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Trial record 58 of 62 for:    Lixisenatide

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 : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE February 9, 2018
First Posted Date  ICMJE February 15, 2018
Last Update Posted Date January 29, 2019
Actual Study Start Date  ICMJE February 20, 2018
Actual Primary Completion Date January 9, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2018)
Change in HbA1c [ Time Frame: Baseline to Week 26 ]
Absolute change from baseline to Week 26 in hemoglobin A1c (HbA1c) (%)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03434119 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2018)
  • 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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010)

    Pharmaceutical form: solution for injection

    Route of administration: subcutaneous

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

    Pharmaceutical form: solution for injection

    Route of administration: subcutaneous

    Other Name: Lantus
Study Arms  ICMJE
  • 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)
    Intervention: Drug: INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010)
  • 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
    Intervention: Drug: Insulin glargine (HOE901)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 25, 2019)
241
Original Estimated Enrollment  ICMJE
 (submitted: February 9, 2018)
1200
Actual Study Completion Date  ICMJE January 9, 2019
Actual Primary Completion Date January 9, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03434119
Other Study ID Numbers  ICMJE LPS14860
U1111-1200-1891 ( Other Identifier: UTN )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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/
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP