|
||||||
|
|
|
|
|||||||||||
|
|||||||||||||
| ||||||||||||||||||||||||||||||||||||
Adding insulin to a regimen of oral medication can help improve blood glucose control in type 2 diabetes, but most people with the disease will need more than one formulation of insulin, according to the 1-year results of the ongoing Treating to Target in Type 2 Diabetes (4-T) study.
After a year of treatment with oral drugs and escalating doses in a
single-formulation insulin regimen, less than a quarter of participants
reached the target outcome of glycated hemoglobin (A1C) levels 
6.5%.
"Most patients are likely to need more than one type of insulin if they are to maintain recommended glucose levels in the longer term," says Rury R. Holman, MB, ChB, of the Diabetes Trials Unit of University of Oxford in England and principal investigator of the 4-T study.
The 1-year results were presented at the 43rd annual meeting of the European Association for the Study of Diabetes, held September 18–21 in Amsterdam and were simultaneously published by the New England Journal of Medicine.1
INITIATING INSULIN
The 4-T trial is designed to provide data to help clinicians decide how to start insulin therapy and, in particular, which formulation of insulin to use.
"There is no evidence-based consensus about how to best initiate insulin therapy in primary care," explains Jonathan C. Levy, MD, clinical director of the Oxford Centre for Diabetes, Endocrinology and Metabolism.
More than 700 people with type 2 diabetes were recruited from 58 U.K.
medical centers to participate in the 4-T study. To be eligible, participants
needed to be 18 years, have type 2 diabetes 
1 year, and have poorly
controlled glycemia despite maximal tolerated doses of metformin and
sulfonylurea for 4 months. Participants had A1C levels of 7–10% and
a body mass index (BMI) 40.
The study participants' diabetes was inadequately controlled on maximum doses of oral medications, so they needed additional insulin—making them "similar to populations typically seen in primary care," says Levy.
Participants were randomized to one of three single-formulation insulin regimens: twice daily biphasic (premixed combination) insulin (NovoMix 30, Novo Nordisk); prandial insulin (NovoRapid, Novo Nordisk, three times a day); or once daily basal insulin (Levemir, Novo Nordisk, before bed with a morning insulin injection added as necessary).
Patients were also scheduled to continue with their oral medications for the first year. Clinician visits with patients were scheduled at 2, 6, 12, 24, 38, and 52 weeks, with periodic follow-up by phone. "The frequency of contacts was designed to be appropriate for insulin initiation in primary care," says Levy.
Dosages of insulin were increased if one-third of self-monitored blood glucose readings were above target levels and reduced if patients experienced hypoglycemia.
Overall, patients followed the care plan fairly well. "About 90% of participants adhered to dosage adjustments," says Holman. "In general, people are comfortable with adjusting dosages."
FIRST-YEAR FINDINGS
Analysis of data revealed that at the end of 1 year of therapy, A1C levels were lowered 1.3% among those taking biphasic insulin, 1.4% among those taking prandial insulin, and 0.8% among those on basal insulin. According to the investigators, most of the therapeutic effect of insulin on A1C was seen during the first 3 months of therapy.
Among the major findings:
Target A1C values 6.5% were achieved by only 17% of those on biphasic
insulin, 24% on prandial insulin, and 8.1% on basal insulin.
There were no significant differences among the treatment groups regarding quality of life or incidence of severe hypoglycemia. By testing different insulin regimens head-to-head for the first time, the 4-T study shows that "the addition of a single insulin analog to metformin and sulfonylurea can lower A1C by 0.8–1.4% and sustain those values for more than a year," says Holman.
As the 4-T study continues, investigators are studying modifications of the
drug regimens. Participants who did not reach an A1C level 6.5% after 1
year will stop taking sulfonylurea drugs and will have a second formulation of
insulin added to their regimens in the second and third years of the study.
Those taking biphasic insulin will have prandial insulin added to the regimen,
those on prandial insulin will have basal insulin added, and those on basal
insulin will have prandial insulin added.
Novo Nordisk supported but did not conduct this research study. 
References
CiteULike 
Del.icio.us 
Digg 
Reddit 
Technorati What's this?
| ||||||||||||||||||||||||||||||||||||
|
||||||
|
| DOC News | Diabetes | Diabetes Care | Clinical Diabetes | Diabetes Spectrum |
