AzTrials
AzTrials

Diabetes Mellitus, Type 1Phase 4NCT02407899

Protective Effects of Saxagliptin (And Vitamin D3) on β Cell Function in Adult-onset Latent Autoimmune Diabetes

A Phase 4 study testing Saxagliptin, Vitamin D3 and Insulin in people with Diabetes Mellitus, Type 1, run by Second Xiangya Hospital of Central South University at 39 sites in China.

Completed

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

Official record
Search all trials

Trial summary

The main purpose of this study is to evaluate whether saxagliptin or (and vitamin D3) with metformin (and insulin) therapy can better protect islet β cell function than metformin(and insulin) . Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
Saxagliptin, Vitamin D3 and Insulin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
39 sitesChina
Study dates
Mar 2015to 31 Dec 2020
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Volunteer to participate in the study with informed consent;
  • The LADA patients to be included in this study are defined as:
  • Meet the 1999 WHO Diagnostic Criteria for Diabetes Mellitus; (2) Age at diagnosis of DM ≧ 18 years old; (3) Glutamic acid decarboxylase antibody (GADA) positive; (4) Serum fasting C-peptide ≥ 100 pmol/L or 2-hour postprandial C-peptide≥ 200 pmol/L; 3. Age between 18-70 years old; 4. Diabetes duration <4 year; 5. Outpatient or inpatient.

Who cannot join

  • Pregnancy, breastfeeding or planned pregnancy within two years;
  • Gestational diabetes mellitus or other specific types of diabetes;
  • Allergic to saxagliptin, vitamin D3 and their excipient;
  • Treatment with any anti-diabetic medication other than insulin in the last 8 weeks prior to randomization;
  • Use of systemic corticosteroids therapy (oral, intravenous) continuously for more than 7 days over the past 6 months;
  • Treatment with cytochrome P450 3A4/5 (CYP450 3A4/5) inhibitor;
Show all 12Show fewer
  • Alanine aminotransferase (ALT) or aspartate transaminase(AST) more than 3 times of the normal upper limit, total bilirubin (TBIL) more than 2 times of the normal upper limit;
  • Creatinine levels ≧ 1.5 mg/dL(132μmol/L) for males and ≧ 1.4 mg/dL (123μmol/L) for females or creatinine clearance ≦ 50 mL/min;
  • History of malignant tumors;
  • History of mental disorders;
  • History of alcohol abuse or illegal drug abuse;
  • Serious systemic disease which the investigators think would not be suitable for the study.

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

China39 sites

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

  • Beijing Hospital of the Ministry of Health

    Beijing, Beijing Municipality, 100730

  • The Second Hospital of Jilin University

    Changchun, Jilin, 130000

  • Jilin Province People's Hospital

    Changchun, Jilin, 130021

  • The First People's Hospital of Changde

    Changde, Hunan, 415003

  • Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University

    Changsha, Hunan, 410011

  • Heping Hospital of Changzhi Medical College

    Changzhi, Shanxi, 046000

  • Affiliated Heji Hospital of Changzhi Medical College

    Changzhi, Shanxi, 140400

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400042

  • Dongguan People's Hospital

    Dongguan, Guangdong, 523059

  • The First Affiliated Hospital of Fujian Medical University

    Fujian, Fuzhou, 350005

  • Guangdong General Hospital

    Guangzhou, Guangdong, 510080

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 510120

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510120

  • Hainan General Hospital

    Haikou, Hainan, 570311

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

  • Harbin Medical University

    Harbin, Heilongjiang, 150081

  • The First Affiliated Hospital of South China University

    Hengyang, Hunan, 421001

  • The Second Hospital University of South China

    Hengyang, Hunan, 421001

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 010050

  • The First People's Hospital of Huaihua

    Huaihua, Hunan, 418000

  • First People's Hospital of Yunnan Province

    Kunming, Yunnan, 650032

  • Gansu Provincial Hospital

    Lanzhou, Gansu, 730000

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 471023

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • The Third Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330008

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266000

  • Quanzhou First Hospital, Fujian

    Quanzhou, Fujian, 350005

  • Shanghai Xuhui District Central Hospital

    Shanghai, Shanghai Municipality, 200031

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110122

  • Tangshan Gongren Hospital063000

    Tangshan, Hebei, 063000

  • Tangshan Gongren Hospital

    Tangshan, Hebei, 063000

  • The Second Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

  • The First Affiliated Hospital of The Fourth Military Medical University

    Xi’an, Shanxi, 710032

  • The Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu, 225001

  • The First People's Hospital of Yueyang

    Yueyang, Hunan, 414000

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450003

Other trials in China

About this study

Official title: A Randomized Controlled, Open-label, Multi-center Study With 104-week Saxagliptin or (and) Vitamin D3 Assessing Protective Effects on Beta Cell Function in Latent Autoimmune Diabetes in Adults (LADA) Treated With Metformin (and Insulin)

The main purpose of this study is to evaluate whether saxagliptin or (and vitamin D3) with metformin (and insulin) therapy can better protect islet β cell function than metformin(and insulin) .

