Type 1 DiabetesPhase 4NCT02307695
The Effect of Saxagliptin on Glucose Fluctuation and Immune Regulation in Patients With Type 1 Diabetes
A Phase 4 study testing Saxagliptin and Insulin in people with Type 1 Diabetes, run by Nanjing Medical University at 1 site in China.
Trial summary
To investigate whether saxagliptin could reduce the fluctuation of glycemia and improve the glycemic control in those type 1 diabetes through mechanisms of suppressing glucagon secretion, improving beta cell function, and re-regulating of the T cell immune system. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Saxagliptin and Insulin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteChina
- Study dates
- Nov 2014to Mar 2017
- 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 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures;
- Diagnosed with type 1 diabetes;
- Men or women who are 12 to 65 years of age at time of consenting upon Visit 1.;
- Positivity for at least one of the four islet autoantibodies(IA-2A、IAA、GADA、ZnT8A);
- 6.5% ≤ HbA1c ≤10.0%.
Who cannot join
- type 2 diabetes；
- Evidence of chronic or acute complications of diabetes which is unstable and requires hospitalization；
- Evidence of disease stress；
- History of administration of any antihyperglycemic therapy (other than insulin) during the 12 weeks prior to Visit 1；
- Have a history of, or currently have, acute or chronic pancreatitis；
- Immunocompromised individuals such as patients that have undergone organ transplantation or patients diagnosed with HIV or patients with agranulocytosis；
Show all 23Show fewer
- Evidence of chronic or acute infection；
- Active liver disease and/or significant abnormal liver function defined as Aspartate transaminase(AST) ≥3x Upper Limit of Normal(ULN) and/or Alanine aminotransferase (ALT) ≥3x Upper Limit of Normal(ULN)；
- History of unstable or rapidly progressing renal disease, creatinine clearance(CrCl) ≤50ml/min;
- Congestive heart failure defined as New York Heart Association (NYHA) class III or IV and/or left ventricular ejection fraction of ≤ 40%；
- Rheumatoid arthritis or other autoimmune disease(except AITD);
- Hypersensitivity to saxagliptin；
- History of drug allergy or allergic disease
- History of alcohol abuse, illegal drug abuse, mental disease or other disease which is not eligible for the study
- Pregnant or breastfeeding patients；
- Patients with any diseases which in the judgement of the investigator would compromise the patient's safety or successful participation in the clinical study
- Any condition where, in the opinion of the investigator, participation in this study may pose a significant risk to the patient or could render the patient unable to successfully complete the study
- Any disease or condition which the investigator feels would interfere with the trial;
- Treatment with other immunosuppressive agent such as systemic glucocorticoids other than replacement therapy. Inhaled, local injected and topical use of glucocorticoids is allowed during the last 90 days prior to Visit 1;
- Participation in a clinical study during the last 90 days prior to Visit 1;
- Patients who are participating in other clinical study;
- Treatment with strong cytochrome P450 3A4/5 (CYP3A4/5) inhibitors or other contraindications to therapy as outlined in the saxagliptin package insert;
- History of haemoglobinopathies (sickle cell anaemia or thalassemias, sideroblastic anaemia).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital, Nanjing Medical University
Nanjing, Jiangsu, 210029
Tao Yang, PhD, 86-25-83718836 ext. 6466, yangt@njmu.edu.cn
Tao Yang, PhD
About this study
To investigate whether saxagliptin could reduce the fluctuation of glycemia and improve the glycemic control in those type 1 diabetes through mechanisms of suppressing glucagon secretion, improving beta cell function, and re-regulating of the T cell immune system.
Read the detailed description
Type 1 diabetes mellitus (T1DM) is characterized by immune mediated beta-cell destruction. Due to the imbalance between glucagon and insulin, long-term T1DM patients experience frequent hypoglycaemia and high glucose variability despite of multiple daily injections of insulin.
Dipeptidyl peptidase 4 (DPP-4) inhibitors are a new class of anti-diabetic agents and are widely used in clinical practice to improve glycemic control and protect β-cell function in patients with type 2 diabetes mellitus(T2DM). Saxagliptin, a DPP-4 inhibitor, improves glycemic control in patients with T2DM by increasing endogenous active, intact glucagon-like peptide 1 and glucose-dependent insulinotropic polypeptide in response to food, which augments insulin secretion and decreases glucagon release. This mechanism can lead to the reduction of glucose variation. In some pilot studies, incretin-based therapy in patients with T1DM can improve glucose control and reduce hypoglycemia, the mechanism probably is that it regulates glucagon level. In type 1 diabetic mouse models, DPP-4 inhibitors preserves beta-cell mass and stimulating beta-cell replication.
