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Status:

TERMINATED

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

Lead Sponsor:

Sanofi

Conditions:

Type 2 Diabetes Mellitus

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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 ...

Detailed Description

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.

Eligibility Criteria

Inclusion

  • 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.
  • 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.
  • 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 (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

    Key Trial Info

    Start Date :

    February 20 2018

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 7 2019

    Estimated Enrollment :

    241 Patients enrolled

    Trial Details

    Trial ID

    NCT03434119

    Start Date

    February 20 2018

    End Date

    January 7 2019

    Last Update

    March 28 2022

    Active Locations (85)

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    Page 1 of 22 (85 locations)

    1

    Investigational Site Number 8400072

    Montgomery, Alabama, United States, 36106

    2

    Investigational Site Number 8400077

    Little Rock, Arkansas, United States, 72204

    3

    Investigational Site Number 8400095

    Little Rock, Arkansas, United States, 72205

    4

    Investigational Site Number 8400013

    Little Rock, Arkansas, United States, 72211