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

ID: NCT03434119
Status: Recruiting
Phase: Phase 3
Start Date: February 07, 2018
First Submitted: February 09, 2018
Last Updated: February 20, 2018
Results: N/A
Organization: Sanofi
Sponsors & Collaborators: Sanofi
Location: United States
Conditions: Type 2 Diabetes Mellitus
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Study Description

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 as approximately 29 weeks including 2 weeks screening period, 26 weeks open label treatment period, and a 3 days follow-up period.
Condition or disease Intervention/treatment Phase

Type 2 Diabetes Mellitus

Drug: INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010)
Other Names
Soliqua 100/33
Drug: Insulin glargine (HOE901)
Other Names
Lantus
Phase 3

Tracking Information

First Submitted DateFebruary 09, 2018
Last Update Posted DateFebruary 20, 2018
Actual Start DateFebruary 07, 2018
Anticipated Completion DateSeptember 01, 2019
Actual Primary Completion DateSeptember 01, 2019
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Change in HbA1c [Time Frame: Baseline to Week 26]

    Absolute change from baseline to Week 26 in hemoglobin A1c (HbA1c) (%)

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Patients with HbA1c<7% [Time Frame: Week 26]

    Percentage (%) of patients achieving the HbA1c target of <7% at Week 26

  • Change in 2-hour post-prandial glucose (PPG) [Time Frame: Baseline to Week 26]

    Change in the 2-hour post-prandial glucose (PPG) as measured utilizing a standardized meal test at Week 26

  • Change in 2-hour glucose excursion [Time Frame: Baseline to Week 26]

    Change in 2-hour glucose excursions as measured utilizing a standardized meal test at Week 26

  • Change in insulin glargine dose [Time Frame: Baseline to Week 26]

    Change from baseline to Week 26 in daily insulin glargine dose

  • Change in body weight [Time Frame: Baseline to Week 26]

    Change from baseline to Week 26 in body weight

  • Hypoglycemia events [Time Frame: Baseline to Week 26]

    Percentage of patients with documented hypoglycemia (plasma glucose values ≤70 mg/dL [3.9 mmol/L])

  • Hypoglycemia events [Time Frame: Baseline to Week 26]

    Percentage of patients with documented hypoglycemia (plasma glucose values <54 mg/dL [3.0 mmol/L])

  • Hypoglycemia events [Time Frame: Baseline to Week 26]

    Percentage of patients with severe hypoglycemia

  • Adverse events (AEs) [Time Frame: Up to Week 26]

    Number of AEs including serious AEs/AEs leading to death and AEs leading to permanent treatment discontinuation

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleEfficacy 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
Official TitleA 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
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 as approximately 29 weeks including 2 weeks screening period, 26 weeks open label treatment period, and a 3 days follow-up period.

Study TypeInterventional
Study PhasePhase 3
Estimated Enrollment
1200
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
None (Open Label)
Primary Purpose
Treatment
Conditions
Type 2 Diabetes Mellitus
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010)

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Other Names
Soliqua 100/33
Drug: Insulin glargine (HOE901)

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Other Names
Lantus
Study Groups/Cohorts
Soliqua 100/33
Soliqua 100/33 once daily in the morning an hour before breakfast on top of background 1 or 2 antidiabetic agents (OADs)

Lantus
Lantus once daily at any time of the day but at about the same time every day on top of background 1 or 2 OADs

Study Arms
Active Comparator Lantus
Lantus once daily at any time of the day but at about the same time every day on top of background 1 or 2 OADs
Drug : Insulin glargine (HOE901)
Pharmaceutical form: solution for injection Route of administration: subcutaneous

Experimental Soliqua 100/33
Soliqua 100/33 once daily in the morning an hour before breakfast on top of background 1 or 2 antidiabetic agents (OADs)
Drug : INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010)
Pharmaceutical form: solution for injection Route of administration: subcutaneous

Arm Intervention/Treatment
Active Comparator Lantus
Lantus once daily at any time of the day but at about the same time every day on top of background 1 or 2 OADs
Drug : Insulin glargine (HOE901)
Experimental Soliqua 100/33
Soliqua 100/33 once daily in the morning an hour before breakfast on top of background 1 or 2 antidiabetic agents (OADs)
Drug : INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010)

Recruitment Information

Recruitment Status:Recruiting
Enrollment1200
Completion DateSeptember 01, 2019
Eligibility Criteria: Inclusion criteria :
- Patients 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).
- Patients who are Hispanics of any race, non-Hispanic black/African Americans or non-Hispanic Asians. Note: Decision for ethnic/racial inclusion will be made based on the patient's self-identification. Mixed-race patients must select 1 of the above-mentioned categories. If such selection cannot be made, the candidate will be ineligible to participate in the study.
- Patients who have 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) has been stable for at least 3 months prior to Visit 1.
- The basal insulin dose has 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 ≤8.5%, and
- 15 to 40 units/day if HbA1c at Visit 1 is >8.5%.
- Patients receiving 1 or 2 of the following oral anti-diabetic (OAD) drugs: metformin, pioglitazone/rosiglitazone, an SGLT-2 inhibitor or a sulfonylurea (SU), at stable doses for at least 12 weeks prior to Visit 1.
Exclusion criteria:
- Age <18 years of age at Visit 1.
- A body mass index (BMI) ≤20 or >40 kg/m2 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.
- Any use of OAD drugs other than those described in the inclusion criteria (e.g., but not limited to, glucagon like peptide-1 receptor agonist (GLP-1 RA), dipeptidyl peptidase 4 (DPP4) inhibitors) within 12 weeks prior 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 (ie, ≤10 days) with other insulin types due to intercurrent illness is 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 patient's potential participation in a clinical trial.
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
United States

Administrative Information

NCT Number:NCT03434119
Other Study ID Numbers
LPS14860
U1111-1200-1891
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Sanofi
Collaborators
Not Available
Investigators
Study Director
Clinical Sciences & Operations
Sanofi