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Type 2 Diabetes MellitusPhase 4NCT03194945

Effects of Sequential Treatment Based on Lina/MET After Short-term Intensive Insulin in Newly Diagnosed Type 2 Diabetes

A Phase 4 study testing CSII followed by Lina+MET, CSII followed by Lina and CSII followed by MET in people with Type 2 Diabetes Mellitus, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Short-term intensive insulin therapy(SIIT) is able to reverse β cell dysfunction and induce glycemic remission in patients with newly diagnosed type 2 diabetes. However, proportion of patients with response gradually decreases over time. Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
CSII followed by Lina+MET, CSII followed by Lina and CSII followed by MET
Could I receive a placebo?
No, everyone receives an active treatment
How many people
412 participants
Where
1 siteChina
Study dates
1 Nov 2017to 31 Dec 2022
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 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with type 2 diabetes who have never received any hypoglycemic treatment；
  • Fasting plasma glucose (FPG) between 7.0 mmol/l (126 mg/dl) and 16.7 mmol/l (300 mg/dl);
  • glycosylated hemoglobin A1C≥8.5%;
  • Aged between 20 and 70 years 5） body mass index (BMI) 22-35 kg/m2.

Who cannot join

  • Type 1 diabetes or special type of diabetes;
  • Acute complications of diabetes (including DKA, HHS and lactic acidosis)
  • Serious microvascular complications: proliferative stage of retinopathy; urine AER >300 mg/g or urine protein positive, quantification >0.5 g/d; uncontrolled painful diabetic neuropathy and significant diabetic autonomic neuropathy;
  • Severe macrovascular complications: acute cerebrovascular accident, acute coronary syndrome, vascular intervention for peripheral arterial disease or amputation requiring hospitalization within 12 months prior to enrollment;
  • Persistently increased blood pressure >180/110 mmHg;
  • Blood creatinine clearance less than 50 ml/min, alanine aminotransferase ≥2.5×upper limit of normal, total bilirubin ≥1.5×upper limit of normal;
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  • Hemoglobin <100 g/L or need regular blood transfusion;
  • Use of drugs that may influence blood glucose within 12 weeks;
  • Systemic infection or serious concomitant disease; patients with malignancy or chronic diarrhea;
  • Uncontrolled endocrine gland dysfunction;
  • Patients with mental or communication disorders;
  • Chronic cardiac insufficiency, heart function class III and above;
  • Pregnant women, lactating women and women of child bearing age who are not willing to take contraception during the study;
  • Subjects who don't cooperate, cannot be followed up or have difficulty in completing the study considered by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • endocrinology department of the first affiliated hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510080

Other trials in China

About this study

Official title: Effects of Linagliptin and Metformin Monotherapy or Combined Sequential Treatment After Early Short-term Intensive Insulin Treatment on Long-term Blood Glucose Control and Function of β Cells in Patients With Type 2 Diabetes

Short-term intensive insulin therapy(SIIT) is able to reverse β cell dysfunction and induce glycemic remission in patients with newly diagnosed type 2 diabetes. However, proportion of patients with response gradually decreases over time. There is no consensus on which treatment should be given in order to maintain the benefit in glycemic control and β cell recovery. In this multi-center, randomized, controlled study, effects of various sequential treatments ( metformin, linagliptin and combined with both drugs) on long-term blood glucose control as well as preservation of β cell function after SIIT were investigated.

In total, 412 patients with newly diagnosed type 2 diabetes who meet the inclusive criteria will be enrolled in eight centers in China. After baseline assessments, all patients will be treated with insulin pump to achieve and maintain euglycemia for 2 weeks. After completion of intensive treatment, insulin pump will be stopped. Different treatments will be applied to patients for 48 weeks according to randomization: Group A: Linagliptin 5 mg Qd + Metformin 0.5 g bid; Group B: Linagliptin 5 mg Qd; Group C: Metformin 0.5 g bid; Group D: No oral drugs. Primary endpoint is proportion of patients achieving glycosylated hemoglobin A1C <7% at the end of the study. Secondary endpoints include proportion of patients achieving glycosylated hemoglobin A1C <6.5% at the end of study; differences in β-cell function , insulin sensitivity, GLP-1 and glucagon secretion among treatment groups, and differences in adverse events among treatment groups.

