IDegLira HIGH Trial

NCT03737240 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: IRB00104726
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Diabetes Mellitus

Keywords

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin A1c (HbA1c)

  HbA1c will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% or lower, with below 7.0% being preferable.

  Baseline, Week 26

Secondary Outcomes (26)

• Average Fasting Blood Glucose

  Week1, Week 12, Week 26

• Average Daily Blood Glucose

  Week1, Week 12, Week 26

• Participants With HbA1c <7.0% and no Hypoglycemia

  Week 26

• Participants With HbA1c <7.0% and no Weight Gain and no Hypoglycemia

  Week 26

• Participants With HbA1c <7.5% and no Weight Gain and no Hypoglycemia

  Week 26

Study Arms (2)

IDegLira

EXPERIMENTAL

Participants in this group will receive IDegLira (with metformin, unless contraindicated) for 26 weeks.

Drug: IDegLira

Basal-Bolus Insulin

ACTIVE COMPARATOR

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.

Drug: Insulin Degludec (U-100); Drug: Insulin Aspart

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).

Also known as: Xultophy 100/3.6, insulin degludec, liraglutide

IDegLira

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.

Also known as: Tresiba FlexTouch

Basal-Bolus Insulin

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.

Also known as: NovoLog

Basal-Bolus Insulin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes, diagnosed for ≥ 6 months
• HBA1c ≥ 9% - 15%
• Previously treated with oral antidiabetic agents, including metformin, sulfonylurea, repaglinide/nateglinide, pioglitazone, dipeptidyl peptidase-4 (DPP4), inhibitors, SGLT2 inhibitors, (monotherapy + basal insulin) or in combination therapy (2-3 agents), and/or on basal insulin (neutral protamine hagedorn (NPH), detemir or glargine U100) at a total daily dose (TDD) 20-50 units (stable doses of metformin and basal insulin for at least 90 days, defined as up to ±10% variability)
• Body mass index (BMI) ≤ 45 Kg/m2

You may not qualify if:

• Subjects with type 1 diabetes or latent autoimmune diabetes of adults (LADA) (positive glutamic acid decarboxylase (GAD-65) antibody and/or ketones)
• Subjects with a BG \> 400 mg/dL during the screening visit and laboratory evidence of diabetic ketoacidosis
• Previous treatment with glucagon-like peptide-1 (GLP-1) agonists (during prior 3 months)
• Previous treatment with basal-bolus insulin (within prior 3 months)
• Recurrent severe hypoglycemia or known hypoglycemia unawareness.
• Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia 2
• Patients with acute or chronic pancreatitis, pancreatic cancer
• Patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease) or significantly impaired renal function (GFR \< 30 ml/min).
• Treatment with oral or injectable corticosteroid (equivalent or higher than prednisone 5 mg/day), parenteral nutrition and immunosuppressive treatment.
• Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
• Hypersensitivity to study drugs
• Participating in another investigational drug trial
• The receipt of any investigational drug (within 3 months) prior to this trial.
• Previously randomized in this trial
• Heart Failure New York Heart Association (NYHA) class 4 or uncontrolled hypertension (blood pressure \> 180/110 mmHg)

Sponsors & Collaborators

• Emory University: lead
• Novo Nordisk A/S: collaborator

Study Sites (2)

Grady Health System

Atlanta, Georgia, 30303, United States

Location

Emory Clinic

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

IDegLira; insulin degludec; Liraglutide; Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Rodolfo Galindo
• Organization: University of Miami Miller School of Medicine

Rodolfo.galindo@miami.edu

305-243-7707

Study Officials

• Rodolfo Galindo, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomized in a 1 to 1 ratio to receive the study treatment or standard of care.

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 9, 2018
• Study Start: January 15, 2019
• Primary Completion: July 8, 2022
• Study Completion: July 8, 2022
• Last Updated: September 8, 2023
• Results First Posted: September 8, 2023

Record last verified: 2023-08

Locations

US (2)