Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination Versus Insulin Glargine in Patients With Type 2 Diabetes

NCT ID: NCT02058160

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 736 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-07-31

Brief Summary

Primary Objective:

To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) to insulin glargine in glycated hemoglobin (HbA1c) change from baseline to Week 30.

Secondary Objective:

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

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)

FRC once daily (QD) for 30 weeks. Dose individually adjusted.

Group Type: EXPERIMENTAL

Insulin glargine/lixisenatide (HOE901/AVE0010)

Intervention Type: DRUG

Insulin glargine/lixisenatide FRC was self-administered by subcutaneous (SC) injection within 1 hour before breakfast using one of 2 SoloStar® pen-injectors: Pen A (ratio of 2 Units (U) of insulin glargine U 100:1 mcg of lixisenatide) or Pen B (ratio of 3 U of insulin glargine U 100:1 mcg of lixisenatide). After run-in, the FRC was initiated at a dose of either 20 U/10 mcg with Pen A or 30 U/10 mcg with Pen B, depending on participant's dose of Insulin glargine on the day prior to randomization.

Dose was adjusted weekly to reach and maintain fasting self-monitored plasma glucose (SMPG) of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L). Pen A was used for administration of doses up to 40 U/20 mcg and Pen B for administration of doses from 30 U/10 mcg up to 60 U/20 mcg.

Metformin (Background Drug)

Intervention Type: DRUG

Pharmaceutical form: Tablet; Route of administration: Oral administration

Insulin glargine

Insulin glargine 100 U/mL QD for 30 weeks. Dose individually adjusted.

Group Type: ACTIVE_COMPARATOR

Insulin glargine (HOE901)

Intervention Type: DRUG

Insulin glargine was self-administered QD by SC injection at approximately the same time every day.

After screening, eligible participants entered 6 week run-in phase during which they were switched (if necessary) to insulin glargine and dose was stabilized. The first dose after randomization was same as the one administered on the day prior to randomization and then dose was adjusted weekly to reach and maintain fasting SMPG of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L).

Metformin (Background Drug)

Intervention Type: DRUG

Pharmaceutical form: Tablet; Route of administration: Oral administration

Interventions

Insulin glargine/lixisenatide (HOE901/AVE0010)

Insulin glargine/lixisenatide FRC was self-administered by subcutaneous (SC) injection within 1 hour before breakfast using one of 2 SoloStar® pen-injectors: Pen A (ratio of 2 Units (U) of insulin glargine U 100:1 mcg of lixisenatide) or Pen B (ratio of 3 U of insulin glargine U 100:1 mcg of lixisenatide). After run-in, the FRC was initiated at a dose of either 20 U/10 mcg with Pen A or 30 U/10 mcg with Pen B, depending on participant's dose of Insulin glargine on the day prior to randomization.

Dose was adjusted weekly to reach and maintain fasting self-monitored plasma glucose (SMPG) of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L). Pen A was used for administration of doses up to 40 U/20 mcg and Pen B for administration of doses from 30 U/10 mcg up to 60 U/20 mcg.

Intervention Type: DRUG

Insulin glargine (HOE901)

Insulin glargine was self-administered QD by SC injection at approximately the same time every day.

After screening, eligible participants entered 6 week run-in phase during which they were switched (if necessary) to insulin glargine and dose was stabilized. The first dose after randomization was same as the one administered on the day prior to randomization and then dose was adjusted weekly to reach and maintain fasting SMPG of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L).

Intervention Type: DRUG

Metformin (Background Drug)

Pharmaceutical form: Tablet; Route of administration: Oral administration

Intervention Type: DRUG

Other Intervention Names

Lantus

Eligibility 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 40 Units/day for at least 2 months prior to the screening visit.
• For participants 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 could be 1 to 2 out of:

• metformin (more than or equal to 1500 mg/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 participants 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 participants on basal insulin only or basal insulin plus metformin at screening visit.
• Signed written informed consent.

• 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.
• Participant who had previously participated in any clinical trial with lixisenatide or the insulin glargine/lixisenatide FRC or had 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/m^2.
• At screening visit amylase and/or lipase more than 3 times the upper limit of the normal (ULN) laboratory range.
• At screening visit alanine aminotransferase (ALT) or alkaline phosphatase (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 participant was taking metformin.
• Participant who had a renal function impairment with creatinine clearance less than 30 mL/min (using the Cockcroft and Gault formula) or end-stage renal disease for participants, not treated with metformin.

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.

