Time in RangePhase 3NCT06021119
Feasibility of DPP-4 Inhibitor Therapy on Advanced Hybrid Closed Loop System
A Phase 3 study testing Dipeptidyl peptidase-4 inhibitors in people with Time in Range, run by Ain Shams University at 1 site in Egypt.
Trial summary
Background: Ramadan Iftar meal typically causes glucose excursions. Dipeptidyl peptidase-4 inhibitors increase serum concentrations of glucagon-like peptide-1 and thus, decrease blood glucose levels with low risk of hypoglycemia. Read more about this study
- Who is it for?
- Ages 12 to 27 years
- Conditions the study is for
- Time in Range
- What is being tested?
- Dipeptidyl peptidase-4 inhibitors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Mar 2023to 21 Apr 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 27 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients with type 1 diabetes (T1DM )for at least one year
- patients aged 12-27 years
- patients using MiniMed 780G AHCL system (Medtronic, Northridge, CA, USA) at least 6 months before the study
- patients with minimum daily insulin requirement of more than 8 units
- patients willingness and ability to adhere to the study protocol, access to the internet and a computer system that met requirements for uploading the study pump data.
Who cannot join
- patients with any microvascular or macrovascular complications
- pregnancy, lactation
- patients who had a point-of-care screening HbA1c >10.0% (86 mmol/mol)
- patients with hypoglycemic unawareness or recurrent severe hypoglycemic episode in the last 6 months prior to recruitment
- patients with recurrent DKA (more than 2 episodes in the previous 6 months).
- patients with any chronic medical condition, current use of medications (other than insulin) that are known to affect blood glucose level.
- patients who had prior adverse reactions to the adjunctive agent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of DPP-4 Inhibitor for the Treatment of Iftar-Related Glycemic Excursions in Patients With Type 1 Diabetes on MiniMed™ 780G Advanced Hybrid Closed Loop System
Background: Ramadan Iftar meal typically causes glucose excursions. Dipeptidyl peptidase-4 inhibitors increase serum concentrations of glucagon-like peptide-1 and thus, decrease blood glucose levels with low risk of hypoglycemia.
Aim: To investigate the efficacy and safety of vildagliptin as an add-on therapy among adolescents and young adults with type 1 diabetes mellitus (T1DM) on glucose excursions of Iftar Ramadan meals and glycemic metrics during advanced hybrid closed-loop (AHCL) treatment.
Read the detailed description
Current management of people with type 1 diabetes mellitus (T1DM) on intensive insulin therapy recognizes carbohydrates as the most important determinant of postprandial glycaemia; hence, worldwide guidelines recommend carbohydrates counting for determining pre-prandial insulin doses. Currently, the insulin to carbohydrate ratio (ICR) is frequently used to calculate the meal insulin dose. However, ICRs are considered difficult, ineffective and inaccurate for some patient, with an estimation error of around 20% in adults demonstrating only modest improvements in glycated hemoglobin (HbA1c). This lack of effectiveness and the wide variability using ICRs suggests it should be improved upon.
However, there have been only a few randomized control studies that investigated the efficacy and safety of DPP-4 inhibitors as an add-on drug in patients treated with basal insulin. Therefore, we conducted a one-month randomized control trial to investigate the efficacy and safety of DPP-4 inhibitors as an add-on therapy among adolescents and young adults with T1DM on glucose excursions of Iftar Ramadan meals and glucometrics during AHCL treatment .
- Conditions
- Time in Range
- Being tested
- Dipeptidyl peptidase-4 inhibitors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dipeptidyl peptidase-4 inhibitorsDrug
Dipeptidyl peptidase-4 inhibitors with Iftar meal
| Study group | Role | What they receive |
|---|---|---|
| Dipeptidyl peptidase-4 inhibitors | Active comparator | Dipeptidyl peptidase-4 inhibitors with Iftar meal Receives: Drug: Dipeptidyl peptidase-4 inhibitors |
| Control group | No intervention | No Dipeptidyl peptidase-4 inhibitors intake with Iftar meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak postprandial plasma glucose (PPG) level in mg/dl
peak postprandial plasma glucose (PPG) level in mg/dl
Measured: 4 weeks
Secondary outcomes (1)
Time in range %
Time in range %
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start23 Mar 2023
- Primary completion21 Apr 2023
- Study completion21 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Time in RangeStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Samir Elbarbary, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021119
- Sponsor's protocol ID
- Ain Shams University 232212
- Status last verified
- Aug 2023
- First submitted
- 26 Aug 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dyson PA, Twenefour D, Breen C, Duncan A, Elvin E, Goff L, Hill A, Kalsi P, Marsland N, McArdle P, Mellor D, Oliver L, Watson K. Diabetes UK evidence-based nutrition guidelines for the prevention and management of diabetes. Diabet Med. 2018 May;35(5):541-547. doi: 10.1111/dme.13603.
