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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01768559
Other study ID # EFC12626
Secondary ID 2012-004096-38U1
Status Completed
Phase Phase 3
First received January 11, 2013
Last updated December 2, 2015
Start date January 2013
Est. completion date December 2014

Study information

Verified date December 2015
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Primary Objective:

- To compare lixisenatide versus insulin glulisine in terms of HbA1c reduction and body weight change at week 26 in type 2 diabetic patients not adequately controlled on insulin glargine ± metformin.

Secondary Objectives:

- To compare the treatments/regimens on:

- The percentage of patients reaching the target of HbA1c <7% or ≤6.5%

- Body weight

- Self-Monitored Glucose profiles

- Fasting Plasma Glucose (FPG)

- Post-prandial plasma glucose /glucose excursions during a standardized meal test (subset of patients)

- Daily doses of insulins

- Safety and tolerability


Description:

Approximately 41 weeks including a 26 week treatment period


Recruitment information / eligibility

Status Completed
Enrollment 894
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria :

- Patients with type 2 diabetes mellitus diagnosed at least 1 year before screening visit (V1) .

- Patients treated with basal insulin for at least 6 months.

- Patients treated for at least 3 months prior to visit 1 with a stable basal insulin regimen (ie type of insulin and time/frequency of the injection). The insulin dose should be stable (± 20 %) and =20 U/day for at least 2 months prior to visit 1.

- Patients treated with basal insulin alone or in combination with 1 to 3 oral anti-diabetic drugs (OADs) that can be: metformin (=1.5g/day or maximal tolerated dose), a sulfonylurea (SU), a dipeptidyl-peptidase-4 (DPP-4) inhibitor, a glinide. The dose of OADs should be stable for at least 3 months prior to visit 1.

Exclusion criteria:

- At screening: age < legal age of majority

- At screening, HbA1c: < 7.5% and > 10.0% for patients treated with basal insulin alone or in combination with metformin only; < 7.0% and > 10.0% for patients treated with basal insulin and a combination of oral anti-diabetic drugs which includes a SU and/or a DPP-4 inhibitor and/or a glinide.

- Women of childbearing potential with no effective contraceptive method, pregnancy or lactation

- Type 1 diabetes mellitus

- Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria within 3 months prior to screening.

- Previous treatment with short or rapid acting insulin other than in relation to hospitalization or an acute illness.

- Any previous treatment with lixisenatide, or any discontinuation from another GLP-1 receptor agonist due to safety/tolerability issue or lack of efficacy.

- At screening, Body Mass Index (BMI) =20 or >40 kg/m².

- Weight change of more than 5 kg during the 3 months prior to the screening visit; use of weight loss drugs within 3 months prior to screening.

- Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures.

- History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery.

- At screening resting systolic blood pressure > 180 mmHg or diastolic blood pressure > 95 mmHg

- Personal or immediate family history of medullary thyroid cancer (MTC) or genetic condition that predisposes to MTC (e.g. multiple endocrine neoplasia syndromes)

- Contraindication related to metformin (for patient receiving this treatment), insulin glargine, insulin glulisine or lixisenatide.

- Patients with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease.

- At screening, amylase and/or lipase > 3 times the upper limit of the normal laboratory range (ULN)

- At screening ALT or AST>3ULN

- At screening calcitonin =20 pg/ml (5.9 pmol/L)

Exclusion Criteria for randomization at the end of the screening period before randomization:

- HbA1c <7.0% or >9.0%.

- 7-day mean fasting SMPG >140 mg/dl (7.8 mmol/L).

- Amylase and/or lipase > 3 times ULN.

