IDegLira HIGH Trial

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT03737240
Phase
PHASE3
Status
Completed

Conditions

  • Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • IDegLira — DRUG
    Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL).
  • Insulin Degludec (U-100) — DRUG
    Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose.
  • Insulin Aspart — DRUG
    Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL.

Study Details

Basal-bolus insulin therapy is recommended for patients with poorly controlled type 2 diabetes (T2D) and HbA1c \>9%. However, basal-bolus insulin is labor intensive and associated with increased risk of hypoglycemia, glycemic variability, weight gain and poor compliance. Thus, there is a critical need for a simpler treatment regimen that could overcome these limitations. IDegLira, a fixed-ratio combination (FRC) therapy consisting of insulin degludec and liraglutide, is an attractive option for this population given its proven benefits on glycemic control, weight and compliance. This study aims to show that a simpler regimen using a novel FRC agent (IDegLira) can improve glycemic control, decrease hypoglycemia, reduce the burden of diabetes care, and improve satisfaction/adherence in patients with poorly controlled T2D with HbA1c between ≥ 9-12%. This open-label, treat-to- target, two-arm parallel, controlled trial will randomize participants with T2D and HbA1c ≥ 9%, treated with oral anti-diabetic agents and/or basal insulin therapy to lDegLira or basal-bolus insulin for 26 weeks.

Key Dates

Start date
Jan 15, 2019
Status verified
Aug 2023
Primary completion
Jul 8, 2022
Completion
Jul 8, 2022

Study Design

Enrollment
145 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IDegLira
    Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks.
  • Active Comparator: Basal-Bolus Insulin
    Participants in this group will receive basal-bolus insulin (with metformin, unless contraindicated) for 26 weeks. The basal-bolus insulin regimen includes Insulin Degludec (U-100) and Insulin Aspart.

Primary Outcome Measure

Change in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 26 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Emory ClinicAtlantaGeorgia30322-
Grady Health SystemAtlantaGeorgia30303-

Find similar trials in Atlanta, GA

By research site
Emory Clinic· Atlanta, GAGrady Health System· Atlanta, GA

Related Studies