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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lixisenatide (AVE0010)
Self-injector pen device (OptiClik®)
Metformin
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Participants 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
  • Participants who usually did not eat breakfast
  • Type 1 diabetes mellitus
  • Body Mass Index (BMI) ≤ 20 kg/m^2 and > 40 kg/m^2
  • 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 was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Sites / Locations

  • Investigational Site Number 840112
  • Investigational Site Number 840113
  • Investigational Site Number 840105
  • Investigational Site Number 840102
  • Investigational Site Number 840107
  • Investigational Site Number 840116
  • Investigational Site Number 840103
  • Investigational Site Number 840118
  • Investigational Site Number 840104
  • Investigational Site Number 840122
  • Investigational Site Number 840119
  • Investigational Site Number 840114
  • Investigational Site Number 840120
  • Investigational Site Number 840115
  • Investigational Site Number 840101
  • Investigational Site Number 840111
  • Investigational Site Number 840110
  • Investigational Site Number 124102
  • Investigational Site Number 124108
  • Investigational Site Number 124106
  • Investigational Site Number 124113
  • Investigational Site Number 124110
  • Investigational Site Number 124103
  • Investigational Site Number 124101
  • Investigational Site Number 124111
  • Investigational Site Number 124104
  • Investigational Site Number 124105
  • Investigational Site Number 124112
  • Investigational Site Number 203104
  • Investigational Site Number 203102
  • Investigational Site Number 203101
  • Investigational Site Number 203105
  • Investigational Site Number 203103
  • Investigational Site Number 203106
  • Investigational Site Number 250108
  • Investigational Site Number 250102
  • Investigational Site Number 250103
  • Investigational Site Number 250105
  • Investigational Site Number 276103
  • Investigational Site Number 276102
  • Investigational Site Number 276107
  • Investigational Site Number 276101
  • Investigational Site Number 276104
  • Investigational Site Number 276105
  • Investigational Site Number 276108
  • Investigational Site Number 616106
  • Investigational Site Number 616102
  • Investigational Site Number 616101
  • Investigational Site Number 616103
  • Investigational Site Number 616108
  • Investigational Site Number 616105
  • Investigational Site Number 616104
  • Investigational Site Number 616107
  • Investigational Site Number 642101
  • Investigational Site Number 642105
  • Investigational Site Number 642102
  • Investigational Site Number 642104
  • Investigational Site Number 642103
  • Investigational Site Number 643103
  • Investigational Site Number 643101
  • Investigational Site Number 643106
  • Investigational Site Number 643102
  • Investigational Site Number 643107
  • Investigational Site Number 643105
  • Investigational Site Number 643110
  • Investigational Site Number 643108
  • Investigational Site Number 643104
  • Investigational Site Number 724104
  • Investigational Site Number 724103
  • Investigational Site Number 724102
  • Investigational Site Number 724101
  • Investigational Site Number 724107
  • Investigational Site Number 724106
  • Investigational Site Number 724108
  • Investigational Site Number 724105
  • Investigational Site Number 804108
  • Investigational Site Number 804105
  • Investigational Site Number 804102
  • Investigational Site Number 804103
  • Investigational Site Number 804104
  • Investigational Site Number 804106
  • Investigational Site Number 804101

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lixisenatide Main Meal

Lixisenatide Breakfast

Arm Description

Lixisenatide 10 mcg once daily (QD) within 1 hour before "main meal of the day" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24.

Lixisenatide 10 mcg QD within 1 hour before "breakfast" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24.

Outcomes

Primary Outcome Measures

Change in HbA1c From Baseline to Week 24
Change in HbA1C was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using last observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.

