Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 58 of 61 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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 241 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 : January 9, 2019
Actual Study Completion Date : January 9, 2019

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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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


  Hide Study Locations
Locations
Layout table for location information
United States, Alabama
Investigational Site Number 8400072
Montgomery, Alabama, United States, 36106
United States, Arkansas
Investigational Site Number 8400077
Little Rock, Arkansas, United States, 72204
Investigational Site Number 8400095
Little Rock, Arkansas, United States, 72205
Investigational Site Number 8400013
Little Rock, Arkansas, United States, 72211
United States, California
Investigational Site Number 8400076
Anaheim, California, United States, 92801-4123
Investigational Site Number 8400052
Anaheim, California, United States, 92801
Investigational Site Number 8400069
Anaheim, California, United States, 92805
Investigational Site Number 8400060
Burbank, California, United States, 91505
Investigational Site Number 8400049
Cerritos, California, United States, 90703
Investigational Site Number 8400078
Chula Vista, California, United States, 91910
Investigational Site Number 8400047
Escondido, California, United States, 92025
Investigational Site Number 8400066
Fountain Valley, California, United States, 92708
Investigational Site Number 8400050
Greenbrae, California, United States, 94904
Investigational Site Number 8400092
Huntington Park, California, United States, 90255
Investigational Site Number 8400015
Los Angeles, California, United States, 90017
Investigational Site Number 8400011
Los Angeles, California, United States, 90057
Investigational Site Number 8400301
Los Angeles, California, United States, 90094
Investigational Site Number 8400302
Los Angeles, California, United States, 90094
Investigational Site Number 8400303
Los Angeles, California, United States, 90094
Investigational Site Number 8400304
Los Angeles, California, United States, 90094
Investigational Site Number 8400006
Los Gatos, California, United States, 95032
Investigational Site Number 8400048
Oakland, California, United States, 94612
Investigational Site Number 8400053
Orange, California, United States, 92868
Investigational Site Number 8400084
Pomona, California, United States, 91766
Investigational Site Number 8400081
Pomona, California, United States, 91767
Investigational Site Number 8400042
Rancho Cucamonga, California, United States, 91730
Investigational Site Number 8400063
San Carlos, California, United States, 94070
Investigational Site Number 8400091
San Diego, California, United States, 92114
Investigational Site Number 8400086
San Jose, California, United States, 95148
Investigational Site Number 8400074
Santa Ana, California, United States, 92701
Investigational Site Number 8400037
Temecula, California, United States, 92591
Investigational Site Number 8400087
Vallejo, California, United States, 94592
Investigational Site Number 8400024
Van Nuys, California, United States, 91405
Investigational Site Number 8400007
Ventura, California, United States, 93003
United States, Colorado
Investigational Site Number 8400054
Englewood, Colorado, United States, 80113
United States, Connecticut
Investigational Site Number 8400023
Hamden, Connecticut, United States, 06517
United States, Florida
Investigational Site Number 8400041
Gainesville, Florida, United States, 32653
Investigational Site Number 8400075
Jacksonville, Florida, United States, 32204
Investigational Site Number 8400016
Miami Lakes, Florida, United States, 33014
Investigational Site Number 8400036
Miami, Florida, United States, 33144
Investigational Site Number 8400017
Miami, Florida, United States, 33176
Investigational Site Number 8400014
Ocoee, Florida, United States, 34761
Investigational Site Number 8400028
Port Charlotte, Florida, United States, 33952
Investigational Site Number 8400097
Saint Petersburg, Florida, United States, 00000
Investigational Site Number 8400035
Saint Petersburg, Florida, United States, 33713
Investigational Site Number 8400094
Tampa, Florida, United States, 33634
United States, Georgia
Investigational Site Number 8400025
Atlanta, Georgia, United States, 30303
Investigational Site Number 8400051
Atlanta, Georgia, United States, 30310
Investigational Site Number 8400093
Atlanta, Georgia, United States, 30318
Investigational Site Number 8400005
Savannah, Georgia, United States, 31406-2675
United States, Illinois
Investigational Site Number 8400038
Chicago, Illinois, United States, 60607
Investigational Site Number 8400088
Chicago, Illinois, United States, 60607
Investigational Site Number 8400031
Des Plaines, Illinois, United States, 60018
Investigational Site Number 8400064
Evanston, Illinois, United States, 60201
Investigational Site Number 8400057
Gurnee, Illinois, United States, 60031
United States, Louisiana
Investigational Site Number 8400030
Gretna, Louisiana, United States, 70053
Investigational Site Number 8400009
New Orleans, Louisiana, United States, 70124
United States, Maryland
Investigational Site Number 8400065
Baltimore, Maryland, United States, 21237
Investigational Site Number 8400061
Rockville, Maryland, United States, 20852
United States, Michigan
Investigational Site Number 8400079
Chelsea, Michigan, United States, 48118
Investigational Site Number 8400001
Flint, Michigan, United States, 48504
Investigational Site Number 8400012
Flint, Michigan, United States, 48532-3447
United States, Nevada
Investigational Site Number 8400090
Las Vegas, Nevada, United States, 89117
Investigational Site Number 8400082
Las Vegas, Nevada, United States, 89148
United States, New Jersey
Investigational Site Number 8400018
Linden, New Jersey, United States, 07036
United States, New York
Investigational Site Number 8400003
Bronx, New York, United States, 10455
United States, Pennsylvania
Investigational Site Number 8400062
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Investigational Site Number 8400043
Columbia, South Carolina, United States, 29204
United States, Texas
Investigational Site Number 8400021
Dallas, Texas, United States, 75230
Investigational Site Number 8400040
Fort Worth, Texas, United States, 76132
Investigational Site Number 8400045
Houston, Texas, United States, 77089
Investigational Site Number 8400002
Humble, Texas, United States, 77338
Investigational Site Number 8400039
Kerrville, Texas, United States, 78028
Investigational Site Number 8400096
Lufkin, Texas, United States, 75904
Investigational Site Number 8400027
San Antonio, Texas, United States, 78228
Investigational Site Number 8400083
San Antonio, Texas, United States, 78230
Investigational Site Number 8400008
Splendora, Texas, United States, 77372
Investigational Site Number 8400055
Spring, Texas, United States, 77379
Investigational Site Number 8400070
Sugar Land, Texas, United States, 77478
Investigational Site Number 8400085
Sugar Land, Texas, United States, 77479
Investigational Site Number 8400059
Webster, Texas, United States, 77598
United States, Virginia
Investigational Site Number 8400044
Manassas, Virginia, United States, 20110
Investigational Site Number 8400068
Norfolk, Virginia, United States, 23510
Investigational Site Number 8400033
Richmond, Virginia, United States, 23219
United States, Washington
Investigational Site Number 8400029
Richland, Washington, United States, 99352
Sponsors and Collaborators
Sanofi
Investigators
Layout table for investigator information
Study Director: Clinical Sciences & Operations Sanofi

Layout table for additonal information
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: January 29, 2019
Last Verified: January 2019
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/

Layout table for additional information
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:
Layout table for MeSH terms
Lixisenatide
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs