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Erschienen in: Acta Diabetologica 1/2008

01.03.2008 | Original Article

Therapeutic options for elderly diabetic subjects: open label, randomized clinical trial of insulin glargine added to oral antidiabetic drugs versus increased dosage of oral antidiabetic drugs

verfasst von: G. Papa, V. Fedele, A. Chiavetta, I. Lorenti, C. Leotta, S. Luca, A. M. Rabuazzo, S. Piro, C. Alagona, L. Spadaro, F. Purrello, V. Pezzino

Erschienen in: Acta Diabetologica | Ausgabe 1/2008

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Abstract

Glycemic control in elderly persons with type 2 diabetes mellitus (T2DM) is challenging because they are more likely to have other age-associated medical conditions and to experience hypoglycemia during intensive therapy. A best therapeutic strategy for these patients has not yet been defined. We investigated the efficacy and safety of adding once-daily insulin glargine to patients’ current oral antidiabetic drugs (OAD) regimen, compared to increasing the OAD doses. The study enrolled patients aged 65 years or more, with poor glycemic control. Patients were randomized to two groups and entered a 3-week titration period in which their actual therapy was adjusted to meet the study’s glycemic goals, by either adding insulin glargine to current therapy (group A, 27 patients) or increasing current OAD dosages (group B, 28 patients). Thereafter, therapies were continued unchanged for a 24-week observation period. The mean therapeutic dosage of insulin glargine in group A was 14.9 IU/day (SD = 5.0 IU/day). During the observation period, mean levels of glycosylated hemoglobin (HbA1c) reduced by 1.5% in group A and 0.6% in group B (= 0.381). An HbA1c level <7.0% was achieved by five patients in each group. Mean fasting blood glucose levels reduced by 29 and 15% in groups A and B, respectively (= 0.029). Group A had fewer total hypoglycemic events (23 vs. 79, = 0.030) and fewer patients experiencing any such event (9 vs. 17, = 0.045). Neither a serious hypoglycemic event nor other adverse event occurred. These results suggest that, compared to increasing OAD dosage, the addition of insulin glargine to current OAD therapy is as effective but safer in terms of the risk for hypoglycemia in elderly patients with T2DM.
Literatur
1.
Zurück zum Zitat Harris MI, Flegal KM, Cowie CC, Eberhardt MS, Goldstein DE, Little RR, Wiedmeyer HM, Byrd-Holt DD (1998) Prevalence of diabetes, IFG and IGT in U.S. adults. The third national health and nutrition examination survey, 1988–94. Diabetes Care 21(4):518–524PubMedCrossRef Harris MI, Flegal KM, Cowie CC, Eberhardt MS, Goldstein DE, Little RR, Wiedmeyer HM, Byrd-Holt DD (1998) Prevalence of diabetes, IFG and IGT in U.S. adults. The third national health and nutrition examination survey, 1988–94. Diabetes Care 21(4):518–524PubMedCrossRef
2.
Zurück zum Zitat Schwartz AV, Hillier TA, Sellmeyer DE, Resnick HE, Gregg E, Ensrud KE, Schreiner PJ, Margolis KL, Cauley JA, Nevitt MC, Black DM, Cummings SR (2002) Older woman with diabetes have a higher risk of falls: a prospective study. Diabetes Care 25(10):1749–1754PubMedCrossRef Schwartz AV, Hillier TA, Sellmeyer DE, Resnick HE, Gregg E, Ensrud KE, Schreiner PJ, Margolis KL, Cauley JA, Nevitt MC, Black DM, Cummings SR (2002) Older woman with diabetes have a higher risk of falls: a prospective study. Diabetes Care 25(10):1749–1754PubMedCrossRef
3.
Zurück zum Zitat Songer TJ (1995) Disability in diabetes. In: Harris MI, Cowie CC, Stern MP et al (eds) Diabetes in America, 2nd edn. National Institutes of Health, Bethesda, pp 259–282 Songer TJ (1995) Disability in diabetes. In: Harris MI, Cowie CC, Stern MP et al (eds) Diabetes in America, 2nd edn. National Institutes of Health, Bethesda, pp 259–282
4.
