UnknownPhase 4

The Efficacy and Safety of Insulin Degludec/Liraglutide Combination (IDegLira) in Patients With Type 2 Diabetes

The Evaluation of the Efficacy and Safety of Switching to Once-daily IDegLira in Patients With Type 2 Diabetes Receiving Premixed Insulin Therapy, a Multi-center, Randomized Control Trial

Lead sponsor

Peking University People's Hospital

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

256

Study population

Type 2 diabetes

Eligibility highlights

•BMI ≥23•HbA1c 7.5-11%

Primary endpoint

•HbA1c, change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06408532

Org study IDRD 2023-02

Timeline

Milestones

Study start2024-04-30estimated

Study first posted2024-05-10actual

Last update posted2024-05-10actual

Primary completion2024-10-30estimated

Study completion2025-02-28estimated

Assets

Investigational agents

Liraglutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosed with type 2 diabetes for ≥3 months. Meets the diabetes diagnostic criteria established by the World Health Organization (WHO) in 1999.

•Age ≥18 years, regardless of gender.

•Body mass index ≥23.0 kg/m^2.

•HbA1c ≥7.5% and ≤11.0% at screening.

•Concurrently taking metformin, with a metformin dose ≥1500 mg/day or the maximum tolerated dose (not less than 1000 mg/day), and may be combined with oral sodium-glucose cotransporter-2 inhibitors, thiazolidinediones, or alpha-glucosidase inhibitors. Combination oral medications must be at a stable dose for ≥8 weeks and continued during the study period.

•For 8 weeks prior to screening, has been on a stable, regular regimen of premixed human insulin (including premixed insulin analogs) administered subcutaneously twice daily, with a total daily insulin dose of 15-50 units, in addition to diet and exercise control.

•Has signed the informed consent form.

•Willing and able to self-monitor blood glucose (SMBG) and record the diary card on time.

•Fully understands the study purpose and can communicate well with the investigator, and can understand and comply with all requirements of this study.

Exclusion criteria

•Subjects who have previously tested positive for diabetes autoantibodies (including anti-glutamic acid decarboxylase antibodies, anti-islet cell antibodies, anti-insulin antibodies, anti-zinc transporter 8 antibodies, and anti-protein tyrosine phosphatase antibodies).

•Fasting C-peptide level ≤0.6 ng/mL.

•Used a glucagon-like peptide-1 (GLP-1) receptor agonist within the 3 months prior to screening.

•Concomitant use of sulfonylureas, glinides, and dipeptidyl peptidase-4 inhibitors within the 3 months prior to screening.

•History of medullary thyroid carcinoma, multiple endocrine neoplasia type 2, or a family history of these conditions.

•History of acute/chronic pancreatitis.

•Experienced a serious gastrointestinal disease (such as active ulcer) or underwent gastrointestinal surgery (except appendectomy or cholecystectomy) or had clinically significant gastric emptying abnormalities (such as pyloric obstruction, gastroparesis) or long-term use of medications that directly affect gastrointestinal motility, or deemed unsuitable for the study by the investigator within the 3 months prior to screening.

•Concurrent severe diseases, including but not limited to severe cardiovascular, cerebrovascular, hepatic, or renal diseases, or severe diabetes-related complications, and deemed unsuitable for the study by the investigator.

•Pregnant or breastfeeding female subjects, or subjects (including male subjects' female partners) with plans for pregnancy or sperm/egg donation within 3 months after the last dose, or unwilling to use at least one effective contraceptive method or device.

•Unwilling to wear an invasive monitoring device.

•Clear reasons that prevent the use of continuous glucose monitoring (CGM), such as severe allergy or skin conditions, and deemed unsuitable for the study by the investigator.

•Subjects with skin lesions, scarring, redness, infection, or edema at the sensor application site that may affect the accuracy of sensor placement or interstitial glucose measurement.

•Received long-term (continuous or cumulative ≥7 days) treatment with systemic corticosteroids or growth hormone that may affect blood glucose within 1 month prior to screening.

•History of malignancy within the past 3 years, excluding basal cell carcinoma, squamous cell carcinoma, and any in situ cancers.

•Participated in another drug or medical device clinical trial (except for registry studies) within the 3 months prior to screening.

•Presence of severe psychiatric disorders or language barriers, unwilling or unable to fully understand and cooperate.

•Experienced diabetic ketoacidosis (DKA), hyperosmolar hyperglycemic state (HHS), or lactic acidosis (LAD) within the 3 months prior to screening.

•Fasting triglycerides >5.65 mmol/L (can be retested within one week) at screening.

