NCT03434119

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

A 26-week Randomized, Open-label, Active-controlled, 2-treatment Arm, Parallel Group Multi-center Study, Comparing the Efficacy and Safety of Soliqua™100/33 Versus Lantus® in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 241 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Insulin glargine/Lixisenatide	Insulin glargine (100 units per milliliter \[U/mL\]) and lixisenatide (33 micrograms per milliliter \[mcg/mL\]) self administered by a subcutaneous injection using a prefilled pen. Dose was individually titrated to achieve target fasting self-monitoring of plasma glucose (SMPG) of 80 to 100 milligrams per deciliter (mg/dL) (4.4 to 5.6 millimoles per liter \[mmol/L\]) while avoiding hypoglycemia.
DRUG	Insulin glargine (HOE901)	Insulin glargine 100 U/mL self-administered by a subcutaneous injection using a prefilled pen. Dose was individually titrated to achieve target fasting SMPG of 80 to 100 mg/dL (4.4 to 5.6 mmol/L) while avoiding hypoglycemia.
DRUG	Background therapy	Oral Anti diabetics Drugs (OADs) administered orally according to the locally approved label.

Timeline

• Start date: 2018-02-20
• Primary completion: 2019-01-07
• Completion: 2019-01-07
• First posted: 2018-02-15
• Last updated: 2022-03-28
• Results posted: 2020-01-13

Locations

85 sites across 1 country: United States

Regulatory

• FDA-regulated drug study