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Type 1 Diabetes MellitusPhase 4NCT02688933

A Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo Versus Lantus in Patients With Type 1 Diabetes Mellitus

A Phase 4 study testing HOE901-U300 (Insulin Glargine 300 U/ml), Lantus (Insulin Glargine 100 U/ml) and Mandated back ground therapy in people with Type 1 Diabetes Mellitus, run by Sanofi at 100 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Primary Objective: To demonstrate that morning injection of Toujeo (HOE901-U300) compared to Lantus provides better glycemic control evaluated by Continuous Glucose Monitoring (CGM) in adult participants with type 1 diabetes mellitus. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
HOE901-U300 (Insulin Glargine 300 U/ml), Lantus (Insulin Glargine 100 U/ml) and Mandated back ground therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
638 participants
Where
100 sitesin 2 countries
Study dates
5 May 2016to 19 Jun 2017
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult participants (male and female) with type 1 diabetes mellitus (T1DM).
  • Signed written informed consent.

Who cannot join

  • Age <18 years or >70 years.
  • Fasting c-peptide ≥0.3 nmol/L as per source document or central lab test at Visit 1.
  • Glycated hemoglobin (HbA1c) ≤ 6.5 % or ≥ 10.0% via central lab test at Visit 1.
  • Participants who experienced none of episode of documented symptomatic and/or severe hypoglycemia (as per the American Diabetes Association (ADA) classification) during the past month prior to screening.
  • Participants who experienced >1 episode of severe hypoglycemia resulting in coma/seizures during the last 12 months before screening.
  • Participants received less than 1 year treatment with basal plus mealtime insulin.
Show all 17Show fewer
  • Used any basal insulins other than long-acting insulin analogs (ie, Lantus, Toujeo, Levemir, and Tresiba) in the past 3 months before screening.
  • Required >80 U/day basal insulin analogs or not on stable dose (±20% total dose) within 30 days prior to screening.
  • Used fewer than 2 injections of rapid-acting insulin analog per day within 30 days prior to screening.
  • Used human regular insulin as mealtime insulin within 30 days prior to screening.
  • Used an insulin pump during the last 6 months before screening.
  • History of unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to required treatment (e.g., laser, surgical treatment, or injectable drugs) during the study period.
  • Pregnant or breast-feeding women or planned pregnancy during the duration of the study.
  • Use of any other investigational drug(s) within 1 month or 5 half-lives, whichever was longer prior to screening.
  • Inappropriate CGM use during screening period evidenced by failure to obtain a minimum of 4 days of usable records by the end of screening.
  • Noncompliance with self-monitored plasma glucose (SMPG) performance evidenced by failure to demonstrate at least 5 days of 5 point SMPG records by the end of screening.
  • The above information is not intended to contain all considerations relevant to a participants's potential participation in a clinical trial.

Trial locations and contacts

100 sites in 2 countries.

