigational Site Number 392041
  • Investigational Site Number 392068
  • Investigational Site Number 392114
  • Investigational Site Number 392086
  • Investigational Site Number 392044
  • Investigational Site Number 392119
  • Investigational Site Number 392001
  • Investigational Site Number 392028
  • Investigational Site Number 392092
  • Investigational Site Number 392108
  • Investigational Site Number 392075
  • Investigational Site Number 392032
  • Investigational Site Number 392118
  • Investigational Site Number 392107
  • Investigational Site Number 392088
  • Investigational Site Number 392113
  • Investigational Site Number 392122
  • Investigational Site Number 392076
  • Investigational Site Number 392042
  • Investigational Site Number 392078
  • Investigational Site Number 392148
  • Investigational Site Number 392026
  • Investigational Site Number 392101
  • Investigational Site Number 392128
  • Investigational Site Number 392131
  • Investigational Site Number 392134
  • Investigational Site Number 392154
  • Investigational Site Number 392127
  • Investigational Site Number 392050
  • Investigational Site Number 392115
  • Investigational Site Number 392071
  • Investigational Site Number 392095
  • Investigational Site Number 392117
  • Investigational Site Number 392144
  • Investigational Site Number 392040
  • Investigational Site Number 392084
  • Investigational Site Number 392069
  • Investigational Site Number 392030
  • Investigational Site Number 392074
  • Investigational Site Number 392047
  • Investigational Site Number 392089
  • Investigational Site Number 392150
  • Investigational Site Number 392097
  • Investigational Site Number 392004
  • Investigational Site Number 392103
  • Investigational Site Number 392070
  • Investigational Site Number 392034
  • Investigational Site Number 392110
  • Investigational Site Number 392021
  • Investigational Site Number 392098
  • Investigational Site Number 392037
  • Investigational Site Number 392081
  • Investigational Site Number 392019
  • Investigational Site Number 392018
  • Investigational Site Number 392027
  • Investigational Site Number 392056
  • Investigational Site Number 392146
  • Investigational Site Number 392051
  • Investigational Site Number 392061
  • Investigational Site Number 392111
  • Investigational Site Number 392029
  • Investigational Site Number 392073
  • Investigational Site Number 392063
  • Investigational Site Number 392093
  • Investigational Site Number 392039
  • Investigational Site Number 392067
  • Investigational Site Number 392012
  • Investigational Site Number 392126
  • Investigational Site Number 392035

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

LixiLan

insulin glargine

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline in HbA1c

Secondary Outcome Measures

Percentage of patients reaching HbA1c <7% or ≤6.5%
Change from baseline in 2-hour postprandial glucose (PPG) during standardized meal test
Change from baseline in 7 point self monitored plasma glucose (SMPG) profiles during standardized meal test
Change from baseline in body weight
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
Percentage of patients reaching HbA1c <7% at Week 26 with no documented (PG ≤70 mg/dL [3.9 mmol/L]) symptomatic hypoglycemia
Percentage of patients requiring a rescue therapy
Number of adverse events
Number of hypoglycemic events
Measurement of anti-lixisenatide antibodies from baseline
Measurement of anti-insulin antibodies from baseline