Secondary Outcome Measures

Percentage of Participants With HbA1c Level <7 % or ≤6.5% at Week 24
Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.
Change in Average 7-point SMPG Profiles From Baseline to Week 24
Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime two times in a week before baseline, before visit Week 8, before visit Week 12 and before visit week 24. The average value across the profiles performed in the week a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to the day of last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline 7-point SMPG assessment during on-treatment period.
Change in FPG From Baseline to Week 24
Change in FPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 1 day after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline FPG assessment during on-treatment period.
Change in Body Weight From Baseline to Week 24
Change in body weight was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during on-treatment period.
Percentage of Participants Who Reached the Target of HbA1c <7% at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (Plasma Glucose [PG] <60 mg/dL [3.3 mmol/L]) During 24-Week Treatment Period
Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemic episode with an accompanying PG<60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate if no PG measurement was available. On-treatment period for symptomatic hypoglycemia assessment was defined as time from first dose of study drug up to 1 day after last dose of study drug. Participants without any post-baseline on-treatment value for HbA1c were counted as non-responders if they experienced at least one symptomatic hypoglycemia. Otherwise, they were counted as missing.
Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24
Participants without post-baseline on-treatment values for (HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (HbA1c and/or body weight) was available and showed no response. Otherwise, they were counted as missing.
Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (PG<60 mg/dL [3.3 mmol/L]) During the 24-Week Treatment Period
Participants without post-baseline on-treatment values (for HbA1c and body weight) that were no more than 30 days apart not more than 30-days apart were counted as non-responders if at least one of components (HbA1c and/or body weight) was available and showed no response. Otherwise, they were counted as missing.
Percentage of Participants Who Reached the Target of HbA1c <7% And Had a 2-hour Postprandial Plasma Glucose (PPG) <140mg/dL After Breakfast or Main Meal At Week 24
On-treatment period for 2-hour PPG assessment was defined as the time from the first dose of study drug up to the day of last dose of study drug. Participants without post-baseline on-treatment values (for HbA1c and 2-hour PPG) that were no more than 30-days apart were counted as non-responders if at least one of the components (HbA1cand/or 2-hour PPG) was available and showed no response. Otherwise, they were counted as missing.
Change in Diabetes Treatment Satisfaction Questionnaire Score (DTSQs) From Baseline to Week 24
DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1, 4, 5, 6, 7 and 8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. On-treatment period for treatment satisfaction assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. Missing data was imputed using LOCF. Here, number of participants analyzed = participants with both baseline and Week 24 DTSQ score assessment during on-treatment period.