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
lixisenatide (AVE0010)
Pharmaceutical form:solution for injection (disposable self injector) Route of administration: subcutaneous injection
insulin glulisine (HMR1964)
Pharmaceutical form:solution for injection (disposable self injector) Route of administration: subcutaneous injection
Insulin Glargine
Doses to be adjusted to maintain a fasting SMPG between 4.4 to 5.6 mmol/L (80 to 100 mg/dL)
Metformin
If previously taken Metformin to be continued at stable dose ( =1.5 g/day) throughout the study

Locations

Country Name City State
Canada Investigational Site Number 124008 Brampton
Canada Investigational Site Number 124015 Burlington
Canada Investigational Site Number 124018 Chatham
Canada Investigational Site Number 124004 Coquitlam
Canada Investigational Site Number 124016 Etobicoke
Canada Investigational Site Number 124014 Hamilton
Canada Investigational Site Number 124011 Montreal
Canada Investigational Site Number 124020 Montreal
Canada Investigational Site Number 124017 Newmarket
Canada Investigational Site Number 124021 Quebec
Canada Investigational Site Number 124003 Red Deer
Canada Investigational Site Number 124002 Sherbrooke
Canada Investigational Site Number 124012 St-Romuald
Canada Investigational Site Number 124001 Toronto
Canada Investigational Site Number 124010 Toronto
Canada Investigational Site Number 124005 Vancouver
Canada Investigational Site Number 124006 Victoria
Canada Investigational Site Number 124007 Winnipeg
Chile Investigational Site Number 152101 Santiago
Chile Investigational Site Number 152102 Santiago
Chile Investigational Site Number 152103 Santiago
Chile Investigational Site Number 152105 Santiago
Chile Investigational Site Number 152106 Santiago
Chile Investigational Site Number 152107 Santiago
Chile Investigational Site Number 152108 Santiago
Chile Investigational Site Number 152109 Santiago
Czech Republic Investigational Site Number 203107 Beroun
Czech Republic Investigational Site Number 203103 Jilove U Prahy
Czech Republic Investigational Site Number 203101 Ostrava 2
Czech Republic Investigational Site Number 203110 Police Nad Metuji
Czech Republic Investigational Site Number 203102 Praha 4
Czech Republic Investigational Site Number 203105 Praha 4
Czech Republic Investigational Site Number 203108 Praha 4
Czech Republic Investigational Site Number 203104 Trutnov
Estonia Investigational Site Number 233102 Pärnu
Estonia Investigational Site Number 233103 Tallinn
Estonia Investigational Site Number 233104 Tallinn
Estonia Investigational Site Number 233101 Viljandimaa
France Investigational Site Number 250108 Bois Guillaume
France Investigational Site Number 250105 Corbeil Essonnes
France Investigational Site Number 250104 La Rochelle Cedex
France Investigational Site Number 250106 Lyon
France Investigational Site Number 250107 Lyon
France Investigational Site Number 250109 Mantes La Jolie
France Investigational Site Number 250102 Paris Cedex 15
France Investigational Site Number 250101 Vandoeuvre Les Nancy
France Investigational Site Number 250103 Venissieux
Germany Investigational Site Number 276112 Bad Mergentheim
Germany Investigational Site Number 276108 Berlin
Germany Investigational Site Number 276102 Dortmund
Germany Investigational Site Number 276106 Dresden
Germany Investigational Site Number 276120 Dresden
Germany Investigational Site Number 276117 Frankfurt A.M.
Germany Investigational Site Number 276116 Görlitz
Germany Investigational Site Number 276113 Heidelberg
Germany Investigational Site Number 276118 Leipzig
Germany Investigational Site Number 276119 Magdeburg
Germany Investigational Site Number 276103 Neumünster
Germany Investigational Site Number 276115 Speyer
Germany Investigational Site Number 276109 St. Ingbert-Oberwürzbach
Hungary Investigational Site Number 348102 Budapest
Hungary Investigational Site Number 348107 Budapest
Hungary Investigational Site Number 348108 Budapest
Hungary Investigational Site Number 348101 Eger
Hungary Investigational Site Number 348103 Pápa
Hungary Investigational Site Number 348106 Sátoraljaújhely
Hungary Investigational Site Number 348104 Szeged
Hungary Investigational Site Number 348105 Zalaegerszeg
Italy Investigational Site Number 380103 Bologna
Italy Investigational Site Number 380102 Catania
Italy Investigational Site Number 380101 Milano
Italy Investigational Site Number 380105 Napoli
