Type 1 Diabetes MellitusPhase 2NCT01658579

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 study testing HOE901-U300 (new formulation of insulin glargine) and Lantus (insulin glargine) in people with Type 1 Diabetes Mellitus, run by Sanofi at 3 sites in United States.

Completed

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

Official record

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Trial 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… 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 (new formulation of insulin glargine) and Lantus (insulin glargine)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 59 participants
Where: 3 sitesUnited States
Study dates: Aug 2012to May 2013
Phase: Phase 2
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

Participants with Type 1 diabetes mellitus

Who cannot join

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;

Show all 13Show fewer

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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Investigational Site Number 840001
Minneapolis, Minnesota, 55416
Investigational Site Number 840003
Portland, Oregon, 97201-3098
Investigational Site Number 840002
Temecula, California, 92591

Other trials in United States

About this study

Official title: A 16-week, Randomized, Open-label, Controlled Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine Versus Lantus in Patients With Type 1 Diabetes Mellitus

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.

Conditions: Type 1 Diabetes Mellitus
Being tested: HOE901-U300 (new formulation of insulin glargine), Lantus (insulin glargine)
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 (new formulation of insulin glargine)Drug
Lantus (insulin glargine)Drug

Study groups in NCT01658579
Study group	Role	What they receive
HOE901-U300 Morning Then Evening	Experimental	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). Receives: Drug: HOE901-U300 (new formulation of insulin glargine)
HOE901-U300 Evening Then Morning	Experimental	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. Receives: Drug: HOE901-U300 (new formulation of insulin glargine)
Lantus Morning Then Evening	Active comparator	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. Receives: Drug: Lantus (insulin glargine)
Lantus Evening Then Morning	Active comparator	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. Receives: Drug: Lantus (insulin glargine)

What is being measured

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

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

Secondary outcomes (9)

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.
Measured: Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)
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.
Measured: Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)
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.
Measured: Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)
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.
Measured: Weeks 7-8 in Period A and Weeks 15-16 in Period B
Change in HbA1c From Baseline to Week 8 and 16
Measured: Baseline, Week 8, 16
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 8 and 16
Measured: Baseline, Week 8, 16
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.
Measured: Baseline, Week 8, 16
Change in Basal Insulin Daily Dose From Baseline to Week 8 and 16
Measured: Baseline, Week 8, 16
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).
Measured: Up to Week 16

Timeline

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

Aug 2012May 2013

First posted7 Aug 2012 (estimated)
Study startAug 2012
Primary completionMay 2013
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by SanofiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 59 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01658579
Sponsor's protocol ID: PDY12777
Other IDs: U1111-1130-3593
Status last verified: May 2015
First submitted: 26 Jul 2012
Last updated: 1 Jun 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 16-week, Randomized, Open-label, Controlled Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine Versus Lantus in Patients With Type 1 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01658579
Acronym / sponsor ID: PDY12777
Conditions: Type 1 Diabetes Mellitus
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 59 participants (actual)
Lead sponsor: SanofiIndustry (pharma, biotech, devices)
Study start: Aug 2012
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 7 Aug 2012 (estimated)
Results: Posted 7 May 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
HOE901-U300 Morning Then Evening	Experimental	Drug: HOE901-U300 (new formulation of insulin glargine)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).
HOE901-U300 Evening Then Morning	Experimental	Drug: HOE901-U300 (new formulation of insulin glargine)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.
Lantus Morning Then Evening	Active comparator	Drug: Lantus (insulin glargine)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.
Lantus Evening Then Morning	Active comparator	Drug: Lantus (insulin glargine)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.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Participants with Type 1 diabetes mellitus

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HOE901-U300 (new formulation of insulin glargine)	Drug	HOE901-U300 Evening Then Morning, HOE901-U300 Morning Then Evening
Lantus (insulin glargine)	Drug	Lantus Evening Then Morning, Lantus Morning Then Evening

Primary outcome

Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL])
Time frame: Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 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.

9 secondary outcomes

Percentage of Time Above the Upper Limit of Glycemic Range (Greater Than [>] 7.8 mmol/L [(140 mg/dL])
Time frame: Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)
Percentage of Time Below The Lower Limit of Glycemic Range (<4.4 mmol/L [80 mg/dL])
Time frame: Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)
Evaluation of Diurnal Glucose Exposure, Variability, and Stability
Time frame: Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)
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
Time frame: Weeks 7-8 in Period A and Weeks 15-16 in Period B
Change in HbA1c From Baseline to Week 8 and 16
Time frame: Baseline, Week 8, 16
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 8 and 16
Time frame: Baseline, Week 8, 16
Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profile From Baseline to Week 8 and 16
Time frame: Baseline, Week 8, 16
Change in Basal Insulin Daily Dose From Baseline to Week 8 and 16
Time frame: Baseline, Week 8, 16
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline Up to Week 16
Time frame: Up to Week 16

Results and safety

Results posted to the registry on 7 May 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HOE901-U300 Morning Then Evening	15	14
HOE901-U300 Evening Then Morning	15	15
Lantus Morning Then Evening	15	14
Lantus Evening Then Morning	14	13

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

Time frame: Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B). Least squares mean (Standard Error). Unit: percentage of time

Measure	HOE901-U300 Combined n = 30	Lantus Combined n = 27
Value	31.75 (1.5)	30.99 (1.58)

HOE901-U300 Combined vs Lantus Combined: Least Squares (LS) Mean Difference: 0.75 (95% CI -3.614 to 5.124), p = 0.7304, Linear Mixed Model

Population analysed: Continuous glucose monitoring (CGM) population: All participants who received at least 1 dose, had evaluable post-baseline CGM data, irrespective of compliance. Number of participants analyzed = participants with baseline, Weeks 7-8 (Period A) and/or Weeks 15-16 (Period B) CGM assessment. Missing data imputed using last observation carried forward.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HOE901-U300 Combined	1 of 30 (3.3%)	18 of 30 (60%)	Not reported
Lantus Combined	0 of 29 (0%)	17 of 29 (58.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28115474Bergenstal 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Sciences & Operations study director

Sanofi

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HOE901-U300 (new formulation of insulin glargine) and Lantus (insulin glargine) in people with Type 1 Diabetes Mellitus, run by Sanofi at 3 sites in United States.

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 1 inclusion and 13 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 1 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 7 May 2015). 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 in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL]) (time frame: Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)). 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 NCT01658579, which also lists 1 linked publication.

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 1 Jun 2015.