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CompletedNCT01658579Updated Jun 1, 2015Results posted

Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus on Basal Plus Mealtime Insulin

A Phase 2 interventional study of HOE901-U300 (new formulation of insulin glargine) and Lantus (insulin glargine) in Type 1 Diabetes Mellitus, sponsored by Sanofi. Completed at 3 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-06-01.

Sponsored by Sanofi · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
59
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Primary Objective:

  • To compare the glucose control during treatment with a new formulation of insulin glargine and Lantus in adult participants with type 1 diabetes mellitus

Secondary Objectives:

  • To compare a new formulation of insulin glargine and Lantus given in the morning or in the evening
  • To compare the incidence and frequency of hypoglycemic episodes
  • To assess the safety and tolerability of the new formulation of insulin glargine
Read the detailed description
  • Up to 4-week screening period;
  • 16-week open-label comparative efficacy and safety treatment period;
  • 4-week post-treatment safety follow-up period.
02

Conditions studied

  • Type 1 Diabetes Mellitus
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 59 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Participants with Type 1 diabetes mellitus

Exclusion criteria

Exclusion criteria:

  • HbA1c greater than (>) 9% (at screening)
  • Participants receiving >0.5 U/kg body weight basal insulin in the last 30 days prior to screening visit
  • Participants not on stable insulin dose (+/- 20% total basal insulin dose) in the last 30 days prior to screening visit
  • Less than 1 year on any basal plus mealtime insulin
  • Participants using pre-mix insulins, human regular insulin as mealtime insulin and/or any antidiabetic drugs other than basal insulin and mealtime analogue insulin in the last 3 months before screening visit
  • Use of an insulin pump in the last 6 months before screening visit;
  • Any contraindication to use of insulin glargine as defined in the national product label
  • Not willing to inject insulin glargine as assigned by the randomization process once daily in the morning or evening
  • Hospitalization for diabetic ketoacidosis or history of severe hypoglycemia (requiring 3rd party assistance) in the last 6 months prior to randomization
  • Initiation of any glucose-lowering agents in the last 3 months before screening visit
  • Weight change of greater than equal to (>=) 5 kg during the last 3 months prior to screening visit
  • Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require laser, surgical treatment or injectable drugs during the study period

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
59 participants (actual)

Study arms

  • Experimental
    HOE901-U300 Morning Then Evening

    HOE901-U300 (new insulin glargine 300 units per milliliter \[U/mL\]) subcutaneous (SC) injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 millimole per liter (mmol/L).

    Drug: HOE901-U300 (new formulation of insulin glargine)

  • Experimental
    HOE901-U300 Evening Then Morning

    HOE901-U300 (new insulin glargine 300 U/mL) SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L.

    Drug: HOE901-U300 (new formulation of insulin glargine)

  • Active comparator
    Lantus Morning Then Evening

    Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L.

    Drug: Lantus (insulin glargine)

  • Active comparator
    Lantus Evening Then Morning

    Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L.

    Drug: Lantus (insulin glargine)

Interventions

  • DrugHOE901-U300 (new formulation of insulin glargine)
  • DrugLantus (insulin glargine)
06

What researchers measure

Primary outcomes

  1. Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL])

    Percentage of time with glucose within glycemic range (4.4-7.8 mmol/L) was assessed by the total time within glycemic range divided by the length of the assessment interval.

    Time frame: Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)

Secondary outcomes

  1. Percentage of Time Above the Upper Limit of Glycemic Range (Greater Than [>] 7.8 mmol/L [(140 mg/dL])

    Percentage of time with glucose above the upper limit of glycemic range (\>7.8 mmol/L) was assessed by the total time above the upper limit of glycemic range divided by the length of the assessment interval.

    Time frame: Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)

  2. Percentage of Time Below The Lower Limit of Glycemic Range (<4.4 mmol/L [80 mg/dL])

    Percentage of time with glucose below the lower limit of glycemic range (\<4.4 mmol/L) was assessed by the total time below the lower limit of glycemic range divided by the length of the assessment interval.

    Time frame: Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)

  3. Evaluation of Diurnal Glucose Exposure, Variability, and Stability

    The diurnal glucose exposure is measured as the average diurnal glucose concentration, diurnal glucose variability is measured by interquartile range (IQR), that is, average distance between the 25th and the 75th point-wise percentiles and diurnal glucose stability is assessed in terms of the mean absolute rate of change (mmol/l), that is, the area under the absolute rate of change of the median curve (based on the median point values between two adjacent hourly basket intervals), divided by the length of the assessment interval.

