Type 1 Diabetes Mellitus With Diabetic GastroparesisNCT04965051
Safety and Efficacy of Insulin Degludec/Insulin Aspart in Patients With T1DM
A study testing insulin degludec/insulin aspart (IDegAsp) and basal insulin plus pre-prandial insulin in people with Type 1 Diabetes Mellitus With Diabetic Gastroparesis and HbA1c, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
In this prospective, randomized, open-label, parallel group trial, the safety and efficacy of insulin degludec/insulin aspart (IDegAsp) twice daily will be compared with basal insulin once or twice daily plus pre-prandial insulin after 16 weeks of treatment in patients with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 1 Diabetes Mellitus With Diabetic Gastroparesis, HbA1c, Time in Range
- What is being tested?
- insulin degludec/insulin aspart (IDegAsp) and basal insulin plus pre-prandial insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Aug 2021to Dec 2023
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 and ≤75 years with type 1 diabetes;
- Diagnosed as T1DM ≥ 12 months before enrollment in the study;
- HbA1c ≥ 7.0 to ≤10.0%;
- Receipt of basal plus pre-prandial insulin and/or oral anti-diabetic agents ≥ 12 weeks before enrollment in the study;
- BMI ≤ 35kg / m2.
Who cannot join
- Patients with any of the following conditions will be excluded:
- Pregnant or lactating women
- Severe hypoglycemia within one month;
- Myocardial infarction, stroke or other severe cardiovascular events within 6 months prior to informed consent
- Receipt of Sulfonylureas, Meglitinides derivatives, Thiazolidinediones, Dpp-4 inhibitors or GLP-1 agonists within 3 months prior to informed consent;
- Current treatment with systemic steroids or immunosuppressive agents, or have immunologic deficiency disease at time of informed consent
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- Severe mental instability, or alcohol abuse, or drug abuse
- Cancer within 5 years prior to informed consent
- Pancreatitis of severe infectious diseases within 1 months prior to informed consent
- Known hypersensitivity or allergy to the insulin
- Renal impairment (CKD-EPI eGFR<60ml/min)
- Impaired hepatic function, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined
- Participation in another trial within 2 months prior to informed consent
- Patients that investigators believe may fail to complete the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Yuezhong Ren, +8657189713764, renyuez@zju.edu.cn
Yuezhong Z Ren, MD
About this study
Official title: A Prospective, Randomized, Open-label, Parallel Group Study to Evaluate Safety and Efficacy of Insulin Degludec/Insulin Aspart in Patients With Type 1 Diabetes Mellitus
In this prospective, randomized, open-label, parallel group trial, the safety and efficacy of insulin degludec/insulin aspart (IDegAsp) twice daily will be compared with basal insulin once or twice daily plus pre-prandial insulin after 16 weeks of treatment in patients with type 1 diabetes. This trial will enable assessment of the clinically relevant endpoint of a change in HbA1c and Time in Range (TIR).
Read the detailed description
The objective of the current study is to investigate the efficacy and safety of IDegAsp twice daily compared to basal insulin once or twice daily plus pre-prandial insulin for 16 weeks in patients with type 1 diabetes mellitus. The primary endpoint in this study is the change from baseline in HbA1c. Patients with type 1 diabetes who meet the entry criteria are planned for inclusion in this trial. Approximately 40 patients will be enrolled in the study. Patients who qualify will be randomized to IDegAsp group or basal plus pre-prandial insulin group. Duration of treatment includes 2-week screening period, 16-week treatment observation period and 1-week follow-up.
- Being tested
- insulin degludec/insulin aspart (IDegAsp), basal insulin plus pre-prandial insulin
- Keywords
- Type 1 Diabetes, insulin degludec/insulin aspart, HbA1c, Time in Range
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin degludec/insulin aspart (IDegAsp)Drug
Also called Ryzodeg
To evaluate the efficacy and safety of the IDegAsp in T1DM
basal insulin plus pre-prandial insulinDrug
Also called Levemir/Lantus/Tresiba plus NovoLog/Humalog/Apidra
To evaluate the efficacy and safety of basal insulin plus pre-prandial insulin in T1DM
| Study group | Role | What they receive |
|---|---|---|
| IDegAsp group | Experimental | IDegAsp twice daily Receives: Drug: insulin degludec/insulin aspart (IDegAsp) |
| basal insulin plus pre-prandial insulin group | Active comparator | basal insulin once or twice daily plus pre-prandial insulin Receives: Drug: basal insulin plus pre-prandial insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
the change from baseline in HbA1c after 16 weeks of treatment in all patients
Measured: 16 weeks
Secondary outcomes (6)
Time In Range (TIR)
The change from baseline in Time in Range (3.9-10mmol/L) after 16 weeks of treatment in all patients (using flash continuous glucose monitoring (FCGM)).
Measured: 16 weeks
Time to occurrence of treat to target
Fasting glucose on treatment <7mmol/L and non-fasting glucose <10mmol/L, or TIR >70%) (SMBG or FCGM)
Measured: 16 weeks
Occurrence of a treat to target response and without any hypoglycemic episodes
Occurrence of a treat to target response and without any hypoglycemic episodes
Measured: 16 weeks
EQ-5D Health Questionnaire
the EQ-5D descriptive system The change from baseline after 16 weeks of treatment
Measured: 16 weeks
Short Form 36 (SF-36)
The change from baseline after 16 weeks of treatment
Measured: 16 weeks
Insulin dose
The change from baseline after 16 weeks of treatment
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study startAug 2021 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes Mellitus With Diabetic GastroparesisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuezhong Ren, MD, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965051
- Sponsor's protocol ID
- 2021-0407
- Status last verified
- Jul 2021
- First submitted
- 7 Jul 2021
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open-label, Parallel Group Study to Evaluate Safety and Efficacy of Insulin Degludec/Insulin Aspart in Patients With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04965051
- Acronym / sponsor ID
- 2021-0407
- Keywords
- Type 1 Diabetes, insulin degludec/insulin aspart, HbA1c, Time in Range
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- Aug 2021 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 16 Jul 2021 (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.
In this prospective, randomized, open-label, parallel group trial, the safety and efficacy of insulin degludec/insulin aspart (IDegAsp) twice daily will be compared with basal insulin once or twice daily plus pre-prandial insulin after 16 weeks of treatment in patients with type 1 diabetes. This trial will enable assessment of the clinically relevant endpoint of a change in HbA1c and Time in Range (TIR).
Detailed description
The objective of the current study is to investigate the efficacy and safety of IDegAsp twice daily compared to basal insulin once or twice daily plus pre-prandial insulin for 16 weeks in patients with type 1 diabetes mellitus. The primary endpoint in this study is the change from baseline in HbA1c. Patients with type 1 diabetes who meet the entry criteria are planned for inclusion in this trial. Approximately 40 patients will be enrolled in the study. Patients who qualify will be randomized to IDegAsp group or basal plus pre-prandial insulin group. Duration of treatment includes 2-week screening period, 16-week treatment observation period and 1-week follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IDegAsp group | Experimental | Drug: insulin degludec/insulin aspart (IDegAsp)IDegAsp twice daily |
| basal insulin plus pre-prandial insulin group | Active comparator | Drug: basal insulin plus pre-prandial insulinbasal insulin once or twice daily plus pre-prandial insulin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients ≥ 18 and ≤75 years with type 1 diabetes;
- Diagnosed as T1DM ≥ 12 months before enrollment in the study;
- HbA1c ≥ 7.0 to ≤10.0%;
- Receipt of basal plus pre-prandial insulin and/or oral anti-diabetic agents ≥ 12 weeks before enrollment in the study;
- BMI ≤ 35kg / m2.
Key exclusion criteria (14 listed)
- Patients with any of the following conditions will be excluded:
- Pregnant or lactating women
- Severe hypoglycemia within one month;
- Myocardial infarction, stroke or other severe cardiovascular events within 6 months prior to informed consent
- Receipt of Sulfonylureas, Meglitinides derivatives, Thiazolidinediones, Dpp-4 inhibitors or GLP-1 agonists within 3 months prior to informed consent;
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 |
|---|---|---|
| insulin degludec/insulin aspart (IDegAsp)Also: RyzodegTo evaluate the efficacy and safety of the IDegAsp in T1DM | Drug | IDegAsp group |
| basal insulin plus pre-prandial insulinAlso: Levemir/Lantus/Tresiba plus NovoLog/Humalog/ApidraTo evaluate the efficacy and safety of basal insulin plus pre-prandial insulin in T1DM | Drug | basal insulin plus pre-prandial insulin group |
Primary outcome
HbA1c
Time frame: 16 weeks
the change from baseline in HbA1c after 16 weeks of treatment in all patients
6 secondary outcomes
Time In Range (TIR)
Time frame: 16 weeks
Time to occurrence of treat to target
Time frame: 16 weeks
Occurrence of a treat to target response and without any hypoglycemic episodes
Time frame: 16 weeks
EQ-5D Health Questionnaire
Time frame: 16 weeks
Short Form 36 (SF-36)
Time frame: 16 weeks
Insulin dose
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Yuezhong Ren, MD principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing insulin degludec/insulin aspart (IDegAsp) and basal insulin plus pre-prandial insulin in people with Type 1 Diabetes Mellitus With Diabetic Gastroparesis and HbA1c, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 5 inclusion and 14 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 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 Yuezhong Ren, MD (+86 0571 87783516, renyuez@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 16 weeks). 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 16 Jul 2021.