Italy Investigational Site Number 380104 Torino
Latvia Investigational Site Number 428103 Jelgava
Latvia Investigational Site Number 428104 Ogre
Latvia Investigational Site Number 428102 Riga
Latvia Investigational Site Number 428105 Riga
Latvia Investigational Site Number 428101 Sigulda
Lithuania Investigational Site Number 440104 Jonava
Lithuania Investigational Site Number 440101 Kaunas
Lithuania Investigational Site Number 440102 Kaunas
Lithuania Investigational Site Number 440103 Kaunas
Lithuania Investigational Site Number 440105 Klaipeda
Mexico Investigational Site Number 484108 Chihuahua
Mexico Investigational Site Number 484101 Cuernavaca
Mexico Investigational Site Number 484111 Durango
Mexico Investigational Site Number 484104 Guadalajara
Mexico Investigational Site Number 484105 Guadalajara
Mexico Investigational Site Number 484107 Guadalajara
Mexico Investigational Site Number 484109 Guadalajara
Mexico Investigational Site Number 484110 Guadalajara
Mexico Investigational Site Number 484102 México
Mexico Investigational Site Number 484103 Mexico Df
Mexico Investigational Site Number 484106 Monterrey
Poland Investigational Site Number 616101 Bialystok
Poland Investigational Site Number 616103 Bydgoszcz
Poland Investigational Site Number 616102 Bytom
Poland Investigational Site Number 616104 Krakow
Poland Investigational Site Number 616106 Krakow
Poland Investigational Site Number 616105 Pulawy
Poland Investigational Site Number 616107 Warszawa
Romania Investigational Site Number 642105 Bacau
Romania Investigational Site Number 642108 Cluj Napoca
Romania Investigational Site Number 642106 Deva
Romania Investigational Site Number 642113 Galati
Romania Investigational Site Number 642107 Hunedoara
Romania Investigational Site Number 642117 Iasi
Romania Investigational Site Number 642103 Oradea
Romania Investigational Site Number 642104 Oradea
Romania Investigational Site Number 642112 Pitesti
Romania Investigational Site Number 642114 Ploiesti
Romania Investigational Site Number 642102 Resita
Romania Investigational Site Number 642111 Sibiu
Romania Investigational Site Number 642109 Targu Mures
Romania Investigational Site Number 642110 Targu Mures
Romania Investigational Site Number 642101 Timisoara
Romania Investigational Site Number 642115 Timisoara
Romania Investigational Site Number 642116 Timisoara
Russian Federation Investigational Site Number 643105 Moscow
Russian Federation Investigational Site Number 643107 Moscow
Russian Federation Investigational Site Number 643111 Moscow
Russian Federation Investigational Site Number 643110 Penza
Russian Federation Investigational Site Number 643102 Saratov
Russian Federation Investigational Site Number 643101 St-Petersburg
Russian Federation Investigational Site Number 643103 St-Petersburg
Russian Federation Investigational Site Number 643104 St-Petersburg
Russian Federation Investigational Site Number 643108 St-Petersburg
Russian Federation Investigational Site Number 643109 St-Petersburg
Russian Federation Investigational Site Number 643106 St. Petersburg
Spain Investigational Site Number 724102 El Ferrol
Spain Investigational Site Number 724105 La Coruña
Spain Investigational Site Number 724103 Malaga
Spain Investigational Site Number 724104 Sevilla
Ukraine Investigational Site Number 804104 Chernivtsi
Ukraine Investigational Site Number 804103 Donetsk
Ukraine Investigational Site Number 804107 Donetsk
Ukraine Investigational Site Number 804108 Mykolaiv
Ukraine Investigational Site Number 804110 Odessa
Ukraine Investigational Site Number 804102 Vinnytsya
Ukraine Investigational Site Number 804105 Vinnytsya
Ukraine Investigational Site Number 804111 Zaporizhia
United Kingdom Investigational Site Number 826006 Ashton-Under-Lyne
United Kingdom Investigational Site Number 826002 Birmingham
United Kingdom Investigational Site Number 826007 Carmarthen
United Kingdom Investigational Site Number 826005 Chester
United Kingdom Investigational Site Number 826008 Coventry
United Kingdom Investigational Site Number 826009 Dundee
United Kingdom Investigational Site Number 826001 Durham
United Kingdom Investigational Site Number 826011 Haddington
United Kingdom Investigational Site Number 826012 Leicester
United Kingdom Investigational Site Number 826010 Plymouth
United Kingdom Investigational Site Number 826004 Sheffield
United Kingdom Investigational Site Number 826003 St Helens
