Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 50 of 61 for:    Lixisenatide

Comparison of the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine in Patients With Type 2 Diabetes Insufficiently Controlled on Basal Insulin (Lixilan-L-CN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03798080
Recruitment Status : Recruiting
First Posted : January 9, 2019
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

To demonstrate the superiority of iGlarLixi (fixed ratio combination of insulin glargine and lixisenatide) to insulin glargine on glycemic control as assessed by glycated hemoglobin A1c (HbA1c) change in patients with type 2 diabetes mellitus (T2DM) who are not sufficiently controlled with basal insulin.

Secondary Objectives:

  • To assess the effects of iGlarLixi in comparison with insulin glargine
  • To assess the safety in each treatment group

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Insulin glargine/Lixisenatide (HOE901/AVE0010) Drug: Insulin glargine (HOE901) Drug: Metformin Phase 3

Detailed Description:
The maximum study duration per patient will be approximately 33 weeks: an up to 2-week screening period (it can be exceptionally extended up to one additional week), a 30-week, open label randomized treatment period comparing iGlarLixi to insulin glargine (± metformin for both treatments), and a 3-day post-treatment safety follow-up period.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 426 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, 30-week, Active-controlled, Open-label, 2 Treatment-arm, Parallel Group, Multicenter Study Comparing Efficacy and Safety of iGlarLixi to Insulin Glargine With or Without Metformin in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled on Basal Insulin With or Without Oral Antidiabetic Drug(s)
Actual Study Start Date : February 19, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Soliqua (insulin glargine/lixisenatide)
iGlarLixi (insulin glargine/lixisenatide) will be self-administered subcutaneously once daily in the morning with or without metformin for 30 weeks
Drug: Insulin glargine/Lixisenatide (HOE901/AVE0010)

Pharmaceutical form: solution

Route of administration: subcutaneous

Other Names:
  • Soliqua
  • iGlarLixi

Drug: Metformin

Pharmaceutical form: tablet

Route of administration: oral


Active Comparator: Lantus (insulin glargine)
Insulin glargine will be self-administered subcutaneously once daily at any time of the day with or without metformin for 30 weeks
Drug: Insulin glargine (HOE901)

Pharmaceutical form: solution

Route of administration: subcutaneous

Other Name: Lantus

Drug: Metformin

Pharmaceutical form: tablet

Route of administration: oral





Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: From Baseline to Week 30 ]
    Change in glycated hemoglobin (HbA1c) from baseline to Week 30


Secondary Outcome Measures :
  1. Patients with HbA1c <7.0% [ Time Frame: At Week 30 ]
    Percentage of patients reaching HbA1c <7% at Week 30

  2. Patients with HbA1c ≤ 6.5% [ Time Frame: At Week 30 ]
    Percentage of patients reaching HbA1c ≤ 6.5% at Week 30

  3. Change in postprandial plasma glucose (PPG) [ Time Frame: From Baseline to Week 30 ]
    Absolute change in 2-hour blood glucose excursion and PPG during meal test from baseline to Week 30

  4. Change in self-monitored plasma glucose (SMPG) profile [ Time Frame: From Baseline to Week 30 ]
    Absolute change in 7-point SMPG profiles from baseline to Week 30 (each time point and average daily value)

  5. Patients with HbA1c <7.0% with no body weight gain [ Time Frame: At Week 30 ]
    Percentage of patients reaching HbA1c <7% with no body weight gain at Week 30

  6. Change in body weight [ Time Frame: From Baseline to Week 30 ]
    Absolute change in body weight from baseline to Week 30

  7. Patients with HbA1c <7.0% with no body weight gain and no documented symptomatic hypoglycemia [ Time Frame: At Week 30 ]
    Percentage of patients reaching HbA1c <7% with no body weight gain at Week 30 and no documented (plasma glucose [PG] ≤70 mg/dL [3.9mmol/L]) symptomatic hypoglycemia during the 30-week randomized treatment period

  8. Patients requiring rescue therapy [ Time Frame: From Baseline to Week 30 ]
    Percentage of patients requiring rescue therapy during the 30-week randomized treatment period

  9. Change in fasting plasma glucose (FPG) [ Time Frame: From Baseline to Week 30 ]
    Absolute change in FPG from baseline to Week 30

  10. Confirmed hypoglycemia [ Time Frame: From Baseline to Week 30 ]
    Severe hypoglycemia and episodes of hypoglycemia documented with PG ≤ 70 mg/dL (3.9mmol/L) regardless of symptoms

  11. Adverse events (AEs) [ Time Frame: From Baseline to Week 30 ]
    Number of AEs, Serious AEs, AEs of Special Interest, and AEs requiring specific monitoring from baseline to Week 30

  12. Immunogenicity (antibody variables) [ Time Frame: From Baseline to Week 30 ]
    Anti-lixisenatide antibodies (in iGlarLixi group) and anti-insulin antibodies from baseline to Week 30



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Patients with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year and treated with basal insulin for at least 6 months before screening visit (V1).
  • Patients who have been treated with a stable basal insulin regimen (ie, type of insulin and time/frequency of the injection), for at least 3 months before screening visit (V1).
  • Stable total daily basal insulin dose (±20 %) in the range of 10 and 25 U/day for at least 2 months before screening visit (V1). Total daily dose should be within the range of 10-25 U, both inclusive, on the day of screening, but individual fluctuations of ±20% within 2 months prior to screening are acceptable.
  • For patients receiving basal insulin AND 1 or 2 oral anti-diabetic drugs (OADs): the OAD dose(s) must be stable during the 3 months prior to screening. The OAD(s) can be 1 to 2 out of:
  • Metformin (≥1500 mg/day or maximal tolerated dose).
  • Sulfonylurea (SU)/glinide.
  • Alpha-glucosidase inhibitor (alpha-GI).
  • Sodium-glucose co-transporter 2 (SGLT2) inhibitor.
  • Dipeptidyl-peptidase-4 (DPP-4) inhibitor.
  • Fasting plasma glucose (FPG) ≤160 mg/dL (8.9 mmol/L) at screening visit (V1) (can be repeated once to confirm).
  • Signed written informed consent.

Exclusion criteria:

  • Age <18 years at screening visit (V1).
  • Screening glycated hemoglobin A1c(HbA1c) <7.0% or >10.5%.
  • History of hypoglycemia unawareness.
  • History of metabolic acidosis, including diabetic ketoacidosis within one year prior to screening.
  • Use of oral or injectable glucose-lowering agents other than those stated in the inclusion criteria within 3 months prior to screening.
  • Previous use of insulin regimen other than basal insulin, eg, prandial or pre-mixed insulin, within one year prior to screening (Note: Short term treatment [≤10 days] due to intercurrent illness is allowed).
  • History of discontinuation of a previous treatment with glucagon-like-peptide-1 receptor agonists (GLP-1 RAs) due to safety/tolerability reason or lack of efficacy.
  • Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 1 week or more within 3 months prior to screening.
  • Use of weight loss drugs within 3 months prior to screening.
  • Use of any investigational drug within 1 month or 5 half-lives, whichever is longer, prior to screening.
  • Within 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization.
  • Planned coronary, carotid, or peripheral revascularization procedures to be performed during the study period.
  • Known history of drug or alcohol abuse within 6 months prior to screening.
  • Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic blood pressure >180 mmHg or diastolic blood pressure >95 mmHg.
  • Laboratory findings at screening visit:
  • Amylase and/or lipase >3 times the upper limit of normal (ULN) laboratory range.
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 ULN.
  • Total bilirubin >1.5 ULN (except in case of Gilbert's syndrome).
  • Calcitonin ≥20 pg/mL (5.9 pmol/L).
  • Hemoglobin <10.5 g/dL and/or neutrophils <1500/mm3 and/or platelets <100 000/mm3.
  • Positive test for hepatitis B surface antigen (HBsAg) and/or hepatitis C antibody (HCAb).
  • Positive urine pregnancy test in female of childbearing potential.
  • For patient not treated with metformin at screening: severe renal function impairment with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 or end-stage renal disease.
  • Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (ie, worsening) or not controlled (ie, prolonged nausea and vomiting) gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening visit; or history of surgery affecting gastric emptying.
  • History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy has been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy.
  • Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (eg, multiple endocrine neoplasia syndromes).
  • Mean fasting self-monitored plasma glucose (SMPG) is >160 mg/dL (8.9 mmol/L), calculated from all available (minimum of 4 self-measurements) values during the 7 days prior to randomization.

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): NCT03798080


Contacts
Layout table for location contacts
Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-US@sanofi.com

Locations
Layout table for location information
China
Investigational Site Number 1560044 Recruiting
Baotou, China, 014010
Investigational Site Number 1560001 Recruiting
Beijing, China, 100034
Investigational Site Number 1560039 Recruiting
Beijing, China, 102218
Investigational Site Number 1560005 Recruiting
Changchun, China, 130033
Investigational Site Number 1560054 Recruiting
Changchun, China, 130041
Investigational Site Number 1560015 Recruiting
Changsha, China, 410013
Investigational Site Number 1560010 Recruiting
Chenzhou, China
Investigational Site Number 1560025 Recruiting
Fuzhou, China, 354200
Investigational Site Number 1560053 Recruiting
Guangzhou, China, 510080
Investigational Site Number 1560045 Recruiting
Guangzhou, China, 510515
Investigational Site Number 1560021 Recruiting
Hefei, China, 230022
Investigational Site Number 1560018 Recruiting
Hohhot, China, 010017
Investigational Site Number 1560019 Recruiting
Huanggang, China
Investigational Site Number 1560041 Recruiting
Jiaxing, China
Investigational Site Number 1560007 Recruiting
Jinan, China, 250013
Investigational Site Number 1560026 Recruiting
Jinzhou, China, 121000
Investigational Site Number 1560042 Recruiting
Kaifeng, China, 475000
Investigational Site Number 1560032 Recruiting
Lanzhou, China, 730000
Investigational Site Number 1560033 Recruiting
Luoyang, China
Investigational Site Number 1560028 Recruiting
Nanjing, China, 210008
Investigational Site Number 1560013 Recruiting
Nanjing, China, 210011
Investigational Site Number 1560017 Recruiting
Nanjing, China, 210029
Investigational Site Number 1560035 Recruiting
Nanjing, China
Investigational Site Number 1560046 Recruiting
Nantong, China, 226001
Investigational Site Number 1560008 Recruiting
Pingxiang, China, 337055
Investigational Site Number 1560031 Recruiting
Qinhuangdao, China
Investigational Site Number 1560011 Recruiting
Shanghai, China, 200240
Investigational Site Number 1560002 Recruiting
Shanghai, China, 201700
Investigational Site Number 1560027 Recruiting
Shanghai, China
Investigational Site Number 1560047 Recruiting
Shanghai, China
Investigational Site Number 1560012 Recruiting
Shenyang, China, 110004
Investigational Site Number 1560006 Recruiting
Tianjin, China, 300121
Investigational Site Number 1560049 Recruiting
Urumqi, China, 830000
Investigational Site Number 1560020 Recruiting
Xining, China, 810007
Investigational Site Number 1560036 Recruiting
Xuzhou, China
Investigational Site Number 1560023 Recruiting
Yangzhou, China, 225001
Investigational Site Number 1560022 Recruiting
Zhuzhou, China, 412007
Investigational Site Number 1560052 Recruiting
Zigong, China, 643002
Sponsors and Collaborators
Sanofi
Investigators
Layout table for investigator information
Study Director: Clinical Sciences & Operations Sanofi

Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03798080     History of Changes
Other Study ID Numbers: EFC14944
U1111-1190-7781 ( Other Identifier: UTN )
First Posted: January 9, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Lixisenatide
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Metformin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs