The effect of insulin degludec on risk of symptomatic nocturnal hypoglycaemia in adults with type 1 diabetes and high risk of nocturnal severe hypoglycaemia (the HypoDeg trial): study rationale and design
Abstract Background Hypoglycaemia, especially nocturnal, remains the main limiting factor of achieving good glycaemic control in type 1 diabetes. The effect of first generation long-acting insulin analogues in reducing nocturnal hypoglycaemia is well documented in patient with type 1 diabetes. The e...
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| Format: | Article |
| Language: | English |
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BMC
2019-07-01
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| Series: | BMC Endocrine Disorders |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12902-019-0408-x |
| _version_ | 1818541573074321408 |
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| author | Rikke Mette Agesen Amra Ciric Alibegovic Henrik Ullits Andersen Henning Beck-Nielsen Peter Gustenhoff Troels Krarup Hansen Christoffer Hedetoft Tonny Jensen Claus Bogh Juhl Susanne Søgaard Lerche Kirsten Nørgaard Hans-Henrik Parving Lise Tarnow Birger Thorsteinsson Ulrik Pedersen-Bjergaard |
| author_facet | Rikke Mette Agesen Amra Ciric Alibegovic Henrik Ullits Andersen Henning Beck-Nielsen Peter Gustenhoff Troels Krarup Hansen Christoffer Hedetoft Tonny Jensen Claus Bogh Juhl Susanne Søgaard Lerche Kirsten Nørgaard Hans-Henrik Parving Lise Tarnow Birger Thorsteinsson Ulrik Pedersen-Bjergaard |
| author_sort | Rikke Mette Agesen |
| collection | DOAJ |
| description | Abstract Background Hypoglycaemia, especially nocturnal, remains the main limiting factor of achieving good glycaemic control in type 1 diabetes. The effect of first generation long-acting insulin analogues in reducing nocturnal hypoglycaemia is well documented in patient with type 1 diabetes. The effect of the newer long-acting insulin degludec on risk of nocturnal hypoglycaemia remains undocumented in patients with type 1 diabetes and recurrent severe nocturnal hypoglycaemia. The HypoDeg trial is designed to investigate whether insulin degludec in comparison with insulin glargine U100 is superior in limiting the occurrence of nocturnal hypoglycaemia in patients with recurrent nocturnal severe hypoglycaemia. This paper reports the study design of the HypoDeg trial. Methods/design A Danish investigator-initiated, prospective, randomised, open, blinded endpoint (PROBE), multicentre, two-year cross-over study investigating the effect of insulin degludec versus insulin glargine U100 on frequency of nocturnal hypoglycaemia in patients with type 1 diabetes and one or more episodes of nocturnal severe hypoglycaemia during the preceding two years as the major inclusion criteria. Patients are randomised (1:1) to basal therapy with insulin degludec or insulin glargine. Insulin aspart is used as bolus therapy in both treatment arms. Discussion In contrast to most other insulin studies the HypoDeg trial includes only patients at high risk of hypoglycaemia. The HypoDeg trial will compare treatment with insulin degludec to insulin glargine U100 in terms of risk of nocturnal hypoglycaemic episodes in patients with type 1 diabetes with the greatest potential to benefit from near-physiological insulin replacement therapy. www.clinicaltrials.gov: NCT02192450. |
| first_indexed | 2024-12-11T22:11:03Z |
| format | Article |
| id | doaj.art-56c340efa21f4ca096ea9c50af1669e9 |
| institution | Directory Open Access Journal |
| issn | 1472-6823 |
| language | English |
| last_indexed | 2024-12-11T22:11:03Z |
| publishDate | 2019-07-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Endocrine Disorders |
| spelling | doaj.art-56c340efa21f4ca096ea9c50af1669e92022-12-22T00:48:46ZengBMCBMC Endocrine Disorders1472-68232019-07-011911810.1186/s12902-019-0408-xThe effect of insulin degludec on risk of symptomatic nocturnal hypoglycaemia in adults with type 1 diabetes and high risk of nocturnal severe hypoglycaemia (the HypoDeg trial): study rationale and designRikke Mette Agesen0Amra Ciric Alibegovic1Henrik Ullits Andersen2Henning Beck-Nielsen3Peter Gustenhoff4Troels Krarup Hansen5Christoffer Hedetoft6Tonny Jensen7Claus Bogh Juhl8Susanne Søgaard Lerche9Kirsten Nørgaard10Hans-Henrik Parving11Lise Tarnow12Birger Thorsteinsson13Ulrik Pedersen-Bjergaard14Department of Endocrinology and Nephrology, Nordsjællands HospitalSteno Diabetes Center CopenhagenSteno Diabetes Center CopenhagenDepartment of Endocrinology M, Odense University HospitalDepartment of Endocrinology, Aalborg University