Phase 3
N=145
IDegLira HIGH Trial
Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT03737240 ↗Enrolled (actual)
145
Serious AEs
17.9%
Results posted
Sep 2023
Primary outcome: Primary: Change in Hemoglobin A1c (HbA1c) — -3.18; -3.00 percentage of HbA1c
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- IDegLira (Drug); Insulin Degludec (U-100) (Drug); Insulin Aspart (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hemoglobin A1c (HbA1c) |
-3.18; -3.00 | — |
| SECONDARY Average Fasting Blood Glucose |
202.37; 206.53; 131.94; 125.18; 143.31; 143.14 | — |
| SECONDARY Average Daily Blood Glucose |
220.81; 225.18; 143.80; 135.08; 134.59; 144.25 | — |
| SECONDARY Participants With HbA1c <7.0% and no Hypoglycemia |
21; 8 | — |
| SECONDARY Participants With HbA1c <7.0% and no Weight Gain and no Hypoglycemia |
8; 1 | — |
| SECONDARY Participants With HbA1c <7.5% and no Weight Gain and no Hypoglycemia |
19.6; 5.2 | — |
| SECONDARY Participants With HbA1c >10% Achieving HbA1c <7.5% |
56.8; 37.5 | — |
| SECONDARY Participants With HbA1c >10% Achieving HbA1c <8.0% |
61.4; 45.8 | — |
| SECONDARY Participants With HbA1c >11% Achieving HbA1c <7.5% |
52.0; 25.9 | — |
| SECONDARY Participants With HbA1c >11% Achieving HbA1c <8.0% |
60.0; 29.6 | — |
| SECONDARY Participants With HbA1c <7.0% and no Weight Gain |
13; 3 | — |
| SECONDARY Participants With HbA1c <7.0% and no Hypoglycemia |
21; 8 | — |
| SECONDARY Number of Participants With Documented Symptomatic Hypoglycemic Events |
20; 35; 21; 26 | — |
| SECONDARY Asymptomatic Hypoglycemic Events |
— | — |
| SECONDARY Number of Participants With Severe Hypoglycemic Events |
7; 14 | — |
| SECONDARY Nocturnal Symptomatic Hypoglycemic Events |
0.15; 0.16 | — |
| SECONDARY Nocturnal Asymptomatic Hypoglycemic Events |
4.81; 3.45 | — |
| SECONDARY Percentage of Time With Interstitial Glucose <70 mg/dL |
2.67; 1.23 | — |
| SECONDARY Percentage of Time With Interstitial Glucose <54 mg/dL |
0.31; 0.72 | — |
| SECONDARY Percentage of Time With Interstitial Glucose Between 70 and 180 mg/dL |
38.39; 31.17 | — |
| SECONDARY Glycemic Variability |
50.5; 51.6; 41.8; 47.1; 43.6; 48.4 | — |
| SECONDARY Diabetes Treatment Satisfaction Questionnaire - Status (DTSQs) Score |
26.00; 29.07; 33.15; 33.94 | — |
| SECONDARY Diabetes Treatment Satisfaction Questionnaire - Change (DTSQc) Score |
15.55; 15.77 | — |
| SECONDARY Treatment-Related Impact Measures for Diabetes (TRIM-D) Survey Score |
14.94; 15.37; 14.82; 15.29; 15.19; 15.29 | — |
| SECONDARY Number of Emergency Room (ER) Visits |
14; 12 | — |
| SECONDARY Number of Hospital Readmissions |
0; 4 | — |
| SECONDARY Total Daily Insulin Dose |
24.56; 46.05; 35.74; 75.65 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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 180/110 mmHg)
- Female subjects who are pregnant or breast-feeding at time of enrollment into the study
- Females of childbearing potential who are not using adequate contraceptive methods (as required by local law or practice)
- Known or suspected allergy to trial medications (degludec, liraglutide, aspart), excipients, or related products.
- Subjects could be excluded based on PI's discretion
- Unable to comply with trial protocol, and/or at investigator discretion
- Patients receiving treatment for active diabetic retinopathy or with proliferative retinopathy
Data sourced from ClinicalTrials.gov (NCT03737240). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.