A randomized, 30-week, active-controlled, open label, 2-treatment arm, parallel-group, multicenter study comparing the efficacy and safety of the insulin glargine/lixisenatide fixed ratio combination to insulin glargine with or without metformin in patients with T2DM.

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Updated on 23 November 2020
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Summary

A randomized, 30-week, active-controlled, open label, 2-treatment arm, parallel-group, multicenter study comparing the efficacy and safety of the insulin glargine/lixisenatide fixed ratio combination to insulin glargine with or without metformin in patients with T2DM.

Description

To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination to insulin glargine in HbA1c change from baseline to Week 30.

IRB Number: 014-027

Location: Wadley Tower #656

Facility Name: Baylor Endocrine Center

Facility Street Address: 3600 Gaston Ave.
City: Dallas Zip Code: 75246

Lead Principal Investigator: Dr. Priscilla Hollander

Details
Clinical Study IdentifierTX138965
Last Modified on23 November 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

Gender: Male or Female
Patients with type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year before the screening visit
Patients who have been treated with a basal insulin for at least 6 months before the screening visit
Patients who have been treated with a stable basal insulin regimen (ie, type of insulin and time/frequency of the injection), for at least 3 months before the screening visit
Stable total daily basal insulin dose (±20 %) of between 15 and 40 U/day for at least 2 months before the screening visit
For patients receiving basal insulin AND 1 or 2 oral anti-diabetic drugs (OADs): the OAD dose(s) must be stable during the 3 months before the screening visit
The OADs can be 1 to 2 out of
A metformin (more than or equal to1500mg/day or maximal tolerated dose)
A sulfonylurea (SU)
A glinide
A dipeptidyl-peptidase-4 inhibitor (DPP-4 inhibitor) or a sodium glucose co-transporter 2 inhibitor (SGLT-2 inhibitor)

Exclusion Criteria

At screening visit, age under legal age of adulthood
HbA1c at screening visit <7.5% or >10%
Use of oral or injectable glucose-lowering agents other than those stated in the inclusion criteria in the 3 months before screening
Previous use of insulin regimen other than basal insulin eg, prandial or pre-mixed insulin
History of discontinuation of a previous treatment with glucagon like peptide-1 (GLP-1) receptor agonist for safety/tolerability reasons or lack of efficacy
Any contraindication to metformin use, according to local labeling if the patient is taking metformin
Patient who has a renal function impairment or end-stage renal disease for patients not treated with metformin
History of allergic reaction to any GLP-1 receptor agonist in the past or to metacresol
Contraindication to use of insulin glargine according to local labeling
History of hypersensitivity to insulin glargine or to any of the excipients
History of pancreatitis chronic pancreatitis, pancreatitis during a previous treatment with incretin therapies, pancreatectomy, stomach/gastric surgery
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