Clinical trial NCT06408532: The Efficacy and Safety of Insulin Degludec/Liraglutide Combination (IDegLira) in Patients With Type 2 Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Hemoglobin A1c (HbA1c)
timeFrame: From baseline to the end of the study (week 0-week 14 ± 7days).
Secondary outcomes:
measure: Time in Range (TIR, 3.9-10.0 mmol/L) obtained from Continuous Glucose Monitoring (CGM)
timeFrame: CGM data collected at the end of the study (week 14 ± 7days).
measure: Time in Tight Range (TTIR, 3.9-7.8 mmol/L)
timeFrame: CGM data collected at the end of the study (week 14 ± 7days).
measure: Glucose Management Indicator (GMI)
timeFrame: CGM data collected at the end of the study (week 14 ± 7days).
measure: 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)
timeFrame: CGM data collected at the end of the study (week 14 ± 7days).
measure: Prolonged Hyperglycemic Events (defined as glucose >13.9 mmol/L for ≥120 minutes, with event ending when glucose ≤10 mmol/L for ≥15 minutes)
timeFrame: CGM data collected at the end of the study (week 14 ± 7days).
measure: Percentage of patients with TIR (3.9-10 mmol/L) >70%
timeFrame: CGM data collected at the end of the study (week 14 ± 7days).
measure: Percentage of patients with ≥5% improvement in TIR (3.9-10 mmol/L) from baseline at study end.
timeFrame: CGM data collected at the end of the study (week 14 ± 7days).
measure: Percentage of patients with ≥10% improvement in TIR (3.9-10 mmol/L) from baseline at study end
timeFrame: CGM data collected at the end of the study (week 14 ± 7days).
measure: Percentage of patients with Time Below Range (TBR, <3.9 mmol/L) <4%
timeFrame: CGM data collected at the end of the study (week 14 ± 7days).
measure: Percentage of patients with Time Below Range (TBR, <3.0 mmol/L) <1%
timeFrame: CGM data collected at the end of the study (week 14 ± 7days).
measure: Percentage of patients with Time Above Range (TAR, >10.0 mmol/L) <25%
timeFrame: CGM data collected at the end of the study (week 14 ± 7days).
measure: Percentage of patients with Time Above Range (TAR, >13.9 mmol/L) <5%
timeFrame: CGM data collected at the end of the study (week 14 ± 7days).
measure: The frequency of confirmed hypoglycemia
timeFrame: From baseline to the end of the study (week 0-week 14 ± 7days).
measure: Frequency of confirmed nocturnal hypoglycemia
timeFrame: From baseline to the end of the study (week 0-week 14 ± 7days).
measure: Frequency of severe hypoglycemia
timeFrame: From baseline to the end of the study (week 0-week 14 ± 7days).
measure: Change in body weight from baseline
timeFrame: From baseline to the end of the study (week 0-week 14 ± 7days).
measure: Change in waist circumference from baseline
timeFrame: From baseline to the end of the study (week 0-week 14 ± 7days).
measure: Short-Form Health Survey (SF-36)
timeFrame: At the end of the study (week 14 ± 7days).
measure: Diabetes Treatment Satisfaction Questionnaire (DTSQs) ④ Exploratory Evaluation Indicators
timeFrame: At the end of the study (week 14 ± 7days).
measure: Changes in the Ambulatory Glucose Profile (AGP) graph obtained from CGM
timeFrame: From baseline to the end of the study (week 0-week 14 ± 7days).
Other outcomes:
Locations:
Study officials:
References: