DelfaGLP-1 Atlas

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CompletedPhase 3Results posted

IDegLira HIGH Trial

A Randomized Controlled Trial Comparing the Safety and Efficacy of IDegLira Versus Basal Bolus in Patients With Poorly Controlled Type 2 Diabetes

Lead sponsor

Emory University

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

2

Recruiting sites

—

Enrollment

145

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≤45•HbA1c 9-15%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03737240
Org study IDIRB00104726

Timeline

Milestones

Study first posted2018-11-09actual
Study start2019-01-15actual
Primary completion2022-07-08actual
Study completion2022-07-08actual
Last update posted2023-09-08actual
Results first posted2023-09-08actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

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 < 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)
•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

Endpoints (54)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
33
Safety / tolerability / PK
12
Patient-reported / QoL
6
Cardiovascular outcomes
2
Other clinical outcomes
1

Cardiovascular outcomes

2 endpoints
Secondary/registry result

Number of Hospital Readmissions

Time frame:Baseline through Week 26

All-cause hospitalization

event count, event

Posted result

GroupValue (number), Number of Hospital readmissions95% CI
IDegLira0—
Basal-Bolus Insulin4—
Secondary/protocol endpoint

Number of Hospital Readmissions

Time frame:Baseline through Week 26

All-cause hospitalization

event count, event

Glycemic / diabetes

33 endpoints
Primary/registry result

Change in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (mean), percentage of HbA1c95% CI
IDegLira-3.18—
Basal-Bolus Insulin-3.00—
Primary/protocol endpoint

Change in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Average Fasting Blood Glucose

Time frame:Week1, Week 12, Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (mean), mg/dL95% CI
IDegLiraBaseline (Week 1)202.37—
Week 12131.94—
Week 26143.31—
Basal-Bolus InsulinBaseline (Week 1)206.53—
Week 12125.18—
Week 26143.14—
Secondary/registry result

Average Daily Blood Glucose

Time frame:Week1, Week 12, Week 26

descriptive, improvement

Posted result

GroupValue (mean), mg/dL95% CI
IDegLiraWeek 1 (Baseline)220.81—
Week 12143.80—
Week 26134.59—
Basal-Bolus InsulinWeek 1 (Baseline)225.18—
Week 12135.08—
Week 26144.25—
Secondary/registry result

Participants With HbA1c <7.0% and no Hypoglycemia

Time frame:Week 26

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Documented hypoglycemia

Posted result

GroupValue (count_of_participants), Participants95% CI
IDegLira19—
Basal-Bolus Insulin6—
Secondary/registry result

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

Time frame:Week 26

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Body weight, absolute change (kg), Documented hypoglycemia

Posted result

GroupValue (count_of_participants), Participants95% CI
IDegLira8—
Basal-Bolus Insulin1—
Secondary/registry result/low confidence

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

Time frame:Week 26

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Body weight, absolute change (kg), Documented hypoglycemia

Posted result

GroupValue (number), percentage of participants95% CI
IDegLira19.6—
Basal-Bolus Insulin5.2—
Secondary/registry result

Participants With HbA1c >10% Achieving HbA1c <7.5%

Time frame:Baseline, Week 26

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), percentage of participants95% CI
IDegLira56.8—
Basal-Bolus Insulin37.5—
Secondary/registry result

Participants With HbA1c >10% Achieving HbA1c <8.0%

Time frame:Baseline, Week 26

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), percentage of participants95% CI
IDegLira61.4—
Basal-Bolus Insulin45.8—
Secondary/registry result

Participants With HbA1c >11% Achieving HbA1c <7.5%

Time frame:Baseline, Week 26

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), percentage of participants95% CI
IDegLira52.0—
Basal-Bolus Insulin25.9—
Secondary/registry result

Participants With HbA1c >11% Achieving HbA1c <8.0%

Time frame:Baseline, Week 26

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (number), percentage of participants95% CI
IDegLira60.0—
Basal-Bolus Insulin29.6—
Secondary/registry result

Participants With HbA1c <7.0% and no Weight Gain

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

GroupValue (count_of_participants), Participants95% CI
IDegLira13—
Basal-Bolus Insulin3—
Secondary/registry result

