Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A 24-week, Open-label, Randomized, 2-arm Parallel Group, Multinational, Multi-center Clinical Trial to Compare the Efficacy and Safety of Lixisenatide Injected Prior to the Main Meal of the Day Versus Lixisenatide Injected Prior to Breakfast in Type 2 Diabetic Patients Not Adequately Controlled on Metformin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01517412
• Other study ID #: EFC12261
• Secondary ID: 2011-002416-85U1
• Status: Completed
• Phase: Phase 3
• First received: January 16, 2012
• Last updated: May 6, 2014
• Start date: February 2012
• Est. completion date: May 2013

Study information

• Verified date: May 2014
• 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 the two treatment regimens in terms of change of HbA1c from baseline to endpoint (week 24)

Secondary Objective:

• To assess the effect of the 2 lixisenatide regimens on:

• The percentage of patients who reached the target of HbA1c < 7% or ≤ 6.5% at week 24

• Fasting Plasma Glucose (FPG)

• 7-point Self-Monitored Plasma Glucose (SMPG) profiles

• Body weight

• To assess the safety and tolerability of the 2 lixisenatide regimens

Description:

The maximum study duration will be 28 weeks per patient, including a 24-week randomized treatment period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 451
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Patients with type 2 diabetes mellitus, diagnosed for at least 1 year before screening visit

• Metformin treatment at a stable dose of at least 1.5 g/day for at least 3 months prior to screening visit.

Exclusion criteria:

• Screening HbA1c < 7.0% and > 10.0%

• Fasting plasma glucose at screening > 250 mg/dL (> 13.9 mmol/L)

• Treatment with glucose-lowering agent(s) other than metformin in a period of 3 months prior to screening, previous use of insulin

• Patients who usually do not eat breakfast

• Type 1 diabetes mellitus

• Body Mass Index (BMI) = 20 kg/m² and > 40 kg/ m²

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

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

• Alanine aminotransferase (ALT) > 3 ULN at screening

• Calcitonin ? 20 pg/ml (5.9 pmol/L) at screening

• History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy.

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

• Any contra-indication related to metformin

• Any previous treatment with lixisenatide

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: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Lixisenatide (AVE0010)
Pharmaceutical form: solution for injection Route of administration: subcutaneous

Device:
• Pen auto-injector

Drug:
• Metformin
To be kept at stable dose throughout the study

Locations

Country	Name	City	State
Canada	Investigational Site Number 124102	Brampton
Canada	Investigational Site Number 124108	Coquitlam
Canada	Investigational Site Number 124106	Etobicoke
Canada	Investigational Site Number 124113	Kelowna
Canada	Investigational Site Number 124110	Laval
Canada	Investigational Site Number 124103	Newmarket
Canada	Investigational Site Number 124101	Oakville
Canada	Investigational Site Number 124111	St-Romuald
Canada	Investigational Site Number 124104	Thornhill
Canada	Investigational Site Number 124105	Toronto
Canada	Investigational Site Number 124112	Vancouver
Czech Republic	Investigational Site Number 203104	Plzen
Czech Republic	Investigational Site Number 203101	Praha 10
Czech Republic	Investigational Site Number 203102	Praha 10
Czech Republic	Investigational Site Number 203105	Praha 2
Czech Republic	Investigational Site Number 203103	Trutnov
Czech Republic	Investigational Site Number 203106	Ujezd U Brna
France	Investigational Site Number 250108	Clermont Ferrand
France	Investigational Site Number 250102	Menton
France	Investigational Site Number 250103	Nanterre
France	Investigational Site Number 250105	Rennes
Germany	Investigational Site Number 276103	Asslar
Germany	Investigational Site Number 276102	Bad Mergentheim
Germany	Investigational Site Number 276107	Berlin
Germany	Investigational Site Number 276101	Heidelberg
Germany	Investigational Site Number 276104	Künzing
Germany	Investigational Site Number 276105	Pirna
Germany	Investigational Site Number 276108	St. Ingbert-Oberwürzbach
Poland	Investigational Site Number 616106	Bytom
Poland	Investigational Site Number 616102	Gdansk
Poland	Investigational Site Number 616101	Krakow
Poland	Investigational Site Number 616103	Lublin
Poland	Investigational Site Number 616108	Oswiecim
Poland	Investigational Site Number 616104	Wroclaw
Poland	Investigational Site Number 616105	Wroclaw
Poland	Investigational Site Number 616107	Wroclaw
Romania	Investigational Site Number 642101	Bucuresti
Romania	Investigational Site Number 642105	Oradea
Romania	Investigational Site Number 642102	Ploiesti
Romania	Investigational Site Number 642104	Resita
Romania	Investigational Site Number 642103	Timisoara
Russian Federation	Investigational Site Number 643101	Moscow
Russian Federation	Investigational Site Number 643103	Moscow
Russian Federation	Investigational Site Number 643106	Nizhny Novgorod
Russian Federation	Investigational Site Number 643102	Samara
Russian Federation	Investigational Site Number 643105	St-Petersburg
Russian Federation	Investigational Site Number 643107	St-Petersburg
Russian Federation	Investigational Site Number 643110	St-Petersburg
Russian Federation	Investigational Site Number 643108	Vladimir
Russian Federation	Investigational Site Number 643104	Voronezh
Spain	Investigational Site Number 724103	Barcelona
Spain	Investigational Site Number 724104	Barcelona
Spain	Investigational Site Number 724102	El Ferrol
Spain	Investigational Site Number 724101	Hostalets De Balenyà
Spain	Investigational Site Number 724107	La Coruña
Spain	Investigational Site Number 724106	Málaga
Spain	Investigational Site Number 724108	Segovia
Spain	Investigational Site Number 724105	Sevilla
Ukraine	Investigational Site Number 804108	Kharkiv
Ukraine	Investigational Site Number 804105	Kharkov
Ukraine	Investigational Site Number 804102	Kiev
Ukraine	Investigational Site Number 804103	Kyiv
Ukraine	Investigational Site Number 804104	Mykolaiv
Ukraine	Investigational Site Number 804106	Poltava
Ukraine	Investigational Site Number 804101	Zaporozhie
United States	Investigational Site Number 840115	Billings	Montana
United States	Investigational Site Number 840119	Chicago	Illinois
United States	Investigational Site Number 840122	Chicago	Illinois
United States	Investigational Site Number 840111	Fargo	North Dakota
United States	Investigational Site Number 840120	Flint	Michigan
United States	Investigational Site Number 840112	Glendale	Arizona
United States	Investigational Site Number 840113	Mesa	Arizona
United States	Investigational Site Number 840116	Mission Viejo	California
United States	Investigational Site Number 840103	Northridge	California
United States	Investigational Site Number 840105	Phoenix	Arizona
United States	Investigational Site Number 840118	Redlands	California
United States	Investigational Site Number 840101	Sea Girt	New Jersey
United States	Investigational Site Number 840114	Springfield	Illinois
United States	Investigational Site Number 840104	Temecula	California
United States	Investigational Site Number 840102	Tempe	Arizona
United States	Investigational Site Number 840107	Tempe	Arizona
United States	Investigational Site Number 840110	West Jordan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Canada,  Czech Republic,  France,  Germany,  Poland,  Romania,  Russian Federation,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c from baseline to week 24		baseline, week 24	No
Secondary	Percentage of patients reaching HbA1c <7 % at week 24		week 24	No
Secondary	Percentage of patients reaching HbA1c =6.5 % at week 24		week 24	No
Secondary	Percentage of patients reaching HbA1c <7% at week 24 and not experiencing confirmed (Plasma Glucose (PG) <60mg/dL) symptomatic hypoglycemia during the 24-week treatment period		week 24	No
Secondary	Percentage of patients reaching HbA1c<7% and having no weight gain at week 24		week 24	No
Secondary	Percentage of patients reaching HbA1c <7% and having no weight gain at week 24 and not experiencing confirmed (Plasma Glucose (PG) <60mg/dL) symptomatic hypoglycemia during the 24-week treatment period		week 24	No
Secondary	Percentage of patients reaching HbA1c <7% and having a 2-h Postprandial Plasma Glucose (PPG) < 140mg/dL after breakfast or main meal (depending on the treatment group) at week 24		week 24	No
Secondary	Change in 7-point self-monitored plasma glucose (SMPG) profiles from baseline to week 24		baseline, week 24	No
Secondary	Change in Fasting Plasma Glucose (FPG) from baseline to week 24		baseline, week 24	No
Secondary	Change in body weight from baseline to week 24		baseline, week 24	No
Secondary	Change in treatment satisfaction from baseline to week 24		baseline, week 24	No