Interestingly, DPP-4 is also known as cluster of differentiation antigen 26(CD26).It is expressed on the membrane of many types of lymphocyte, e.g. T, B and natural killer(NK)cells, and is involved in their cellular functions. CD26 plays a key role in many aspects in lymphocyte function beyond its DPP-4 enzymatic activity.These observations make it a promising therapeutic target.
Recently, the attention of saxagliptin has been mainly focused on type 2 diabetes, data in type 1 diabetes is rare. We are going to carry out this phase 4 study to testify our hypothesis that saxagliptin could reduce the fluctuation of glycemia and improve the glycemic control in those type 1 diabetes through mechanisms of suppressing glucagon secretion, improving beta cell function, and re-regulating of the T cell immune system.
- Conditions
- Type 1 Diabetes
- Being tested
- Saxagliptin, Insulin
- Keywords
- Saxagliptin, Type 1 Diabetes, Glycemic variability, 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, DPP-IV inhibitor
saxagliptin 5 mg p.o. qd, 24 week
InsulinDrug
Patients will be treated according to routine clinical practice at the discretion of the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| insulin+Saxagliptin | Experimental | Patients who have diagnosed type 1 diabetes are assigned to receive Saxagliptin tablets 5 mg and insulin for 24-week. Receives: Drug: Saxagliptin; Drug: Insulin |
| insulin | Active comparator | Patients who have diagnosed type 1 diabetes only use insulin. Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Mean amplitude of glycemic excursions (MAGE) from baseline in patients with type 1 diabetes treated with saxagliptin plus insulin or insulin alone by continuous glucose monitoring system (CGMS)
Measured: 24 week
Secondary outcomes (3)
Change of C-peptide area under the curve (AUC C-peptide) or fasting C-peptide from baseline in patients with type 1 diabetes treated with saxagliptin plus insulin or insulin alone by 3-hour mixed meal tolerance test(MMTT)
Measured: 24 week
Change of Haemoglobin A1c (HbA1c) from baseline in patients with type 1 diabetes treated with saxagliptin plus insulin or insulin alone
Measured: 24 week
Change of insulin dosage (U/kg/d) from baseline in patients with type 1 diabetes treated with saxagliptin plus insulin or insulin alone
Measured: 24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe 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
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Tao, Nanjing Medical University
- Investigators
- Tao Yang, MD/PhD, Principal investigator, First Affiliated Hospital, Nanjing Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307695
- Sponsor's protocol ID
- 2014-SR-123
- Status last verified
- Jul 2016
- First submitted
- 12 Nov 2014
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shi Y, Shen M, Gu Y, Chen Y, Xu K, Hu J, Fang C, Guo H, Xu N, Wang G, Lu W, Tao S, Zhao S, Fang C, Ma J, Yan R, Sun R, Qian L, Wu C, Jiang H, Yang T. Heterogeneous effect of saxagliptin on glucose fluctuation and beta-cell function in T1DM: a multicentre, randomised trial. Nutr Diabetes. 2026 Mar 2;16(1):5. doi: 10.1038/s41387-026-00411-3.
PubMed 41771842
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Saxagliptin on Glucose Fluctuation and Immune Regulation in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02307695
- Acronym / sponsor ID
- 2014-SR-123
- Conditions
- Type 1 Diabetes
- Keywords
- Saxagliptin, Type 1 Diabetes, Glycemic variability, C-Peptide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 4 Dec 2014 (estimated)
- 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.
To investigate whether saxagliptin could reduce the fluctuation of glycemia and improve the glycemic control in those type 1 diabetes through mechanisms of suppressing glucagon secretion, improving beta cell function, and re-regulating of the T cell immune system.
Detailed description
Type 1 diabetes mellitus (T1DM) is characterized by immune mediated beta-cell destruction. Due to the imbalance between glucagon and insulin, long-term T1DM patients experience frequent hypoglycaemia and high glucose variability despite of multiple daily injections of insulin.
Dipeptidyl peptidase 4 (DPP-4) inhibitors are a new class of anti-diabetic agents and are widely used in clinical practice to improve glycemic control and protect β-cell function in patients with type 2 diabetes mellitus(T2DM). Saxagliptin, a DPP-4 inhibitor, improves glycemic control in patients with T2DM by increasing endogenous active, intact glucagon-like peptide 1 and glucose-dependent insulinotropic polypeptide in response to food, which augments insulin secretion and decreases glucagon release. This mechanism can lead to the reduction of glucose variation. In some pilot studies, incretin-based therapy in patients with T1DM can improve glucose control and reduce hypoglycemia, the mechanism probably is that it regulates glucagon level. In type 1 diabetic mouse models, DPP-4 inhibitors preserves beta-cell mass and stimulating beta-cell replication.