    Time frame: Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)

  4. Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL]) in the Last Four Hours of Each Dosing Interval at Weeks 7 and 8 in Period A and Weeks 15 and 16 in Period B

    Percentage of time with glucose within glycemic range (4.4-7.8 mmol/L) was assessed by the total time within glycemic range divided by the length of the assessment interval.

    Time frame: Weeks 7-8 in Period A and Weeks 15-16 in Period B

  5. Change in HbA1c From Baseline to Week 8 and 16

    Time frame: Baseline, Week 8, 16

  6. Change in Fasting Plasma Glucose (FPG) From Baseline to Week 8 and 16

    Time frame: Baseline, Week 8, 16

  7. Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profile From Baseline to Week 8 and 16

    Change in average of 7-point SMPG. 7-point SMPG was assessed starting with a measurement at before breakfast and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; at bedtime.

    Time frame: Baseline, Week 8, 16

  8. Change in Basal Insulin Daily Dose From Baseline to Week 8 and 16

    Time frame: Baseline, Week 8, 16

  9. Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline Up to Week 16

    Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of \<=3.9 mmol/L \[70 mg/dL\]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level \<=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level \<=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level \>3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose \<=3.9 mmol/L).

    Time frame: Up to Week 16

07

Results

Posted May 7, 2015

Participant flow

Treatment Period A
Participant flow — Treatment Period A
MilestoneHOE901-U300 Morning Then EveningHOE901-U300 Evening Then MorningLantus Morning Then EveningLantus Evening Then Morning
Started15151514
Completed14151413
Not completed1011
Withdrew: Other0011
Withdrew: Adverse event1000
Treatment Period B
Participant flow — Treatment Period B
MilestoneHOE901-U300 Morning Then EveningHOE901-U300 Evening Then MorningLantus Morning Then EveningLantus Evening Then Morning
Started14151413
Completed14151412
Not completed0001
Withdrew: Other0001

Outcome measures

PrimaryPercentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL])

Percentage of time with glucose within glycemic range (4.4-7.8 mmol/L) was assessed by the total time within glycemic range divided by the length of the assessment interval.

Time frame:
Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)
Reported as:
Least squares mean · percentage of time
Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL])
percentage of timeHOE901-U300 CombinedLantus Combined
Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL])31.75 ± 1.530.99 ± 1.58
Statistical analysis
  • HOE901-U300 Combined vs Lantus Combined · Linear Mixed Model · p = 0.7304 · Least squares (ls) mean difference: 0.75 · 95% CI -3.614 to 5.124
SecondaryPercentage of Time Above the Upper Limit of Glycemic Range (Greater Than [>] 7.8 mmol/L [(140 mg/dL])

Percentage of time with glucose above the upper limit of glycemic range (\>7.8 mmol/L) was assessed by the total time above the upper limit of glycemic range divided by the length of the assessment interval.

Time frame:
Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)
Reported as:
Least squares mean · percentage of time
Percentage of Time Above the Upper Limit of Glycemic Range (Greater Than [>] 7.8 mmol/L [(140 mg/dL])
percentage of timeHOE901-U300 CombinedLantus Combined
Percentage of Time Above the Upper Limit of Glycemic Range (Greater Than [>] 7.8 mmol/L [(140 mg/dL])58.24 ± 2.0957.38 ± 2.2
SecondaryPercentage of Time Below The Lower Limit of Glycemic Range (<4.4 mmol/L [80 mg/dL])

Percentage of time with glucose below the lower limit of glycemic range (\<4.4 mmol/L) was assessed by the total time below the lower limit of glycemic range divided by the length of the assessment interval.

Time frame:
Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)
Reported as:
Least squares mean · percentage of time
Percentage of Time Below The Lower Limit of Glycemic Range (<4.4 mmol/L [80 mg/dL])
percentage of timeHOE901-U300 CombinedLantus Combined
Percentage of Time Below The Lower Limit of Glycemic Range (<4.4 mmol/L [80 mg/dL])10.01 ± 1.0211.64 ± 1.08
SecondaryEvaluation of Diurnal Glucose Exposure, Variability, and Stability

The diurnal glucose exposure is measured as the average diurnal glucose concentration, diurnal glucose variability is measured by interquartile range (IQR), that is, average distance between the 25th and the 75th point-wise percentiles and diurnal glucose stability is assessed in terms of the mean absolute rate of change (mmol/l), that is, the area under the absolute rate of change of the median curve (based on the median point values between two adjacent hourly basket intervals), divided by the length of the assessment interval.

Time frame:
Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)
Reported as:
Least squares mean · mmol/L
Evaluation of Diurnal Glucose Exposure, Variability, and Stability
mmol/LHOE901-U300 CombinedLantus Combined
Diurnal Glucose Exposure8.869 ± 0.248.910 ± 0.26
Diurnal Glucose Stability0.673 ± 0.030.703 ± 0.03
Diurnal Glucose Variability4.931 ± 0.225.279 ± 0.23
SecondaryPercentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL]) in the Last Four Hours of Each Dosing Interval at Weeks 7 and 8 in Period A and Weeks 15 and 16 in Period B

Percentage of time with glucose within glycemic range (4.4-7.8 mmol/L) was assessed by the total time within glycemic range divided by the length of the assessment interval.

Time frame:
Weeks 7-8 in Period A and Weeks 15-16 in Period B
Reported as:
Mean · percentage of time
Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL]) in the Last Four Hours of Each Dosing Interval at Weeks 7 and 8 in Period A and Weeks 15 and 16 in Period B
percentage of timeHOE901-U300 CombinedLantus Combined
Week 7, 8 (n=28, 27)32.08 ± 14.7429.07 ± 13.82
Week 15, 16 (n=29, 26)33.02 ± 13.4828.70 ± 14.57
SecondaryChange in HbA1c From Baseline to Week 8 and 16
Time frame:
Baseline, Week 8, 16
Reported as:
Mean · percentage of hemoglobin
Change in HbA1c From Baseline to Week 8 and 16
percentage of hemoglobinHOE901-U300 CombinedLantus Combined
Week 8 (n= 29, 20)-0.22 ± 0.48-0.23 ± 0.54
Week 16 (n= 28, 27)-0.44 ± 0.51-0.22 ± 0.58
SecondaryChange in Fasting Plasma Glucose (FPG) From Baseline to Week 8 and 16
Time frame:
Baseline, Week 8, 16
Reported as:
Mean · mmol/L
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 8 and 16
mmol/LHOE901-U300 CombinedLantus Combined
Week 8 (n=24, 23)-0.89 ± 5.04-0.10 ± 5.81
Week 16 (n= 24, 22)-0.99 ± 5.270.78 ± 4.92
SecondaryChange in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profile From Baseline to Week 8 and 16

Change in average of 7-point SMPG. 7-point SMPG was assessed starting with a measurement at before breakfast and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; at bedtime.

Time frame:
Baseline, Week 8, 16
Reported as:
Mean · mmol/L
Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profile From Baseline to Week 8 and 16
mmol/LHOE901-U300 CombinedLantus Combined
Week 8-0.39 ± 1.840.39 ± 1.54
Week 16-0.47 ± 1.310.58 ± 2.13
SecondaryChange in Basal Insulin Daily Dose From Baseline to Week 8 and 16
Time frame:
Baseline, Week 8, 16
Reported as:
Mean · U/kg
Change in Basal Insulin Daily Dose From Baseline to Week 8 and 16
U/kgHOE901-U300 CombinedLantus Combined
Week 8 (n= 30, 29)0.06 ± 0.090.03 ± 0.09
Week 16 (n=29, 27)0.05 ± 0.090.03 ± 0.08
SecondaryPercentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline Up to Week 16

Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of \<=3.9 mmol/L \[70 mg/dL\]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level \<=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level \<=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level \>3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose \<=3.9 mmol/L).

Time frame:
Up to Week 16
Reported as:
Number · percentage of participants
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline Up to Week 16
percentage of participantsHOE901-U300 CombinedLantus Combined
Any Hypoglycemia Event: All Hypoglycemia100100
Severe Hypoglycemia: All Hypoglycemia3.310.3
Documented Symptomatic: All Hypoglycemia93.396.6
Asymptomatic: All Hypoglycemia86.796.6
Probable Symptomatic: All Hypoglycemia16.727.6
Relative: All Hypoglycemia0.06.9
Severe and/or Confirmed: All Hypoglycemia100100
Any Hypoglycemia Event: Nocturnal Hypoglycemia80.093.1
Severe Hypoglycemia: Nocturnal Hypoglycemia0.06.9
Documented Symptomatic: Nocturnal Hypoglycemia66.779.3
Asymptomatic: Nocturnal Hypoglycemia40.048.3
Probable Symptomatic: Nocturnal Hypoglycemia3.310.3
Relative: Nocturnal Hypoglycemia0.06.9
Severe and/or Confirmed: Nocturnal Hypoglycemia80.093.1

Adverse events

Collected over All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Week 16) regardless of seriousness or relationship to investigational product.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
HOE901-U300 Combined—1/30 (3.3%)18/30 (60%)
Lantus Combined—0/29 (0%)17/29 (58.6%)
Most frequent serious events
Most frequent serious events
EventHOE901-U300 CombinedLantus Combined
Intestinal obstructionGastrointestinal disorders1/300/29
Most frequent other events
Showing 10 of 15
Most frequent other events
EventHOE901-U300 CombinedLantus Combined
NasopharyngitisInfections and infestations9/306/29
HeadacheNervous system disorders2/304/29
InfluenzaInfections and infestations2/303/29
VomitingGastrointestinal disorders0/303/29
DiarrhoeaGastrointestinal disorders3/301/29
Implant site bruisingGeneral disorders3/300/29
PyrexiaGeneral disorders3/302/29
CoughRespiratory, thoracic and mediastinal disorders1/302/29
Nasal congestionRespiratory, thoracic and mediastinal disorders1/302/29
Oropharyngeal painRespiratory, thoracic and mediastinal disorders1/302/29

Baseline characteristics

Randomized population: all screened participants (who originally met inclusion criteria and signed informed consent) allocated to a treatment arm and recorded in Interactive Voice/Web Response System (IVRS/IWRS) database, regardless of whether treatment was used or not. Participants were analyzed in treatment arm to which they were randomized.

Age, Continuous
Age, Continuous(years)HOE901-U300 Morning Then EveningHOE901-U300 Evening Then MorningLantus Morning Then EveningLantus Evening Then MorningTotal
Mean43.6 ± 14.646.2 ± 15.939.7 ± 12.547.6 ± 14.144.2 ± 14.3
Sex: Female, Male
Sex: Female, Male(Participants)HOE901-U300 Morning Then EveningHOE901-U300 Evening Then MorningLantus Morning Then EveningLantus Evening Then MorningTotal
Female11241027
Male41311432
Body Mass Index (BMI)
Body Mass Index (BMI)(kilogram per square meter (kg/m^2))HOE901-U300 Morning Then EveningHOE901-U300 Evening Then MorningLantus Morning Then EveningLantus Evening Then MorningTotal
Mean27.5 ± 4.927.4 ± 5.028.3 ± 6.226.1 ± 5.127.3 ± 5.3
Glycated Hemoglobin (HbA1c)
Glycated Hemoglobin (HbA1c)(participants)HOE901-U300 Morning Then EveningHOE901-U300 Evening Then MorningLantus Morning Then EveningLantus Evening Then MorningTotal
Less Than (<) 81114121249
Greater Than or Equal to (>=) 8413210
Duration of Diabetes
Duration of Diabetes(years)HOE901-U300 Morning Then EveningHOE901-U300 Evening Then MorningLantus Morning Then EveningLantus Evening Then MorningTotal
Median16.8 (3 to 48)23.9 (2 to 54)20.6 (5 to 47)16.7 (6 to 44)20.7 (2 to 54)
Basal Insulin Daily Dose
Basal Insulin Daily Dose(units per kilogram (U/kg))HOE901-U300 Morning Then EveningHOE901-U300 Evening Then MorningLantus Morning Then EveningLantus Evening Then MorningTotal
Mean0.309 ± 0.0860.283 ± 0.0880.341 ± 0.1000.267 ± 0.0550.301 ± 0.087
Total Insulin Daily Dose
Total Insulin Daily Dose(U/kg)HOE901-U300 Morning Then EveningHOE901-U300 Evening Then MorningLantus Morning Then EveningLantus Evening Then MorningTotal
Mean0.600 ± 0.2370.620 ± 0.1790.677 ± 0.2040.513 ± 0.1150.603 ± 0.193
08

Study locations

3 sites
  • Investigational Site Number 840002
    Temecula, California 92591, United States
  • Investigational Site Number 840001
    Minneapolis, Minnesota 55416, United States
  • Investigational Site Number 840003
    Portland, Oregon 97201-3098, United States
09

References and documents

Publications

  • Bergenstal RM, Bailey TS, Rodbard D, Ziemen M, Guo H, Muehlen-Bartmer I, Ahmann AJ. Comparison of Insulin Glargine 300 Units/mL and 100 Units/mL in Adults With Type 1 Diabetes: Continuous Glucose Monitoring Profiles and Variability Using Morning or Evening Injections. Diabetes Care. 2017 Apr;40(4):554-560. doi: 10.2337/dc16-0684. Epub 2017 Jan 23. PubMed 28115474 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01658579
Lead sponsor
Sanofi
Responsible party
Sponsor
First posted
Aug 7, 2012
Start date
Aug 2012
Primary completion
May 2013
Completion
May 2013
Results posted
May 7, 2015
Last update
Jun 1, 2015

Study contacts

Clinical Sciences & Operations
study director · Sanofi

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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