NCT03737240

IDegLira HIGH Trial

Completed Phase 3 Results posted Last updated 8 September 2023

What this trial tests

Phase 3 trial testing IDegLira in Diabetes Mellitus in 145 participants. Completed in 8 July 2022.

Timeline

15 January 2019

Primary endpoint
8 July 2022

8 July 2022

Quick facts

Lead sponsor	Emory University
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	145
Start date	15 January 2019
Primary completion	8 July 2022
Estimated completion	8 July 2022
Sites	2 locations across United States

Drugs / interventions tested

• IDegLira — full drug profile →
• Insulin Degludec (U-100) — full drug profile →
• Insulin Aspart (INSULIN ASPART) — full drug profile →

Conditions studied

• Diabetes Mellitus — all drugs for Diabetes Mellitus →

Sponsor

Emory University

Who can join

Adults 18 to 80, any sex, with Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Hemoglobin A1c (HbA1c) Primary · Baseline, Week 26

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.

Group	Value	95% CI
IDegLira	-3.18	± 2.29
Basal-Bolus Insulin	-3.00	± 1.79

Average Fasting Blood Glucose Secondary · Week1, Week 12, Week 26

Mean fasting blood glucose will be compared between study arms. Participants will perform an 8-point, self-monitored blood glucose (SMBG) check by testing their blood sugar at 8 different time points. The measurement taken before breakfast is used to assess fasting blood glucose. For people without diabetes, fasting blood glucose is typically between 70-100 mg/dL while fasting blood glucose for those with diabetes is in the range of 70-130 mg/dL.

Baseline (Week 1)

Group	Value	95% CI
IDegLira	202.37	± 63.73
Basal-Bolus Insulin	206.53	± 58.04

Week 12

Group	Value	95% CI
IDegLira	131.94	± 45.59
Basal-Bolus Insulin	125.18	± 29.29

Week 26

Group	Value	95% CI
IDegLira	143.31	± 89.55
Basal-Bolus Insulin	143.14	± 62.81

Average Daily Blood Glucose Secondary · Week1, Week 12, Week 26

Mean daily blood glucose will be compared between study arms. Participants will perform an 8-point, self-monitored blood glucose (SMBG) check by testing their blood sugar at 8 different time points. Blood glucose levels vary depending on when and what food has been consumed. A blood glucose level taken regardless of timing of meals of greater than 200 mg/dL often indicates diabetes. Blood glucose decreases with improved diabetes management.

Week 1 (Baseline)

Group	Value	95% CI
IDegLira	220.81	± 64.43
Basal-Bolus Insulin	225.18	± 65.74

Week 12

Group	Value	95% CI
IDegLira	143.80	± 47.72
Basal-Bolus Insulin	135.08	± 33.51

Week 26

Group	Value	95% CI
IDegLira	134.59	± 36.35
Basal-Bolus Insulin	144.25	± 40.70

Participants With HbA1c <7.0% and no Hypoglycemia Secondary · Week 26

Percent of study participants experiencing HbA1c \<7.0% and no hypoglycemia will be compared between groups. 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. Hypoglycemia is defined as a blood glucose level of \< 70 mg/dL.

Group	Value	95% CI
IDegLira	19
Basal-Bolus Insulin	6

Participants With HbA1c <7.0% and no Weight Gain and no Hypoglycemia Secondary · Week 26

Percent of study participants reaching A1c \< 7% without weight gain and no hypoglycemia will be compared between groups. Weight control is typically important in persons with type 2 diabetes and basal-bolus insulin is associated with weight gain. 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. Hypoglycemia is defined as a blood glucose level of \< 70 mg/dL.

Group	Value	95% CI
IDegLira	8
Basal-Bolus Insulin	1

Participants With HbA1c <7.5% and no Weight Gain and no Hypoglycemia Secondary · Week 26

Percent of study participants reaching A1c \< 7.5% without weight gain and no hypoglycemia will be compared between groups. Weight control is typically important in persons with type 2 diabetes and basal-bolus insulin is associated with weight gain. 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. Hypoglycemia is defined as a blood glucose level of \< 70 mg/dL.

Group	Value	95% CI
IDegLira	19.6
Basal-Bolus Insulin	5.2

Participants With HbA1c >10% Achieving HbA1c <7.5% Secondary · Baseline, Week 26

Percent of study participants with baseline HbA1c \>10% reaching A1c \< 7.5% 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% bein

Group	Value	95% CI
IDegLira	56.8
Basal-Bolus Insulin	37.5

Participants With HbA1c >10% Achieving HbA1c <8.0% Secondary · Baseline, Week 26

Percent of study participants with baseline HbA1c \>10% reaching A1c \< 8.0% 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% bein

Group	Value	95% CI
IDegLira	61.4
Basal-Bolus Insulin	45.8

Participants With HbA1c >11% Achieving HbA1c <7.5% Secondary · Baseline, Week 26

Percent of study participants with baseline HbA1c \>11% reaching A1c \< 7.5% 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% bein

Group	Value	95% CI
IDegLira	52.0
Basal-Bolus Insulin	25.9

Participants With HbA1c >11% Achieving HbA1c <8.0% Secondary · Baseline, Week 26

Percent of study participants with baseline HbA1c \>11% reaching A1c \< 8.0% 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% bein

Group	Value	95% CI
IDegLira	60.0
Basal-Bolus Insulin	29.6

Participants With HbA1c <7.0% and no Weight Gain Secondary · Week 26

Percent of study participants reaching A1c \< 7% without weight gain will be compared between groups.

Group	Value	95% CI
IDegLira	13
Basal-Bolus Insulin	3

Participants With HbA1c <7.0% and no Hypoglycemia Secondary · Week 12

Percent of study participants reaching A1c \< 7% without hypoglycemia will be compared between groups. Hypoglycemia is defined as a blood glucose level of \< 70 mg/dL.

Group	Value	95% CI
IDegLira	21
Basal-Bolus Insulin	8

Adverse events — posted to ClinicalTrials.gov

Time frame: Duration of the study participation from enrollment up to 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

IDegLira

Serious: 14/72 (19%)

Deaths: 0/72

Basal-Bolus Insulin

Serious: 12/73 (16%)

Deaths: 0/73

Serious adverse events (2 terms)

Reaction	System	IDegLira	Basal-Bolus Insulin
Emergency Room Visits	General disorders	—	—
Hospital Readmissions	General disorders	—	—

Other adverse events (4 terms — click to expand)

Reaction	System	IDegLira	Basal-Bolus Insulin
Nausea	Gastrointestinal disorders	—	—
Abdominal Pain	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—

Most-reported serious reactions: Emergency Room Visits, Hospital Readmissions.

Data from ClinicalTrials.gov NCT03737240 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Randomized Controlled Trial Comparing the Efficacy and Safety of IDegLira Versus Basal-Bolus in Patients With Poorly Controlled Type 2 Diabetes and Very High HbA1c ≥9-15%: DUAL HIGH Trial.
   Galindo RJ, Moazzami B, Scioscia MF, Zambrano C, et al · · 2023 · cited 12× · PMID 37459574 · DOI 10.2337/dc22-2426
2. Efficacy of Simplifying Complex Insulin Regimen on Glycometabolic Parameters and Target Organ Damage in Type 2 Diabetes: A Retrospective Cohort Study.
   Fejes R, Kádár C, Kovács-Huber R, Taybani Z, et al · · 2025 · PMID 40264573 · DOI 10.1155/jdr/9141564