Back to resultsComparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus on Basal Plus Mealtime Insulin
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
HOE901-U300 (new formulation of insulin glargine)
Lantus (insulin glargine)
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus
Eligibility Criteria
Inclusion criteria :
- Participants with Type 1 diabetes mellitus
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.
Sites / Locations
- Investigational Site Number 840002
- Investigational Site Number 840001
- Investigational Site Number 840003
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
HOE901-U300 Morning Then Evening
HOE901-U300 Evening Then Morning
Lantus Morning Then Evening
Lantus Evening Then Morning
Arm Description
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 (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 (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 (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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Change in HbA1c From Baseline to Week 8 and 16
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 8 and 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.
Change in Basal Insulin Daily Dose From Baseline to Week 8 and 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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01658579
Brief Title
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus on Basal Plus Mealtime Insulin
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HOE901-U300 Morning Then Evening
Arm Type
Experimental
Arm Description
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).
Arm Title
HOE901-U300 Evening Then Morning
Arm Type
Experimental
Arm Description
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.
Arm Title
Lantus Morning Then Evening
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Lantus Evening Then Morning
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
HOE901-U300 (new formulation of insulin glargine)
Intervention Type
Drug
Intervention Name(s)
Lantus (insulin glargine)
Primary Outcome Measure Information:
Title
Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL])
Description
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 Outcome Measure Information:
Title
Percentage of Time Above the Upper Limit of Glycemic Range (Greater Than [>] 7.8 mmol/L [(140 mg/dL])
Description
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)
Title
Percentage of Time Below The Lower Limit of Glycemic Range (<4.4 mmol/L [80 mg/dL])
Description
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)
Title
Evaluation of Diurnal Glucose Exposure, Variability, and Stability
Description
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)
Title
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
Description
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
Title
Change in HbA1c From Baseline to Week 8 and 16
Time Frame
Baseline, Week 8, 16
Title
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 8 and 16
Time Frame
Baseline, Week 8, 16
Title
Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profile From Baseline to Week 8 and 16
Description
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
Title
Change in Basal Insulin Daily Dose From Baseline to Week 8 and 16
Time Frame
Baseline, Week 8, 16
Title
Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline Up to Week 16
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria :
Participants with Type 1 diabetes mellitus
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 840002
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
Investigational Site Number 840001
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Investigational Site Number 840003
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201-3098
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28115474
Citation
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.
Results Reference
derived
Learn more about this trial
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus on Basal Plus Mealtime Insulin
We'll reach out to this number within 24 hrs