Read the detailed description

LADA is actually a form of type 1 diabetes, which is caused by autoimmune damage of islet β cells and triggered by environmental factors based on genetic susceptibility. LADA shows some characteristics of type 2 diabetes at its onset, which develops slowly and latent, and easily be misdiagnosed as type 2 diabetes due to slowly β cell function deterioration. This is a multi-center, open- label, 1:1:1 randomized controlled trial to investigate the protective effects of saxagliptin and vitamin D3 in LADA patients. The study comprises the 0-6weeks of screening period and the 104-week intervention period. After obtaining the informed consent，the screening will find out the eligible patients according to the inclusion/exclusion criteria, then the patients will be randomized to the 104-week intervention period. Subjects will be randomized into one of the three groups(arms) through central dynamic randomization: metformin (and insulin), metformin(and insulin) +saxagliptin, metformin(and insulin) +saxagliptin+vitamin D3. Our previous randomized- controlled pilot study showed that dipeptidyl peptidase 4 (DPP-4) inhibitors could significantly improve islet β-cell function in patients with LADA. The main purpose of this study: To evaluate whether saxagliptin (and vitamin D3) with metformin (and insulin) therapy can better protect islet β cell function than metformin (and insulin).

Being tested
Saxagliptin, Vitamin D3, Insulin, Metformin
Keywords
LADA, saxagliptin, vitamin D3, C-Peptide
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.

  • SaxagliptinDrug

    Also called Onglyza, Dipeptidyl peptidase 4 (DPP-4) inhibitor

    Take saxagliptin tablet 5mg p.o. qd. for 104 weeks after randomization.

  • Vitamin D3Drug

    Also called Cholecalciferol

    Take vitamin D drops 2000 IU p.o. qd. for 104 weeks after randomization.

  • InsulinDrug

    Also called Recombinant Human Insulin, Insulin analogue.

    For optimal control of patients' glucose, researchers can initiate insulin therapy at any time in this trial, choose any brands of insulin after discussion with the patient.

  • MetforminDrug

    Also called Metformin Hydrochloride tablet

    Take Metformin tablet 1.5g p.o. per day for 104 weeks (adjust the dose between 1-1.7g per day according to subject's specific situation) before or after randomization.

Study groups in NCT02407899
Study groupRoleWhat they receive
Metformin (and insulin) + saxagliptinExperimentalPatients who have diagnosed LADA are assigned to receive Saxagliptin tablets 5mg/d and Metformin 1.5g/d (and insulin at individual dose) for 104-week.
Receives: Drug: Saxagliptin; Drug: Insulin; Drug: Metformin
Metformin(insulin)+saxagliptin +vitamin D3ExperimentalPatients who have diagnosed LADA are assigned to receive Saxagliptin tablets 5 mg/d, vitamin D drop 2000IU/d, Metformin 1.5g/d (and insulin at individual dose) for 104-week.
Receives: Drug: Saxagliptin; Drug: Vitamin D3; Drug: Insulin; Drug: Metformin
Metformin (and insulin)Active comparatorPatients who have diagnosed LADA are assigned to receive Metformin 1.5g/d(and insulin at individual dose) for 104-week.
Receives: Drug: Insulin; Drug: Metformin

What is being measured

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

  1. Absolute changes from baseline in Fasting C-peptide levels at week 104.

    1. To evaluate the efficacy of saxagliptin plus metformin (and insulin) on beta cell function in LADA patients compared with metformin (and insulin) treatment. By measure absolute changes from baseline in Fasting C-peptide levels at week 104.
    2. To evaluate the efficacy of saxagliptin (add on vitamin D) plus metformin (and insulin) on beta cell function in LADA patients compared with metformin (and insulin) treatment.By measure absolute changes from baseline in Fasting C-peptide levels at week 104.

    Measured: From baseline to 104 week

Secondary outcomes (9)

  1. Absolute changes from baseline in fasting C-peptide levels and at week 26, 52 and 78.

    To evaluate the efficacy of saxagliptin (add on vitamin D) plus metformin (and insulin) on indicators of beta cell function compared with LADA patients treated with metformin (and insulin). By measure absolute changes from baseline in fasting C-peptide levels and at week 26, 52 and 78.

    Measured: From baseline to 26, 52, 78 week

  2. Absolute changes from baseline in C peptide at 60-min and 120-min (AUC) during a mixed-meal tolerance test and at week 26, 52, 78 and 104.

    To evaluate the efficacy of saxagliptin (add on vitamin D) plus metformin (and insulin) on indicators of beta cell function compared with LADA patients treated with metformin (and insulin). By measure absolute changes from baseline in C peptide at 60-min and 120-min (AUC) during a mixed-meal tolerance test and at week 26, 52, 78 and 104.

    Measured: From baseline to 26, 52, 78, 104 week

  3. The proportion of subjects with increased (decreased, unchanged) fasting or post-stimulus C peptide level compared with baseline after 104 weeks of treatment.

    To evaluate the efficacy of saxagliptin (add on vitamin D) plus metformin (and insulin) on indicators of beta cell function compared with LADA patients treated with metformin (and insulin). By measure the proportion of subjects with increased (decreased, unchanged) fasting or post-stimulus C peptide level compared with baseline after 104 weeks of treatment.

    Measured: From baseline to 104 week

  4. The increased percentage of C peptide pre-and post mixed-meal tolerance test (Delta C peptide) after 104 weeks of treatment.

    To evaluate the efficacy of saxagliptin (add on vitamin D) plus metformin (and insulin) on indicators of beta cell function compared with LADA patients treated with metformin (and insulin). By measure the increased percentage of C peptide pre-and post mixed-meal tolerance test (Delta C peptide) after 104 weeks of treatment

    Measured: From baseline to 104 week

  5. Changes of HbA1c levels from baseline and at week 26, 52, 78 and 104.

    To evaluate the efficacy of saxagliptin (add on vitamin D) plus metformin (and insulin) on glycemic control compared with LADA patients treated with metformin (and insulin). By measure Changes of HbA1c levels from baseline and at week 26, 52, 78 and 104.

    Measured: 26, 52, 78, 104 week

  6. The proportion of subjects responding to glucose therapy (i.e. HbA1c<7%) after 104 weeks of treatment.

    To evaluate the efficacy of saxagliptin (add on vitamin D) plus metformin (and insulin) on glycemic control compared with LADA patients treated with metformin (and insulin). By measure the proportion of subjects responding to glucose therapy (i.e. HbA1c<7%) after 104 weeks of treatment.

    Measured: 104 week

  7. Changes of average daily insulin dose (U/kg/d) from baseline and at week 26, 52, 78 and 104

    To evaluate the efficacy of saxagliptin (add on vitamin D) plus metformin (and insulin) on glycemic control /insulin-sparing compared with LADA patients treated with metformin (and insulin). By measure Changes of average daily insulin dose (U/kg/d) from baseline and at week 26, 52, 78 and 104.

    Measured: From baseline to 26, 52, 78, 104 week

  8. Changes of GADA titers from baseline and at week 52 and 104.

    To evaluate the efficacy of saxagliptin (add on vitamin D) plus metformin (and insulin) on glycemic control /insulin-sparing/changes of autoantibody titer compared with LADA patients treated with metformin (and insulin). By measure changes of GADA titers from baseline and at week 52 and 104.

    Measured: From baseline to 52, 104 week

  9. Absolute changes of body weight and BMI level from baseline and at week 26, 52, 78 and 104.

    To evaluate the efficacy of saxagliptin (add on vitamin D) plus metformin (and insulin) on body weight/BMI level compared with LADA patients treated with metformin (and insulin). By measure Changes of BMI from baseline and at week 26, 52, 78 and 104.

    Measured: From baseline to 26, 52, 78, 104 week

Timeline

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

  1. First posted3 Apr 2015 (estimated)
  2. Study startMar 2015
  3. Primary completion30 Dec 2020
  4. Study completion31 Dec 2020

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
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02407899
Sponsor's protocol ID
NCRCMD LADA SAX 2015
Status last verified
Apr 2021
First submitted
31 Mar 2015
Last updated
20 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated device
No

Publications

  • Yan X, Li X, Liu B, Huang J, Xiang Y, Hu Y, Tang X, Zhang Z, Huang G, Xie Z, Zhou H, Liu Z, Wang X, Leslie RD, Zhou Z. Combination therapy with saxagliptin and vitamin D for the preservation of beta-cell function in adult-onset type 1 diabetes: a multi-center, randomized, controlled trial. Signal Transduct Target Ther. 2023 Apr 20;8(1):158. doi: 10.1038/s41392-023-01369-9.

    PubMed 37076476

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Saxagliptin, Vitamin D3 and Insulin in people with Diabetes Mellitus, Type 1, run by Second Xiangya Hospital of Central South University at 39 sites 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 3 inclusion and 12 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 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites 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?

Absolute changes from baseline in Fasting C-peptide levels at week 104. (time frame: From baseline to 104 week). 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 NCT02407899, 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 20 Apr 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in