Zurück zum Zitat Brown AF, Mangione CM, Saliba D, Sarkisian CA (2003) California healthcare foundation/American geriatrics society panel on improving care for elders with diabetes. Guidelines for improving the care of the older person with diabetes mellitus. J Am Geriatr Soc 51(5 Suppl Guidelines):S265–S280PubMed Brown AF, Mangione CM, Saliba D, Sarkisian CA (2003) California healthcare foundation/American geriatrics society panel on improving care for elders with diabetes. Guidelines for improving the care of the older person with diabetes mellitus. J Am Geriatr Soc 51(5 Suppl Guidelines):S265–S280PubMed
5.
Zurück zum Zitat Peyrot M, Rubin RR (1997) Levels and risks of depression and anxiety symptomatology among diabetic adults. Diabetes Care 20(4):585–590PubMedCrossRef Peyrot M, Rubin RR (1997) Levels and risks of depression and anxiety symptomatology among diabetic adults. Diabetes Care 20(4):585–590PubMedCrossRef
6.
Zurück zum Zitat Gregg EW, Yaffe K, Cauley JA, Rolka DB, Blackwell TL, Narayan KM, Cummings SR (2000) Is diabetes associated with cognitive impairment and cognitive decline among older woman? Study of osteoporotic fractures research group. Arch Intern Med 160(2):174–180PubMedCrossRef Gregg EW, Yaffe K, Cauley JA, Rolka DB, Blackwell TL, Narayan KM, Cummings SR (2000) Is diabetes associated with cognitive impairment and cognitive decline among older woman? Study of osteoporotic fractures research group. Arch Intern Med 160(2):174–180PubMedCrossRef
7.
Zurück zum Zitat Shorr RI, Franse LV, Resnick HE et al (2000) Glycemic control of older adults with type 2 diabetes: findings from the third national health and nutrition examination survey, 1988–1994. J Am Geriatr Soc 48(3):264–267PubMed Shorr RI, Franse LV, Resnick HE et al (2000) Glycemic control of older adults with type 2 diabetes: findings from the third national health and nutrition examination survey, 1988–1994. J Am Geriatr Soc 48(3):264–267PubMed
8.
Zurück zum Zitat American Diabetes Association (2006) Standards of medical care for patients with diabetes mellitus. Diabetes Care 26(Suppl 1):S33–S50 American Diabetes Association (2006) Standards of medical care for patients with diabetes mellitus. Diabetes Care 26(Suppl 1):S33–S50
9.
Zurück zum Zitat Matyka K, Evans M, Lomas J, Cranston I, Macdonald I, Amiel SA (1997) Altered hierarchy of protective responses against severe hypoglycemia in normal aging in healthy men. Diabetes Care 20:135–141PubMedCrossRef Matyka K, Evans M, Lomas J, Cranston I, Macdonald I, Amiel SA (1997) Altered hierarchy of protective responses against severe hypoglycemia in normal aging in healthy men. Diabetes Care 20:135–141PubMedCrossRef
10.
Zurück zum Zitat Shorr RI, Ray WA, Daugherty JR, Griffin MR (1997) Incidence and risk factors for serious hypoglycemia in older persons using insulin or sulfonylureas. Arch Intern Med 157:1681–1686PubMedCrossRef Shorr RI, Ray WA, Daugherty JR, Griffin MR (1997) Incidence and risk factors for serious hypoglycemia in older persons using insulin or sulfonylureas. Arch Intern Med 157:1681–1686PubMedCrossRef
11.
Zurück zum Zitat Janka HU, Plewe G, Busch K (2007) Combination of oral antidiabetic agents with basal insulin versus premixed insulin alone in randomized elderly patients with type 2 diabetes mellitus. J Am Geriatr Soc 55(2):182–188PubMedCrossRef Janka HU, Plewe G, Busch K (2007) Combination of oral antidiabetic agents with basal insulin versus premixed insulin alone in randomized elderly patients with type 2 diabetes mellitus. J Am Geriatr Soc 55(2):182–188PubMedCrossRef
13.
Zurück zum Zitat Rosenstock J, Schawartz SL, Clark CM Jr, Park GD, Donley DW, Edwards MB (2001) Basal insulin therapy in type 2 diabetes: 28-week comparison of insulin glargine (HOE901) and NPH insulin. Diabetes Care 24:631–636PubMedCrossRef Rosenstock J, Schawartz SL, Clark CM Jr, Park GD, Donley DW, Edwards MB (2001) Basal insulin therapy in type 2 diabetes: 28-week comparison of insulin glargine (HOE901) and NPH insulin. Diabetes Care 24:631–636PubMedCrossRef
14.
Zurück zum Zitat Hamann A, Matthaei S, Rosak C, Silestre L; HOE901/4007 Study Group (2003) A randomized clinical trial comparing breakfast, dinner or bedtime administration of insulin glargine in patients with type 1 diabetes. Diabetes Care 26(6):1738–1744PubMedCrossRef Hamann A, Matthaei S, Rosak C, Silestre L; HOE901/4007 Study Group (2003) A randomized clinical trial comparing breakfast, dinner or bedtime administration of insulin glargine in patients with type 1 diabetes. Diabetes Care 26(6):1738–1744PubMedCrossRef
