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Trial record 28 of 61 for:    Lixisenatide

Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes (LixiLan-India)

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03529123
Recruitment Status : Active, not recruiting
First Posted : May 18, 2018
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine by demonstrating change in glycosylated hemoglobin (HbA1c).

Secondary Objectives:

  • To assess the effects of the FRC in comparison with insulin glargine on:
  • Percentage of patients reaching HbA1c targets (<7% );
  • Glycemic control in relation to a meal as evaluated by 2-hour Post-prandial Plasma Glucose; (PPG);
  • Body weight
  • Fasting Plasma Glucose (FPG);
  • Percentage of patients reaching HbA1c targets of <7% with no body weight gain and no hypoglycemia (as defined in the evaluation criteria);
  • 7-point Self-Monitoring Plasma Glucose (SMPG) profile;
  • Insulin glargine dose.
  • To assess the safety and tolerability 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 Drug: Insulin Glulisine (HMR1964) Phase 3

Detailed Description:
The maximum study duration per patient is 33 weeks.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 254 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, 24-week, Controlled, Open Label, Parallel Arm, Multicenter Study Comparing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine in Type 2 Diabetes Patients, Inadequately Controlled on Basal Insulin With or Without Metformin
Actual Study Start Date : June 19, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tested Drug
Insulin glargine/lixisenatide fixed ratio combination (FRC)
Drug: INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010)

Pharmaceutical form: Injection

Route of administration: Subcutaneous

Other Name: Soliqua, Insulin Glargine/Lixisenatide Fixed Ratio Combination

Drug: Metformin

Pharmaceutical form: Tablet

Route of administration: Oral


Drug: Insulin Glulisine (HMR1964)

Pharmaceutical form: Injection

Route of administration: Subcutaneous

Other Name: Apidra

Active Comparator: Control Drug
Insulin glargine (Lantus®)
Drug: INSULIN GLARGINE (HOE901)

Pharmaceutical form: Injection

Route of administration: Subcutaneous

Other Name: Lantus®

Drug: Metformin

Pharmaceutical form: Tablet

Route of administration: Oral


Drug: Insulin Glulisine (HMR1964)

Pharmaceutical form: Injection

Route of administration: Subcutaneous

Other Name: Apidra




Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: From baseline to Week 24 ]
    Mean change in glycosylated hemoglobin (HbA1c) from baseline to Week 24


Secondary Outcome Measures :
  1. Patients with HbA1c <7% [ Time Frame: At Week 24 ]
    Number of patients reaching HbA1c <7 % at the end of Week 24

  2. Change in 2-hour Post prandial glucose (PPG) [ Time Frame: From baseline to Week 24 ]
    Change in 2-hour PPG from baseline to Week 24

  3. Change in body weight [ Time Frame: From baseline to Week 24 ]
    Change in body weight from baseline to Week 24

  4. Patients with HbA1c <7% with no body weight gain and no hypoglycemia [ Time Frame: At Week 24 ]
    Number of patients reaching HbA1c <7% with no body weight gain and no hypoglycemia at the end of Week 24

  5. Change in Fasting Plasma Glucose [ Time Frame: From baseline to Week 24 ]
    Mean change in FPG from baseline to Week 24

  6. Adverse events (AE) [ Time Frame: Up to 33 weeks ]
    Number of AEs

  7. Patients with HbA1c <7% with no body weight gain [ Time Frame: At Week 24 ]
    Number of patients reaching HbA1c <7% with no body weight gain at the end of Week 24

  8. Change in SMPG profiles [ Time Frame: From baseline to Week 24 ]
    Change in 7-point self-monitoring plasma glucose (SMPG) profiles from baseline to Week 24



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (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 before the screening visit,
  • At screening:
  • Age should be ≥ 18 years of age to < 65 years;
  • Glycosylated hemoglobin (HbA1c) at screening visit ≥ 7.5% or ≤ 10%;
  • Body mass index (BMI) ≥ 19 kg/m2 and ≤ 40 kg/m2.
  • Patients who have been treated with a basal insulin for at least 6 months before the screening visit, and who have been on a stable basal insulin regimen (ie, type of insulin and time/frequency of the injection), for at least 3 months before the screening visit. The stable total daily dose should be within the range of 15-40 U, both inclusive, on the day of screening, but individual fluctuations of ± 20% within 2 months prior to screening are acceptable.

Exclusion criteria:

  • Use of oral or injectable glucose-lowering agents other than those stated in the inclusion criteria in the 3 months before screening.
  • Previous use of insulin regimen other than basal insulin eg, prandial or pre-mixed insulin (Note: Short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the investigator).
  • For patients taking metformin, any contraindication to metformin use, according to local labeling.
  • 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.
  • Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposes to MTC (eg, multiple endocrine neoplasia syndromes).
  • 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.
  • Average insulin glargine daily dose <20 U or >50 U calculated for the last 3 days before Visit 6.
  • Amylase and/or lipase >3 upper limit normal (ULN) at Visit 5 (Week -1).

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): NCT03529123


Locations
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India
Investigational Site Number 01
Bangalore, India, 560092
Investigational Site Number 012
Belgaum, India, 590010
Investigational Site Number 013
Chennai, India, 600086
Investigational Site Number 017
Coimbatore, India, 641009
Investigational Site Number 06
Hyderabad, India, 500063
Investigational Site Number 07
Hyderabad, India, 500072
Investigational Site Number 08
Jaipur, India
Investigational Site Number 04
Kolkata, India, 700107
Investigational Site Number 018
Lucknow, India
Investigational Site Number 014
Madurai, India, 625020
Investigational Site Number 05
Nasik, India, 422002
Investigational Site Number 010
New Delhi, India, 110029
Investigational Site Number 016
Pune, India, 411040
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03529123     History of Changes
Other Study ID Numbers: INSLIL08556
U1111-1200-1162 ( Other Identifier: UTN )
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 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/

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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:
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Lixisenatide
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Metformin
Insulin Glargine
Insulin glulisine
Hypoglycemic Agents
Physiological Effects of Drugs