Efficacy and Safety of Glimepiride With or Without Linagliptin Treatment in Patients With HNF1A Diabetes (Maturity-Onset Diabetes of the Young Type 3): A Randomized, Double-Blinded, Placebo-Controlled, Crossover Trial (GLIMLINA)

Publikation: Bidrag til tidsskriftTidsskriftartikelfagfællebedømt

Standard

Efficacy and Safety of Glimepiride With or Without Linagliptin Treatment in Patients With HNF1A Diabetes (Maturity-Onset Diabetes of the Young Type 3) : A Randomized, Double-Blinded, Placebo-Controlled, Crossover Trial (GLIMLINA). / Christensen, Alexander S.; Haedersdal, Sofie; Stoy, Julie; Storgaard, Heidi; Kampmann, Ulla; Forman, Julie L.; Seghieri, Marta; Holst, Jens J.; Hansen, Torben; Knop, Filip K.; Vilsboll, Tina.

I: Diabetes Care, Bind 43, Nr. 9, 2020, s. 2025-2033.

Publikation: Bidrag til tidsskriftTidsskriftartikelfagfællebedømt

Harvard

Christensen, AS, Haedersdal, S, Stoy, J, Storgaard, H, Kampmann, U, Forman, JL, Seghieri, M, Holst, JJ, Hansen, T, Knop, FK & Vilsboll, T 2020, 'Efficacy and Safety of Glimepiride With or Without Linagliptin Treatment in Patients With HNF1A Diabetes (Maturity-Onset Diabetes of the Young Type 3): A Randomized, Double-Blinded, Placebo-Controlled, Crossover Trial (GLIMLINA)', Diabetes Care, bind 43, nr. 9, s. 2025-2033. https://doi.org/10.2337/dc20-0408

APA

Christensen, A. S., Haedersdal, S., Stoy, J., Storgaard, H., Kampmann, U., Forman, J. L., Seghieri, M., Holst, J. J., Hansen, T., Knop, F. K., & Vilsboll, T. (2020). Efficacy and Safety of Glimepiride With or Without Linagliptin Treatment in Patients With HNF1A Diabetes (Maturity-Onset Diabetes of the Young Type 3): A Randomized, Double-Blinded, Placebo-Controlled, Crossover Trial (GLIMLINA). Diabetes Care, 43(9), 2025-2033. https://doi.org/10.2337/dc20-0408

Vancouver

Christensen AS, Haedersdal S, Stoy J, Storgaard H, Kampmann U, Forman JL o.a. Efficacy and Safety of Glimepiride With or Without Linagliptin Treatment in Patients With HNF1A Diabetes (Maturity-Onset Diabetes of the Young Type 3): A Randomized, Double-Blinded, Placebo-Controlled, Crossover Trial (GLIMLINA). Diabetes Care. 2020;43(9):2025-2033. https://doi.org/10.2337/dc20-0408

Author

Christensen, Alexander S. ; Haedersdal, Sofie ; Stoy, Julie ; Storgaard, Heidi ; Kampmann, Ulla ; Forman, Julie L. ; Seghieri, Marta ; Holst, Jens J. ; Hansen, Torben ; Knop, Filip K. ; Vilsboll, Tina. / Efficacy and Safety of Glimepiride With or Without Linagliptin Treatment in Patients With HNF1A Diabetes (Maturity-Onset Diabetes of the Young Type 3) : A Randomized, Double-Blinded, Placebo-Controlled, Crossover Trial (GLIMLINA). I: Diabetes Care. 2020 ; Bind 43, Nr. 9. s. 2025-2033.

