Efficacy and Safety of Soliqua Versus Lantus in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT03434119
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
* To demonstrate the superiority of Soliqua 100/33 versus Lantus in the hemoglobin A1c (HbA1c) change within the overall population.
* To demonstrate the benefit of Soliqua 100/33 versus Lantus in the HbA1c within each ethnic/racial subgroup evaluated (ie, Hispanics of any race, non-Hispanic black/African Americans and non-Hispanic Asians).
Secondary Objective:
* To assess the effects of Soliqua 100/33 versus Lantus on the secondary efficacy parameters within each ethnic/racial subgroup evaluated.
* To assess the change in daily insulin glargine dose within each ethnic/racial subgroup.
* To evaluate the safety and tolerability (e.g., gastrointestinal tolerability) of Soliqua 100/33 versus Lantus within each ethnic/racial subgroup.
- Detailed Description
The study duration was approximately 29 weeks including 2 weeks screening period, 26 weeks open label treatment period, and a 3 days follow-up period.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 241
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lantus Background therapy Lantus (Insulin glargine) once daily at any time of the day but at about the same time every day on top of OAD therapy for 26 weeks. Soliqua 100/33 Insulin glargine/Lixisenatide Soliqua 100/33 (Insulin glargine/lixisenatide) once daily in the morning within 1 hour before breakfast, on top of oral anti-diabetic drug (OAD) therapy for 26 weeks. Lantus Insulin glargine (HOE901) Lantus (Insulin glargine) once daily at any time of the day but at about the same time every day on top of OAD therapy for 26 weeks. Soliqua 100/33 Background therapy Soliqua 100/33 (Insulin glargine/lixisenatide) once daily in the morning within 1 hour before breakfast, on top of oral anti-diabetic drug (OAD) therapy for 26 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 Baseline, Week 26 Change in HbA1c was calculated by subtracting baseline value from Week 26 value.
- Secondary Outcome Measures
Name Time Method Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test at Week 26 Baseline, Week 26 Change From Baseline in Daily Insulin Glargine Dose at Week 26 Baseline, Week 26 Change in daily dose was calculated by subtracting baseline value from Week 26 value.
Change From Baseline in Body Weight at Week 26 Baseline, Week 26 Change in body weight was calculated by subtracting baseline value from Week 26 value.
Percentage of Participants Achieving HbA1c Target of <7% at Week 26 Week 26 Participants who had no available assessment for HbA1c at Week 26 were considered as non-responders.
Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Standardized Mixed Meal at Week 26 Baseline, Week 26 The 2-hour PPG test measured blood glucose 2 hours after eating a standardized breakfast meal.
Percentage of Participants With Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Hypoglycemia) During the On-Treatment Period Baseline to Week 26 Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented hypoglycemia with plasma glucose cut-off of \<=70 mg/dL (3.9 mmol/L) was any hypoglycemia documented by a measured plasma glucose \<=70 mg/dL (3.9 mmol/L) and excluding plasma glucose \<54 mg/dL regardless of symptoms. Documented hypoglycemia with plasma glucose cut-off of \<54 mg/dL (3.0 mmol/L) was any hypoglycemia documented by a measured plasma glucose \<54 mg/dL (3.0 mmol/L) regardless of symptoms.
Trial Locations
- Locations (85)
Investigational Site Number 8400069
🇺🇸Anaheim, California, United States
Investigational Site Number 8400043
🇺🇸Columbia, South Carolina, United States
Investigational Site Number 8400072
🇺🇸Montgomery, Alabama, United States
Investigational Site Number 8400013
🇺🇸Little Rock, Arkansas, United States
Investigational Site Number 8400060
🇺🇸Burbank, California, United States
Investigational Site Number 8400076
🇺🇸Anaheim, California, United States
Investigational Site Number 8400052
🇺🇸Anaheim, California, United States
Investigational Site Number 8400049
🇺🇸Cerritos, California, United States
Investigational Site Number 8400078
🇺🇸Chula Vista, California, United States
Investigational Site Number 8400050
🇺🇸Greenbrae, California, United States
Investigational Site Number 8400047
🇺🇸Escondido, California, United States
Investigational Site Number 8400066
🇺🇸Fountain Valley, California, United States
Investigational Site Number 8400092
🇺🇸Huntington Park, California, United States
Investigational Site Number 8400015
🇺🇸Los Angeles, California, United States
Investigational Site Number 8400011
🇺🇸Los Angeles, California, United States
Investigational Site Number 8400301
🇺🇸Los Angeles, California, United States
Investigational Site Number 8400302
🇺🇸Los Angeles, California, United States
Investigational Site Number 8400303
🇺🇸Los Angeles, California, United States
Investigational Site Number 8400304
🇺🇸Los Angeles, California, United States
Investigational Site Number 8400006
🇺🇸Los Gatos, California, United States
Investigational Site Number 8400048
🇺🇸Oakland, California, United States
Investigational Site Number 8400053
🇺🇸Orange, California, United States
Investigational Site Number 8400081
🇺🇸Pomona, California, United States
Investigational Site Number 8400042
🇺🇸Rancho Cucamonga, California, United States
Investigational Site Number 8400063
🇺🇸San Carlos, California, United States
Investigational Site Number 8400086
🇺🇸San Jose, California, United States
Investigational Site Number 8400074
🇺🇸Santa Ana, California, United States
Investigational Site Number 8400037
🇺🇸Temecula, California, United States
Investigational Site Number 8400087
🇺🇸Vallejo, California, United States
Investigational Site Number 8400024
🇺🇸Van Nuys, California, United States
Investigational Site Number 8400023
🇺🇸Hamden, Connecticut, United States
Investigational Site Number 8400007
🇺🇸Ventura, California, United States
Investigational Site Number 8400041
🇺🇸Gainesville, Florida, United States
Investigational Site Number 8400075
🇺🇸Jacksonville, Florida, United States
Investigational Site Number 8400016
🇺🇸Miami Lakes, Florida, United States
Investigational Site Number 8400014
🇺🇸Ocoee, Florida, United States
Investigational Site Number 8400028
🇺🇸Port Charlotte, Florida, United States
Investigational Site Number 8400097
🇺🇸Saint Petersburg, Florida, United States
Investigational Site Number 8400035
🇺🇸Saint Petersburg, Florida, United States
Investigational Site Number 8400025
🇺🇸Atlanta, Georgia, United States
Investigational Site Number 8400051
🇺🇸Atlanta, Georgia, United States
Investigational Site Number 8400005
🇺🇸Savannah, Georgia, United States
Investigational Site Number 8400038
🇺🇸Chicago, Illinois, United States
Investigational Site Number 8400093
🇺🇸Atlanta, Georgia, United States
Investigational Site Number 8400088
🇺🇸Chicago, Illinois, United States
Investigational Site Number 8400064
🇺🇸Evanston, Illinois, United States
Investigational Site Number 8400031
🇺🇸Des Plaines, Illinois, United States
Investigational Site Number 8400065
🇺🇸Baltimore, Maryland, United States
Investigational Site Number 8400061
🇺🇸Rockville, Maryland, United States
Investigational Site Number 8400003
🇺🇸Bronx, New York, United States
Investigational Site Number 8400021
🇺🇸Dallas, Texas, United States
Investigational Site Number 8400062
🇺🇸Philadelphia, Pennsylvania, United States
Investigational Site Number 8400040
🇺🇸Fort Worth, Texas, United States
Investigational Site Number 8400002
🇺🇸Humble, Texas, United States
Investigational Site Number 8400039
🇺🇸Kerrville, Texas, United States
Investigational Site Number 8400096
🇺🇸Lufkin, Texas, United States
Investigational Site Number 8400008
🇺🇸Splendora, Texas, United States
Investigational Site Number 8400070
🇺🇸Sugar Land, Texas, United States
Investigational Site Number 8400085
🇺🇸Sugar Land, Texas, United States
Investigational Site Number 8400055
🇺🇸Spring, Texas, United States
Investigational Site Number 8400059
🇺🇸Webster, Texas, United States
Investigational Site Number 8400044
🇺🇸Manassas, Virginia, United States
Investigational Site Number 8400068
🇺🇸Norfolk, Virginia, United States
Investigational Site Number 8400029
🇺🇸Richland, Washington, United States
Investigational Site Number 8400045
🇺🇸Houston, Texas, United States
Investigational Site Number 8400036
🇺🇸Miami, Florida, United States
Investigational Site Number 8400017
🇺🇸Miami, Florida, United States
Investigational Site Number 8400091
🇺🇸San Diego, California, United States
Investigational Site Number 8400027
🇺🇸San Antonio, Texas, United States
Investigational Site Number 8400083
🇺🇸San Antonio, Texas, United States
Investigational Site Number 8400054
🇺🇸Englewood, Colorado, United States
Investigational Site Number 8400012
🇺🇸Flint, Michigan, United States
Investigational Site Number 8400001
🇺🇸Flint, Michigan, United States
Investigational Site Number 8400082
🇺🇸Las Vegas, Nevada, United States
Investigational Site Number 8400077
🇺🇸Little Rock, Arkansas, United States
Investigational Site Number 8400079
🇺🇸Chelsea, Michigan, United States
Investigational Site Number 8400030
🇺🇸Gretna, Louisiana, United States
Investigational Site Number 8400095
🇺🇸Little Rock, Arkansas, United States
Investigational Site Number 8400090
🇺🇸Las Vegas, Nevada, United States
Investigational Site Number 8400018
🇺🇸Linden, New Jersey, United States
Investigational Site Number 8400094
🇺🇸Tampa, Florida, United States
Investigational Site Number 8400084
🇺🇸Pomona, California, United States
Investigational Site Number 8400009
🇺🇸New Orleans, Louisiana, United States
Investigational Site Number 8400033
🇺🇸Richmond, Virginia, United States
Investigational Site Number 8400057
🇺🇸Gurnee, Illinois, United States