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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT02058160
First received: February 6, 2014
Last updated: September 15, 2014
Last verified: September 2014
  Purpose

Primary Objective:

To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination to insulin glargine in HbA1c change from baseline to week 30.

Secondary Objective:

To compare the overall efficacy and safety of insulin glargine/lixisenatide fixed ratio combination to insulin glargine (with or without metformin) over a 30 week treatment period in patients with type 2 diabetes


Condition Intervention Phase
Type 2 Diabetes
Drug: Insulin glargine/lixisenatide HOE901/AVE0010
Drug: Insulin glargine HOE901
Drug: Metformin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, 30-week, Active-controlled, Open Label, 2- Treatment Arm, Parallel-group, Multicenter Study Comparing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine With or Without Metformin in Patients With T2DM

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change in HbA1c from baseline [ Time Frame: week 30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients reaching HbA1c targets [ Time Frame: week 30 ] [ Designated as safety issue: No ]
  • Change in 2-hour Post Prandial Glucose and in blood glucose excursion during standardized meal test from baseline to week 30 [ Time Frame: week 30 ] [ Designated as safety issue: No ]
  • Change in body weight from baseline [ Time Frame: week 30 ] [ Designated as safety issue: No ]
  • Change in 7-point Self-Monitoring Plasma Glucose profiles from baseline [ Time Frame: week 30 ] [ Designated as safety issue: No ]
  • Change in daily dose of insulin glargine from baseline [ Time Frame: week 30 ] [ Designated as safety issue: No ]
  • Change in Fasting Plasma Glucose from baseline [ Time Frame: week 30 ] [ Designated as safety issue: No ]
  • Documented (plasma glucose less than or equal to 70 mg/dl) symptomatic hypoglycemia [ Time Frame: 30 weeks ] [ Designated as safety issue: Yes ]
  • Severe symptomatic hypoglycemia [ Time Frame: 30 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 700
Study Start Date: January 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin glargine/lixisenatide fixed ratio combination
Insulin glargine/lixisenatide fixed ratio combination is injected subcutaneously s.c. (under the skin) once daily. Dose individually adjusted. If taken prior to entry in the trial metformin treatment should be continued.
Drug: Insulin glargine/lixisenatide HOE901/AVE0010
Pharmaceutical form:solution for injection (disposable self injector) Route of administration: subcutaneous injection
Drug: Metformin
Pharmaceutical form:tablet Route of administration: oral administration
Active Comparator: Insulin glargine
Insulin glargine is injected subcutaneously s.c. (under the skin) once daily. Dose individually adjusted. If taken prior to entry in the trial metformin treatment should be continued.
Drug: Insulin glargine HOE901
Pharmaceutical form:solution for injection (disposable self injector) Route of administration: subcutaneous injection
Drug: Metformin
Pharmaceutical form:tablet Route of administration: oral administration

Detailed Description:

Maximum duration of approximately 39 weeks: an up to 8-week screening period, a 30-week randomized treatment period and 3 days post-treatment safety follow up period.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria :

  • Type 2 diabetes mellitus diagnosed at least 1 year before the screening visit.
  • Treatment with basal insulin for at least 6 months before the screening visit.
  • Stable basal insulin regimen (i.e. type of insulin and time/frequency of the injection) for at least 3 months before the screening visit.
  • Stable (plus/minus 20 percent) total daily basal insulin dose between 15 and 40U/day for at least 2 months prior to the screening visit.
  • 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 before the screening visit. The OADs can be 1 to 2 out of:

    • metformin (more than or equal to1500mg/day or maximal tolerated dose),
    • a sulfonylurea
    • a glinide,
    • a dipeptidyl-peptidase-4 inhibitor
    • a sodium glucose co-transporter 2 inhibitor
  • Fasting plasma glucose (FPG) less than or equal to 180 mg/dL(10.0 mmol/L) at screening visit for patients receiving basal insulin in combination with 2 OADs or with 1 OAD other than metformin; FPG less than or equal to 200 mg/dL (11.1 mmol/L) at screening visit for patients on basal insulin only or basal insulin plus metformin at screening visit,
  • Signed written informed consent.

Exclusion criteria:

  • Age under legal age of adulthood at screening visit
  • HbA1c at screening visit less than 7.5% or above 10%.
  • Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.
  • Use of other oral or injectable glucose-lowering agents than stated in the inclusion criteria in a period of 3 months prior to screening.
  • Previous use of insulin other than basal insulin eg, prandial or pre-mixed insulin, in the year prior to screening. Note: Short term treatment (≤10 days) due to intercurrent illness is allowed.
  • History discontinuation of a previous treatment with Glucagon Like Peptide -1 Receptor Agonists for safety/tolerability or lack of efficacy.
  • Patient who has previously participated in any clinical trial with lixisenatide or the insulin glargine/lixisenatide fixed ratio combination or has previously received lixisenatide.
  • Use of weight loss drugs within 3 months prior to screening visit.
  • Within the last 6 months prior to screening visit: history of stroke, myocardial infarction, unstable angina, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures to be performed during the study period.
  • History of pancreatitis (unless pancreatitis was related to gallstones and cholecystectomy was already performed), chronic pancreatitis, pancreatitis during a previous treatment with incretin therapies, pancreatectomy, stomach/gastric surgery.
  • Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predispose to MTC (eg, multiple endocrine neoplasia syndromes).
  • Uncontrolled or inadequately controlled hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 95 mmHg) at screening visit
  • At screening visit, Body Mass Index (BMI) less than or equal to 20 or above 40 kg/m²
  • At screening visit amylase and/or lipase more than 3 times the upper limit of the normal (ULN) laboratory range,
  • At screening visit ALT or AST more than 3 ULN
  • At screening visit calcitonin above or equal to 20 pg/mL (5.9 pmol/L)
  • Any contraindication to metformin use, according to local labeling, if the patient is taking metformin.
  • Patient who has a renal function impairment with creatinine clearance less than 30 mL/min (using the Cockroft and Gault formula) or end-stage renal disease for patients, not treated with metformin.

Exclusion criteria for randomization:

  • HbA1c less than 7% or above 10% .
  • Mean fasting Self Measured Plasma Glucose (SMPG) calculated from the self-measurements for 7 days the week before randomization visit is above 140 mg/dL (7.8 mmol/L).
  • Average insulin glargine daily dose less than 20U or above 50U ( in the week before randomization visit).
  • Amylase and/or lipase more than 3 ULN .

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: NCT02058160

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

  Show 254 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02058160     History of Changes
Other Study ID Numbers: EFC12405, 2013-003132-79, U1111-1148-4351
Study First Received: February 6, 2014
Last Updated: September 15, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Glargine
Metformin
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014