Type 1 Diabetic NephropathyPhase 3NCT06115460
The Impact of Sitagliptin as an Add on Therapy With Closed Loop Control in Adolescents With Diabetic Nephropathy
A Phase 3 study testing oral sitagliptin supplementation in people with Type 1 Diabetic Nephropathy, run by Ain Shams University at 1 site in Egypt.
Trial summary
Diabetic nephropathy (DN) is one of the most frequent microvascular complications of diabetes mellitus, affecting 25 to 40% of patients with type 1 diabetes (T1DM). Early diagnosis, appropriate patient follow-up and treatment are essential to improve the outcomes. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Type 1 Diabetic Nephropathy
- What is being tested?
- oral sitagliptin supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to 15 Jun 2023
- Phase
- Phase 3
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- T1DM patients aged 12-18 years with at least 5 years disease duration defined according to the criteria of International Society for Pediatric and Adolescent Diabetes (ISPAD) .
- Patients on insulin pump therapy using Medtronic advanced hybrid closed system (Medtronic, Northridge, USA) with Guardian™ 3 sensor or Guardian™ 4 sensor and Guardian link transmitter initiated at least 6 months before the study, patients with minimum daily insulin requirement of more than 8 units, willingness and ability to adhere to the study protocol, and access to the internet as well as a computer system that met requirements for uploading the study pump data.
- Active diabetic nephropathy in the form of microalbuminuria (urinary albumin excretion ) 30-299 mg/g creatinine in two of three samples over a 3- to 6-months period despite angiotensin converting enzyme inhibitors).
- Hemoglobin A1c (HbA1c) ≤8.5%.
- Patients on regular visits to clinic.
Who cannot join
- patients with other diabetic microvascular complications (neuropathy or retinopathy) or with macrovascular complications.
- Patients with history of liver disease or any disorder likely to impair liver functions or elevated liver enzymes.
- Patients with any evidence of renal impairment due to causes other than diabetes.
- Patients with hypertension.
- Hepatitis virus infection (B or C) or any evidence of infection
- Participation in a previous investigational drug study within 3 months preceding screening.
Show all 10Show fewer
- Hypoglycemic unawareness or recurrent severe hypoglycemic episodes in the last 6 months prior to recruitment.
- Recurrent diabetic ketoacidosis (DKA) (more than 2 episodes in the previous 6 months).
- Taking other oral hypoglycemic medications which could affect blood glucose.
- Patients with known allergy to sitagliptin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Sitagliptin as an Add on Therapy With Closed Loop Control in Adolescents With Type 1 Diabetes Mellitus and Diabetic Nephropathy
Diabetic nephropathy (DN) is one of the most frequent microvascular complications of diabetes mellitus, affecting 25 to 40% of patients with type 1 diabetes (T1DM). Early diagnosis, appropriate patient follow-up and treatment are essential to improve the outcomes. There is a need for improvements in insulin therapy for people with T1DM as the majority of patients are struggling to achieve glycemic targets. Technological advancements and oral adjuncts to insulin therapies are starting to be licensed for the use of people with T1DM.
Dipeptidyl peptidase-4 (DPP-4), a multifunctional serine protease with a dual function (regulatory protease and binding protein), can modulate inflammation and immune cell-mediated β-cell destruction. DPP-4 degrades the peptide hormones glucagon-like peptide 1 (GLP-1) and gastric inhibitory peptide (GIP). Several studies have suggested that the upregulated DPP-4 activity is correlated with T1DM pathophysiology.
Read the detailed description
Evidence from preclinical investigation suggests that DPP-4 inhibition may have beneficial effects on various metabolic indicators in diabetes. DPP-4 inhibitors, such as sitagliptin, have been widely used as outstanding blood glucose-dependent antidiabetic agents for patients with type 2 diabetes(T2DM). DPP-4 inhibitors have a lowering effect on the glycemic level and were not associated with increasing incidence of adverse events. The reno-protective effects of DPP-4 inhibition in diabetic nephropathy could be a consequence of the antidiabetic actions of DPP-4 inhibitors.
A second-generation advanced hybrid closed loop ( AHCL) system has been developed to further improve glycemic control and usability, with adjustable target glucose and automated correction boluses. This system provides proportional integral derivate (PID) algorithm with insulin feedback with adaptive insulin limits and model based auto-corrections located on the pump. Sitagliptin demonstrated an overall decrease in blood glucose concentrations in adults with T1DM when used as an adjunct therapy with an insulin only closed loop (CL) system.
Stromal cell-derived factor-1 (SDF-1) is ubiquitously expressed in diverse organs and has multiple functions. SDF-1 is cleaved and inactivated by the DPP-4 enzyme. The DPP-4 enzyme is highly expressed in the kidney. It has been suggested that renal SDF-1 upregulation by DPP-4 inhibition produces multiple protective actions on the diabetic kidney.
In view of these data, the investigators assessed the impact of sitagliptin as add on therapy with closed loop control in adolescents with T1DM on glycemic control, diabetic nephropathy and SDF-1 as a marker for nephropathy.
- Conditions
- Type 1 Diabetic Nephropathy
- Being tested
- oral sitagliptin supplementation
- Keywords
- Type 1 diabetes, Diabetic nephropathy, Sitagliptin, Time in Range, Advanced hybrid closed system, Stromal cell-derived factor-1 (SDF-1)
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral sitagliptin supplementationDrug
oral sitagliptin supplementation for three months
| Study group | Role | What they receive |
|---|---|---|
| Oral sitagliptin 50 mg supplementation for three months | Active comparator | Intervention group includes: adolescents with diabetic nephropathy on advanced hybrid closed loop system receiving oral sitagliptin 50 mg for three months on a daily basis Receives: Drug: oral sitagliptin supplementation |
| Control group ( No intake of oral sitagliptin 50 mg supplementation for three months) | No intervention | Control group includes: adolescents with diabetic nephropathy on advanced hybrid closed loop system who did not take oral sitagliptin 50 mg for three months on a daily basis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Time in range
Change in Time in range (TIR) in intervention group in comparison to control group
Measured: 3 months
Secondary outcomes (2)
Level of microalbuminuria
Change in microalbuminuria level in intervention group in comparison to control group
Measured: 3 months
Level of Stromal cell-derived factor-1 (SDF-1)
Change in Stromal cell-derived factor-1 (SDF-1)in intervention group in comparison to control group
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start1 Mar 2022
- Primary completion1 Jun 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetic NephropathyStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Ahram Canadian University
- Responsible party
- Principal investigator, Nancy Samir Elbarbary, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06115460
- Sponsor's protocol ID
- Ain Shams University202388
- Status last verified
- Nov 2023
- First submitted
- 30 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All data are available upon request
Publications
Zhong J, Rajagopalan S. Dipeptidyl Peptidase-4 Regulation of SDF-1/CXCR4 Axis: Implications for Cardiovascular Disease. Front Immunol. 2015 Sep 25;6:477. doi: 10.3389/fimmu.2015.00477. eCollection 2015.
PubMed 26441982Weisman A, Bai JW, Cardinez M, Kramer CK, Perkins BA. Effect of artificial pancreas systems on glycaemic control in patients with type 1 diabetes: a systematic review and meta-analysis of outpatient randomised controlled trials. Lancet Diabetes Endocrinol. 2017 Jul;5(7):501-512. doi: 10.1016/S2213-8587(17)30167-5. Epub 2017 May 19.
PubMed 28533136Williams-Herman D, Engel SS, Round E, Johnson J, Golm GT, Guo H, Musser BJ, Davies MJ, Kaufman KD, Goldstein BJ. Safety and tolerability of sitagliptin in clinical studies: a pooled analysis of data from 10,246 patients with type 2 diabetes. BMC Endocr Disord. 2010 Apr 22;10:7. doi: 10.1186/1472-6823-10-7.
PubMed 20412573Garg SK, Weinzimer SA, Tamborlane WV, Buckingham BA, Bode BW, Bailey TS, Brazg RL, Ilany J, Slover RH, Anderson SM, Bergenstal RM, Grosman B, Roy A, Cordero TL, Shin J, Lee SW, Kaufman FR. Glucose Outcomes with the In-Home Use of a Hybrid Closed-Loop Insulin Delivery System in Adolescents and Adults with Type 1 Diabetes. Diabetes Technol Ther. 2017 Mar;19(3):155-163. doi: 10.1089/dia.2016.0421. Epub 2017 Jan 30.
PubMed 28134564Bergenstal RM, Nimri R, Beck RW, Criego A, Laffel L, Schatz D, Battelino T, Danne T, Weinzimer SA, Sibayan J, Johnson ML, Bailey RJ, Calhoun P, Carlson A, Isganaitis E, Bello R, Albanese-O'Neill A, Dovc K, Biester T, Weyman K, Hood K, Phillip M; FLAIR Study Group. A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes (FLAIR): a multicentre, randomised, crossover trial. Lancet. 2021 Jan 16;397(10270):208-219. doi: 10.1016/S0140-6736(20)32514-9.
PubMed 33453783Ho TK, Shiwen X, Abraham D, Tsui J, Baker D. Stromal-Cell-Derived Factor-1 (SDF-1)/CXCL12 as Potential Target of Therapeutic Angiogenesis in Critical Leg Ischaemia. Cardiol Res Pract. 2012;2012:143209. doi: 10.1155/2012/143209. Epub 2012 Feb 22.