15.
Zurück zum Zitat Riddle MC, Rosenstock J, Gerich J (2003) Randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. The treat-to-target trial. Diabetes Care 26:3080–3086PubMedCrossRef Riddle MC, Rosenstock J, Gerich J (2003) Randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. The treat-to-target trial. Diabetes Care 26:3080–3086PubMedCrossRef
16.
Zurück zum Zitat Yki-Jarvinen H, Dressler A, Ziemen M; HOE 901/300s Study Group (2000) Less nocturnal hypoglycaemia and better post-dinner glucose control with bedtime insulin glargine compared with bedtime NPH insulin during insulin combination therapy in type 2 diabetes. HOE 901/3002 Study Group. Diabetes Care 23:1130–1136PubMedCrossRef Yki-Jarvinen H, Dressler A, Ziemen M; HOE 901/300s Study Group (2000) Less nocturnal hypoglycaemia and better post-dinner glucose control with bedtime insulin glargine compared with bedtime NPH insulin during insulin combination therapy in type 2 diabetes. HOE 901/3002 Study Group. Diabetes Care 23:1130–1136PubMedCrossRef
17.
Zurück zum Zitat Taskinen MR, Sane T, Helve E, Karonen SL, Nikkita EA, Yki-Jarvinen H (1989) Bedtime insulin for suppression of overnight free fatty acid, blood glucose, and glucose production in NIDDM. Diabetes 38:580–588PubMedCrossRef Taskinen MR, Sane T, Helve E, Karonen SL, Nikkita EA, Yki-Jarvinen H (1989) Bedtime insulin for suppression of overnight free fatty acid, blood glucose, and glucose production in NIDDM. Diabetes 38:580–588PubMedCrossRef
19.
Zurück zum Zitat Shank ML, Del Prato S, DeFronzo RA (1995) Bedtime insulin/daytime glipizide: effective therapy for sulfonylurea failures in NIDDM. Diabetes 44:165–172PubMedCrossRef Shank ML, Del Prato S, DeFronzo RA (1995) Bedtime insulin/daytime glipizide: effective therapy for sulfonylurea failures in NIDDM. Diabetes 44:165–172PubMedCrossRef
20.
Zurück zum Zitat Janka HU, Plewe G, Riddle MC et al (2005) Comparison of basal insulin added to oral agents versus twice-daily premixed insulin as initial insulin therapy for type 2 diabetes. Diabetes Care 28:254–259PubMedCrossRef Janka HU, Plewe G, Riddle MC et al (2005) Comparison of basal insulin added to oral agents versus twice-daily premixed insulin as initial insulin therapy for type 2 diabetes. Diabetes Care 28:254–259PubMedCrossRef
21.
Zurück zum Zitat Rosenstock J, Sugimoto D, Strange P, Stewart JA, Soltes-Rak E, Dailey G (2006) On behalf of the insulin glargine 4014 study investigators. Triple therapy in type 2 diabetes. Diabetes Care 29:554–559PubMedCrossRef Rosenstock J, Sugimoto D, Strange P, Stewart JA, Soltes-Rak E, Dailey G (2006) On behalf of the insulin glargine 4014 study investigators. Triple therapy in type 2 diabetes. Diabetes Care 29:554–559PubMedCrossRef
22.
Zurück zum Zitat Holstein A, Plaschke A, Egberts EH (2003) Clinical characterisation of severe hypoglycaemia: a prospective population-based study. Exp Clin Endocrinol Diabetes 111:364–369PubMedCrossRef Holstein A, Plaschke A, Egberts EH (2003) Clinical characterisation of severe hypoglycaemia: a prospective population-based study. Exp Clin Endocrinol Diabetes 111:364–369PubMedCrossRef
23.
Zurück zum Zitat Lager E (2005) Weight gain and insulin treatment. Diabetes Metab 31(4 Pt 2):4S54–4S56 Lager E (2005) Weight gain and insulin treatment. Diabetes Metab 31(4 Pt 2):4S54–4S56
Metadaten
Titel
Therapeutic options for elderly diabetic subjects: open label, randomized clinical trial of insulin glargine added to oral antidiabetic drugs versus increased dosage of oral antidiabetic drugs
verfasst von
G. Papa
V. Fedele
A. Chiavetta
I. Lorenti
C. Leotta
S. Luca
A. M. Rabuazzo
S. Piro
C. Alagona
L. Spadaro
F. Purrello
V. Pezzino
Publikationsdatum
01.03.2008
Verlag
Springer Milan
Erschienen in
Acta Diabetologica / Ausgabe 1/2008
Print ISSN: 0940-5429
Elektronische ISSN: 1432-5233
DOI
https://doi.org/10.1007/s00592-007-0023-6

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