•History of alcohol or drug abuse (more than 14 units of alcohol per week [1 unit = 360 mL of 5% beer, or 45 mL of 40% spirits, or 150 mL of 12% wine]).

•Known or suspected allergy to GLP-1 class drugs or excipients.

•Any other reason deemed by the investigator to make the subject unsuitable for participation in the study.

Endpoints (21)

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

Safety / tolerability / PK

Weight & body composition

Patient-reported / QoL

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Change in body weight from baseline

Time frame:From baseline to the end of the study (week 0-week 14 ± 7days).

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference from baseline

Time frame:From baseline to the end of the study (week 0-week 14 ± 7days).

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

13 endpoints

Primary/protocol endpoint

Hemoglobin A1c (HbA1c)

Time frame:From baseline to the end of the study (week 0-week 14 ± 7days).

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Time in Range (TIR, 3.9-10.0 mmol/L) obtained from Continuous Glucose Monitoring (CGM)

Time frame:CGM data collected at the end of the study (week 14 ± 7days).

CGM time-in-range

descriptive, improvement

Secondary/protocol endpoint

Time in Tight Range (TTIR, 3.9-7.8 mmol/L)

Time frame:CGM data collected at the end of the study (week 14 ± 7days).

CGM time-in-range

descriptive, improvement

Secondary/protocol endpoint/low confidence

Glucose Management Indicator (GMI)

Time frame:CGM data collected at the end of the study (week 14 ± 7days).

descriptive, improvement

Secondary/protocol endpoint/low confidence

Prolonged Hyperglycemic Events (defined as glucose >13.9 mmol/L for ≥120 minutes, with event ending when glucose ≤10 mmol/L for ≥15 minutes)

Time frame:CGM data collected at the end of the study (week 14 ± 7days).

event count, improvement

Secondary/protocol endpoint

Percentage of patients with TIR (3.9-10 mmol/L) >70%

Time frame:CGM data collected at the end of the study (week 14 ± 7days).

CGM time-in-range

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of patients with ≥5% improvement in TIR (3.9-10 mmol/L) from baseline at study end.

Time frame:CGM data collected at the end of the study (week 14 ± 7days).

CGM time-in-range

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of patients with ≥10% improvement in TIR (3.9-10 mmol/L) from baseline at study end

Time frame:CGM data collected at the end of the study (week 14 ± 7days).

CGM time-in-range

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of patients with Time Below Range (TBR, <3.9 mmol/L) <4%

Time frame:CGM data collected at the end of the study (week 14 ± 7days).

CGM time-below-range

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of patients with Time Below Range (TBR, <3.0 mmol/L) <1%

Time frame:CGM data collected at the end of the study (week 14 ± 7days).

CGM time-below-range

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of patients with Time Above Range (TAR, >10.0 mmol/L) <25%

Time frame:CGM data collected at the end of the study (week 14 ± 7days).

CGM time-above-range

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of patients with Time Above Range (TAR, >13.9 mmol/L) <5%

Time frame:CGM data collected at the end of the study (week 14 ± 7days).

CGM time-above-range

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Changes in the Ambulatory Glucose Profile (AGP) graph obtained from CGM

Time frame:From baseline to the end of the study (week 0-week 14 ± 7days).

descriptive

Patient-reported / QoL

2 endpoints

Secondary/protocol endpoint

Short-Form Health Survey (SF-36)

Time frame:At the end of the study (week 14 ± 7days).

SF-36 total

descriptive, improvement

Secondary/protocol endpoint

Diabetes Treatment Satisfaction Questionnaire (DTSQs) ④ Exploratory Evaluation Indicators

Time frame:At the end of the study (week 14 ± 7days).

descriptive, improvement

Safety / tolerability / PK

4 endpoints

Secondary/protocol endpoint

Prolonged Hypoglycemic Events (defined as glucose <3.9 mmol/L for ≥120 minutes, with event ending when glucose ≥3.9 mmol/L for ≥15 minutes)

Time frame:CGM data collected at the end of the study (week 14 ± 7days).

event count, event

Secondary/protocol endpoint

The frequency of confirmed hypoglycemia

Time frame:From baseline to the end of the study (week 0-week 14 ± 7days).

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Frequency of confirmed nocturnal hypoglycemia

Time frame:From baseline to the end of the study (week 0-week 14 ± 7days).

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Frequency of severe hypoglycemia

Time frame:From baseline to the end of the study (week 0-week 14 ± 7days).

Severe hypoglycemia

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

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 6, 2026 snapshot.