Participants With HbA1c <7.0% and no Hypoglycemia

Time frame:Week 12

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Documented hypoglycemia

LOINC 4548-4

Posted result

GroupValue (count_of_participants), Participants95% CI
IDegLira21—
Basal-Bolus Insulin8—
Secondary/registry result

Percentage of Time With Interstitial Glucose <70 mg/dL

Time frame:Baseline through Week 26

CGM time-below-range

descriptive, improvement

Posted result

GroupValue (mean), % of time95% CI
IDegLira2.67—
Basal-Bolus Insulin1.23—
Secondary/registry result

Percentage of Time With Interstitial Glucose Between 70 and 180 mg/dL

Time frame:Baseline through Week 26

CGM time-in-range

descriptive, improvement

Posted result

GroupValue (mean), % of time95% CI
IDegLira38.39—
Basal-Bolus Insulin31.17—
Secondary/registry result

Glycemic Variability

Time frame:Week1, Week 12, Week 26

descriptive, improvement

Posted result

GroupValue (mean), mg/dl95% CI
IDegLiraCGM Week 150.5—
CGM Week 1241.8—
CGM Week 2643.6—
Basal-Bolus InsulinCGM Week 151.6—
CGM Week 1247.1—
CGM Week 2648.4—
Secondary/registry result

Total Daily Insulin Dose

Time frame:Baseline, Week 26

change from baseline, improvement

Posted result

GroupValue (mean), units per day95% CI
IDegLiraBaseline24.56—
26 weeks35.74—
Basal-Bolus InsulinBaseline46.05—
26 weeks75.65—
Secondary/protocol endpoint

Average Fasting Blood Glucose

Time frame:Week1, Week 12, Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Average Daily Blood Glucose

Time frame:Week1, Week 12, Week 26

descriptive, improvement

Secondary/protocol endpoint

Participants With HbA1c <7.0% and no Hypoglycemia

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Documented hypoglycemia

Secondary/protocol endpoint

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

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Body weight, absolute change (kg), Documented hypoglycemia

LOINC 4548-4

Secondary/protocol endpoint

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

Time frame:Week 26

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Body weight, absolute change (kg), Documented hypoglycemia

Secondary/protocol endpoint

Participants With HbA1c >10% Achieving HbA1c <7.5%

Time frame:Baseline, Week 26

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants With HbA1c >10% Achieving HbA1c <8.0%

Time frame:Baseline, Week 26

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants With HbA1c >11% Achieving HbA1c <7.5%

Time frame:Baseline, Week 26

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants With HbA1c >11% Achieving HbA1c <8.0%

Time frame:Baseline, Week 26

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants With HbA1c <7.0% and no Weight Gain

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Body weight, absolute change (kg)

LOINC 4548-4

Secondary/protocol endpoint

Participants With HbA1c <7.0% and no Hypoglycemia

Time frame:Week 12

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Documented hypoglycemia

Secondary/protocol endpoint

Percentage of Time With Interstitial Glucose <70 mg/dL

Time frame:Baseline through Week 26

CGM time-below-range

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of Time With Interstitial Glucose <54 mg/dL

Time frame:Baseline through Week 26

CGM time-below-range

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of Time With Interstitial Glucose Between 70 and 180 mg/dL

Time frame:Baseline through Week 26

CGM time-in-range

percent change from baseline, improvement

Secondary/protocol endpoint

Glycemic Variability

Time frame:Week1, Week 12, Week 26

descriptive, improvement

Secondary/protocol endpoint

Total Daily Insulin Dose

Time frame:Baseline, Week 26

change from baseline, improvement

Patient-reported / QoL

6 endpoints
Secondary/registry result

Diabetes Treatment Satisfaction Questionnaire - Status (DTSQs) Score

Time frame:Baseline, Week 12

change from baseline, improvement

Posted result

GroupValue (mean), score on a scale95% CI
IDegLiraBaseline26.00—
Follow up at 24 weeks33.15—
Basal-Bolus InsulinBaseline29.07—
Follow up at 24 weeks33.94—
Secondary/registry result