Being tested
CSII followed by Lina+MET, CSII followed by Lina, CSII followed by MET, CSII alone
Keywords
Type 2 diabetes mellitus, Continuous subcutaneous insulin infusion, Metformin, Linagliptin
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.

  • CSII followed by Lina+METDrug

    Also called CSII+Lina+Met

    short-term intensive CSII followed by Linagliptin 5mg qd and Metformin 0.5g bid for 48 weeks

  • CSII followed by LinaDrug

    Also called CSII+Lina

    short-term intensive CSII followed by Linagliptin 5mg qd for 48 weeks

  • CSII followed by METDrug

    Also called CSII+Met

    short-term intensive CSII followed by Metformin 0.5g bid for 48 weeks

  • CSII aloneDrug

    Also called CSII

    No OHA is given after short-term intensive CSII

Study groups in NCT03194945
Study groupRoleWhat they receive
Linagliptin plus metforminActive comparatorCSII followed by Linagliptin 5 mg Qd + Metformin 0.5 g bid for 48 weeks
Receives: Drug: CSII followed by Lina+MET
LinagliptinActive comparatorCSII followed by Linagliptin 5mg Qd for 48 weeks
Receives: Drug: CSII followed by Lina
MetforminActive comparatorCSII followed by Metformin 0.5 bid for 48 weeks
Receives: Drug: CSII followed by MET
Lifestyle aloneActive comparatorNo OHA is given after CSII
Receives: Drug: CSII alone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. proportion of subjects with optimal glycemic control

    proportion of patients achieving glycosylated hemoglobin A1C <7% at the end of sequential treatment in each treatment group.

    Measured: 48 weeks

Secondary outcomes (4)

  1. proportion of subjects with excellent glycemic control

    proportion of patients achieving glycosylated hemoglobin A1C <6.5% at the end of sequential treatment in each treatment group.

    Measured: 48 weeks

  2. Change of β cell function

    Differences in β-cell indicators among treatment arms at the end of study.

    Measured: 48 weeks

  3. Change of insulin sensitivity

    Differences in insulin sensitivity indicators among treatment arms at the end of study.

    Measured: 48 weeks

  4. Incidence of adverse events

    Differences in incidence of adverse events among treatment arms at the end of study.

    Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2017
  2. Study start1 Nov 2017
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2022

Resources

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
None (open label)
Enrolment
412 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03194945
Sponsor's protocol ID
2016146
Status last verified
Jun 2024
First submitted
19 Jun 2017
Last updated
18 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Liu L, Ke W, Li H, Li F, Fan G, Kuang J, Ma J, Zhang X, Ji B, Li S, Du Y, Xue Y, Lyu Z, Gao L, Qu S, Shi Y, Yan L, Deng W, Xu C, Dai P, Xu L, Liu J, Wan X, Wei G, Yu S, Hong S, Zhang P, Huang Z, Cao X, Liao Z, Xiao H, Mu Y, Handelsman Y, Li Y. Intense simplified strategy for newly diagnosed type 2 diabetes in patients with severe hyperglycaemia: multicentre, open label, randomised trial. BMJ. 2024 Oct 15;387:e080122. doi: 10.1136/bmj-2024-080122.

    PubMed 39406449

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing CSII followed by Lina+MET, CSII followed by Lina and CSII followed by MET in people with Type 2 Diabetes Mellitus, run by Sun Yat-sen University 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 4 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: finished, as of the sponsor's last update on 18 Jun 2024. 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.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

proportion of subjects with optimal glycemic control (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03194945, which also lists 1 linked publication.

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 18 Jun 2024.

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