Clinical Trial Results:
An interventional, Open-Label, Single-Arm, Multicenter, 24 Weeks Phase 4 Study Assessing the Efficacy and Safety of Toujeo in Patients with Type 2 Diabetes Inadequately Controlled with Basal Insulin
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Summary
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EudraCT number |
2015-002416-33 |
Trial protocol |
FR |
Global end of trial date |
24 Jul 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
03 Aug 2018
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First version publication date |
03 Aug 2018
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
GLARGL07667
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02967237 | ||
WHO universal trial number (UTN) |
U1111-1176-6203 | ||
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Sponsors
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Sponsor organisation name |
Sanofi Aventis France
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Sponsor organisation address |
82, avenue Raspail, Gentilly Cedex, France, 94255
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Public contact |
Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
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Scientific contact |
Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
27 Nov 2017
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
24 Jul 2017
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To describe the effect of HOE901-U300 in subjects with type 2 diabetes inadequately controlled by their basal insulin and eligible for a change of basal insulin, according to the investigator’s judgement, in terms of improvement of glycated hemoglobin (HbA1c).
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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.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
04 Jan 2016
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
France: 140
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Worldwide total number of subjects |
140
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EEA total number of subjects |
140
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
79
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From 65 to 84 years |
60
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85 years and over |
1
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Recruitment
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Recruitment details |
The study was conducted in France. A total of 194 subjects were screened between 04 January 2016 and 29 December 2016, of which 54 subjects were screen failures. Screen failures were mainly due to inclusion criteria not met. A total of 140 subjects were included. | ||||||||||||||||||
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Pre-assignment
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Screening details |
Among 140 subjects, 3 subjects did not receive any dose of investigational medicinal product (IMP) and 137 subjects were included in the safety population. | ||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||
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Arms
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Arm title
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Insulin glargine: HOE901-U300 | ||||||||||||||||||
Arm description |
Subjects received HOE901-U300 (Insulin glargine, 300 U/mL) once daily for 24 weeks. The dose was adjusted every 3-4 days to achieve fasting self-measured plasma glucose (SMPG) in the target range of 80-130 mg/dL, as recommended by the American diabetes association/ European association for the Study of Diabetes (ADA/EASD). | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Insulin glargine
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Investigational medicinal product code |
HOE901
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Other name |
Toujeo®
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Pharmaceutical forms |
Solution for injection in pre-filled pen
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
HOE901-U300 was administered by subcutaneous injection at approximately the same time every day (i.e., without exceeding ± 3 hours compared to the usual time).
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Baseline characteristics reporting groups
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Reporting group title |
Overall Study
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Reporting group description |
Subjects received HOE901-U300 (Insulin glargine, 300 U/mL) once daily for 24 weeks. The dose was adjusted every 3-4 days to achieve fasting self-measured plasma glucose (SMPG) in the target range of 80-130 mg/dL, as recommended by the American diabetes association/ European association for the study of Diabetes (ADA/EASD). | |||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Insulin glargine: HOE901-U300
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Reporting group description |
Subjects received HOE901-U300 (Insulin glargine, 300 U/mL) once daily for 24 weeks. The dose was adjusted every 3-4 days to achieve fasting self-measured plasma glucose (SMPG) in the target range of 80-130 mg/dL, as recommended by the American diabetes association/ European association for the Study of Diabetes (ADA/EASD). | ||
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End point title |
Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 24 [1] | ||||||||
End point description |
Change in HbA1c was calculated by subtracting baseline value from Week 24 value. Analysis was performed on modified intention-to-treat population (mITT) population that included all subjects in the study who received at least one dose of IMP and were assessable for the primary endpoint. Here, "subjects analysed" = subjects with available data for this endpoint.
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End point type |
Primary
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End point timeframe |
Baseline, Week 24
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| 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: The study consisted of single-arm hence, no comparative analysis was performed. The 95% CI is given adjusted by baseline value. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Subjects Reaching Fasting Self-monitored Plasma Glucose (SMPG) Target Range of 90-130 mg/dL at Week 12 and Week 24 | ||||||||||||
End point description |
Fasting SMPG values at Week 24 time-point was calculated by the mean of the last 3 readings in the week prior to the specified week visit. Analysis was performed on mITT population.
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End point type |
Secondary
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End point timeframe |
Week 12 and Week 24
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Subjects with HbA1c <7.0%, <7.5% and <8% at Week 24 | ||||||||||||||
End point description |
Analysis was performed on mITT population.
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End point type |
Secondary
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End point timeframe |
Week 24
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Change From Baseline in HbA1c Across HbA1c Subgroups Categories (=<8%, >8 to 9%, and >9%) at Week 12 and Week 24 | ||||||||||||||||||||
End point description |
Change in HbA1c was calculated by subtracting baseline value from Week 12 and Week 24 time point value for each subgroup category at baseline. Analysis was performed on mITT population.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 12 and Week 24
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 and Week 24 | ||||||||||||
End point description |
Change in FPG was calculated by subtracting baseline value from Week 12 and Week 24 time point value. Analysis was performed on mITT population.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 12 and Week 24
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Change From Baseline in Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score at Week 24 | ||||||||||||||
End point description |
The DTSQs is a validated questionnaire to assess subject’s satisfaction with their diabetes treatment. It consisted of 8 questions (Q1- Q8), each item is rated on a 7-point scale ranged from 0 to 6 (0 [never] to 6 [most of the time]). Treatment satisfaction score consists of the sum of 6 items (Q1 and Q4 - Q8). Total DTSQ score ranged from 0 (very dissatisfied) to 36 (very satisfied); higher score = more satisfaction. Q2 and Q3 are related to blood glucose and rated separately from the satisfaction-related items. Question 2 gives an indication on the perception of frequency of hyperglycemias and question 3 gives an indication on the perception of frequency of hypoglycaemia. Each question was rated on a 7-point scale ranges from 0 (never) to 6 (most of the time), where higher score indicates higher recurrence. Analysis was performed on mITT population.
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End point type |
Secondary
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End point timeframe |
Baseline, Week 24
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| No statistical analyses for this end point | |||||||||||||||
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End point title |
Percentage of Subjects With At Least One Hypoglycemia Event (Any Hypoglycemia, Symptomatic Documented Hypoglycemia, Severe Hypoglycemia) During On-Treatment Period | ||||||||||||||
End point description |
Categories of hypoglycaemia event were based on ADA classification. Severe hypoglycemia was an event in which the subject required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycemia was an event during which subjects didn’t need assistance to treat the hypoglycemia but had at least one symptom (tremor, perspiration, dizziness, hunger sensation, headaches, weakness, irritability, palpitations, loss of consciousness, convulsions, other) with measured plasma glucose concentration of <=70 mg/dL. Percentage of subjects with symptomatic documented, severe and any hypoglycaemia (severe or symptomatic) were reported. On-treatment period was defined as the time from first dose of IMP up to 24 weeks of treatment period. Analysis was performed on safety population that consisted of all included subjects in the study and who had received at least one treatment dose.
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End point type |
Secondary
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End point timeframe |
First dose of study drug up to 24 weeks
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| No statistical analyses for this end point | |||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 24) regardless of seriousness or relationship to investigational product.
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Adverse event reporting additional description |
Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the ‘on treatment period’ (from the first dose IMP up to 24 weeks of treatment period). Analysis was performed on safety population.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
20.1
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Reporting groups
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Reporting group title |
Insulin glargine: HOE901-U300
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Reporting group description |
Subjects received HOE901-U300 (Insulin glargine, 300 U/mL) once daily for 24 weeks. The dose was adjusted every 3-4 days to achieve fasting SMPG in the target range of 80-130 mg/dL, as recommended by the ADA/EASD. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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21 Jun 2016 |
Following amendment were made:
Selection criteria was modified and updated as: - subjects treated or not treated with oral antidiabetic agents (including metformin, sulfonylureas, glinides, DPP-4 inhibitors, SGLT2 inhibitors…) in the 8 weeks prior to the screening visit.
Inclusion criteria was modified and updated as: - Mean of the last 3 fasting plasma glucose values measured in the week prior to the inclusion visit of >130 mg/dl or at least 2 fasting plasma glucose values in the week prior to the inclusion visit >130 mg/dl. - “The last 3 measurements” was replaced by “these measurements” and text was updated as: these measurements before the V1 will allow to evaluate the corresponding inclusion criterion.
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