HospitalSteno Diabetes Center AarhusDepartment of Internal MedicineDepartment of Medical Endocrinology, Copenhagen University Hospital (Rigshospitalet)Department of Medicine, Sydvestjysk SygehusDepartment of Diabetes and Hormonal Diseases, Lillebælt Hospital KoldingSteno Diabetes Center CopenhagenHealth, University of AarhusHealth, University of AarhusDepartment of Endocrinology and Nephrology, Nordsjællands HospitalDepartment of Endocrinology and Nephrology, Nordsjællands HospitalAbstract Background Hypoglycaemia, especially nocturnal, remains the main limiting factor of achieving good glycaemic control in type 1 diabetes. The effect of first generation long-acting insulin analogues in reducing nocturnal hypoglycaemia is well documented in patient with type 1 diabetes. The effect of the newer long-acting insulin degludec on risk of nocturnal hypoglycaemia remains undocumented in patients with type 1 diabetes and recurrent severe nocturnal hypoglycaemia. The HypoDeg trial is designed to investigate whether insulin degludec in comparison with insulin glargine U100 is superior in limiting the occurrence of nocturnal hypoglycaemia in patients with recurrent nocturnal severe hypoglycaemia. This paper reports the study design of the HypoDeg trial. Methods/design A Danish investigator-initiated, prospective, randomised, open, blinded endpoint (PROBE), multicentre, two-year cross-over study investigating the effect of insulin degludec versus insulin glargine U100 on frequency of nocturnal hypoglycaemia in patients with type 1 diabetes and one or more episodes of nocturnal severe hypoglycaemia during the preceding two years as the major inclusion criteria. Patients are randomised (1:1) to basal therapy with insulin degludec or insulin glargine. Insulin aspart is used as bolus therapy in both treatment arms. Discussion In contrast to most other insulin studies the HypoDeg trial includes only patients at high risk of hypoglycaemia. The HypoDeg trial will compare treatment with insulin degludec to insulin glargine U100 in terms of risk of nocturnal hypoglycaemic episodes in patients with type 1 diabetes with the greatest potential to benefit from near-physiological insulin replacement therapy. www.clinicaltrials.gov: NCT02192450.http://link.springer.com/article/10.1186/s12902-019-0408-xType 1 diabetesNocturnal hypoglycaemiaSevere hypoglycaemiaInsulin degludecInsulin glargineRCT |
| spellingShingle | Rikke Mette Agesen Amra Ciric Alibegovic Henrik Ullits Andersen Henning Beck-Nielsen Peter Gustenhoff Troels Krarup Hansen Christoffer Hedetoft Tonny Jensen Claus Bogh Juhl Susanne Søgaard Lerche Kirsten Nørgaard Hans-Henrik Parving Lise Tarnow Birger Thorsteinsson Ulrik Pedersen-Bjergaard The effect of insulin degludec on risk of symptomatic nocturnal hypoglycaemia in adults with type 1 diabetes and high risk of nocturnal severe hypoglycaemia (the HypoDeg trial): study rationale and design BMC Endocrine Disorders Type 1 diabetes Nocturnal hypoglycaemia Severe hypoglycaemia Insulin degludec Insulin glargine RCT |
| title | The effect of insulin degludec on risk of symptomatic nocturnal hypoglycaemia in adults with type 1 diabetes and high risk of nocturnal severe hypoglycaemia (the HypoDeg trial): study rationale and design |
| title_full | The effect of insulin degludec on risk of symptomatic nocturnal hypoglycaemia in adults with type 1 diabetes and high risk of nocturnal severe hypoglycaemia (the HypoDeg trial): study rationale and design |
| title_fullStr | The effect of insulin degludec on risk of symptomatic nocturnal hypoglycaemia in adults with type 1 diabetes and high risk of nocturnal severe hypoglycaemia (the HypoDeg trial): study rationale and design |
| title_full_unstemmed | The effect of insulin degludec on risk of symptomatic nocturnal hypoglycaemia in adults with type 1 diabetes and high risk of nocturnal severe hypoglycaemia (the HypoDeg trial): study rationale and design |
| title_short | The effect of insulin degludec on risk of symptomatic nocturnal hypoglycaemia in adults with type 1 diabetes and high risk of nocturnal severe hypoglycaemia (the HypoDeg trial): study rationale and design |
| title_sort | effect of insulin degludec on risk of symptomatic nocturnal hypoglycaemia in adults with type 1 diabetes and high risk of nocturnal severe hypoglycaemia the hypodeg trial study rationale and design |
| topic | Type 1 diabetes Nocturnal hypoglycaemia Severe hypoglycaemia Insulin degludec Insulin glargine RCT |
| url | http://link.springer.com/article/10.1186/s12902-019-0408-x |
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