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Efficacy and Safety of Soliqu...

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

Last Updated: 2022-03-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

241 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-20

Study Completion Date

2019-01-07

Brief Summary

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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.

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Detailed Description

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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

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Soliqua 100/33

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.

Group Type EXPERIMENTAL

Insulin glargine/Lixisenatide

Intervention Type DRUG

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.

Background therapy

Intervention Type DRUG

Oral Anti diabetics Drugs (OADs) administered orally according to the locally approved label.

Lantus

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.

Group Type ACTIVE_COMPARATOR

Insulin glargine (HOE901)

Intervention Type DRUG

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.

Background therapy

Intervention Type DRUG

Oral Anti diabetics Drugs (OADs) administered orally according to the locally approved label.

Interventions

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Insulin glargine/Lixisenatide

Intervention Type DRUG

Insulin glargine (HOE901)

Intervention Type DRUG

Background therapy

Oral Anti diabetics Drugs (OADs) administered orally according to the locally approved label.

Intervention Type DRUG

Other Intervention Names

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Soliqua 100/33 HOE901/AVE0010 Lantus HOE901

Eligibility Criteria

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Inclusion Criteria

* Participants with type 2 diabetes mellitus (T2DM) diagnosed at least 1 year prior to the screening visit (signing of informed consent).
* Uncontrolled diabetes as demonstrated by a screening centrally measured hemoglobin A1c (HbA1c) between 7.5% and 10% (inclusive).
* Participants who were Hispanics of any race, non-Hispanic black/African Americans or non-Hispanic Asians. Note: Decision for ethnic/racial inclusion was made based on the participant's self-identification. Mixed-race participants must select 1 of the above-mentioned categories. If such selection could not be made, the candidate would be ineligible to participate in the study.
* Participants who had been treated with any basal insulin (ie, glargine - U100 or U300, detemir, degludec, intermediate-acting \[human Neutral Protamine Hagedorn (NPH\]) for at least 6 months prior to Visit 1.
* The basal insulin regimen (ie, type of insulin and time/frequency of the injection) had been stable for at least 3 months prior to Visit 1.
* The basal insulin dose had been stable (defined as up to ±20% \[1/5 of the dose\] variability) for at least 2 months prior to Visit 1 within the following dose ranges:
* 15 to 50 units/day if HbA1c at Visit 1 is less than or equal to (\<=)8.5%, and
* 15 to 40 units/day if HbA1c at Visit 1 is greater than (\>)8.5%.
* Participants receiving 1 or 2 of the following OAD drugs: metformin, pioglitazone/rosiglitazone, an sodium-glucose transport protein 2 (SGLT-2) inhibitor or a sulfonylurea (SU), at stable doses for at least 12 weeks prior to Visit 1.

* Use of any other type of insulin except for basal insulin (e.g., prandial or premixed insulin, insulin pump) within 6 months prior to Visit 1. Note: History of short-term treatment (i.e, \<=10 days) with other insulin types due to intercurrent illness was permitted at the discretion of the Investigator.
* Known history of discontinuation of treatment with a GLP-1 RA due to safety/tolerability reasons.
* Use of systemic glucocorticoids for a total duration of \>7 days within 12 weeks prior to Visit 1.
* Initiation/change in type or dose of a weight loss drug within 12 weeks prior to Visit 1.

The above information is not intended to contain all considerations relevant to a participants's potential participation in a clinical trial.

Exclusion Criteria

* Age \<18 years of age at Visit 1.
* A body mass index (BMI) \<=20 or \>40 kg/m\^2 at Visit 1.
* Fasting plasma glucose (FPG) \>200 mg/dL (by central lab measurement) at Visit 1 (1-time repeat measurement before Visit 2 is permitted).
* Type 1 DM or any diabetes other than T2DM.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Investigational Site Number 8400072

Montgomery, Alabama, United States

Site Status

Investigational Site Number 8400077

Little Rock, Arkansas, United States

Site Status

Investigational Site Number 8400095

Little Rock, Arkansas, United States

Site Status

Investigational Site Number 8400013

Little Rock, Arkansas, United States

Site Status

Investigational Site Number 8400076

Anaheim, California, United States

Site Status

Investigational Site Number 8400052

Anaheim, California, United States

Site Status

Investigational Site Number 8400069

Anaheim, California, United States

Site Status

Investigational Site Number 8400060

Burbank, California, United States

Site Status

Investigational Site Number 8400049

Cerritos, California, United States

Site Status

Investigational Site Number 8400078

Chula Vista, California, United States

Site Status

Investigational Site Number 8400047

Escondido, California, United States

Site Status

Investigational Site Number 8400066

Fountain Valley, California, United States

Site Status

Investigational Site Number 8400050

Greenbrae, California, United States

Site Status