The Effect of Simple Basal Insulin Titration Metformin Plus Liraglutide for Type 2 Diabetes With Very Elevated HbA1c - The SIMPLE Study

  • STATUS
    Not Recruiting
  • participants needed
    100
  • sponsor
    University of Texas Southwestern Medical Center
Updated on 23 January 2021
insulin
type 2 diabetes mellitus
metformin
hemoglobin a1c
glycosylated hemoglobin
liraglutide

Summary

The aim of this clinical trial is to assess and compare the effect of insulin detemir in combination with liraglutide and metformin versus insulin detemir in combination with insulin aspart and metformin in subjects with very uncontrolled Type 2 Diabetes (A1c > 10%).

Description

The aim of this study is to compare a GLP-1 plus basal insulin and metformin treatment regimen to a basal-bolus plus metformin treatment regimen in patients with very uncontrolled (HbA1c>10%) type 2 diabetes. The investigators will compare the two regimens with respect to efficacy in improving glycemic control, rate of hypoglycemia, change in weight, effect on patient quality of life, treatment burden, physician time, as well as healthcare related cost. The investigators hypothesize that at 26 weeks from randomization the two treatment regimens will have similar percentage of patients reaching A1c levels <7.0%, while more patients on the GLP-1 plus basal insulin strategy will achieve the composite end point of A1c levels <7.0% without severe hypoglycemia or significant weight gain.

Details
Condition NIDDM, Diabetes Mellitus
Treatment Metformin, Liraglutide, Insulin Aspart, Detemir
Clinical Study IdentifierNCT01966978
SponsorUniversity of Texas Southwestern Medical Center
Last Modified on23 January 2021

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