Full Information

First Posted
January 16, 2012
Last Updated
August 22, 2016
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01517412
Brief Title
Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Primary Objective: - To compare the two treatment regimens in terms of change of glycosylated hemoglobin (HbA1c) from baseline to endpoint (Week 24) Secondary Objective: To assess the effect of the 2 lixisenatide regimens on: The percentage of participants 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
Detailed Description
The maximum study duration was 28 weeks per participant, including a 24-week randomized treatment period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
451 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lixisenatide Main Meal
Arm Type
Experimental
Arm Description
Lixisenatide 10 mcg once daily (QD) within 1 hour before "main meal of the day" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24.
Arm Title
Lixisenatide Breakfast
Arm Type
Active Comparator
Arm Description
Lixisenatide 10 mcg QD within 1 hour before "breakfast" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24.
Intervention Type
Drug
Intervention Name(s)
Lixisenatide (AVE0010)
Intervention Description
Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous
Intervention Type
Device
Intervention Name(s)
Self-injector pen device (OptiClik®)
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
Route of administration: Oral
Intervention Description
To be kept at stable dose (≥1.5 g/day) throughout the study.
Primary Outcome Measure Information:
Title
Change in HbA1c From Baseline to Week 24
Description
Change in HbA1C was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using last observation carried forward (LOCF). On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 14 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.
Time Frame
Baseline, Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants With HbA1c Level <7 % or ≤6.5% at Week 24
Description
Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.
Time Frame
Week 24
Title
Change in Average 7-point SMPG Profiles From Baseline to Week 24
Description
Participants recorded a 7-point plasma glucose profile measured before and 2 hours after each meal and at bedtime two times in a week before baseline, before visit Week 8, before visit Week 12 and before visit week 24. The average value across the profiles performed in the week a visit for the 7-time points was calculated. Change in average 7-point SMPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to the day of last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline 7-point SMPG assessment during on-treatment period.
Time Frame
Baseline, Week 24
Title
Change in FPG From Baseline to Week 24
Description
Change in FPG was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. The on-treatment period for this efficacy variable was the time from the first dose of study drug up to 1 day after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline FPG assessment during on-treatment period.
Time Frame
Baseline, Week 24
Title
Change in Body Weight From Baseline to Week 24
Description
Change in body weight was calculated by subtracting baseline value from Week 24 value. Missing data was imputed using LOCF. On-treatment period for this efficacy variable was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. Here, number of participants analyzed = participants with baseline and at least one post-baseline body weight assessment during on-treatment period.
Time Frame
Baseline, Week 24
Title
Percentage of Participants Who Reached the Target of HbA1c <7% at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (Plasma Glucose [PG] <60 mg/dL [3.3 mmol/L]) During 24-Week Treatment Period
Description
Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemic episode with an accompanying PG<60 mg/dL (3.3 mmol/L) or associated with prompt recovery after oral carbohydrate if no PG measurement was available. On-treatment period for symptomatic hypoglycemia assessment was defined as time from first dose of study drug up to 1 day after last dose of study drug. Participants without any post-baseline on-treatment value for HbA1c were counted as non-responders if they experienced at least one symptomatic hypoglycemia. Otherwise, they were counted as missing.
Time Frame
Week 24
Title
Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24
Description
Participants without post-baseline on-treatment values for (HbA1c and body weight) that were no more than 30 days apart were counted as non-responders if at least one of the components (HbA1c and/or body weight) was available and showed no response. Otherwise, they were counted as missing.
Time Frame
Week 24
Title
Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24 And Did Not Experience Confirmed Symptomatic Hypoglycemia (PG<60 mg/dL [3.3 mmol/L]) During the 24-Week Treatment Period
Description
Participants without post-baseline on-treatment values (for HbA1c and body weight) that were no more than 30 days apart not more than 30-days apart were counted as non-responders if at least one of components (HbA1c and/or body weight) was available and showed no response. Otherwise, they were counted as missing.
Time Frame
Week 24
Title
Percentage of Participants Who Reached the Target of HbA1c <7% And Had a 2-hour Postprandial Plasma Glucose (PPG) <140mg/dL After Breakfast or Main Meal At Week 24
Description
On-treatment period for 2-hour PPG assessment was defined as the time from the first dose of study drug up to the day of last dose of study drug. Participants without post-baseline on-treatment values (for HbA1c and 2-hour PPG) that were no more than 30-days apart were counted as non-responders if at least one of the components (HbA1cand/or 2-hour PPG) was available and showed no response. Otherwise, they were counted as missing.
Time Frame
Week 24
Title
Change in Diabetes Treatment Satisfaction Questionnaire Score (DTSQs) From Baseline to Week 24
Description
DTSQ is a validated measure to assess how satisfied participants with diabetes are with their treatment and how they perceive hyper- and hypoglycemia. It consists of 8 questions which are answered on a Likert scale from 0 to 6. DTSQ treatment satisfaction score is the sum of question 1, 4, 5, 6, 7 and 8 scores and ranges between 0 and 36, where higher scores indicate more treatment satisfaction. On-treatment period for treatment satisfaction assessment was defined as the time from the first dose of study drug up to 3 days after the last dose of study drug. Missing data was imputed using LOCF. Here, number of participants analyzed = participants with both baseline and Week 24 DTSQ score assessment during on-treatment period.
Time Frame
Baseline, Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Participants 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 Participants who usually did not eat breakfast Type 1 diabetes mellitus Body Mass Index (BMI) ≤ 20 kg/m^2 and > 40 kg/m^2 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 was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 840112
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Investigational Site Number 840113
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85213
Country
United States
Facility Name
Investigational Site Number 840105
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85028
Country
United States
Facility Name
Investigational Site Number 840102
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
Investigational Site Number 840107
City
Tempe
State/Province
Arizona
Country
United States
Facility Name
Investigational Site Number 840116
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Investigational Site Number 840103
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Investigational Site Number 840118
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Investigational Site Number 840104
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
Investigational Site Number 840122
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Investigational Site Number 840119
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
Investigational Site Number 840114
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
Facility Name
Investigational Site Number 840120
City
Flint
State/Province
Michigan
ZIP/Postal Code
48504
Country
United States
Facility Name
Investigational Site Number 840115
City
Billings
State/Province
Montana
ZIP/Postal Code
59103
Country
United States
Facility Name
Investigational Site Number 840101
City
Sea Girt
State/Province
New Jersey
ZIP/Postal Code
08750
Country
United States
Facility Name
Investigational Site Number 840111
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Investigational Site Number 840110
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Investigational Site Number 124102
City
Brampton
ZIP/Postal Code
L6R 3J5
Country
Canada
Facility Name
Investigational Site Number 124108
City
Coquitlam
ZIP/Postal Code
V3K 3P4
Country
Canada
Facility Name
Investigational Site Number 124106
City
Etobicoke
ZIP/Postal Code
M9R 4E1
Country
Canada
Facility Name
Investigational Site Number 124113
City
Kelowna
ZIP/Postal Code
V1Y 1Z9
Country
Canada
Facility Name
Investigational Site Number 124110
City
Laval
ZIP/Postal Code
H7T 2P5
Country
Canada
Facility Name
Investigational Site Number 124103
City
Newmarket
ZIP/Postal Code
L3Y 5G8
Country
Canada
Facility Name
Investigational Site Number 124101
City
Oakville
ZIP/Postal Code
L6H 3P1
Country
Canada
Facility Name
Investigational Site Number 124111
City
St-Romuald
ZIP/Postal Code
G6W 5M6
Country
Canada
Facility Name
Investigational Site Number 124104
City
Thornhill
ZIP/Postal Code
L4J 8L7
Country
Canada
Facility Name
Investigational Site Number 124105
City
Toronto
ZIP/Postal Code
M9V 4B4
Country
Canada
Facility Name
Investigational Site Number 124112
City
Vancouver
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Investigational Site Number 203104
City
Plzen
ZIP/Postal Code
32600
Country
Czech Republic
Facility Name
Investigational Site Number 203102
City
Praha 10
ZIP/Postal Code
10000
Country
Czech Republic
Facility Name
Investigational Site Number 203101
City
Praha 10
ZIP/Postal Code
10034
Country
Czech Republic
Facility Name
Investigational Site Number 203105
City
Praha 2
ZIP/Postal Code
12808
Country
Czech Republic
Facility Name
Investigational Site Number 203103
City
Trutnov
ZIP/Postal Code
54101
Country
Czech Republic
Facility Name
Investigational Site Number 203106
City
Ujezd U Brna
ZIP/Postal Code
664 53
Country
Czech Republic
Facility Name