Full Information

First Posted
April 20, 2016
Last Updated
June 11, 2020
Sponsor
Sanofi
search

1. Study Identification

Unique Protocol Identification Number
NCT02752828
Brief Title
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
Acronym
LIXILAN JP-O2
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 Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
May 23, 2016 (undefined)
Primary Completion Date
March 12, 2018 (Actual)
Study Completion Date
March 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
521 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LixiLan
Arm Type
Experimental
Arm Description
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.
Arm Title
insulin glargine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Insulin glargine/lixisenatide (HOE901/AVE0010)
Other Intervention Name(s)
LixiLan
Intervention Description
Pharmaceutical form: solution Route of administration: subcutaneous
Intervention Type
Drug
Intervention Name(s)
Insulin glargine (HOE901)
Intervention Description
Pharmaceutical form: solution Route of administration: subcutaneous
Intervention Type
Drug
Intervention Name(s)
Oral anti-diabetic drugs
Intervention Description
Pharmaceutical form: tablet Route of administration: oral
Primary Outcome Measure Information:
Title
Change from baseline in HbA1c
Time Frame
Baseline, 26 weeks
Secondary Outcome Measure Information:
Title
Percentage of patients reaching HbA1c <7% or ≤6.5%
Time Frame
26 weeks
Title
Change from baseline in 2-hour postprandial glucose (PPG) during standardized meal test
Time Frame
Baseline, 26 weeks
Title
Change from baseline in 7 point self monitored plasma glucose (SMPG) profiles during standardized meal test
Time Frame
Baseline, 26 weeks
Title
Change from baseline in body weight
Time Frame
Baseline, 26 weeks
Title
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
Title
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
Title
Percentage of patients requiring a rescue therapy
Time Frame
26 weeks
Title
Number of adverse events
Time Frame
26 weeks
Title
Number of hypoglycemic events
Time Frame
26 weeks
Title
Measurement of anti-lixisenatide antibodies from baseline
Time Frame
Baseline, 26 weeks
Title
Measurement of anti-insulin antibodies from baseline
Time Frame
Baseline, 26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 392002
City
Adachi-Ku
Country
Japan
Facility Name
Investigational Site Number 392132
City
Annaka-Shi
Country
Japan
Facility Name
Investigational Site Number 392009
City
Arakawa-Ku
Country
Japan
Facility Name
Investigational Site Number 392025
City
Atsugi-Shi
Country
Japan
Facility Name
Investigational Site Number 392024
City
Chiba-Shi
Country
Japan
Facility Name
Investigational Site Number 392151
City
Chiba-Shi
Country
Japan
Facility Name
Investigational Site Number 392011
City
Chigasaki-Shi
Country
Japan
Facility Name
Investigational Site Number 392013
City
Chiyoda-Ku
Country
Japan
Facility Name
Investigational Site Number 392052
City
Chiyoda-Ku
Country
Japan
Facility Name
Investigational Site Number 392003
City
Chuo-Ku
Country
Japan
Facility Name
Investigational Site Number 392017
City
Chuo-Ku
Country
Japan
Facility Name
Investigational Site Number 392055
City
Chuo-Ku
Country
Japan
Facility Name
Investigational Site Number 392155
City
Chuo-Ku
Country
Japan
Facility Name
Investigational Site Number 392008
City
Fujimi-Shi
Country
Japan
Facility Name
Investigational Site Number 392143
City
Fujisawa-Shi
Country
Japan
Facility Name
Investigational Site Number 392054
City
Fukuoka-Shi
Country
Japan
Facility Name
Investigational Site Number 392094
City
Fukuoka-Shi
Country
Japan
Facility Name
Investigational Site Number 392147
City
Fukuoka-Shi
Country
Japan
Facility Name
Investigational Site Number 392100
City
Gifu-Shi
Country
Japan
Facility Name
Investigational Site Number 392059
City
Hachioji-Shi
Country
Japan
Facility Name
Investigational Site Number 392083
City
Hakodate-Shi
Country
Japan
Facility Name
Investigational Site Number 392048
City
Hamamatsu-Shi
Country
Japan
Facility Name
Investigational Site Number 392102
City
Hamamatsu-Shi
Country
Japan
Facility Name
Investigational Site Number 392079
City
Hiki-Gun
Country
Japan
Facility Name
Investigational Site Number 392112
City
Hirosaki-Shi
Country
Japan
Facility Name
Investigational Site Number 392109
City
Hofu-Shi
Country
Japan
Facility Name
Investigational Site Number 392057
City
Iruma-Shi
Country
Japan
Facility Name
Investigational Site Number 392022
City
Ise-Shi
Country
Japan
Facility Name
Investigational Site Number 392020
City
Izumisano-Shi
Country
Japan
Facility Name
Investigational Site Number 392139
City
Kagoshima-Shi
Country
Japan
Facility Name
Investigational Site Number 392136
City
Kamogawa-Shi
Country
Japan
Facility Name
Investigational Site Number 392066
City
Kashiwa-Shi
Country
Japan
Facility Name
Investigational Site Number 392045
City
Kashiwara-Shi
Country
Japan
Facility Name
Investigational Site Number 392006
City
Kasugai-Shi
Country
Japan
Facility Name
Investigational Site Number 392053
City
Kawagoe-Shi
Country
Japan
Facility Name
Investigational Site Number 392065
City
Kawagoe-Shi
Country
Japan
Facility Name
Investigational Site Number 392007
City
Kawaguchi-Shi
Country
Japan
Facility Name
Investigational Site Number 392062
City
Kawaguchi-Shi
Country
Japan
Facility Name
Investigational Site Number 392077
City
Kawasaki-Shi
Country
Japan
Facility Name
Investigational Site Number 392082
City
Kawasaki-Shi
Country
Japan
Facility Name
Investigational Site Number 392091
City
Kawasaki-Shi
Country
Japan
Facility Name
Investigational Site Number 392142
City
Kawasaki-Shi
Country
Japan
Facility Name
Investigational Site Number 392133
City
Kitaazumi-Gun
Country
Japan
Facility Name
Investigational Site Number 392129
City
Kitakyushu-Shi
Country
Japan
Facility Name
Investigational Site Number 392041
City
Kitakyusyu-Shi
Country
Japan
Facility Name
Investigational Site Number 392068
City
Kitakyusyu-Shi
Country
Japan
Facility Name
Investigational Site Number 392114
City
Kitamoto-Shi
Country
Japan
Facility Name
Investigational Site Number 392086
City
Kobe-Shi
Country
Japan
Facility Name
Investigational Site Number 392044
City
Koga-Shi
Country
Japan
Facility Name
Investigational Site Number 392119
City
Kokubunji-Shi
Country
Japan
Facility Name
Investigational Site Number 392001
City
Koriyama-Shi
Country
Japan
Facility Name
Investigational Site Number 392028
City
Kumamoto-Shi
Country
Japan
Facility Name
Investigational Site Number 392092
City
Kumamoto-Shi
Country
Japan
Facility Name
Investigational Site Number 392108
City
Kumamoto-Shi
Country
Japan
Facility Name
Investigational Site Number 392075
City
Kure-Shi
Country
Japan
Facility Name
Investigational Site Number 392032
City
Kurume-Shi
Country
Japan
Facility Name
Investigational Site Number 392118
City
Kushiro-Shi
Country
Japan
Facility Name
Investigational Site Number 392107
City
Kyoto-Shi
Country
Japan
Facility Name
Investigational Site Number 392088
City
Maebashi-Shi
Country
Japan
Facility Name
Investigational Site Number 392113
City
Matsumoto-Shi
Country
Japan
Facility Name
Investigational Site Number 392122
City
Minato-Ku
Country
Japan
Facility Name
Investigational Site Number 392076
City
Misato-Shi
Country
Japan
Facility Name
Investigational Site Number 392042
City
Mito-Shi
Country
Japan
Facility Name
Investigational Site Number 392078
City
Mito-Shi
Country
Japan
Facility Name
Investigational Site Number 392148
City
Nagano-Shi
Country
Japan
Facility Name
Investigational Site Number 392026
City
Nagoya-Shi
Country
Japan
Facility Name
Investigational Site Number 392101
City
Nagoya-Shi
Country
Japan
Facility Name
Investigational Site Number 392128
City
Nagoya-Shi
Country
Japan
Facility Name
Investigational Site Number 392131
City
Nagoya-Shi
Country
Japan
Facility Name
Investigational Site Number 392134
City
Nagoya-Shi
Country
Japan
Facility Name
Investigational Site Number 392154
City
Naka-Shi
Country
Japan
Facility Name
Investigational Site Number 392127
City
Niigata-Shi
Country
Japan
Facility Name
Investigational Site Number 392050
City
Niihama-Shi
Country
Japan
Facility Name
Investigational Site Number 392115
City
Ogawa-Machi, Hikigun
Country
Japan
Facility Name
Investigational Site Number 392071
City
Okayama-Shi
Country
Japan
Facility Name
Investigational Site Number 392095
City
Onga-Gun
Country
Japan
Facility Name
Investigational Site Number 392117
City
Osaka-Shi
Country
Japan
Facility Name
Investigational Site Number 392144
City
Osaka-Shi
Country
Japan
Facility Name
Investigational Site Number 392040
City
Oyama-Shi
Country
Japan
Facility Name
Investigational Site Number 392084
City
Saga-Shi
Country
Japan
Facility Name
Investigational Site Number 392069
City
Saijo-Shi
Country
Japan
Facility Name
Investigational Site Number 392030
City
Saitama-Shi
Country
Japan
Facility Name
Investigational Site Number 392074
City
Sanda-Shi
Country
Japan
Facility Name
Investigational Site Number 392047
City
Sapporo-Shi
Country
Japan
Facility Name
Investigational Site Number 392089
City
Sapporo-Shi
Country
Japan
Facility Name
Investigational Site Number 392150
City
Sapporo-Shi
Country
Japan
Facility Name
Investigational Site Number 392097
City
Sasebo-Shi
Country
Japan
Facility Name
Investigational Site Number 392004
City
Sendai-Shi
Country
Japan
Facility Name
Investigational Site Number 392103
City
Sendai-Shi
Country
Japan
Facility Name
Investigational Site Number 392070
City
Shimonoseki-Shi
Country
Japan
Facility Name
Investigational Site Number 392034
City
Shimotsuke-Shi
Country
Japan
Facility Name
Investigational Site Number 392110
City
Shinagawa-Ku
Country
Japan
Facility Name
Investigational Site Number 392021
City
Shinjuku-Ku
Country
Japan
Facility Name
Investigational Site Number 392098
City
Shinjuku-Ku
Country
Japan
Facility Name
Investigational Site Number 392037
City
Shizuoka-Shi
Country
Japan
Facility Name
Investigational Site Number 392081
City
Shizuoka-Shi
Country
Japan
Facility Name
Investigational Site Number 392019
City
Shobara-Shi
Country
Japan
Facility Name
Investigational Site Number 392018
City
Shunan-Shi
Country
Japan
Facility Name
Investigational Site Number 392027
City
Suita-Shi
Country
Japan
Facility Name
Investigational Site Number 392056
City
Taito-Ku
Country
Japan
Facility Name
Investigational Site Number 392146
City
Takamatsu-Shi
Country
Japan
Facility Name
Investigational Site Number 392051
City
Takatsuki-Shi
Country
Japan
Facility Name
Investigational Site Number 392061
City
Tokorozawa-Shi
Country
Japan
Facility Name
Investigational Site Number 392111
City
Tomakomai-Shi
Country
Japan
Facility Name
Investigational Site Number 392029
City
Toyonaka-Shi
Country
Japan
Facility Name
Investigational Site Number 392073
City
Tsu-Shi
Country
Japan
Facility Name
Investigational Site Number 392063
City
Ube-Shi
Country
Japan
Facility Name
Investigational Site Number 392093
City
Ube-Shi
Country
Japan
Facility Name
Investigational Site Number 392039
City
Yamato-Shi
Country
Japan
Facility Name
Investigational Site Number 392067
City
Yatsushiro-Shi
Country
Japan
Facility Name
Investigational Site Number 392012
City
Yokohama-Shi
Country
Japan
Facility Name
Investigational Site Number 392126
City
Yokohama-Shi
Country
Japan
Facility Name
Investigational Site Number 392035
City
Zentsuji-Shi
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
32291880
Citation
Terauchi Y, Nakama T, Spranger R, Amano A, Inoue T, Niemoeller E. Efficacy and safety of insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi 1:1) in Japanese patients with type 2 diabetes mellitus inadequately controlled on oral antidiabetic drugs: A randomized, 26-week, open-label, multicentre study: The LixiLan JP-O2 randomized clinical trial. Diabetes Obes Metab. 2020 Sep;22 Suppl 4:14-23. doi: 10.1111/dom.14036.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs