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

Phase 3

Terminated

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Insulin glargine/Lixisenatide; Drug: Insulin glargine (HOE901); Drug: Background therapy

• 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.

Study Timeline

• Study First Submitted: 2018-02-09
• Study First Submitted QC: 2018-02-09
• Study First Posted: 2018-02-15
• Study Start: 2018-02-20
• Primary Completion: 2019-01-07
• Study Completion: 2019-01-07
• Results First Submitted: 2019-12-24
• Results First Submitted QC: 2020-01-09
• Results First Posted: 2020-01-13
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-21
• Last Update Posted: 2022-03-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 241

Inclusion Criteria

Not provided

Exclusion Criteria

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.
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.
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.

Trial Locations

Locations (85)

Investigational Site Number 8400072; 🇺🇸 Montgomery, Alabama, United States

Investigational Site Number 8400077; 🇺🇸 Little Rock, Arkansas, United States

Investigational Site Number 8400095; 🇺🇸 Little Rock, Arkansas, United States

Investigational Site Number 8400013; 🇺🇸 Little Rock, Arkansas, United States

Investigational Site Number 8400076; 🇺🇸 Anaheim, California, United States

Investigational Site Number 8400052; 🇺🇸 Anaheim, California, United States

Investigational Site Number 8400069; 🇺🇸 Anaheim, California, United States

Investigational Site Number 8400060; 🇺🇸 Burbank, California, United States

Investigational Site Number 8400049; 🇺🇸 Cerritos, California, United States

Investigational Site Number 8400078; 🇺🇸 Chula Vista, California, United States

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