Bibtex

@article{b1f99a4532ae49d6b4220a90e5a4f801,
title = "Efficacy and Safety of Glimepiride With or Without Linagliptin Treatment in Patients With HNF1A Diabetes (Maturity-Onset Diabetes of the Young Type 3): A Randomized, Double-Blinded, Placebo-Controlled, Crossover Trial (GLIMLINA)",
abstract = "OBJECTIVE Sulfonylureas are first-line treatment of hepatocyte nuclear factor 1-alpha (HNF1A) diabetes (maturity-onset diabetes of the young type 3), but many patients do not achieve optimal glycemic control without episodes of hypoglycemia. We investigated the combination of the sulfonylurea glimepiride and the dipeptidyl peptidase 4 inhibitor linagliptin versus glimepiride monotherapy with respect to glycemic variability, glycemic control, and risk of hypoglycemia. RESEARCH DESIGN AND METHODS In a randomized, double-blinded, crossover trial, patients with HNF1A diabetes (n= 19; mean +/- SD age 43 +/- 14 years, BMI 24.8 +/- 2.8 kg/m(2), and glycated hemoglobin [HbA(1c)] 7.4 +/- 0.2% [57.1 +/- 7.3 mmol/mol]) were randomly assigned to treatment with glimepiride + linagliptin 5 mg (16 weeks), washout (4 weeks), and glimepiride + placebo (16 weeks) (or vice versa). Glimepiride was titrated targeting a fasting plasma glucose of 4.5-6.0 mmol/L without hypoglycemia. Treatments were evaluated by continuous glucose monitoring (CGM), HbA(1c), and meal test. RESULTS Compared with glimepiride + placebo, glimepiride + linagliptin did not significantly improve the primary end point, mean amplitude of glycemic excursions (MAGE) (mean difference -0.7 mmol/L,P =0.1540), but displayed significant reductions in coefficient of variation on CGM (-3.6%,P =0.0401), HbA(1c)(-0.5%,P =0.0048), and glimepiride dose (-0.7 mg/day,P =0.0099). beta-cell glucose sensitivity (assessed as C-peptide-to-glucose ratio) during meal test improved with glimepiride + linagliptin. Incidences of hypoglycemia were similar with both treatments. CONCLUSIONS Linagliptin as add-on treatment to glimepiride improved glycemic variability and control without increasing risk of hypoglycemia in patients with HNF1A diabetes.",
keywords = "NUCLEAR FACTOR-1-ALPHA, INSULIN-SECRETION, GLUCOSE, MUTATIONS, HYPOGLYCEMIA, SENSITIVITY, INHIBITION, GENES, ALPHA, RISK",
author = "Christensen, {Alexander S.} and Sofie Haedersdal and Julie Stoy and Heidi Storgaard and Ulla Kampmann and Forman, {Julie L.} and Marta Seghieri and Holst, {Jens J.} and Torben Hansen and Knop, {Filip K.} and Tina Vilsboll",
year = "2020",
doi = "10.2337/dc20-0408",
language = "English",
volume = "43",
pages = "2025--2033",
journal = "Diabetes Care",
issn = "0149-5992",
publisher = "American Diabetes Association",
number = "9",

}

RIS

TY - JOUR

T1 - Efficacy and Safety of Glimepiride With or Without Linagliptin Treatment in Patients With HNF1A Diabetes (Maturity-Onset Diabetes of the Young Type 3)

T2 - A Randomized, Double-Blinded, Placebo-Controlled, Crossover Trial (GLIMLINA)

AU - Christensen, Alexander S.

AU - Haedersdal, Sofie

AU - Stoy, Julie

AU - Storgaard, Heidi

AU - Kampmann, Ulla

AU - Forman, Julie L.

AU - Seghieri, Marta

AU - Holst, Jens J.

AU - Hansen, Torben

AU - Knop, Filip K.