• HbA1c less than 7% or above 10% .
• Mean fasting SMPG calculated from the self-measurements for 7 days the week before randomization visit was above 140 mg/dL (7.8 mmol/L).
• Average insulin glargine daily dose less than 20 Units or above 50 Units (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 participant's potential participation in a clinical trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 840607

Birmingham, Alabama, United States

Investigational Site Number 840570

Sun City, Arizona, United States

Investigational Site Number 840562

Tempe, Arizona, United States

Investigational Site Number 840577

Tucson, Arizona, United States

Investigational Site Number 840517

Little Rock, Arkansas, United States

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Little Rock, Arkansas, United States

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Bell Gardens, California, United States

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Chino, California, United States

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Chula Vista, California, United States

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Corona, California, United States

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Fresno, California, United States

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Greenbrae, California, United States

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Lancaster, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Mission Viejo, California, United States

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Northridge, California, United States

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Palm Springs, California, United States

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Port Hueneme, California, United States

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San Ramon, California, United States

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Santa Ana, California, United States

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Tarzana, California, United States

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West Hills, California, United States

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Aurora, Colorado, United States

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Denver, Colorado, United States

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Wilmington, Delaware, United States

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Miami, Florida, United States

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New Port Richey, Florida, United States

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Ocala, Florida, United States

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Ocoee, Florida, United States

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Palm Harbor, Florida, United States

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Columbus, Georgia, United States

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Lawrenceville, Georgia, United States

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Roswell, Georgia, United States

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Idaho Falls, Idaho, United States

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Arlington Heights, Illinois, United States

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Chicago, Illinois, United States

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Evansville, Indiana, United States

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Evansville, Indiana, United States

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Evansville, Indiana, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Louisville, Kentucky, United States

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Lewiston, Maine, United States

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Baltimore, Maryland, United States

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Rockville, Maryland, United States

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Dearborn, Michigan, United States

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Flint, Michigan, United States

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Minneapolis, Minnesota, United States

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Butte, Montana, United States

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Omaha, Nebraska, United States

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Henderson, Nevada, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Albuquerque, New Mexico, United States

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Jamaica, New York, United States

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New Hyde Park, New York, United States

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Syracuse, New York, United States

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Durham, North Carolina, United States

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Greenville, North Carolina, United States

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Hickory, North Carolina, United States

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Morehead City, North Carolina, United States

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Salisbury, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Maumee, Ohio, United States

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Eugene, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Smithfield, Pennsylvania, United States

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Tipton, Pennsylvania, United States

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Charleston, South Carolina, United States

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Rapid City, South Dakota, United States

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Amarillo, Texas, United States

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Austin, Texas, United States

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Austin, Texas, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Edinburg, Texas, United States

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Houston, Texas, United States

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Hurst, Texas, United States

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N Richland Hill, Texas, United States

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Draper, Utah, United States

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Murray, Utah, United States

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Ogden, Utah, United States

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Orem, Utah, United States

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Salt Lake City, Utah, United States

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Burlington, Vermont, United States

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Chesapeake, Virginia, United States

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Norfolk, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Salem, Virginia, United States

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Federal Way, Washington, United States

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Spokane, Washington, United States

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Tacoma, Washington, United States

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Milwaukee, Wisconsin, United States

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Heidelberg, , Australia

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Parkville, , Australia

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Beamsville, , Canada

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Brampton, , Canada

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Guelph, , Canada

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Kelowna, , Canada

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Montreal, , Canada

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Saint Romuald, , Canada

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Toronto, , Canada

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Toronto, , Canada

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Vancouver, , Canada

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Victoria, , Canada

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Santiago, , Chile

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Talagante, , Chile

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Temuco, , Chile

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Cheb, , Czechia

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Hranice, , Czechia

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Krnov, , Czechia

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Liberec, , Czechia

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Olomouc, , Czechia

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Pilsen, , Czechia

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Pilsen, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Prostějov, , Czechia