100 sites in 2 countries

United States99 sites

  • Investigational Site Number 840-125

    Arlington Heights, Illinois, 60005

  • Investigational Site Number 840-001

    Atlanta, Georgia, 30318

  • Investigational Site Number 840-162

    Bend, Oregon, 97702

  • Investigational Site Number 840-143

    Bennington, Vermont, 05201

  • Investigational Site Number 840-067

    Billings, Montana, 59101

  • Investigational Site Number 840-139

    Bridgeport, West Virginia, 26330

  • Investigational Site Number 840-056

    Burlington, Vermont, 05405

  • Investigational Site Number 840-058

    Chattanooga, Tennessee, 37411

  • Investigational Site Number 840-011

    Chicago, Illinois, 60612

  • Investigational Site Number 840-064

    Columbus, Georgia, 31904

  • Investigational Site Number 840-123

    Columbus, Ohio, 43203

  • Investigational Site Number 840-071

    Concord, California, 94520-2270

  • Investigational Site Number 840-072

    Coral Gables, Florida, 33124

  • Investigational Site Number 840-062

    Covington, Kentucky, 41011

  • Investigational Site Number 840-134

    Crystal Lake, Illinois, 60012

  • Investigational Site Number 840-003

    Dallas, Texas, 75230

  • Investigational Site Number 840-019

    Dallas, Texas, 75231

  • Investigational Site Number 840-075

    Dallas, Texas, 75235

  • Investigational Site Number 840-005

    Dallas, Texas, 75246

  • Investigational Site Number 840-013

    Dallas, Texas, 75246

  • Investigational Site Number 840-039

    Denver, Colorado, 80209

  • Investigational Site Number 840-021

    Denver, Colorado, 80246

  • Investigational Site Number 840-070

    Denver, Colorado, 80262

  • Investigational Site Number 840-153

    El Paso, Texas, 79925

  • Investigational Site Number 840-046

    Englewood, Colorado, 80113

  • Investigational Site Number 840-149

    Escondido, California, 92025

  • Investigational Site Number 840-051

    Fargo, North Dakota, 58103

  • Investigational Site Number 840-037

    Flint, Michigan, 48532

  • Investigational Site Number 840-026

    Fort Worth, Texas, 76132

  • Investigational Site Number 840-157

    Framingham, Massachusetts, 01702

  • Investigational Site Number 840-004

    Fresno, California, 93720

  • Investigational Site Number 840-110

    Greenbrae, California, 94904

  • Investigational Site Number 840-045

    Greenville, North Carolina, 27834

  • Investigational Site Number 840-040

    Henderson, Nevada, 89052

  • Investigational Site Number 840-133

    Hialeah, Florida, 33016

  • Investigational Site Number 840-081

    Houston, Texas, 77024

  • Investigational Site Number 840-160

    Houston, Texas, 77043

  • Investigational Site Number 840-156

    Houston, Texas, 77079

  • Investigational Site Number 840-152

    Houston, Texas, 77089

  • Investigational Site Number 840-031

    Houston, Texas, 77095

  • Investigational Site Number 840-054

    Hyattsville, Maryland, 20782

  • Investigational Site Number 840-060

    Idaho Falls, Idaho, 83404

  • Investigational Site Number 840-124

    La Jolla, California, 92037

  • Investigational Site Number 840-030

    La Mesa, California, 91942

  • Investigational Site Number 840-017

    Las Vegas, Nevada, 89148

  • Investigational Site Number 840-012

    Lawrenceville, Georgia, 30046

  • Investigational Site Number 840-042

    Lexington, Kentucky, 40503

  • Investigational Site Number 840-094

    Lincoln, Nebraska, 68526

  • Investigational Site Number 840-151

    Little Rock, Arkansas, 72205

  • Investigational Site Number 840-044

    Los Angeles, California, 90036

  • Investigational Site Number 840-022

    Los Angeles, California, 90057

  • Investigational Site Number 840-129

    Los Gatos, California, 95032

  • Investigational Site Number 840-140

    Lufkin, Texas, 75904

  • Investigational Site Number 840-137

    Maitland, Florida, 32751

  • Investigational Site Number 840-104

    Mentor, Ohio, 44060

  • Investigational Site Number 840-029

    Mesquite, Texas, 75149

  • Investigational Site Number 840-009

    Metairie, Louisiana, 70006

  • Investigational Site Number 840-049

    Miami, Florida, 33155

  • Investigational Site Number 840-076

    Miami, Florida, 33176

  • Investigational Site Number 840-010

    Morehead City, North Carolina, 28557

  • Investigational Site Number 840-080

    Morehead City, North Carolina, 28557

  • Investigational Site Number 840-083

    Murray, Utah, 84123

  • Investigational Site Number 840-032

    New Orleans, Louisiana, 70115

  • Investigational Site Number 840-023

    New Port Richey, Florida, 34652

  • Investigational Site Number 840-102

    New York, New York, 10001

  • Investigational Site Number 840-108

