Clinical Trial Results:
Suliqua® (iGlarLixi) in Participants Uncontrolled on Basal Insulin to Evaluate the Change of Time in Target Range By Using Continuous Glucose Monitoring
|
Summary
|
|
EudraCT number |
2019-004080-43 |
Trial protocol |
HU CZ |
Global end of trial date |
04 Apr 2022
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
14 Apr 2023
|
First version publication date |
14 Apr 2023
|
Other versions |
|
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
|
Trial identification
|
|||
Sponsor protocol code |
LPS16664
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
U1111-1242-0304 | ||
|
Sponsors
|
|||
Sponsor organisation name |
Sanofi-Aventis Private Co. Ltd.
|
||
Sponsor organisation address |
Váci út 133. E building, 3rd floor, Budapest, Hungary, 1138
|
||
Public contact |
Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
|
||
Scientific contact |
Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
|
||
|
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
|
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
12 May 2022
|
||
Is this the analysis of the primary completion data? |
No
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
04 Apr 2022
|
||
Was the trial ended prematurely? |
No
|
||
|
General information about the trial
|
|||
Main objective of the trial |
To investigate the effect of Suliqua® once-daily on glycemic control as evaluated by Continuous Glucose Monitoring (CGM) in subjects with type-2 diabetes mellitus (T2DM) uncontrolled on their previous basal insulin.
|
||
Protection of trial subjects |
Subjects were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the subject and considering the local culture. During the course of the trial, subjects were provided with individual subject cards indicating the nature of the trial the subject is participating, contact details and any information needed in the event of a medical emergency. Collected personal data and human biological samples were processed in compliance with the Sanofi-Aventis Group Personal Data Protection Charter ensuring that the Group abides by the laws governing personal data protection in force in all countries in which it operates.
|
||
Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
08 Jan 2021
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
|
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Czechia: 29
|
||
Country: Number of subjects enrolled |
Hungary: 22
|
||
Worldwide total number of subjects |
51
|
||
EEA total number of subjects |
51
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
22
|
||
From 65 to 84 years |
29
|
||
85 years and over |
0
|
||
|
|||||||
|
Recruitment
|
|||||||
Recruitment details |
Study was conducted at 6 active sites in Hungary and the Czech Republic. A total of 70 subjects were screened from 08 January 2021 to 12 November 2021, out of which 19 subjects were screen failures mainly due to not meeting eligibility criteria. | ||||||
|
Pre-assignment
|
|||||||
Screening details |
A total of 51 subjects were enrolled and treated with study intervention. | ||||||
|
Period 1
|
|||||||
Period 1 title |
Overall study (overall period)
|
||||||
Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
|
||||||
Blinding used |
Not blinded | ||||||
|
Arms
|
|||||||
|
Arm title
|
Suliqua® (All subjects) | ||||||
Arm description |
Subjects self-administered subcutaneous (SC) injection of Suliqua® once daily before a meal for 17 weeks in addition to the mandated background therapy with metformin with or without optional background therapy with sodium-glucose Cotransporter-2 (SGLT-2). | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Insulin glargine, lixisenatide
|
||||||
Investigational medicinal product code |
|||||||
Other name |
Suliqua® 100/50 or Suliqua® 100/33
|
||||||
Pharmaceutical forms |
Solution for injection in pre-filled pen
|
||||||
Routes of administration |
Subcutaneous use
|
||||||
Dosage and administration details |
Subjects self-administered SC injection of fixed ratio combination of insulin glargine/lixisenatide using a pre-filled disposable SoloStar® pen-injector (100 Units per millilitre [U/ml] insulin glargine with 50 micrograms per millilitre [mcg/ml] or 33 mcg/ml lixisenatide depending on the pen Suliqua® 100/50 or Suliqua® 100/33, respectively in the hour before the meal once daily for 17 weeks.
|
||||||
|
|||||||
|
||||||||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
||||||||||||||||||||||||||||||||||
Reporting group title |
Suliqua® (All subjects)
|
|||||||||||||||||||||||||||||||||
Reporting group description |
Subjects self-administered subcutaneous (SC) injection of Suliqua® once daily before a meal for 17 weeks in addition to the mandated background therapy with metformin with or without optional background therapy with sodium-glucose Cotransporter-2 (SGLT-2). | |||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
Suliqua® (All subjects)
|
||
Reporting group description |
Subjects self-administered subcutaneous (SC) injection of Suliqua® once daily before a meal for 17 weeks in addition to the mandated background therapy with metformin with or without optional background therapy with sodium-glucose Cotransporter-2 (SGLT-2). | ||
|
|||||||||
End point title |
Mean Change From Baseline in Percentage of Time of Glucose Concentration Within the Target Range of Greater Than or Equal to (>=) 70 to Less Than or Equal to (<=) 180 Milligrams per Decilitre (mg/dL) at Week 18 [1] | ||||||||
End point description |
The Continuous Glucose Monitoring (CGM) system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyse glucose levels in real time. Analysis was performed on per-protocol analysis set (PPAS) which included all subjects who had received at least one dose of Suliqua®, and had at least one post Baseline assessment of any efficacy variable; had at least 12 weeks of exposure with Suliqua® with no major violation of study entry criteria (inclusion/exclusion) and no major violation of trial procedures and had a valid Baseline and follow-up CGM for assessment for the primary endpoint.
