Diabetes Mellitus, Type 2Phase 4NCT06408532
The Efficacy and Safety of Insulin Degludec/Liraglutide Combination (IDegLira) in Patients With Type 2 Diabetes
A Phase 4 study testing IDegLira and Premixed insulin in people with Diabetes Mellitus, Type 2, run by Peking University People's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- IDegLira and Premixed insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2024to 28 Feb 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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
- Being tested
- IDegLira, Premixed insulin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDegLiraDrug
The participants in this group will be switched to IDegLira once daily injection therapy.
Premixed insulinDrug
The participants in this group will be have optimized premixed insulin regimen.
| Study group | Role | What they receive |
|---|---|---|
| Premixed insulin dose optimization group | Active comparator | The participants in this group will get optimized insulin dosage adjustment on premixed insulin. Receives: 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. Receives: Drug: IDegLira |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c (HbA1c)
The change in glycated hemoglobin levels from baseline at the end of the study
Measured: 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)
Measured: CGM data collected at the end of the study (week 14 ± 7days).
Time in Tight Range (TTIR, 3.9-7.8 mmol/L)
Measured: CGM data collected at the end of the study (week 14 ± 7days).
Glucose Management Indicator (GMI)
Measured: 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)
Measured: 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)
Measured: CGM data collected at the end of the study (week 14 ± 7days).
Percentage of patients with TIR (3.9-10 mmol/L) >70%
Measured: 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.
Measured: 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
Measured: 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%
Measured: 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%
Measured: 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%
Measured: 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%
Measured: CGM data collected at the end of the study (week 14 ± 7days).
The frequency of confirmed hypoglycemia
Having symptoms of hypoglycemia and a fingerstick blood glucose measurement of <4mmol/L.
Measured: From baseline to the end of the study (week 0-week 14 ± 7days).
Frequency of confirmed nocturnal hypoglycemia
Confirmed hypoglycemia occurring at night
Measured: From baseline to the end of the study (week 0-week 14 ± 7days).
Frequency of severe hypoglycemia
hypoglycemia that the individual cannot self-treat and requires assistance from another person
Measured: From baseline to the end of the study (week 0-week 14 ± 7days).
Change in body weight from baseline
Measured: From baseline to the end of the study (week 0-week 14 ± 7days).
Change in waist circumference from baseline
Measured: From baseline to the end of the study (week 0-week 14 ± 7days).
Short-Form Health Survey (SF-36)
A score ranging from 0 to 100. Higher scores indicate better health status.
Measured: At the end of the study (week 14 ± 7days).
Diabetes Treatment Satisfaction Questionnaire (DTSQs) ④ Exploratory Evaluation Indicators
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).
Measured: At the end of the study (week 14 ± 7days).
Changes in the Ambulatory Glucose Profile (AGP) graph obtained from CGM
Measured: From baseline to the end of the study (week 0-week 14 ± 7days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start30 Apr 2024 (estimated)
- Primary completion30 Oct 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Liu, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408532
- Sponsor's protocol ID
- RD 2023-02
- Status last verified
- May 2024
- First submitted
- 25 Apr 2024
- Last updated
- 10 May 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) could be accessed with proper reason from the PI.
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06408532
- Acronym / sponsor ID
- RD 2023-02
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 30 Apr 2024 (estimated)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Premixed insulin dose optimization group | Active comparator | Drug: Premixed insulinThe participants in this group will get optimized insulin dosage adjustment on premixed insulin. |
| IDegLira once daily injection group | Experimental | Drug: IDegLiraThe participants in this group will switch from premixed insulin to IDegLira once daily injection therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IDegLiraThe participants in this group will be switched to IDegLira once daily injection therapy. | Drug | IDegLira once daily injection group |
| Premixed insulinThe participants in this group will be have optimized premixed insulin regimen. | Drug | Premixed insulin dose optimization group |
Primary outcome
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
20 secondary outcomes
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).
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).
Glucose Management Indicator (GMI)
Time frame: 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).
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).
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).
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).
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).
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).
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).
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).
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).
The frequency of confirmed hypoglycemia
Time frame: 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).
Frequency of severe hypoglycemia
Time frame: 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).
Change in waist circumference from baseline
Time frame: 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).
Diabetes Treatment Satisfaction Questionnaire (DTSQs) ④ Exploratory Evaluation Indicators
Time frame: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Individual participant dataSharing planned: No. Individual participant data (IPD) could be accessed with proper reason from the PI.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IDegLira and Premixed insulin in people with Diabetes Mellitus, Type 2, run by Peking University People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Liu, M.D. (+86-10-88324105, liuwei03@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c (HbA1c) (time frame: From baseline to the end of the study (week 0-week 14 ± 7days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.