United States Investigational Site Number 840004 Avon Indiana
United States Investigational Site Number 840055 Avon Indiana
United States Investigational Site Number 840016 Baltimore Maryland
United States Investigational Site Number 840025 Buckley Michigan
United States Investigational Site Number 840032 Chattanooga Tennessee
United States Investigational Site Number 840024 Chicago Illinois
United States Investigational Site Number 840034 Corpus Christi Texas
United States Investigational Site Number 840001 Dallas Texas
United States Investigational Site Number 840048 Dearborn Michigan
United States Investigational Site Number 840041 Denver Colorado
United States Investigational Site Number 840027 Des Moines Iowa
United States Investigational Site Number 840009 Evanston Illinois
United States Investigational Site Number 840028 Fargo North Dakota
United States Investigational Site Number 840020 Houston Texas
United States Investigational Site Number 840026 Kalamazoo Michigan
United States Investigational Site Number 840031 La Mesa California
United States Investigational Site Number 840049 Las Vegas Nevada
United States Investigational Site Number 840045 Lawrenceville Georgia
United States Investigational Site Number 840047 Lexington Kentucky
United States Investigational Site Number 840003 Little Rock Arkansas
United States Investigational Site Number 840022 Marrero Louisiana
United States Investigational Site Number 840012 Miami Florida
United States Investigational Site Number 840061 Miami Florida
United States Investigational Site Number 840010 Milwaukee Wisconsin
United States Investigational Site Number 840005 Mission Viejo California
United States Investigational Site Number 840052 Myrtle Beach South Carolina
United States Investigational Site Number 840036 Nampa Idaho
United States Investigational Site Number 840033 Nashville Tennessee
United States Investigational Site Number 840029 New Hyde Park New York
United States Investigational Site Number 840018 Norfolk Virginia
United States Investigational Site Number 840057 Northridge California
United States Investigational Site Number 840007 Oklahoma City Oklahoma
United States Investigational Site Number 840056 Paducah Kentucky
United States Investigational Site Number 840021 Pittsburgh Pennsylvania
United States Investigational Site Number 840017 Rockville Maryland
United States Investigational Site Number 840015 Salem Virginia
United States Investigational Site Number 840011 Salisbury North Carolina
United States Investigational Site Number 840035 Santa Ana California
United States Investigational Site Number 840060 Smithtown New York
United States Investigational Site Number 840030 Staten Island New York
United States Investigational Site Number 840043 Sun City Arizona
United States Investigational Site Number 840002 Temecula California
United States Investigational Site Number 840042 Tempe Arizona
United States Investigational Site Number 840037 Walnut Creek California
United States Investigational Site Number 840023 West Hills California
United States Investigational Site Number 840006 Wichita Kansas

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Canada,  Chile,  Czech Republic,  Estonia,  France,  Germany,  Hungary,  Italy,  Latvia,  Lithuania,  Mexico,  Poland,  Romania,  Russian Federation,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in HbA1c week 26 No
Primary Change from baseline in body weight week 26 No
Secondary Percentage of patients reaching HbA1c <7% week 26 No
Secondary Percentage of patients reaching HbA1c =6.5% week 26 No
Secondary Change in body weight from baseline week 26 No
Secondary Percentage of patients with no weight gain week 26 No
Secondary Change in 7-point SMPG profiles from baseline week 26 No
Secondary Change from baseline in FPG week 26 No
Secondary Change from baseline in post-prandial glucose /glucose excursions during a standardized meal test (subset of patients) week 26 No
Secondary Change from baseline in insulin glargine dose week 26 No
Secondary Daily dose of insulin glulisine week 26 No
Secondary Total daily dose of insulin week 26 No
Secondary Documented (PG <60 mg/dl) symptomatic hypoglycemia (percentage of subjects with at least one episode, number of events per patient-year) 26 weeks Yes
Secondary Severe hypoglycemia 26 weeks Yes
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