A Study Comparing the Efficacy and Safety of the Morning Injection of Toujeo Versus Lantus in Patients With Type 1 Diabetes Mellitus
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.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 4
Contacts and Locations
Study Locations
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Manati, Puerto Rico, 00674
- Investigational Site Number 840-111
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Arkansas
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Little Rock, Arkansas, United States, 72205
- Investigational Site Number 840-151
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California
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Concord, California, United States, 94520-2270
- Investigational Site Number 840-071
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Escondido, California, United States, 92025
- Investigational Site Number 840-149
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Fresno, California, United States, 93720
- Investigational Site Number 840-004
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Greenbrae, California, United States, 94904
- Investigational Site Number 840-110
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La Jolla, California, United States, 92037
- Investigational Site Number 840-124
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La Mesa, California, United States, 91942
- Investigational Site Number 840-030
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Los Angeles, California, United States, 90036
- Investigational Site Number 840-044
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Los Angeles, California, United States, 90057
- Investigational Site Number 840-022
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Los Gatos, California, United States, 95032
- Investigational Site Number 840-129
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Northridge, California, United States, 91325
- Investigational Site Number 840-024
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Pomona, California, United States, 91766
- Investigational Site Number 840-069
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Pomona, California, United States, 91767
- Investigational Site Number 840-090
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Rolling Hills Estates, California, United States, 90274
- Investigational Site Number 840-132
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San Jose, California, United States, 95148
- Investigational Site Number 840-130
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San Ramon, California, United States, 94583
- Investigational Site Number 840-055
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Santa Barbara, California, United States
- Investigational Site Number 840-028
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Tarzana, California, United States, 91356
- Investigational Site Number 840-063
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Tustin, California, United States, 92780-6953
- Investigational Site Number 840-138
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Ventura, California, United States, 93003
- Investigational Site Number 840-016
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Colorado
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Denver, Colorado, United States, 80209
- Investigational Site Number 840-039
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Denver, Colorado, United States, 80246
- Investigational Site Number 840-021
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Denver, Colorado, United States, 80262
- Investigational Site Number 840-070
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Englewood, Colorado, United States, 80113
- Investigational Site Number 840-046
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Florida
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Coral Gables, Florida, United States, 33124
- Investigational Site Number 840-072
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Hialeah, Florida, United States, 33016
- Investigational Site Number 840-133
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Maitland, Florida, United States, 32751
- Investigational Site Number 840-137
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Miami, Florida, United States, 33155
- Investigational Site Number 840-049
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Miami, Florida, United States, 33176
- Investigational Site Number 840-076
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New Port Richey, Florida, United States, 34652
- Investigational Site Number 840-023
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Ocoee, Florida, United States, 34761
- Investigational Site Number 840-053
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Ormond Beach, Florida, United States, 32174
- Investigational Site Number 840-112
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Palm Harbor, Florida, United States, 34684
- Investigational Site Number 840-018
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Port Charlotte, Florida, United States, 33952
- Investigational Site Number 840-047
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Tampa, Florida, United States, 33612
- Investigational Site Number 840-114
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West Palm Beach, Florida, United States, 33401
- Investigational Site Number 840-036
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Georgia
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Atlanta, Georgia, United States, 30318
- Investigational Site Number 840-001
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Columbus, Georgia, United States, 31904
- Investigational Site Number 840-064
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Lawrenceville, Georgia, United States, 30046
- Investigational Site Number 840-012
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Roswell, Georgia, United States, 30076
- Investigational Site Number 840-008
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Stockbridge, Georgia, United States, 30281
- Investigational Site Number 840-014
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Idaho
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Idaho Falls, Idaho, United States, 83404
- Investigational Site Number 840-060
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Illinois
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Arlington Heights, Illinois, United States, 60005
- Investigational Site Number 840-125
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Chicago, Illinois, United States, 60612
- Investigational Site Number 840-011
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Crystal Lake, Illinois, United States, 60012
- Investigational Site Number 840-134
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Iowa
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West Des Moines, Iowa, United States, 50265
- Investigational Site Number 840-002
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Kansas
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Wichita, Kansas, United States, 67226
- Investigational Site Number 840-073
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Kentucky
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Covington, Kentucky, United States, 41011
- Investigational Site Number 840-062
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Lexington, Kentucky, United States, 40503
- Investigational Site Number 840-042
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Louisiana
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Metairie, Louisiana, United States, 70006
- Investigational Site Number 840-009
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New Orleans, Louisiana, United States, 70115
- Investigational Site Number 840-032
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Maryland
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Hyattsville, Maryland, United States, 20782
- Investigational Site Number 840-054
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Rockville, Maryland, United States, 20852
- Investigational Site Number 840-006
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Massachusetts
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Framingham, Massachusetts, United States, 01702
- Investigational Site Number 840-157
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Waltham, Massachusetts, United States, 02453
- Investigational Site Number 840-122
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Michigan
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Flint, Michigan, United States, 48532
- Investigational Site Number 840-037
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Montana
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Billings, Montana, United States, 59101
- Investigational Site Number 840-067
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Nebraska
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Lincoln, Nebraska, United States, 68526
- Investigational Site Number 840-094
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Omaha, Nebraska, United States, 68114
- Investigational Site Number 840-033
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Omaha, Nebraska, United States, 68124
- Investigational Site Number 840-142
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Nevada
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Henderson, Nevada, United States, 89052
- Investigational Site Number 840-040
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Las Vegas, Nevada, United States, 89148
- Investigational Site Number 840-017
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New York
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New York, New York, United States, 10001
- Investigational Site Number 840-102
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New York, New York, United States, 10029
- Investigational Site Number 840-108
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Staten Island, New York, United States, 10301-3914
- Investigational Site Number 840-109
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North Carolina
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Greenville, North Carolina, United States, 27834
- Investigational Site Number 840-045
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Morehead City, North Carolina, United States, 28557
- Investigational Site Number 840-010
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Morehead City, North Carolina, United States, 28557
- Investigational Site Number 840-080
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North Dakota
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Fargo, North Dakota, United States, 58103
- Investigational Site Number 840-051
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Ohio
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Columbus, Ohio, United States, 43203
- Investigational Site Number 840-123
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Mentor, Ohio, United States, 44060
- Investigational Site Number 840-104
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Oklahoma
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Norman, Oklahoma, United States, 73069
- Investigational Site Number 840-079
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Oregon
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Bend, Oregon, United States, 97702
- Investigational Site Number 840-162
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Portland, Oregon, United States, 97210
- Investigational Site Number 840-096
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Tennessee
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Chattanooga, Tennessee, United States, 37411
- Investigational Site Number 840-058
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Texas
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Dallas, Texas, United States, 75230
- Investigational Site Number 840-003
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Dallas, Texas, United States, 75231
- Investigational Site Number 840-019
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Dallas, Texas, United States, 75235
- Investigational Site Number 840-075
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Dallas, Texas, United States, 75246
- Investigational Site Number 840-005
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Dallas, Texas, United States, 75246
- Investigational Site Number 840-013
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El Paso, Texas, United States, 79925
- Investigational Site Number 840-153
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Fort Worth, Texas, United States, 76132
- Investigational Site Number 840-026
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Houston, Texas, United States, 77024
- Investigational Site Number 840-081
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Houston, Texas, United States, 77043
- Investigational Site Number 840-160
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Houston, Texas, United States, 77079
- Investigational Site Number 840-156
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Houston, Texas, United States, 77089
- Investigational Site Number 840-152
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Houston, Texas, United States, 77095
- Investigational Site Number 840-031
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Lufkin, Texas, United States, 75904
- Investigational Site Number 840-140
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Mesquite, Texas, United States, 75149
- Investigational Site Number 840-029
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North Richland Hills, Texas, United States, 76180
- Investigational Site Number 840-048
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Pearland, Texas, United States, 77584
- Investigational Site Number 840-150
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Utah
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Murray, Utah, United States, 84123
- Investigational Site Number 840-083
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Ogden, Utah, United States, 84405
- Investigational Site Number 840-101
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Salt Lake City, Utah, United States, 84102
- Investigational Site Number 840-097
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Vermont
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Bennington, Vermont, United States, 05201
- Investigational Site Number 840-143
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Burlington, Vermont, United States, 05405
- Investigational Site Number 840-056
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Washington
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Renton, Washington, United States, 98055
- Investigational Site Number 840-015
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Spokane, Washington, United States, 99207
- Investigational Site Number 840-074
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West Virginia
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Bridgeport, West Virginia, United States, 26330
- Investigational Site Number 840-139
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Adult participants (male and female) with type 1 diabetes mellitus (T1DM).
- Signed written informed consent.
Exclusion criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
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Experimental: HOE901-U300
HOE901-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.
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Self-administered by subcutaneous (SC) injection in the morning (between waking up and breakfast) using a pre-filled pen.
Other Names:
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).
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Active Comparator: Lantus
Lantus (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.
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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).
Self-administered by subcutaneous (SC) injection in the morning (between waking up and breakfast using a pre-filled pen.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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).
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During Week 15 and/or 16
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Percentage of Participants With Documented Symptomatic Nocturnal Hypoglycemia
Time Frame: Baseline up to Week 16
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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).
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Baseline up to Week 16
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Documented Symptomatic Nocturnal Hypoglycemia Event Rate Per Participant-Year
Time Frame: Baseline up to Week 16
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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.
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Baseline up to Week 16
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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
Time Frame: Baseline, during Week 15 and/or Week 16
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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).
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Baseline, during Week 15 and/or Week 16
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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
Time Frame: During Week 15 and/or Week 16
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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).
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During Week 15 and/or Week 16
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Coefficient of Variation (CV%) in Mean CGM Glucose
Time Frame: During Week 15 and/or Week 16
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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.
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During Week 15 and/or Week 16
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Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change From Baseline in Daily Insulin Dose at Week 16
Time Frame: Baseline, Week 16
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Change from Baseline at Week 16 for daily basal insulin dose and daily bolus insulin dose was reported.
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Baseline, Week 16
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Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- LPS14587
- U1111-1176-0936 (Other Identifier: UTN)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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