Diabetes Treatment Satisfaction Questionnaire - Change (DTSQc) Score

Time frame:Week 26

change from baseline, improvement

Posted result

GroupValue (mean), score on a scale95% CI
IDegLira15.55—
Basal-Bolus Insulin15.77—
Secondary/registry result

Treatment-Related Impact Measures for Diabetes (TRIM-D) Survey Score

Time frame:Baseline, Week 12, Week 26

descriptive, improvement

Posted result

GroupValue (mean), score on a scale95% CI
IDegLiraBaseline14.94—
3 months follow up14.82—
6 months follow up15.19—
Basal-Bolus InsulinBaseline15.37—
3 months follow up15.29—
6 months follow up15.29—
Secondary/protocol endpoint

Diabetes Treatment Satisfaction Questionnaire - Status (DTSQs) Score

Time frame:Baseline, Week 12

change from baseline, improvement

Secondary/protocol endpoint

Diabetes Treatment Satisfaction Questionnaire - Change (DTSQc) Score

Time frame:Week 26

PGI, change

change from baseline, improvement

Secondary/protocol endpoint

Treatment-Related Impact Measures for Diabetes (TRIM-D) Survey Score

Time frame:Baseline, Week 12, Week 26

change from baseline, improvement

Safety / tolerability / PK

12 endpoints
Secondary/registry result

Number of Participants With Documented Symptomatic Hypoglycemic Events

Time frame:Baseline through Week 26

Documented hypoglycemia

event count, event

Posted result

GroupValue (number), participants95% CI
IDegLiraHypoglycemia < 70 mg/dL20—
Hypoglycemia < 54 mg/dL by CGM21—
Basal-Bolus InsulinHypoglycemia < 70 mg/dL35—
Hypoglycemia < 54 mg/dL by CGM26—
Secondary/registry result

Asymptomatic Hypoglycemic Events

Time frame:Baseline through Week 26

Documented hypoglycemia

event count, event

Secondary/registry result

Number of Participants With Severe Hypoglycemic Events

Time frame:Baseline through Week 26

Severe hypoglycemia

event count, event

Posted result

GroupValue (number), participants95% CI
IDegLira7—
Basal-Bolus Insulin14—
Secondary/registry result

Nocturnal Symptomatic Hypoglycemic Events

Time frame:Baseline through Week 26

Documented hypoglycemia

event count, event

Posted result

GroupValue (mean), Number of events95% CI
IDegLira0.15—
Basal-Bolus Insulin0.16—
Secondary/registry result

Nocturnal Asymptomatic Hypoglycemic Events

Time frame:Baseline through Week 26

Documented hypoglycemia

event count, event

Posted result

GroupValue (mean), Number of events95% CI
IDegLira4.81—
Basal-Bolus Insulin3.45—
Secondary/registry result

Percentage of Time With Interstitial Glucose <54 mg/dL

Time frame:Baseline through Week 26

CGM time-below-range

descriptive, event

Posted result

GroupValue (mean), % of time95% CI
IDegLira0.31—
Basal-Bolus Insulin0.72—
Secondary/protocol endpoint

Number of Participants With Documented Symptomatic Hypoglycemic Events

Time frame:Baseline through Week 26

Documented hypoglycemia

threshold achievement, event

Secondary/protocol endpoint

Asymptomatic Hypoglycemic Events

Time frame:Baseline through Week 26

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of Participants With Severe Hypoglycemic Events

Time frame:Baseline through Week 26

Severe hypoglycemia

event count, event

Secondary/protocol endpoint

Nocturnal Symptomatic Hypoglycemic Events

Time frame:Baseline through Week 26

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Nocturnal Asymptomatic Hypoglycemic Events

Time frame:Baseline through Week 26

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Number of Emergency Room (ER) Visits

Time frame:Baseline through Week 26

event count, event

Other clinical outcomes

1 endpoint
Secondary/registry result

Number of Emergency Room (ER) Visits

Time frame:Baseline through Week 26

event count, event

Posted result

GroupValue (number), Number of ER visits95% CI
IDegLira14—
Basal-Bolus Insulin12—

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.