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Trial record 4 of 8 for:    LixiLan

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 (LixiLan-D)

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ClinicalTrials.gov Identifier: NCT03434119
Recruitment Status : Terminated ("Trial terminated (recruitment delays)")
First Posted : February 15, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010) Drug: Insulin glargine (HOE901) Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 20, 2018
Actual Primary Completion Date : November 19, 2018
Actual Study Completion Date : November 19, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Other Name: Soliqua 100/33

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

Other Name: Lantus




Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: Baseline to Week 26 ]
    Absolute change from baseline to Week 26 in hemoglobin A1c (HbA1c) (%)


Secondary Outcome Measures :
  1. Patients with HbA1c<7% [ Time Frame: Week 26 ]
    Percentage (%) of patients achieving the HbA1c target of <7% at Week 26

  2. 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

  3. 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

  4. Change in insulin glargine dose [ Time Frame: Baseline to Week 26 ]
    Change from baseline to Week 26 in daily insulin glargine dose

  5. Change in body weight [ Time Frame: Baseline to Week 26 ]
    Change from baseline to Week 26 in body weight

  6. Hypoglycemia events [ Time Frame: Baseline to Week 26 ]
    Percentage of patients with documented hypoglycemia (plasma glucose values ≤70 mg/dL [3.9 mmol/L])

  7. Hypoglycemia events [ Time Frame: Baseline to Week 26 ]
    Percentage of patients with documented hypoglycemia (plasma glucose values <54 mg/dL [3.0 mmol/L])

  8. Hypoglycemia events [ Time Frame: Baseline to Week 26 ]
    Percentage of patients with severe hypoglycemia

  9. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434119


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Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03434119     History of Changes
Other Study ID Numbers: LPS14860
U1111-1200-1891 ( Other Identifier: UTN )
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Lixisenatide
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs