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Trial record 54 of 61 for:    Lixisenatide

Efficacy and Safety of LixiLan Versus Insulin Glargine Alone Both With Metformin in Japanese With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Drugs (LIXILAN JP-L)

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ClinicalTrials.gov Identifier: NCT02752412
Recruitment Status : Completed
First Posted : April 27, 2016
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi

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 mellitus.

Secondary Objective:

To compare overall efficacy and safety of LixiLan to insulin glargine over 26 weeks in patients with type 2 diabetes mellitus.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Insulin glargine/Lixisenatide (HOE901/AVE0010) Drug: Insulin glargine U100 (HOE901) Drug: Metformin Phase 3

Detailed Description:
The maximum study duration per patient will be approximately 41 weeks: an up to 14-week screening period (consisting of an up to 2-week screening phase and a 12-week run-in phase), a 26-week randomized treatment period, and a 3-day post-treatment safety follow-up period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 513 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 the Insulin Glargine/Lixisenatide Combination to Insulin Glargine With Metformin in Japanese Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Drugs
Actual Study Start Date : May 17, 2016
Actual Primary Completion Date : October 4, 2018
Actual Study Completion Date : October 4, 2018


Arm Intervention/treatment
Experimental: LixiLan

LixiLan (insulin glargine/lixisenatide fixed ratio combination) is injected subcutaneously (under the skin) once daily. Dose is individually adjusted.

Metformin will be continued.

Drug: Insulin glargine/Lixisenatide (HOE901/AVE0010)

Pharmaceutical form: solution

Route of administration: subcutaneous

Other Name: LixiLan

Drug: Metformin

Pharmaceutical form: tablet

Route of administration: oral


Active Comparator: insulin glargine

Insulin glargine U100 (Lantus) will be injected subcutaneously (under skin) once daily. Dose will be individually adjusted.

Metformin will be continued.

Drug: Insulin glargine U100 (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 from baseline in HbA1c [ Time Frame: Baseline, 26 weeks ]

Secondary Outcome Measures :
  1. Percentage of patients reaching HbA1c <7% or ≤6.5% [ Time Frame: 26 weeks ]
  2. Change from baseline in 2-hour postprandial plasma glucose (PPG) during standardized meal test [ Time Frame: Baseline, 26 weeks ]
  3. Change from baseline in blood glucose excursion during standardized meal test [ Time Frame: Baseline, 26 weeks ]
  4. Change from baseline in 7-point self-monitoring plasma glucose (SMPG) profiles (each time point and average daily value) [ Time Frame: Baseline, 26 weeks ]
  5. Change from baseline in body weight [ Time Frame: Baseline, 26 weeks ]
  6. Change from baseline in FPG [ Time Frame: Baseline, 26 weeks ]
  7. Change from baseline in daily dose of insulin glargine [ Time Frame: Baseline, 26 weeks ]
  8. Percentage of patients reaching HbA1c <7% with no body weight gain [ Time Frame: 26 weeks ]
  9. 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 ]
  10. Percentage of patients reaching HbA1c <7% with no documented (PG ≤70 mg/dL [3.9 mmol/L]) symptomatic hypoglycemia [ Time Frame: 26 weeks ]
  11. Percentage of patients requiring a rescue therapy [ Time Frame: 26 weeks ]
  12. Number of hypoglycemic events [ Time Frame: 26 weeks ]
  13. Number of adverse events [ Time Frame: 26 weeks ]
  14. Measurement of anti-lixisenatide antibodies from baseline [ Time Frame: Baseline, 26 weeks ]
  15. Measurement of anti-insulin antibodies from baseline [ Time Frame: Baseline, 26 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Patient with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year before the screening visit (V1).
  • Patient treated with a stable, once a day basal insulin regimen (ie, type of insulin and time/frequency of the injection), for at least 3 months before the screening visit.
  • The total daily basal insulin dose should be stable (± 20%) and <15 U/day for at least 1 month before the screening visit.
  • Patient receiving 1 or 2 oral anti-diabetic drugs (OADs): the OAD dose(s) must be stable during the 3 months before the screening visit. The OADs can be 1 to 2 out of:
  • Metformin;
  • Sulfonylurea (SU);
  • Glinide;
  • Dipeptidyl-peptidase-4 (DPP-4) inhibitor;
  • Sodium glucose co-transporter 2 (SGLT2) inhibitor;
  • Alpha glucosidase inhibitor (alpha-GI).
  • Signed written informed consent.

Exclusion criteria:

  • Age <20 years at screening visit.
  • HbA1c at screening visit <7.5% or >9.5%.
  • Fasting plasma glucose (FPG) >180 mg/dL (10.0 mmol/L) at screening visit.
  • 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 in the 3 months before screening visit.
  • Previous use of insulin regimen other than basal insulin, eg, prandial or pre-mixed insulin.

Note: Short-term treatment (≤10 days) due to intercurrent illness including gestational diabetes is allowed at the discretion of the Investigator.

  • Use of thiazolidinedione (TZD) within 6 months prior to screening visit.
  • History of discontinuation of a previous treatment with a glucagon-like peptide-1(GLP-1) receptor agonist due to safety/ tolerability issues or lack of efficacy.
  • Laboratory findings at the screening visit; including:
  • 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.
  • Any contraindication to metformin use according to local labeling.
  • History of hypersensitivity to any GLP-1 receptor agonist or to metacresol.
  • Contraindication to use of insulin glargine or lixisenatide according to local labeling. History of hypersensitivity to insulin glargine or to any of the excipients.
  • 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 now been performed), pancreatitis during previous treatment with incretin therapies, chronic pancreatitis, pancreatectomy, stomach/gastric surgery.
  • Exclusion criteria for randomization at the end of the run-in phase:
  • HbA1c <7.5% or >9.5% at visit 6 (Week -1).
  • Mean fasting self monitored plasma glucose (SMPG) >160 mg/dL (8.9 mmol/L), calculated from all available (minimum of 4 self-measurements) values during the 7 days prior to randomization.

Note:fasting SMPG on the day of randomization can be included if assessed before randomization.

  • Average insulin glargine daily dose ≥15 U/day or <5U/day calculated for the last 3 days before Visit 7.
  • Metformin total daily dose <750 mg/day.
  • Amylase and/or lipase >3 ULN at Visit 6 (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): NCT02752412


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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: NCT02752412     History of Changes
Other Study ID Numbers: EFC14113
U1111-1176-8378 ( Other Identifier: UTN )
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
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
Hypoglycemic Agents
Physiological Effects of Drugs