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Trial record 2 of 10 for:    lixisenatide | Open Studies

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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT02749890
First received: April 20, 2016
Last updated: September 15, 2016
Last verified: September 2016
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change from baseline in HbA1c [ Time Frame: Baseline, 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients reaching HbA1c <7% or ≤6.5% [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in fasting plasma glucose [ Time Frame: Baseline, 26 weeks ] [ Designated as safety issue: No ]
  • Change in from baseline in 7 point self-monitored plasma profiles [ Time Frame: Baseline, 26 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients reaching HbA1c <7% with no body weight gain [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in body weight [ Time Frame: Baseline, 26 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients requiring a rescue therapy [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Change in daily dose of insulin glargine for the combination group [ Time Frame: Day 1, 26 weeks ] [ Designated as safety issue: No ]
  • Number of hypoglycemic events [ Time Frame: 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Number of adverse events [ Time Frame: 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Measurement of anti-lixisenatide antibodies from baseline [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Measurement of anti-insulin antibodies from baseline [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 318
Study Start Date: May 2016
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.
  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02749890

Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi.com

  Show 62 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02749890     History of Changes
Other Study ID Numbers: EFC14112  U1111-1176-8357 
Study First Received: April 20, 2016
Last Updated: September 15, 2016
Health Authority: Japan: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 27, 2016