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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT01517412 (opens ClinicalTrials.gov in a new tab)Other idEFC12261Other id2011-002416-85Other idU1111-1118-0841
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
451 participants (actual)
Sponsor
Sanofi · Industry
Design
Randomized · Open label (no masking)
Countries
10 countries

United States, Canada, Czechia, France, Germany, Poland, Romania, Russia, Spain, Ukraine

Start
Feb 2012
Primary completion
May 2013
Completion
May 2013
First posted
25 Jan 2012 (estimated)
Last update posted
14 Oct 2016 (estimated)
Conditions
Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201220132014
  1. Ph 3

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

    NCT01517412

    Feb 2012 to May 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Lixisenatide (AVE0010)Drug
  • Self-injector pen device (OptiClik®)Device
  • MetforminDrug

Arms2

  • Experimental

    Lixisenatide Main Meal

    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.

  • Active comparator

    Lixisenatide Breakfast

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in HbA1c From Baseline to Week 24

    Time frame · Baseline, Week 24

    Registry 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.

Secondary outcomes(9)

  1. Percentage of Participants With HbA1c Level <7 % or ≤6.5% at Week 24

    Time frame · Week 24

    Registry description

    Here, number of participants analyzed = participants with baseline and at least one post-baseline HbA1c assessment during on-treatment period.

  2. Change in Average 7-point SMPG Profiles From Baseline to Week 24

    Time frame · Baseline, Week 24

    Registry 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.

  3. Change in FPG From Baseline to Week 24

    Time frame · Baseline, Week 24

    Registry 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.

  4. Change in Body Weight From Baseline to Week 24

    Time frame · Baseline, Week 24

    Registry 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.

  5. 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

    Time frame · Week 24

    Registry 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.

  6. Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24

    Time frame · Week 24

    Registry 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.

  7. 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

    Time frame · Week 24

    Registry 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.

  8. 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

    Time frame · Week 24

    Registry 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.

  9. Change in Diabetes Treatment Satisfaction Questionnaire Score (DTSQs) From Baseline to Week 24

    Time frame · Baseline, Week 24

    Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline, Week 24

Change in HbA1c From Baseline to Week 24

GroupValue (Percentage of hemoglobin)Spread
Lixisenatide Main Meal-0.650.074
Lixisenatide Breakfast-0.740.074
Secondary and other outcome results(7)
Secondary outcomeNumber· Week 24

Percentage of Participants With HbA1c Level <7 % or ≤6.5% at Week 24

GroupValue (Percentage of participants)
Lixisenatide Main Meal43.6
Lixisenatide Breakfast42.8
Secondary outcomeLeast squares mean· Baseline, Week 24

Change in Average 7-point SMPG Profiles From Baseline to Week 24

GroupValue (mmol/L)Spread
Lixisenatide Main Meal-0.800.145
Lixisenatide Breakfast-1.100.145
Secondary outcomeLeast squares mean· Baseline, Week 24

Change in FPG From Baseline to Week 24

GroupValue (mmol/L)Spread
Lixisenatide Main Meal-0.350.192
Lixisenatide Breakfast-0.570.193
Secondary outcomeLeast squares mean· Baseline, Week 24

Change in Body Weight From Baseline to Week 24

GroupValue (kg)Spread
Lixisenatide Main Meal-2.600.320
Lixisenatide Breakfast-2.800.319
Secondary outcomeNumber· Week 24

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

GroupValue (Percentage of participants)
Lixisenatide Main Meal40.4
Lixisenatide Breakfast41.0
Secondary outcomeNumber· Week 24

Percentage of Participants Who Reached the Target of HbA1c <7% And Had No Body Weight Gain at Week 24

GroupValue (Percentage of participants)
Lixisenatide Main Meal40.8
Lixisenatide Breakfast38.6
Secondary outcomeNumber· Week 24

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

GroupValue (Percentage of participants)
Lixisenatide Main Meal38.1
Lixisenatide Breakfast37.2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Lixisenatide Main MealLixisenatide 10 mcg SC injection 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 on top of metformin.–7 / 22565 / 225
Lixisenatide BreakfastLixisenatide 10 mcg SC injection QD within 1 hour before "breakfast" for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.–7 / 22660 / 226

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2014

8 results

Equal improvement in glycaemia with lixisenatide given before breakfast or the main meal of the day.

Ahrén et al. 2014Journal of diabetes and its complicationscited by 14

PMID 25012990DOI 10.1016/j.jdiacomp.2014.05.012PUB-25012990

Full text at the publisher8 results
Publisher pageSee results (8)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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