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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)

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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; Hædersdal, Sofie; Støy, Julie; Storgaard, Heidi; Kampmann, Ulla; Forman, Julie L; Seghieri, Marta; Holst, Jens J; Hansen, Torben; Knop, Filip K; Vilsbøll, Tina.

I: Diabetes Care, Bind 43, Nr. 9, 09.2020, s. 2025-2033.

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avisTidsskriftartikelForskningpeer review

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Christensen, Alexander S ; Hædersdal, Sofie ; Støy, Julie ; Storgaard, Heidi ; Kampmann, Ulla ; Forman, Julie L ; Seghieri, Marta ; Holst, Jens J ; Hansen, Torben ; Knop, Filip K ; Vilsbøll, 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{c131738552f24527a2e643c547baec78,
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-α (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/m2, and glycated hemoglobin [HbA1c] 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), HbA1c, 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), HbA1c (-0.5%, P = 0.0048), and glimepiride dose (-0.7 mg/day, P = 0.0099). β-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 = "ALPHA, GENES, GLUCOSE, HYPOGLYCEMIA, INHIBITION, INSULIN-SECRETION, MUTATIONS, NUCLEAR FACTOR-1-ALPHA, RISK, SENSITIVITY",
author = "Christensen, {Alexander S} and Sofie H{\ae}dersdal and Julie St{\o}y 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 Vilsb{\o}ll",
note = "{\textcopyright} 2020 by the American Diabetes Association.",
year = "2020",
month = sep,
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): A Randomized, Double-Blinded, Placebo-Controlled, Crossover Trial (GLIMLINA)

AU - Christensen, Alexander S

AU - Hædersdal, Sofie

AU - Støy, 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 - Vilsbøll, Tina

N1 - © 2020 by the American Diabetes Association.

PY - 2020/9

Y1 - 2020/9

N2 - OBJECTIVE: Sulfonylureas are first-line treatment of hepatocyte nuclear factor 1-α (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/m2, and glycated hemoglobin [HbA1c] 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), HbA1c, 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), HbA1c (-0.5%, P = 0.0048), and glimepiride dose (-0.7 mg/day, P = 0.0099). β-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-α (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/m2, and glycated hemoglobin [HbA1c] 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), HbA1c, 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), HbA1c (-0.5%, P = 0.0048), and glimepiride dose (-0.7 mg/day, P = 0.0099). β-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 - ALPHA

KW - GENES

KW - GLUCOSE

KW - HYPOGLYCEMIA

KW - INHIBITION

KW - INSULIN-SECRETION

KW - MUTATIONS

KW - NUCLEAR FACTOR-1-ALPHA

KW - RISK

KW - SENSITIVITY

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 -