Investigational Site Number 250108
City
Clermont Ferrand
ZIP/Postal Code
63000
Country
France
Facility Name
Investigational Site Number 250102
City
Menton
ZIP/Postal Code
06500
Country
France
Facility Name
Investigational Site Number 250103
City
Nanterre
ZIP/Postal Code
92014
Country
France
Facility Name
Investigational Site Number 250105
City
Rennes
ZIP/Postal Code
35700
Country
France
Facility Name
Investigational Site Number 276103
City
Asslar
ZIP/Postal Code
35614
Country
Germany
Facility Name
Investigational Site Number 276102
City
Bad Mergentheim
ZIP/Postal Code
97980
Country
Germany
Facility Name
Investigational Site Number 276107
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Investigational Site Number 276101
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Investigational Site Number 276104
City
Künzing
ZIP/Postal Code
94550
Country
Germany
Facility Name
Investigational Site Number 276105
City
Pirna
ZIP/Postal Code
01796
Country
Germany
Facility Name
Investigational Site Number 276108
City
St. Ingbert-Oberwürzbach
ZIP/Postal Code
66386
Country
Germany
Facility Name
Investigational Site Number 616106
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Facility Name
Investigational Site Number 616102
City
Gdansk
ZIP/Postal Code
80-858
Country
Poland
Facility Name
Investigational Site Number 616101
City
Krakow
ZIP/Postal Code
31-450
Country
Poland
Facility Name
Investigational Site Number 616103
City
Lublin
ZIP/Postal Code
20-538
Country
Poland
Facility Name
Investigational Site Number 616108
City
Oswiecim
ZIP/Postal Code
32-600
Country
Poland
Facility Name
Investigational Site Number 616105
City
Wroclaw
ZIP/Postal Code
50-127
Country
Poland
Facility Name
Investigational Site Number 616104
City
Wroclaw
ZIP/Postal Code
50-306
Country
Poland
Facility Name
Investigational Site Number 616107
City
Wroclaw
ZIP/Postal Code
50-403
Country
Poland
Facility Name
Investigational Site Number 642101
City
Bucuresti
ZIP/Postal Code
050538
Country
Romania
Facility Name
Investigational Site Number 642105
City
Oradea
ZIP/Postal Code
410169
Country
Romania
Facility Name
Investigational Site Number 642102
City
Ploiesti
ZIP/Postal Code
100097
Country
Romania
Facility Name
Investigational Site Number 642104
City
Resita
ZIP/Postal Code
320076
Country
Romania
Facility Name
Investigational Site Number 642103
City
Timisoara
ZIP/Postal Code
300456
Country
Romania
Facility Name
Investigational Site Number 643103
City
Moscow
ZIP/Postal Code
119435
Country
Russian Federation
Facility Name
Investigational Site Number 643101
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
Investigational Site Number 643106
City
Nizhny Novgorod
ZIP/Postal Code
603018
Country
Russian Federation
Facility Name
Investigational Site Number 643102
City
Samara
ZIP/Postal Code
443067
Country
Russian Federation
Facility Name
Investigational Site Number 643107
City
St-Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Investigational Site Number 643105
City
St-Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Investigational Site Number 643110
City
St-Petersburg
ZIP/Postal Code
195257
Country
Russian Federation
Facility Name
Investigational Site Number 643108
City
Vladimir
ZIP/Postal Code
600023
Country
Russian Federation
Facility Name
Investigational Site Number 643104
City
Voronezh
ZIP/Postal Code
394018
Country
Russian Federation
Facility Name
Investigational Site Number 724104
City
Barcelona
ZIP/Postal Code
08020
Country
Spain
Facility Name
Investigational Site Number 724103
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Investigational Site Number 724102
City
El Ferrol
ZIP/Postal Code
15403
Country
Spain
Facility Name
Investigational Site Number 724101
City
Hostalets De Balenyà
ZIP/Postal Code
08550
Country
Spain
Facility Name
Investigational Site Number 724107
City
La Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Investigational Site Number 724106
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Investigational Site Number 724108
City
Segovia
ZIP/Postal Code
40002
Country
Spain
Facility Name
Investigational Site Number 724105
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Investigational Site Number 804108
City
Kharkiv
ZIP/Postal Code
61002
Country
Ukraine
Facility Name
Investigational Site Number 804105
City
Kharkov
ZIP/Postal Code
61022
Country
Ukraine
Facility Name
Investigational Site Number 804102
City
Kiev
ZIP/Postal Code
2091
Country
Ukraine
Facility Name
Investigational Site Number 804103
City
Kyiv
ZIP/Postal Code
04114
Country
Ukraine
Facility Name
Investigational Site Number 804104
City
Mykolaiv
ZIP/Postal Code
54003
Country
Ukraine
Facility Name
Investigational Site Number 804106
City
Poltava
ZIP/Postal Code
36011
Country
Ukraine
Facility Name
Investigational Site Number 804101
City
Zaporozhie
ZIP/Postal Code
69600
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
25012990
Citation
Ahren B, Vorokhobina N, Souhami E, Demil N, Ye J, Aronson R. Equal improvement in glycaemia with lixisenatide given before breakfast or the main meal of the day. J Diabetes Complications. 2014 Sep-Oct;28(5):735-41. doi: 10.1016/j.jdiacomp.2014.05.012. Epub 2014 Jun 5.
Results Reference
result

Learn more about this trial

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

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