Association between sitagliptin plus vitamin D3 (VIDPP-4i) use and clinical remission in patients with new-onset type 1 diabetes: a retrospective case-control study

Pinheiro, Marcelo Maia; Pinheiro, Felipe Moura Maia; Arruda, Marcelo Müller de; Beato, Geane Moron; Verde, Graciele Alves Corrêa Lima; Bianchini, Georgiana; Casalenuovo, Pedro Rosário Moraes; Argolo, Aline Aparecida Agostini; Souza, Lucilene Telles de; Pessoa, Flávia Gomes; Hirose, Thiago Santos; Senra, Eduardo Filgueiras; Ricordi, Camillo; Fabbri, Andrea; Infante, Marco; Diniz, Susana Nogueira

doi:10.20945/2359-3997000000652

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Original Article • Arch. Endocrinol. Metab. 67 (5) • 2023 • https://doi.org/10.20945/2359-3997000000652 copy

Association between sitagliptin plus vitamin D3 (VIDPP-4i) use and clinical remission in patients with new-onset type 1 diabetes: a retrospective case-control study

Authorship SCIMAGO INSTITUTIONS RANKINGS

ABSTRACT

Objective:

The occurrence of partial remission (honeymoon phase) in type 1 diabetes (T1D) has been associated with a reduced risk of chronic microvascular complications of diabetes. We have published case reports showing that a combination therapy with the DPP-4 inhibitor sitagliptin plus vitamin D3 (VIDPP-4i) can prolong the honeymoon phase in patients with new-onset T1D. In the present case-control study, we investigated the frequency of occurrence of clinical remission (CR) in patients with new-onset T1D after VIDPP-4i treatment.

Subjects and methods:

In this case-control study, we collected data spanning 10 years from medical records of 46 patients (23 females) recently diagnosed with T1D. Overall, 27 participants with CR (insulin dose-adjusted glycated hemoglobin [IDAA1c] ≤ 9) at 12 or 24 months composed the case group, and 19 participants without CR served as the control group. Chi-square with Yates correction was used to analyze the association between VIDPP-4i use and CR, and odds ratio (OR) was used to determine the chance of CR due to VIDPP-4i treatment exposure.

Results:

In all, 37 patients (80.4%) experienced CR at some time over 24 months. The mean CR duration was 13.15 ± 9.91 months. Treatment with VIDPP-4i was significantly associated with CR. At 24 months, the OR of CR after VIDPP-4i exposure was 9.0 (95% confidence interval [CI] 2.21-30.18, p = 0.0036). Additionally, 9 (33.6%) and 4 (14.8%) patients in the VIDPP-4i group experienced insulin-free CR at 12 and 24 months, respectively.

Conclusion:

Therapy with VIDPP-4i was associated with a higher frequency and duration of the honeymoon phase. Randomized controlled trials are needed to confirm these findings.

Keywords
Cholecalciferol; DPP-4 inhibitor; honeymoon phase; type 1 diabetes; vitamin D

	(n = 46)
Age at diagnosis (years)	12.72 ± 6.44 (4-37)
Females (n, %)	23 (50%)
Body weight (kg)	42.11 ± 16.58
Height (m)	1.50 ± 0.20
BMI (kg/m²)	18.96 ± 3.53
BMI z-score	-0.60(±1.45)
DKA at diagnosis (n, %)	19 (41.3%)
FPG (mg/dL)	275.5 ± 117.9
HbA1c (%)	10.67 ± 2.70
TDD (IU/kg of body weight/24h)	0.49 ± 0.27
25(OH)D (ng/mL)	32.41 ± 13.87
Fasting C peptide (ng/mL)	0.82 ± 0.53
GADA antibody (IU/mL) (n = 46)	37(80.4%)^* * Number and % of patients tested who were positive for the antibody.
Islet antigen-2 antibody (IA-2A) (IU/mL) (n = 3)	2^* * Number and % of patients tested who were positive for the antibody. (66.6%)^* * Number and % of patients tested who were positive for the antibody.
Insulin autoantibody (<7.3% binding) (n = 14)	5^* * Number and % of patients tested who were positive for the antibody. (35.7%)^* * Number and % of patients tested who were positive for the antibody.
Islet cell autoantibody (ICA - nonreactive) (n = 18)	10^* * Number and % of patients tested who were positive for the antibody. (55.5%)^* * Number and % of patients tested who were positive for the antibody.
Zinc transporter 8 autoantibody (ZnT8A – UA/mL) (n = 2)	2^* * Number and % of patients tested who were positive for the antibody. (100%)^* * Number and % of patients tested who were positive for the antibody.

	Remitters (n = 27)	Non-remitters (n = 19)	P value
Age at diagnosis (years)	13.89 ± 7.0	11.05 ± 5.1	0.056
Females – n (%)	12 (44.4%)	11 (57.8%)	0.54
Males – n (%)	15 (55.5%)	8 (42.1%)	0.54
BMI (kg/m²)	19.07 ± 3.68	15.86 ± 2.49	0.002
BMI z-score	-0.26 ± 1.12	-1.12 ± 1.69	0.11
DKA at diagnosis – n (%)	10 (38.46%)	9 (47.37%)	0.76
FPG (mg/dL)	262.4 ±101.9	294.1 ± 138.4	0.43
HbA1c (%)	10.7 ± 2.60	10.5 ± 2.91	0.78
TDD (IU/kg of body weight/24h)	0.46 ± 0.31	0.53 ± 0.21	0.21
25(OH)D (ng/mL)	29.55 ± 14.9	36.78 ± 9.29	0.066
Fasting C peptide (ng/mL)	0.81 ± 0.49	0.84 ± 0.69	0.060
Hashimoto's thyroiditis	5 (18.5%)	3(15.78%)	0.715
VIDPP-4i use	21 (77.78%)	6 (31.58%)	0.0025

Study (Country)	n	Age (years)	(F/M) %	DKA %	PR %	DR (Months)	% PR 12 Months	%PR 24 Months	%IFCR 12 Months
Present study, Brazil	46	12.72	50/50	41.3	80.4	13.15	62	51.2	19.5
Camilo and cols., 2020, Brazil	51	10.1	50.9/49.1	29.3	41.2	7	33.3	7.84	0
Bektas and cols., 2020, Turkey	55	10.6	43.7/56.3	47	56.4	NR	21.8	5.5	0
Pecheur and cols., 2014, Belgium	242	8.8	47.5/52.5	25.6	56.2	9.2	28.4	7.5	0
Chiavaroli and cols., 2019, New Zealand	678	9.2	46.3/53.7	27.1	42.4	NR	10.6	7.1^* * Data assessed at 18 months.	0
Nagl and cols., 2017, Germany and Austria	3657	7.9	49/51	15	61	9	28	13	0

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[1] Correspondence to: Marcelo Maia Pinheiro, Avenida Dom Orlando Chaves, 2.655, Cristo Rei 78118-000 – Várzea Grande, MT, Brasil marcelo.pinheiro@univag.edu.br