    New York, New York, 10029

  • Investigational Site Number 840-079

    Norman, Oklahoma, 73069

  • Investigational Site Number 840-048

    North Richland Hills, Texas, 76180

  • Investigational Site Number 840-024

    Northridge, California, 91325

  • Investigational Site Number 840-053

    Ocoee, Florida, 34761

  • Investigational Site Number 840-101

    Ogden, Utah, 84405

  • Investigational Site Number 840-033

    Omaha, Nebraska, 68114

  • Investigational Site Number 840-142

    Omaha, Nebraska, 68124

  • Investigational Site Number 840-112

    Ormond Beach, Florida, 32174

  • Investigational Site Number 840-018

    Palm Harbor, Florida, 34684

  • Investigational Site Number 840-150

    Pearland, Texas, 77584

  • Investigational Site Number 840-069

    Pomona, California, 91766

  • Investigational Site Number 840-090

    Pomona, California, 91767

  • Investigational Site Number 840-047

    Port Charlotte, Florida, 33952

  • Investigational Site Number 840-096

    Portland, Oregon, 97210

  • Investigational Site Number 840-015

    Renton, Washington, 98055

  • Investigational Site Number 840-006

    Rockville, Maryland, 20852

  • Investigational Site Number 840-132

    Rolling Hills Estates, California, 90274

  • Investigational Site Number 840-008

    Roswell, Georgia, 30076

  • Investigational Site Number 840-097

    Salt Lake City, Utah, 84102

  • Investigational Site Number 840-130

    San Jose, California, 95148

  • Investigational Site Number 840-055

    San Ramon, California, 94583

  • Investigational Site Number 840-028

    Santa Barbara, California

  • Investigational Site Number 840-074

    Spokane, Washington, 99207

  • Investigational Site Number 840-109

    Staten Island, New York, 10301-3914

  • Investigational Site Number 840-014

    Stockbridge, Georgia, 30281

  • Investigational Site Number 840-114

    Tampa, Florida, 33612

  • Investigational Site Number 840-063

    Tarzana, California, 91356

  • Investigational Site Number 840-138

    Tustin, California, 92780-6953

  • Investigational Site Number 840-016

    Ventura, California, 93003

  • Investigational Site Number 840-122

    Waltham, Massachusetts, 02453

  • Investigational Site Number 840-002

    West Des Moines, Iowa, 50265

  • Investigational Site Number 840-036

    West Palm Beach, Florida, 33401

  • Investigational Site Number 840-073

    Wichita, Kansas, 67226

Other trials in United States

Puerto Rico1 site

  • Investigational Site Number 840-111

    Manati, 00674

Other trials in Puerto Rico

About this study

Official title: A Randomized, Active-controlled, Parallel Group, 16-Week Open Label Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo (Insulin Glargine-U300) Versus Lantus in Patients With Type 1 Diabetes Mellitus

Primary Objective:

To demonstrate that morning injection of Toujeo (HOE901-U300) compared to Lantus provides better glycemic control evaluated by Continuous Glucose Monitoring (CGM) in adult participants with type 1 diabetes mellitus.

Secondary Objective:

To demonstrate that treatment with HOE901-U300 compared to Lantus provides:

  • Lower incidence rate of nocturnal symptomatic hypoglycemia;
  • Better glucose control coverage during the last hours of CGM before next basal-insulin dosing;
  • Less variability in CGM profile.
Read the detailed description

The maximum study duration per participant was to be of approximately 20 weeks that consisted of an up to a 4-week screening and CGM training period including a 1-2 week baseline (blinded) CGM performance (allowed for re-training), a 14-week open-label, comparative treatment period allowing for dose titration in both basal and meal-time insulin and including a 1-2 week end-of treatment blinded CGM collection with fixed dose of HOE901-U300 and Lantus, and a 2 day post treatment follow-up period.

Being tested
HOE901-U300 (Insulin Glargine 300 U/ml), Lantus (Insulin Glargine 100 U/ml), Mandated back ground therapy
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HOE901-U300 (Insulin Glargine 300 U/ml)Drug

    Also called Toujeo

    Self-administered by subcutaneous (SC) injection in the morning (between waking up and breakfast) using a pre-filled pen.

  • Lantus (Insulin Glargine 100 U/ml)Drug

    Also called HOE901-U100

    Self-administered by subcutaneous (SC) injection in the morning (between waking up and breakfast using a pre-filled pen.

  • Mandated back ground therapyDrug

    Rapid insulin analogs: e.g., insulin glulisine, insulin lispro or insulin aspart, used by participant at least 30 days before screening. Mealtime insulin was to be continued during the study and titrated towards protocol specified postprandial glucose targets (130-180 mg/dL).