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Aarhus C, , Denmark

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København NV, , Denmark

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København S, , Denmark

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Viborg, , Denmark

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Pärnu, , Estonia

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Tallinn, , Estonia

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Tartu, , Estonia

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Budapest, , Hungary

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Debrecen, , Hungary

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Kaposvár, , Hungary

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Kaunas, , Lithuania

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Kaunas, , Lithuania

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Kėdainiai, , Lithuania

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Klaipėda, , Lithuania

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Vilnius, , Lithuania

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Celaya, , Mexico

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Cuernavaca, , Mexico

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Guadalajara, , Mexico

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Guadalajara, , Mexico

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Guadalajara, , Mexico

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México, , Mexico

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Pachuca, , Mexico

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Puebla City, , Mexico

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Almere Stad, , Netherlands

Investigational Site Number 616502

Bialystok, , Poland

Investigational Site Number 616505

Krakow, , Poland

Investigational Site Number 616506

Krakow, , Poland

Investigational Site Number 616507

Płock, , Poland

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Szczecin, , Poland

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Warsaw, , Poland

Investigational Site Number 616501

Warsaw, , Poland

Investigational Site Number 642507

Brasov, , Romania

Investigational Site Number 642510

Bucharest, , Romania

Investigational Site Number 642508

Bucharest, , Romania

Investigational Site Number 642509

Bucharest, , Romania

Investigational Site Number 642506

Hunedoara, , Romania

Investigational Site Number 642505

Iași, , Romania

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Oradea, , Romania

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Sibiu, , Romania

Investigational Site Number 642501

Târgu Mureş, , Romania

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Timișoara, , Romania

Investigational Site Number 642503

Timișoara, , Romania

Investigational Site Number 643511

Arkhangelsk, , Russia

Investigational Site Number 643512

Moscow, , Russia

Investigational Site Number 643508

Penza, , Russia

Investigational Site Number 643501

Saint Petersburg, , Russia

Investigational Site Number 643506

Saint Petersburg, , Russia

Investigational Site Number 643503

Saint Petersburg, , Russia

Investigational Site Number 643504

Saint Petersburg, , Russia

Investigational Site Number 643505

Saint Petersburg, , Russia

Investigational Site Number 643502

Saint Petersburg, , Russia

Investigational Site Number 643513

Samara, , Russia

Investigational Site Number 643507

Saratov, , Russia

Investigational Site Number 643514

Saratov, , Russia

Investigational Site Number 643509

Voronezh, , Russia

Investigational Site Number 703505

Bratislava, , Slovakia

Investigational Site Number 703507

Bytča, , Slovakia

Investigational Site Number 703502

Košice, , Slovakia

Investigational Site Number 703512

Košice, , Slovakia

Investigational Site Number 703510

Košice, , Slovakia

Investigational Site Number 703511

Ľubochňa, , Slovakia

Investigational Site Number 703508

Moldava nad Bodvou, , Slovakia

Investigational Site Number 703504

Nové Mesto nad Váhom, , Slovakia

Investigational Site Number 703509

Nové Zámky, , Slovakia

Investigational Site Number 703513

Trnava, , Slovakia

Investigational Site Number 703501

Žilina, , Slovakia

Investigational Site Number 724508

A Coruña, , Spain

Investigational Site Number 724509

Alicante, , Spain

Investigational Site Number 724506

Alzira, , Spain

Investigational Site Number 724504

Barcelona, , Spain

Investigational Site Number 724510

Barcelona, , Spain

Investigational Site Number 724505

Cáceres, , Spain

Investigational Site Number 724503

Ferrol, , Spain

Investigational Site Number 724501

Sabadell, , Spain

Investigational Site Number 724507

Segovia, , Spain

Investigational Site Number 724502

Valencia, , Spain

Investigational Site Number 752501

Ljungby, , Sweden

Investigational Site Number 752503

Malmo, , Sweden

Investigational Site Number 752504

Rättvik, , Sweden

Investigational Site Number 752506

Stenungssund, , Sweden

Investigational Site Number 752505

Stockholm, , Sweden

Investigational Site Number 752502

Vällingby, , Sweden

Investigational Site Number 804501

Chernivtsi, , Ukraine

Investigational Site Number 804510

Kyiv, , Ukraine

Investigational Site Number 804507

Kyiv, , Ukraine

Investigational Site Number 804511

Kyiv, , Ukraine

Investigational Site Number 804513

Lviv, , Ukraine

Investigational Site Number 804502

Vinnytsia, , Ukraine

Investigational Site Number 804508

Vinnytsia, , Ukraine

Countries

United States; Australia; Canada; Chile; Czechia; Denmark; Estonia; Hungary; Lithuania; Mexico; Netherlands; Poland; Romania; Russia; Slovakia; Spain; Sweden; Ukraine

References

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Reference Type: DERIVED

PMID: 29143919 (View on PubMed)

Wysham C, Bonadonna RC, Aroda VR, Puig Domingo M, Kapitza C, Stager W, Yu C, Niemoeller E, Souhami E, Bergenstal RM; LixiLan-L trial investigators. Consistent findings in glycaemic control, body weight and hypoglycaemia with iGlarLixi (insulin glargine/lixisenatide titratable fixed-ratio combination) vs insulin glargine across baseline HbA1c, BMI and diabetes duration categories in the LixiLan-L trial. Diabetes Obes Metab. 2017 Oct;19(10):1408-1415. doi: 10.1111/dom.12961. Epub 2017 Jun 8.

Reference Type: DERIVED

PMID: 28386990 (View on PubMed)

Other Identifiers

2013-003132-79

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1148-4351

Identifier Type: OTHER

Identifier Source: secondary_id

EFC12405

Identifier Type: -

Identifier Source: org_study_id