PubMed 29443421Brazeau AS, Mircescu H, Desjardins K, Leroux C, Strychar I, Ekoe JM, Rabasa-Lhoret R. Carbohydrate counting accuracy and blood glucose variability in adults with type 1 diabetes. Diabetes Res Clin Pract. 2013 Jan;99(1):19-23. doi: 10.1016/j.diabres.2012.10.024. Epub 2012 Nov 10.
PubMed 23146371Brown SA, Kovatchev BP, Raghinaru D, Lum JW, Buckingham BA, Kudva YC, Laffel LM, Levy CJ, Pinsker JE, Wadwa RP, Dassau E, Doyle FJ 3rd, Anderson SM, Church MM, Dadlani V, Ekhlaspour L, Forlenza GP, Isganaitis E, Lam DW, Kollman C, Beck RW; iDCL Trial Research Group. Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes. N Engl J Med. 2019 Oct 31;381(18):1707-1717. doi: 10.1056/NEJMoa1907863. Epub 2019 Oct 16.
PubMed 31618560Wadwa RP, Reed ZW, Buckingham BA, DeBoer MD, Ekhlaspour L, Forlenza GP, Schoelwer M, Lum J, Kollman C, Beck RW, Breton MD; PEDAP Trial Study Group. Trial of Hybrid Closed-Loop Control in Young Children with Type 1 Diabetes. N Engl J Med. 2023 Mar 16;388(11):991-1001. doi: 10.1056/NEJMoa2210834.
PubMed 36920756Lakshman R, Boughton C, Hovorka R. The changing landscape of automated insulin delivery in the management of type 1 diabetes. Endocr Connect. 2023 Jul 31;12(8):e230132. doi: 10.1530/EC-23-0132.
PubMed 37289734Elbarbary NS, Ismail EAR. Mitigating iftar-related glycemic excursions in adolescents and young adults with type 1 diabetes on MiniMed 780G advanced hybrid closed loop system: a randomized clinical trial for adjunctive oral vildagliptin therapy during Ramadan fasting. Diabetol Metab Syndr. 2023 Dec 7;15(1):257. doi: 10.1186/s13098-023-01232-5.
PubMed 38057844
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of DPP-4 Inhibitor for the Treatment of Iftar-Related Glycemic Excursions in Patients With Type 1 Diabetes on MiniMed™ 780G Advanced Hybrid Closed Loop System
- ClinicalTrials.gov ID
- NCT06021119
- Acronym / sponsor ID
- Ain Shams University 232212
- Conditions
- Time in Range
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 21 Apr 2023 (actual)
- Study completion
- 21 Apr 2023 (actual)
- First posted
- 1 Sep 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.
Background: Ramadan Iftar meal typically causes glucose excursions. Dipeptidyl peptidase-4 inhibitors increase serum concentrations of glucagon-like peptide-1 and thus, decrease blood glucose levels with low risk of hypoglycemia.
Aim: To investigate the efficacy and safety of vildagliptin as an add-on therapy among adolescents and young adults with type 1 diabetes mellitus (T1DM) on glucose excursions of Iftar Ramadan meals and glycemic metrics during advanced hybrid closed-loop (AHCL) treatment.
Detailed description
Current management of people with type 1 diabetes mellitus (T1DM) on intensive insulin therapy recognizes carbohydrates as the most important determinant of postprandial glycaemia; hence, worldwide guidelines recommend carbohydrates counting for determining pre-prandial insulin doses. Currently, the insulin to carbohydrate ratio (ICR) is frequently used to calculate the meal insulin dose. However, ICRs are considered difficult, ineffective and inaccurate for some patient, with an estimation error of around 20% in adults demonstrating only modest improvements in glycated hemoglobin (HbA1c). This lack of effectiveness and the wide variability using ICRs suggests it should be improved upon.