AU - Vilsboll, Tina

PY - 2020

Y1 - 2020

N2 - OBJECTIVE Sulfonylureas are first-line treatment of hepatocyte nuclear factor 1-alpha (HNF1A) diabetes (maturity-onset diabetes of the young type 3), but many patients do not achieve optimal glycemic control without episodes of hypoglycemia. We investigated the combination of the sulfonylurea glimepiride and the dipeptidyl peptidase 4 inhibitor linagliptin versus glimepiride monotherapy with respect to glycemic variability, glycemic control, and risk of hypoglycemia. RESEARCH DESIGN AND METHODS In a randomized, double-blinded, crossover trial, patients with HNF1A diabetes (n= 19; mean +/- SD age 43 +/- 14 years, BMI 24.8 +/- 2.8 kg/m(2), and glycated hemoglobin [HbA(1c)] 7.4 +/- 0.2% [57.1 +/- 7.3 mmol/mol]) were randomly assigned to treatment with glimepiride + linagliptin 5 mg (16 weeks), washout (4 weeks), and glimepiride + placebo (16 weeks) (or vice versa). Glimepiride was titrated targeting a fasting plasma glucose of 4.5-6.0 mmol/L without hypoglycemia. Treatments were evaluated by continuous glucose monitoring (CGM), HbA(1c), and meal test. RESULTS Compared with glimepiride + placebo, glimepiride + linagliptin did not significantly improve the primary end point, mean amplitude of glycemic excursions (MAGE) (mean difference -0.7 mmol/L,P =0.1540), but displayed significant reductions in coefficient of variation on CGM (-3.6%,P =0.0401), HbA(1c)(-0.5%,P =0.0048), and glimepiride dose (-0.7 mg/day,P =0.0099). beta-cell glucose sensitivity (assessed as C-peptide-to-glucose ratio) during meal test improved with glimepiride + linagliptin. Incidences of hypoglycemia were similar with both treatments. CONCLUSIONS Linagliptin as add-on treatment to glimepiride improved glycemic variability and control without increasing risk of hypoglycemia in patients with HNF1A diabetes.

AB - OBJECTIVE Sulfonylureas are first-line treatment of hepatocyte nuclear factor 1-alpha (HNF1A) diabetes (maturity-onset diabetes of the young type 3), but many patients do not achieve optimal glycemic control without episodes of hypoglycemia. We investigated the combination of the sulfonylurea glimepiride and the dipeptidyl peptidase 4 inhibitor linagliptin versus glimepiride monotherapy with respect to glycemic variability, glycemic control, and risk of hypoglycemia. RESEARCH DESIGN AND METHODS In a randomized, double-blinded, crossover trial, patients with HNF1A diabetes (n= 19; mean +/- SD age 43 +/- 14 years, BMI 24.8 +/- 2.8 kg/m(2), and glycated hemoglobin [HbA(1c)] 7.4 +/- 0.2% [57.1 +/- 7.3 mmol/mol]) were randomly assigned to treatment with glimepiride + linagliptin 5 mg (16 weeks), washout (4 weeks), and glimepiride + placebo (16 weeks) (or vice versa). Glimepiride was titrated targeting a fasting plasma glucose of 4.5-6.0 mmol/L without hypoglycemia. Treatments were evaluated by continuous glucose monitoring (CGM), HbA(1c), and meal test. RESULTS Compared with glimepiride + placebo, glimepiride + linagliptin did not significantly improve the primary end point, mean amplitude of glycemic excursions (MAGE) (mean difference -0.7 mmol/L,P =0.1540), but displayed significant reductions in coefficient of variation on CGM (-3.6%,P =0.0401), HbA(1c)(-0.5%,P =0.0048), and glimepiride dose (-0.7 mg/day,P =0.0099). beta-cell glucose sensitivity (assessed as C-peptide-to-glucose ratio) during meal test improved with glimepiride + linagliptin. Incidences of hypoglycemia were similar with both treatments. CONCLUSIONS Linagliptin as add-on treatment to glimepiride improved glycemic variability and control without increasing risk of hypoglycemia in patients with HNF1A diabetes.

KW - NUCLEAR FACTOR-1-ALPHA

KW - INSULIN-SECRETION

KW - GLUCOSE

KW - MUTATIONS

KW - HYPOGLYCEMIA

KW - SENSITIVITY

KW - INHIBITION

KW - GENES

KW - ALPHA

KW - RISK

U2 - 10.2337/dc20-0408

DO - 10.2337/dc20-0408

M3 - Journal article

C2 - 32661107

VL - 43

SP - 2025

EP - 2033

JO - Diabetes Care

JF - Diabetes Care

SN - 0149-5992

IS - 9

ER -

ID: 247541271