Study groups in NCT02688933
Study groupRoleWhat they receive
HOE901-U300ExperimentalHOE901-U300 (Insulin glargine, 300 U/mL) once daily for 16 weeks on top of mealtime insulins analogs. Basal insulin doses were individually titrated (until the end of Week 14) to reach fasting self-measured plasma glucose (SMPG) levels of 80 to 100 mg/dL, while mitigating hypoglycemia.
Receives: Drug: HOE901-U300 (Insulin Glargine 300 U/ml); Drug: Mandated back ground therapy
LantusActive comparatorLantus (Insulin glargine, 100 U/mL) once daily for 16 weeks on top of mealtime insulins analogs. Basal insulin doses were individually titrated (until the end of Week 14) to reach fasting SMPG levels of 80 to 100 mg/dL, while mitigating hypoglycemia.
Receives: Drug: Lantus (Insulin Glargine 100 U/ml); Drug: Mandated back ground therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Time of Mean Glucose Concentration Within the Target Range of 70-180 mg/dL as Obtained From CGM

    The CGM system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyze glucose levels in real time. Adjusted least square (LS) means and standard error (SE) were obtained from a generalized linear model with identity link including post baseline CGM assessment during Week 15 (and/or Week 16).

    Measured: During Week 15 and/or 16

Secondary outcomes (5)

  1. Percentage of Participants With Documented Symptomatic Nocturnal Hypoglycemia

    Documented symptomatic nocturnal hypoglycemia was defined as an event with typical symptoms of hypoglycemia accompanied by SMPG <=70 mg/dL that occurred between 00:00 and 05:59 hours as reported on the hypoglycemia electronic case report form (eCRF).

    Measured: Baseline up to Week 16

  2. Documented Symptomatic Nocturnal Hypoglycemia Event Rate Per Participant-Year

    Documented symptomatic nocturnal hypoglycemia was defined as an event with typical symptoms of hypoglycemia accompanied by SMPG <=70 mg/dL that occurred between 00:00 and 05:59 hours as reported on the hypoglycemia eCRF.

    Measured: Baseline up to Week 16

  3. Mean Change From Baseline in Glucose Level During Last 4 Hours of CGM Data Collection Prior to the Next Day Basal Insulin Injection During Week 15 and/or Week 16

    Adjusted LS means and SE were obtained from mixed model including post baseline CGM assessment during the last 4 hours prior to the next day's basal insulin injection during Week 15 (and/or Week 16).

    Measured: Baseline, during Week 15 and/or Week 16

  4. Percentage of Time Glucose Concentrations Within the Target Range of 70 to 140 mg/dL During Last 4 Hours of CGM Data Collection Prior to Next Day Basal Insulin Injection

    Adjusted LS means and SE were obtained from mixed model including post baseline CGM assessment during the last 4 hours prior to the next day's basal insulin injection during Week 15 (and/or Week 16).

    Measured: During Week 15 and/or Week 16

  5. Coefficient of Variation (CV%) in Mean CGM Glucose

    CV% was a measure of spread of variability relative to mean of population. For CGM glucose values over 24 hours, CV% was measure of glycemic variability across 24-hour day and calculated for each period (total, within day and between days) as ratio of standard deviation of glucose values to mean of glucose values.

    Measured: During Week 15 and/or Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2016 (estimated)
  2. Study start5 May 2016
  3. Primary completion19 Jun 2017
  4. Study completion19 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
638 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02688933
Sponsor's protocol ID
LPS14587
Other IDs
U1111-1176-0936
Status last verified
Mar 2022
First submitted
18 Feb 2016
Last updated
28 Mar 2022
Data monitoring committee
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing HOE901-U300 (Insulin Glargine 300 U/ml), Lantus (Insulin Glargine 100 U/ml) and Mandated back ground therapy in people with Type 1 Diabetes Mellitus, run by Sanofi at 100 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 100 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Time of Mean Glucose Concentration Within the Target Range of 70-180 mg/dL as Obtained From CGM (time frame: During Week 15 and/or 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02688933.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2022.

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