However, there have been only a few randomized control studies that investigated the efficacy and safety of DPP-4 inhibitors as an add-on drug in patients treated with basal insulin. Therefore, we conducted a one-month randomized control trial to investigate the efficacy and safety of DPP-4 inhibitors as an add-on therapy among adolescents and young adults with T1DM on glucose excursions of Iftar Ramadan meals and glucometrics during AHCL treatment .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dipeptidyl peptidase-4 inhibitors | Active comparator | Drug: Dipeptidyl peptidase-4 inhibitorsDipeptidyl peptidase-4 inhibitors with Iftar meal |
| Control group | No intervention | –No Dipeptidyl peptidase-4 inhibitors intake with Iftar meal |
Who may qualify
- Ages
- 12 to 27 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- patients with type 1 diabetes (T1DM )for at least one year
- patients aged 12-27 years
- patients using MiniMed 780G AHCL system (Medtronic, Northridge, CA, USA) at least 6 months before the study
- patients with minimum daily insulin requirement of more than 8 units
- patients willingness and ability to adhere to the study protocol, access to the internet and a computer system that met requirements for uploading the study pump data.
Key exclusion criteria (7 listed)
- patients with any microvascular or macrovascular complications
- pregnancy, lactation
- patients who had a point-of-care screening HbA1c >10.0% (86 mmol/mol)
- patients with hypoglycemic unawareness or recurrent severe hypoglycemic episode in the last 6 months prior to recruitment
- patients with recurrent DKA (more than 2 episodes in the previous 6 months).
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 |
|---|---|---|
| Dipeptidyl peptidase-4 inhibitorsDipeptidyl peptidase-4 inhibitors with Iftar meal | Drug | Dipeptidyl peptidase-4 inhibitors |
Primary outcome
peak postprandial plasma glucose (PPG) level in mg/dl
Time frame: 4 weeks
peak postprandial plasma glucose (PPG) level in mg/dl
1 secondary outcome
Time in range %
Time frame: 4 weeks
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 1 Sep 2023.
- Background: PubMed 29443421Dyson PA, Twenefour D, Breen C, Duncan A, Elvin E, Goff L, Hill A, Kalsi P, Marsland N, McArdle P, Mellor D, Oliver L, Watson K. Diabetes UK evidence-based nutrition guidelines for the prevention and management of diabetes. Diabet Med. 2018 May;35(5):541-547. doi: 10.1111/dme.13603.
- Background: PubMed 23146371Brazeau AS, Mircescu H, Desjardins K, Leroux C, Strychar I, Ekoe JM, Rabasa-Lhoret R. Carbohydrate counting accuracy and blood glucose variability in adults with type 1 diabetes. Diabetes Res Clin Pract. 2013 Jan;99(1):19-23. doi: 10.1016/j.diabres.2012.10.024. Epub 2012 Nov 10.
- Background: PubMed 31618560Brown SA, Kovatchev BP, Raghinaru D, Lum JW, Buckingham BA, Kudva YC, Laffel LM, Levy CJ, Pinsker JE, Wadwa RP, Dassau E, Doyle FJ 3rd, Anderson SM, Church MM, Dadlani V, Ekhlaspour L, Forlenza GP, Isganaitis E, Lam DW, Kollman C, Beck RW; iDCL Trial Research Group. Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes. N Engl J Med. 2019 Oct 31;381(18):1707-1717. doi: 10.1056/NEJMoa1907863. Epub 2019 Oct 16.
- Background: PubMed 36920756Wadwa RP, Reed ZW, Buckingham BA, DeBoer MD, Ekhlaspour L, Forlenza GP, Schoelwer M, Lum J, Kollman C, Beck RW, Breton MD; PEDAP Trial Study Group. Trial of Hybrid Closed-Loop Control in Young Children with Type 1 Diabetes. N Engl J Med. 2023 Mar 16;388(11):991-1001. doi: 10.1056/NEJMoa2210834.
- Background: PubMed 37289734Lakshman R, Boughton C, Hovorka R. The changing landscape of automated insulin delivery in the management of type 1 diabetes. Endocr Connect. 2023 Jul 31;12(8):e230132. doi: 10.1530/EC-23-0132.
- Derived from this study: PubMed 38057844Elbarbary NS, Ismail EAR. Mitigating iftar-related glycemic excursions in adolescents and young adults with type 1 diabetes on MiniMed 780G advanced hybrid closed loop system: a randomized clinical trial for adjunctive oral vildagliptin therapy during Ramadan fasting. Diabetol Metab Syndr. 2023 Dec 7;15(1):257. doi: 10.1186/s13098-023-01232-5.
- 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.
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 Dipeptidyl peptidase-4 inhibitors in people with Time in Range, 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 7 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 1 Sep 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?
peak postprandial plasma glucose (PPG) level in mg/dl (time frame: 4 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 NCT06021119, which also lists 6 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 1 Sep 2023.