|
||||||||
End point type |
Primary
|
||||||||
End point timeframe |
Baseline, Week 18
|
||||||||
| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Statistical analysis data chart is added as attachment. |
|||||||||
|
|||||||||
Attachments |
Statistical Analysis for Primary endpoint |
||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean Percentage of Time of Glucose Concentration Within the Target Range of >=70 to <= 180 mg/dL at Week 18 | ||||||||
End point description |
CGM system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyse glucose levels in real time. Analysis was performed on PPAS.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Week 18
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean Change From Baseline in Percentage of Time in Hyperglycemia Range With Glucose Concentrations Greater than (>) 10 millimoles per Litre (mmol/L) and >13.9 mmol/L at Week 18 | ||||||||
End point description |
The CGM system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyse glucose levels in real time. Analysis was performed on PPAS.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Baseline, Week 18
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean Change From Baseline in Glucose Standard Deviation at Week 18 | ||||||||
End point description |
Analysis was performed on PPAS.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Baseline, Week 18
|
||||||||
|
|||||||||
| Notes [2] - Not enough data was available to allow calculation for this endpoint, hence no analysis performed. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean Change From Baseline in Glucose Coefficient of Variation (CV%) at Week 18 | ||||||||
End point description |
CV% was a measure of spread of variability relative to mean of population. Analysis was performed on PPAS.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Baseline, Week 18
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean Change From Baseline in Mean Amplitude of Glucose Excursions (MAGE) at Week 18 | ||||||||
End point description |
Analysis was performed on PPAS.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Baseline, Week 18
|
||||||||
|
|||||||||
| Notes [3] - Not enough data was available to allow calculation for this endpoint, hence no analysis performed. |
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 18 | ||||||||
End point description |
Analysis was performed on full analysis set (FAS) which included all subjects who received at least one dose of Suliqua® and had at least one post baseline assessment of any efficacy variables, irrespective of compliance with the study protocol and procedures.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Baseline, Week 18
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||||||||
End point title |
Percentage of Subjects With HbA1c Response Rate <7.5%, <7.0% and <=6.5% at Week 18 | ||||||||||||||
End point description |
Percentage of subjects with HbA1c response rate of less than (<) 7.5%, <7.0% and <=6.5% at Week 18 are reported in this endpoint. Analysis was performed on FAS. Here, 'n' = subjects with available data for each specified category.
|
||||||||||||||
End point type |
Secondary
|
||||||||||||||
End point timeframe |
Week 18
|
||||||||||||||
|
|||||||||||||||
| No statistical analyses for this end point | |||||||||||||||
|
|||||||||
End point title |
Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 | ||||||||
End point description |
Mean change from Baseline in FPG at Week 18 was reported in this endpoint. Change was calculated by subtracting Week 18 values from the Baseline values. Analysis was performed on FAS population.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Baseline, Week 18
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean Change From Baseline in Suliqua® Dose at Week 18 | ||||||||
End point description |
Change from Baseline in Suliqua® dose at week 18 was reported in this endpoint. Analysis was performed on FAS population.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Baseline, Week 18
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change From Baseline in Body Weight at Week 18 | ||||||||
End point description |
Change from Baseline in body weight at Week 18 was reported in this endpoint. Analysis was performed on FAS population.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Baseline, Week 18
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Change From Baseline in Diabetes Treatment Satisfaction Questionnaire (DTSQ) at Week 18 | ||||||||
End point description |
The DTSQ contains 8 items assessing overall treatment satisfaction, treatment convenience and flexibility, satisfaction with understanding of diabetes, willingness to continue present treatment and to recommend it to others, and frequency of unacceptably high and unacceptably low blood glucose levels. It uses a 7-point scale where 0=very dissatisfied to 6= very satisfied for a total possible score of 0 (very dissatisfied) to 36 (very satisfied), where higher scores indicate higher satisfaction from treatment. Analysis was performed on PPAS
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Baseline, Week 18
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||
End point title |
Mean Change From Baseline in Percentage of Time in Hypoglycemia Ranges With Glucose Concentrations <=3.9 mmol/L and <3.0 mmol/L at Week 18 | ||||||||
End point description |
CGM system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyse glucose levels in real time. Analysis was performed on Safety population which included all subjects with at least one dose of Suliqua®, regardless of the amount of treatment administered.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Baseline, Week 18
|
||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||||||
End point title |
Number of Subjects With at Least One Hypoglycemic Event | ||||||||||||
End point description |
Severe hypoglycemia was an event in which the subject required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, because the subject was not capable of helping self. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia was accompanied by a measured plasma glucose concentration of <=3.9 mmol/L) (<=70 mg/dL) or < 3.0 mmol/L (< 54mg/dL). Analysis was performed on Safety population.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
From first IMP administration up to 3 days post last IMP administration (i.e., up to Week 18)
|
||||||||||||
|
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||||
End point title |
Number of Hypoglycemia Events Per Subject-Year | ||||||||||||||
End point description |
Number of hypoglycemia events (any, severe and documented) per subject-year of exposure were reported. Severe hypoglycemia was an event in which the subject required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, because the subject was not capable of helping self. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia was accompanied by a measured plasma glucose concentration of <3.9 mmol/L (<70 mg/dL) or < 3.0 mmol/L (< 54mg/dL). Analysis was performed on Safety population.
|
||||||||||||||
End point type |
Secondary
|
||||||||||||||
End point timeframe |
From first IMP administration up to 3 days post last IMP administration (i.e., up to Week 18)
|
||||||||||||||
|
|||||||||||||||
| No statistical analyses for this end point | |||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
From first IMP administration up to 3 days post last IMP administration (i.e., up to Week 18)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description |
Reported AEs were TEAEs that developed/worsened or became serious during on-treatment period (time from first IMP administration up to 3 days post last IMP administration). Analysis was performed on safety population.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
24.1
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Suliqua® (All subjects)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects self-administered SC injection of Suliqua® once daily before a meal for 17 weeks in addition to the mandated background therapy with metformin with or without optional background therapy with SGLT-2. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
