Clinical Trial Details

NCT ID: NCT02787551
Date Last Changed: October 10, 2017

Overview

Research Study Summary

A clinical research study for the treatment of Type 2 Diabetes Mellitus

Research Study Title

A 26-Week Randomized, Open-label, Active Controlled, Parallel-group, Study Assessing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and Metformin (Alone or With Pioglitazone and/or SGLT2 Inhibitors), Followed by a Fixed Ratio Combination Single-arm 26-Week Extension Period

Purpose

Primary Objective:

To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) versus GLP-1 receptor agonist (GLP-1 RA) in hemoglobin A1c (HbA1c) change.

Secondary Objectives:

To compare the overall efficacy and safety of the insulin glargine/lixisenatide fixed ratio combination (FRC) to GLP-1 receptor agonist (GLP-1 RA) on top of metformin (with or without pioglitazone, with or without SGLT2 inhibitor) in patients with type 2 diabetes.

To evaluate safety, efficacy and other endpoints of FRC up to the end of the extension period.

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Recruitment Details

Phase
3
Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Sanofi
Duration
23 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

Inclusion criteria :

  • Patients with type 2 diabetes mellitus diagnosed at least 1 year prior to screening visit.

  • Patients who have been treated with one of the following glucagon-like peptide 1 (GLP-1) receptor agonists for at least 4 months prior to screening visit (V1), and with stable dose for at least 3 months prior to screening visit (V1):

  • Liraglutide (Victoza®) 1.8 mg QD or 1.2 mg QD, if the 1.8 mg QD dose is not well tolerated according to the Investigator's judgment or

  • Exenatide (Byetta®) 10 µg BID or of 5 µg BID, if 10 µg BID dose is not well tolerated according to the Investigator's judgment in combination with metformin (daily dose ≥1500 mg/day or maximum tolerated dose [MTD]), with or without pioglitazone, with or without SGLT2 inhibitor, all at stable dose for at least 3 months prior to screening.

or

Patients who have been treated with stable dose of one of the following GLP-1 receptor agonists for at least 6 months prior to screening visit (V1):

  • Exenatide extended-release (Bydureon®) 2 mg once weekly (QW), if well tolerated according to Investigator's judgment,

  • Albiglutide (Tanzeum®) 50 mg QW or 30 mg QW, if 50 mg QW is not well tolerated according to Investigator's judgment,

  • Dulaglutide (Trulicity®) 1.5 mg QW or 0.75 mg QW, if 1.5 mg QW is not well tolerated according to Investigator's judgment in combination with metformin (daily dose ≥1500 mg/day or MTD), with or without pioglitazone, with or without SGLT2 inhibitor, all at stable dose for at least 3 months prior to screening;

  • Signed written informed consent.

Exclusion criteria:

  • At screening visit, age < 18.

  • Screening HbA1c < 7% and > 9%.

  • Pregnancy or lactation, women of childbearing potential with no effective contraceptive method.

  • Any use of antidiabetic drugs within 3 months prior to the screening visit other than those described in the inclusion criteria.

  • Previous treatment with insulin in the year prior to screening visit (note: short-term treatment with insulin [≤10 days] due to intercurrent illness including gestational diabetes is allowed at the discretion of the study physician).

  • Laboratory findings at the time of screening, including:

  • Fasting plasma glucose (FPG) > 250 mg/dL (13.9 mmol/L),

  • Amylase and/or lipase > 3 times the upper limit of the normal laboratory range (ULN),

  • Alanine transaminase or aspartate transaminase > 3 ULN,

  • Calcitonin ≥20 pg/mL (5.9 pmol/L),

  • Positive pregnancy test.

  • Patient who has renal function impairment with estimated glomerular filtration rate < 30mL/min/1.73m2 (using the Modification of Diet in Renal Disease formula) or end-stage renal disease.

  • Contraindication to use of insulin glargine, or lixisenatide or GLP-1 receptor agonist (Victoza®, Byetta®, Bydureon®, Tanzeum® or Trulicity®) according to local labeling.

  • Any contraindication to metformin or pioglitazone or SGLT2 inhibitor use, according to local labeling.

  • History of hypersensitivity to insulin glargine, or to any of the excipients.

  • History of allergic reaction to any GLP-1 receptor agonist or to meta-cresol.

  • Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposes to MTC (eg, multiple endocrine neoplasia type 2 syndromes).

  • 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.

  • Body mass index ≤20 or > 40 kg/m^2.