PubMed 22462026Elbarbary NS, Ismail EA, El-Hamamsy MH, Ibrahim MZ, Elkholy AA. The DPP-4 inhibitor sitagliptin improves glycaemic control and early-stage diabetic nephropathy in adolescents with type 1 diabetes using the MiniMed 780G advanced hybrid closed-loop system: a randomised controlled trial. Diabetologia. 2024 Dec;67(12):2637-2649. doi: 10.1007/s00125-024-06265-7. Epub 2024 Sep 14.
PubMed 39271520
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Sitagliptin as an Add on Therapy With Closed Loop Control in Adolescents With Type 1 Diabetes Mellitus and Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT06115460
- Acronym / sponsor ID
- Ain Shams University202388
- Conditions
- Type 1 Diabetic Nephropathy
- Keywords
- Type 1 diabetes, Diabetic nephropathy, Sitagliptin, Time in Range, Advanced hybrid closed system, Stromal cell-derived factor-1 (SDF-1)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Ahram Canadian University
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 3 Nov 2023 (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.
Diabetic nephropathy (DN) is one of the most frequent microvascular complications of diabetes mellitus, affecting 25 to 40% of patients with type 1 diabetes (T1DM). Early diagnosis, appropriate patient follow-up and treatment are essential to improve the outcomes. There is a need for improvements in insulin therapy for people with T1DM as the majority of patients are struggling to achieve glycemic targets. Technological advancements and oral adjuncts to insulin therapies are starting to be licensed for the use of people with T1DM.
Dipeptidyl peptidase-4 (DPP-4), a multifunctional serine protease with a dual function (regulatory protease and binding protein), can modulate inflammation and immune cell-mediated β-cell destruction. DPP-4 degrades the peptide hormones glucagon-like peptide 1 (GLP-1) and gastric inhibitory peptide (GIP). Several studies have suggested that the upregulated DPP-4 activity is correlated with T1DM pathophysiology.
Detailed description
Evidence from preclinical investigation suggests that DPP-4 inhibition may have beneficial effects on various metabolic indicators in diabetes. DPP-4 inhibitors, such as sitagliptin, have been widely used as outstanding blood glucose-dependent antidiabetic agents for patients with type 2 diabetes(T2DM). DPP-4 inhibitors have a lowering effect on the glycemic level and were not associated with increasing incidence of adverse events. The reno-protective effects of DPP-4 inhibition in diabetic nephropathy could be a consequence of the antidiabetic actions of DPP-4 inhibitors.
A second-generation advanced hybrid closed loop ( AHCL) system has been developed to further improve glycemic control and usability, with adjustable target glucose and automated correction boluses. This system provides proportional integral derivate (PID) algorithm with insulin feedback with adaptive insulin limits and model based auto-corrections located on the pump. Sitagliptin demonstrated an overall decrease in blood glucose concentrations in adults with T1DM when used as an adjunct therapy with an insulin only closed loop (CL) system.
Stromal cell-derived factor-1 (SDF-1) is ubiquitously expressed in diverse organs and has multiple functions. SDF-1 is cleaved and inactivated by the DPP-4 enzyme. The DPP-4 enzyme is highly expressed in the kidney. It has been suggested that renal SDF-1 upregulation by DPP-4 inhibition produces multiple protective actions on the diabetic kidney.
In view of these data, the investigators assessed the impact of sitagliptin as add on therapy with closed loop control in adolescents with T1DM on glycemic control, diabetic nephropathy and SDF-1 as a marker for nephropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral sitagliptin 50 mg supplementation for three months | Active comparator | Drug: oral sitagliptin supplementationIntervention group includes: adolescents with diabetic nephropathy on advanced hybrid closed loop system receiving oral sitagliptin 50 mg for three months on a daily basis |
| Control group ( No intake of oral sitagliptin 50 mg supplementation for three months) | No intervention | –Control group includes: adolescents with diabetic nephropathy on advanced hybrid closed loop system who did not take oral sitagliptin 50 mg for three months on a daily basis |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- T1DM patients aged 12-18 years with at least 5 years disease duration defined according to the criteria of International Society for Pediatric and Adolescent Diabetes (ISPAD) .
- Patients on insulin pump therapy using Medtronic advanced hybrid closed system (Medtronic, Northridge, USA) with Guardian™ 3 sensor or Guardian™ 4 sensor and Guardian link transmitter initiated at least 6 months before the study, patients with minimum daily insulin requirement of more than 8 units, willingness and ability to adhere to the study protocol, and access to the internet as well as a computer system that met requirements for uploading the study pump data.
- Active diabetic nephropathy in the form of microalbuminuria (urinary albumin excretion ) 30-299 mg/g creatinine in two of three samples over a 3- to 6-months period despite angiotensin converting enzyme inhibitors).
