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

NCT06408532 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: RD 2023-02
• Study Type: interventional
• Target: 256
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study aims to evaluate the efficacy and safety of IDegLira in type 2 diabetes who have failed premixed insulin therapy. The study plans to enroll 256 participants with inadequate glycemic control despite twice-daily subcutaneous injections of premixed insulin and metformin. Participants will be randomly assigned to either the premixed insulin dose optimization group (control group) or IDegLira once daily group, and the difference in change in glycated hemoglobin levels from baseline to 16 weeks of treatment will be assessed between the two groups.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c (HbA1c)

  The change in glycated hemoglobin levels from baseline at the end of the study

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

Secondary Outcomes (20)

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

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

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

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

• Glucose Management Indicator (GMI)

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

• 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)

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

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

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

Study Arms (2)

Premixed insulin dose optimization group

ACTIVE COMPARATOR

The participants in this group will get optimized insulin dosage adjustment on premixed insulin.

Drug: Premixed insulin

IDegLira once daily injection group

EXPERIMENTAL

The participants in this group will switch from premixed insulin to IDegLira once daily injection therapy.

Drug: IDegLira

Interventions

IDegLira DRUG

The participants in this group will be switched to IDegLira once daily injection therapy.

IDegLira once daily injection group

Premixed insulin DRUG

The participants in this group will be have optimized premixed insulin regimen.

Premixed insulin dose optimization group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

IDegLira

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Wei Liu, M.D.

CONTACT

+86-10-88324105; liuwei03@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 10, 2024
• Study Start: April 30, 2024
• Primary Completion: October 30, 2024
• Study Completion: February 28, 2025
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share