Interestingly, DPP-4 is also known as cluster of differentiation antigen 26(CD26).It is expressed on the membrane of many types of lymphocyte, e.g. T, B and natural killer(NK)cells, and is involved in their cellular functions. CD26 plays a key role in many aspects in lymphocyte function beyond its DPP-4 enzymatic activity.These observations make it a promising therapeutic target.
Recently, the attention of saxagliptin has been mainly focused on type 2 diabetes, data in type 1 diabetes is rare. We are going to carry out this phase 4 study to testify our hypothesis that saxagliptin could reduce the fluctuation of glycemia and improve the glycemic control in those type 1 diabetes through mechanisms of suppressing glucagon secretion, improving beta cell function, and re-regulating of the T cell immune system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| insulin+Saxagliptin | Experimental | Drug: Saxagliptin, Drug: InsulinPatients who have diagnosed type 1 diabetes are assigned to receive Saxagliptin tablets 5 mg and insulin for 24-week. |
| insulin | Active comparator | Drug: InsulinPatients who have diagnosed type 1 diabetes only use insulin. |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of informed consent prior to any study specific procedures;
- Diagnosed with type 1 diabetes;
- Men or women who are 12 to 65 years of age at time of consenting upon Visit 1.;
- Positivity for at least one of the four islet autoantibodies(IA-2A、IAA、GADA、ZnT8A);
- 6.5% ≤ HbA1c ≤10.0%.
Key exclusion criteria (23 listed)
- type 2 diabetes；
- Evidence of chronic or acute complications of diabetes which is unstable and requires hospitalization；
- Evidence of disease stress；
- History of administration of any antihyperglycemic therapy (other than insulin) during the 12 weeks prior to Visit 1；
- Have a history of, or currently have, acute or chronic pancreatitis；
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 |
|---|---|---|
| SaxagliptinAlso: Onglyza, DPP-IV inhibitorsaxagliptin 5 mg p.o. qd, 24 week | Drug | insulin+Saxagliptin |
| InsulinPatients will be treated according to routine clinical practice at the discretion of the treating physician. | Drug | insulin, insulin+Saxagliptin |
Primary outcome
Change of Mean amplitude of glycemic excursions (MAGE) from baseline in patients with type 1 diabetes treated with saxagliptin plus insulin or insulin alone by continuous glucose monitoring system (CGMS)
Time frame: 24 week
3 secondary outcomes
Change of C-peptide area under the curve (AUC C-peptide) or fasting C-peptide from baseline in patients with type 1 diabetes treated with saxagliptin plus insulin or insulin alone by 3-hour mixed meal tolerance test(MMTT)
Time frame: 24 week
Change of Haemoglobin A1c (HbA1c) from baseline in patients with type 1 diabetes treated with saxagliptin plus insulin or insulin alone
Time frame: 24 week
Change of insulin dosage (U/kg/d) from baseline in patients with type 1 diabetes treated with saxagliptin plus insulin or insulin alone
Time frame: 24 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
- Derived from this study: PubMed 41771842Shi Y, Shen M, Gu Y, Chen Y, Xu K, Hu J, Fang C, Guo H, Xu N, Wang G, Lu W, Tao S, Zhao S, Fang C, Ma J, Yan R, Sun R, Qian L, Wu C, Jiang H, Yang T. Heterogeneous effect of saxagliptin on glucose fluctuation and beta-cell function in T1DM: a multicentre, randomised trial. Nutr Diabetes. 2026 Mar 2;16(1):5. doi: 10.1038/s41387-026-00411-3.
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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.
Tao Yang, MD/PhD principal investigator
First Affiliated Hospital, Nanjing Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Saxagliptin and Insulin in people with Type 1 Diabetes, run by Nanjing Medical 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 5 inclusion and 23 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 6 Jul 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tao Yang, MD/PhD (86-25-83718836 ext. 6466, yangt@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Mean amplitude of glycemic excursions (MAGE) from baseline in patients with type 1 diabetes treated with saxagliptin plus insulin or insulin alone by continuous glucose monitoring system (CGMS) (time frame: 24 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 NCT02307695, 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 6 Jul 2016.