- Hemoglobin A1c (HbA1c) ≤8.5%.
- Patients on regular visits to clinic.
Key exclusion criteria (10 listed)
- patients with other diabetic microvascular complications (neuropathy or retinopathy) or with macrovascular complications.
- Patients with history of liver disease or any disorder likely to impair liver functions or elevated liver enzymes.
- Patients with any evidence of renal impairment due to causes other than diabetes.
- Patients with hypertension.
- Hepatitis virus infection (B or C) or any evidence of infection
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 |
|---|---|---|
| oral sitagliptin supplementationoral sitagliptin supplementation for three months | Drug | Oral sitagliptin 50 mg supplementation for three months |
Primary outcome
Percentage of Time in range
Time frame: 3 months
Change in Time in range (TIR) in intervention group in comparison to control group
2 secondary outcomes
Level of microalbuminuria
Time frame: 3 months
Level of Stromal cell-derived factor-1 (SDF-1)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Background: PubMed 26441982Zhong J, Rajagopalan S. Dipeptidyl Peptidase-4 Regulation of SDF-1/CXCR4 Axis: Implications for Cardiovascular Disease. Front Immunol. 2015 Sep 25;6:477. doi: 10.3389/fimmu.2015.00477. eCollection 2015.
- Background: PubMed 28533136Weisman A, Bai JW, Cardinez M, Kramer CK, Perkins BA. Effect of artificial pancreas systems on glycaemic control in patients with type 1 diabetes: a systematic review and meta-analysis of outpatient randomised controlled trials. Lancet Diabetes Endocrinol. 2017 Jul;5(7):501-512. doi: 10.1016/S2213-8587(17)30167-5. Epub 2017 May 19.
- Background: PubMed 20412573Williams-Herman D, Engel SS, Round E, Johnson J, Golm GT, Guo H, Musser BJ, Davies MJ, Kaufman KD, Goldstein BJ. Safety and tolerability of sitagliptin in clinical studies: a pooled analysis of data from 10,246 patients with type 2 diabetes. BMC Endocr Disord. 2010 Apr 22;10:7. doi: 10.1186/1472-6823-10-7.
- Background: PubMed 28134564Garg SK, Weinzimer SA, Tamborlane WV, Buckingham BA, Bode BW, Bailey TS, Brazg RL, Ilany J, Slover RH, Anderson SM, Bergenstal RM, Grosman B, Roy A, Cordero TL, Shin J, Lee SW, Kaufman FR. Glucose Outcomes with the In-Home Use of a Hybrid Closed-Loop Insulin Delivery System in Adolescents and Adults with Type 1 Diabetes. Diabetes Technol Ther. 2017 Mar;19(3):155-163. doi: 10.1089/dia.2016.0421. Epub 2017 Jan 30.
- Background: PubMed 33453783Bergenstal RM, Nimri R, Beck RW, Criego A, Laffel L, Schatz D, Battelino T, Danne T, Weinzimer SA, Sibayan J, Johnson ML, Bailey RJ, Calhoun P, Carlson A, Isganaitis E, Bello R, Albanese-O'Neill A, Dovc K, Biester T, Weyman K, Hood K, Phillip M; FLAIR Study Group. A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes (FLAIR): a multicentre, randomised, crossover trial. Lancet. 2021 Jan 16;397(10270):208-219. doi: 10.1016/S0140-6736(20)32514-9.
- Background: PubMed 22462026Ho TK, Shiwen X, Abraham D, Tsui J, Baker D. Stromal-Cell-Derived Factor-1 (SDF-1)/CXCL12 as Potential Target of Therapeutic Angiogenesis in Critical Leg Ischaemia. Cardiol Res Pract. 2012;2012:143209. doi: 10.1155/2012/143209. Epub 2012 Feb 22.
- Derived from this study: PubMed 39271520Elbarbary NS, Ismail EA, El-Hamamsy MH, Ibrahim MZ, Elkholy AA. The DPP-4 inhibitor sitagliptin improves glycaemic control and early-stage diabetic nephropathy in adolescents with type 1 diabetes using the MiniMed 780G advanced hybrid closed-loop system: a randomised controlled trial. Diabetologia. 2024 Dec;67(12):2637-2649. doi: 10.1007/s00125-024-06265-7. Epub 2024 Sep 14.
- Individual participant dataSharing planned: Undecided. All data are available upon request
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing oral sitagliptin supplementation in people with Type 1 Diabetic Nephropathy, run by Ain Shams University at 1 site in Egypt.
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 10 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 7 Nov 2023. 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 Egypt. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Percentage of Time in range (time frame: 3 months). 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 NCT06115460, which also lists 7 linked publications.
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 7 Nov 2023.