Exclusion criteria for the extension period:

  • Patients in the FRC arm with a rescue therapy and HbA1c > 8% at week 22.

  • Patients in the FRC arm who discontinued prematurely from FRC treatment before week 26.

  • Patients in the GLP-1 RA treatment arm after randomization.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Site Locations (130)

Country State City Zip Facility and Contact
United States Alabama Birmingham 35205 Investigational Site Number 8400064
United States Arizona Fountain Hills 85268 Investigational Site Number 8400073
United States Arizona Phoenix 85028 Investigational Site Number 8400047
United States California Bakersfield 93309 Investigational Site Number 8400103
United States California Fresno 93720 Investigational Site Number 8400137
United States California Huntington Park 90255 Investigational Site Number 8400043
United States California Lamont 93241 Investigational Site Number 8400124
United States California Lancaster 93534 Investigational Site Number 8400027
United States California Los Angeles 90017 Investigational Site Number 8400098
United States California Los Angeles 90057 Investigational Site Number 8400013
United States California Mission Hills 91345 Investigational Site Number 8400042
United States California Northridge 91325 Investigational Site Number 8400006
United States California Orange 92868 Investigational Site Number 8400021
United States California Rialto 92377 Investigational Site Number 8400126
United States California Santa Ana 92704 Investigational Site Number 8400094
United States California Ventura 93003 Investigational Site Number 8400009
United States Colorado Denver 80206 Investigational Site Number 8400036
United States Colorado Denver 80209 Investigational Site Number 8400071
United States Florida Jacksonville 32216 Investigational Site Number 8400114
United States Florida Miami 33165 Investigational Site Number 8400133
United States Florida Miami 33175 Investigational Site Number 8400128
United States Florida Port Charlotte 33952 Investigational Site Number 8400058
United States Florida Tampa 33612 Investigational Site Number 8400084
United States Florida West Palm Beach 33401 Investigational Site Number 8400112
United States Georgia Lawrenceville 30045 Investigational Site Number 8400045
United States Georgia Snellville 30078 Investigational Site Number 8400096
United States Illinois Springfield 62711 Investigational Site Number 8400023
United States Indiana Avon 46123 Investigational Site Number 8400038
United States Indiana Avon 46123 Investigational Site Number 8400049
United States Indiana Avon 46123 Investigational Site Number 8400053
United States Indiana Avon 46123 Investigational Site Number 8400085
United States Indiana Avon 46123 Investigational Site Number 8400120
United States Indiana Evansville 47714 Investigational Site Number 8400041
United States Iowa Council Bluffs 51501 Investigational Site Number 8400130
United States Kentucky Lexington 40503 Investigational Site Number 8400091
United States Kentucky Lexington 40504 Investigational Site Number 8400034
United States Louisiana Marrero 70072 Investigational Site Number 8400078
United States Louisiana Metairie 70006 Investigational Site Number 8400032
United States Louisiana New Orleans 70121 Investigational Site Number 8400088
United States Maryland Baltimore 21237 Investigational Site Number 8400033
United States Missouri Jefferson City 65109 Investigational Site Number 8400051
United States Nebraska Papillion 68046 Investigational Site Number 8400083
United States Nevada Henderson 89052 Investigational Site Number 8400044
United States New York Albany 12206 Investigational Site Number 8400079
United States New York New York 10001 Investigational Site Number 8400061
United States New York North Massapequa 11758 Investigational Site Number 8400123
United States New York Staten Island 10301-3914 Investigational Site Number 8400095
United States New York West Seneca 14224 Investigational Site Number 8400067
United States New York Yonkers 10704 Investigational Site Number 8400111
United States North Carolina Morehead City 28557 Investigational Site Number 8400020
United States North Carolina Wilmington 28401 Investigational Site Number 8400065
United States North Dakota Fargo 58103 Investigational Site Number 8400018
United States Ohio Columbus 43201 Investigational Site Number 8400019
United States Ohio Dayton 45439 Investigational Site Number 8400056
United States Ohio Mentor 44060 Investigational Site Number 8400125
United States Oklahoma Oklahoma City 73112 Investigational Site Number 8400099
United States Pennsylvania Scottdale 15683 Investigational Site Number 8400129
United States Pennsylvania Smithfield 15478 Investigational Site Number 8400076
United States Rhode Island Warwick 02818 Investigational Site Number 8400104
United States South Carolina Columbia 29204 Investigational Site Number 8400090
United States Texas Austin 78749 Investigational Site Number 8400139
United States Texas Dallas 75230 Investigational Site Number 8400001
United States Texas Edinburg 78539 Investigational Site Number 8400118
United States Texas Houston 77004 Investigational Site Number 8400008
United States Texas Houston 77070 Investigational Site Number 8400109
United States Texas Houston 77081 Investigational Site Number 8400063
United States Texas Houston 77081 Investigational Site Number 8400106
United States Texas Houston 77081 Investigational Site Number 8400107
United States Texas North Richland Hills 76180 Investigational Site Number 8400014
United States Texas San Antonio 78240 Investigational Site Number 8400089
United States Texas San Antonio 78258 Investigational Site Number 8400075
United States Texas Schertz 78154 Investigational Site Number 8400135
United States Utah Orem 84058 Investigational Site Number 8400054
United States Utah Salt Lake City 84102 Investigational Site Number 8400025
United States Virginia Weber City 24290 Investigational Site Number 8400092
Canada Burlington L7M 4Y1 Investigational Site Number 1240003
Canada Corunna N0N 1G0 Investigational Site Number 1240006
Canada Red Deer T4N 6V7 Investigational Site Number 1240002
Canada Smiths Falls K7A 4W8 Investigational Site Number 1240008
Canada Vancouver V5Y 3W2 Investigational Site Number 1240001
Estonia Pärnu 80018 Investigational Site Number 2330002
Estonia Tallinn 10138 Investigational Site Number 2330003
Estonia Tallinn 13419 Investigational Site Number 2330001
Estonia Viljandimaa 71024 Investigational Site Number 2330004
Germany Dresden 01307 Investigational Site Number 2760001
Germany Hohenmölsen 06679 Investigational Site Number 2760006
Germany Neu-Isenburg 63263 Investigational Site Number 2760004
Germany Oldenburg In Holstein 23758 Investigational Site Number 2760003
Israel Haifa 31096 Investigational Site Number 3760001
Israel Haifa 35251 Investigational Site Number 3760002
Israel Jerusalem 91120 Investigational Site Number 3760005
Israel Jerusalem 93106 Investigational Site Number 3760006
Israel Tel Aviv Investigational Site Number 3760004
Italy Bergamo 24127 Investigational Site Number 3800008
Italy Bologna 40138 Investigational Site Number 3800002
Italy Milano 20132 Investigational Site Number 3800001
Italy Milano 20142 Investigational Site Number 3800006
Italy Milano 20157 Investigational Site Number 3800007
Italy Napoli 80131 Investigational Site Number 3800005
Italy Roma 00128 Investigational Site Number 3800004
Italy Roma 00133 Investigational Site Number 3800003
Romania Bacau 600154 Investigational Site Number 6420004
Romania Brasov 500097 Investigational Site Number 6420006
Romania Bucuresti 020045 Investigational Site Number 6420001
Romania Buzau 120203 Investigational Site Number 6420008
Romania Cluj Napoca 400006 Investigational Site Number 6420003
Romania Oradea 410159 Investigational Site Number 6420002
Romania Targoviste 130083 Investigational Site Number 6420009
Romania Timisoara 300125 Investigational Site Number 6420005
Romania Târgu Mureș Judetul. Mures 540080 Investigational Site Number 6420007
Slovakia Bratislava 85101 Investigational Site Number 7030006
Slovakia Lubochna 3491 Investigational Site Number 7030009
Slovakia Lucenec 98401 Investigational Site Number 7030002
Slovakia Malacky 90101 Investigational Site Number 7030005
Slovakia Presov 08001 Investigational Site Number 7030007
Slovakia Roznava 04801 Investigational Site Number 7030001
Slovakia Sabinov 083 01 Investigational Site Number 7030008
Slovakia Trencin 91101 Investigational Site Number 7030004
Slovakia Zilina 01001 Investigational Site Number 7030003
Spain Alzira 46600 Investigational Site Number 7240012
Spain Barcelona 08035 Investigational Site Number 7240005
Spain Ferrol 15405 Investigational Site Number 7240002
Spain Málaga 29010 Investigational Site Number 7240008
Spain Palma De Mallorca 07120 Investigational Site Number 7240001
Spain Pozuelo De Alarcón 28223 Investigational Site Number 7240011
Spain Quart De Poblet 46930 Investigational Site Number 7240003
Spain Sabadell 08208 Investigational Site Number 7240006
Spain Sevilla 41003 Investigational Site Number 7240007
Spain Sevilla 41010 Investigational Site Number 7240009
Spain Sevilla 41071 Investigational Site Number 7240004

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