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

May 6, 2024 updated by: Wei Liu, Peking University People's Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
256

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Premixed insulin dose optimization group
The participants in this group will get optimized insulin dosage adjustment on premixed insulin.
Drug: Premixed insulin
The participants in this group will be have optimized premixed insulin regimen.
Experimental: IDegLira once daily injection group
The participants in this group will switch from premixed insulin to IDegLira once daily injection therapy.
Drug: IDegLira
The participants in this group will be switched to IDegLira once daily injection therapy.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c (HbA1c)
Time Frame: From baseline to the end of the study (week 0-week 14 ± 7days).
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 data collected at the end of the study (week 14 ± 7days).
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 data collected at the end of the study (week 14 ± 7days).
Glucose Management Indicator (GMI)
Time Frame: CGM data collected at the end of the study (week 14 ± 7days).
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)
Time Frame: CGM data collected at the end of the study (week 14 ± 7days).
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)
Time Frame: CGM data collected at the end of the study (week 14 ± 7days).
CGM data collected at the end of the study (week 14 ± 7days).
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 data collected at the end of the study (week 14 ± 7days).
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 data collected at the end of the study (week 14 ± 7days).
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 data collected at the end of the study (week 14 ± 7days).
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 data collected at the end of the study (week 14 ± 7days).
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 data collected at the end of the study (week 14 ± 7days).
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 data collected at the end of the study (week 14 ± 7days).
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 data collected at the end of the study (week 14 ± 7days).
The frequency of confirmed hypoglycemia
Time Frame: From baseline to the end of the study (week 0-week 14 ± 7days).
Having symptoms of hypoglycemia and a fingerstick blood glucose measurement of <4mmol/L.
From baseline to the end of the study (week 0-week 14 ± 7days).
Frequency of confirmed nocturnal hypoglycemia
Time Frame: From baseline to the end of the study (week 0-week 14 ± 7days).
Confirmed hypoglycemia occurring at night
From baseline to the end of the study (week 0-week 14 ± 7days).
Frequency of severe hypoglycemia
Time Frame: From baseline to the end of the study (week 0-week 14 ± 7days).
hypoglycemia that the individual cannot self-treat and requires assistance from another person
From baseline to the end of the study (week 0-week 14 ± 7days).
Change in body weight from baseline
Time Frame: From baseline to the end of the study (week 0-week 14 ± 7days).
From baseline to the end of the study (week 0-week 14 ± 7days).
Change in waist circumference from baseline
Time Frame: From baseline to the end of the study (week 0-week 14 ± 7days).
From baseline to the end of the study (week 0-week 14 ± 7days).
Short-Form Health Survey (SF-36)
Time Frame: At the end of the study (week 14 ± 7days).
A score ranging from 0 to 100. Higher scores indicate better health status.
At the end of the study (week 14 ± 7days).
Diabetes Treatment Satisfaction Questionnaire (DTSQs) ④ Exploratory Evaluation Indicators
Time Frame: At the end of the study (week 14 ± 7days).
The DTSQs is composed of six items and scored on seven-point response scales ranging from "very satisfied" (assigned a score of 6) to "very unsatisfied" (assigned a score of 0). Higher DTSQs scores indicate greater satisfaction with treatment (range 0 to 36).
At the end of the study (week 14 ± 7days).
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).
From baseline to the end of the study (week 0-week 14 ± 7days).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RD 2023-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) could be accessed with proper reason from the PI.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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