Impact of Prandial Plus Basal vs Basal Insulin on Glycemic Variability in Type 2 Diabetic Patients
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Blood Glucose Self-Monitoring
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Post-prandial glucose excursions remain elevated in most patients with diabetes even when normal fasting plasma glucose levels have been achieved. In 39 patients with type 2 diabetes who had attained basal normoglycaemia by therapy with diet alone, a sulphonylurea, a basal insulin supplement or basal plus prandial insulin the mean glycosylated haemoglobin (HbA1) values were at the upper end (mean +/- 1SD, 8.1 +/- 1.1%) of the normal range (5.0-8.2%). Miglitol, an alpha-glucosidase inhibitor, given in a dose of 50 mg three times a day was studied in a double blind randomized crossover study. In diet and sulphonylurea treated patients, a mean 25% reduction of the post-prandial plasma glucose excursions was obtained whereas in ultralente treated patients miglitol appeared to reduce basal plasma glucose levels (p < 0.006). Side effects were limited to minor gastrointestinal disturbances, usually ameliorating after the first week of therapy. Alpha-glucosidase inhibition to prevent post-prandial glycaemia may have a role in patients in whom sulphonylurea or diet therapy has been used to obtain normal basal glucose concentrations.
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Recent studies have suggested that combining basal insulin and glucagon-like peptide-1 (GLP-1) agonists (e.g., exenatide) might be particularly useful
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Mary, age 53, was seen as a new patient. She had a history of type 2 diabetes for 17 years. Her BMI was 31 kg/m2. She had attempted to adhere to lifestyle measures for treatment of diabetes and had previously consulted with diabetes educators. She was fairly active at her job.
She was taking 90 units of peakless insulin (glargine) at bedtime in addition to pioglitazone, 45 mg daily; metformin, 1,000 mg twice daily; and glimperide, 8 mg daily. Her hemoglobin A1c (A1C) was 8.5%. She had average prebreakfast glucose readings of 110 mg/dl. At other times of day, there were premeal glucose readings of 170-240 mg/dl and some peak postprandial readings > 300 mg/dl.
Under the supervision of her previous health care provider, over a 12-month period of combined glargine and triple oral therapy, the strategies of changing the time of peakless insulin administration to the morning and, later, splitting the peakless insulin dose into equal morning and bedtime components had failed to change her blood glucose pattern. A conceptual diagram of the average daily excursions of blood glucose at the time of her presentation is shown in Figure 1.
Figure 1.
Pattern of blood glucose suggesting insufficient prandial insulin effect.
At the conclusion of the visit, she commented that she wanted to do whatever was necessary to get better results, and she agreed to replace the glimepiride with prandial use of insulin. The glimepiride was discontinued. The pioglitazone dose was reduced to 30 mg daily, with consideration of possible future discontinuation because of cost factors. The metformin was continued.
The combined total amount of the starting doses of insulin under a basal-prandial-correction regimen was assigned at 80% of the former peakless insulin dose. The insulin was divided into 36 units of peakless insulin at bedtime and …
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The provision of sufficient basal insulin to normalize fasting plasma glucose levels may reduce cardiovascular events, but such a possibility has not been formally tested.We randomly assigned 12,537 people (mean age, 63.5 years) with cardiovascular risk factors plus impaired fasting glucose, impaired glucose tolerance, or type 2 diabetes to receive insulin glargine (with a target fasting blood glucose level of ≤95 mg per deciliter [5.3 mmol per liter]) or standard care and to receive n-3 fatty acids or placebo with the use of a 2-by-2 factorial design. The results of the comparison between insulin glargine and standard care are reported here. The coprimary outcomes were nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes and these events plus revascularization or hospitalization for heart failure. Microvascular outcomes, incident diabetes, hypoglycemia, weight, and cancers were also compared between groups.The median follow-up was 6.2 years (interquartile range, 5.8 to 6.7). Rates of incident cardiovascular outcomes were similar in the insulin-glargine and standard-care groups: 2.94 and 2.85 per 100 person-years, respectively, for the first coprimary outcome (hazard ratio, 1.02; 95% confidence interval [CI], 0.94 to 1.11; P=0.63) and 5.52 and 5.28 per 100 person-years, respectively, for the second coprimary outcome (hazard ratio, 1.04; 95% CI, 0.97 to 1.11; P=0.27). New diabetes was diagnosed approximately 3 months after therapy was stopped among 30% versus 35% of 1456 participants without baseline diabetes (odds ratio, 0.80; 95% CI, 0.64 to 1.00; P=0.05). Rates of severe hypoglycemia were 1.00 versus 0.31 per 100 person-years. Median weight increased by 1.6 kg in the insulin-glargine group and fell by 0.5 kg in the standard-care group. There was no significant difference in cancers (hazard ratio, 1.00; 95% CI, 0.88 to 1.13; P=0.97).When used to target normal fasting plasma glucose levels for more than 6 years, insulin glargine had a neutral effect on cardiovascular outcomes and cancers. Although it reduced new-onset diabetes, insulin glargine also increased hypoglycemia and modestly increased weight. (Funded by Sanofi; ORIGIN ClinicalTrials.gov number, NCT00069784.).
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A new insulin regime is described, in which the primary aim is to attain normal basal plasma glucose concentrations by means of a constant insulin delivery rate from the long-acting Ultratard insulin. Additional twice daily Actrapid insulin is given to cover meals, and we have investigated this regime in 29 insulin dependent diabetics, with control assessed by admission for 24 hour profiles. Patients with low insulin requirements only need a basal insulin supplement with Ultratard insulin. With increasing insulin requirements the dose of short-acting insulin increases more than the basal insulin supplement. Thus fixed combinations of short- and long-acting insulins cannot produce good control in all patients. Twenty-one patients were deemed ‘well controlled’ in that they had no symptomatic hypoglycaemia, an overnight plasma glucose concentration of <5·5 mmol/l and a mean late post-prandial glucose concentration of <6·5 mmol/l. Their average ‘mean excess glycaemic exposure’ (mean incremental plasma glucose above 5 mmol/l) was 0·7 mmol/l (normal range 0–0·5 mmol/l), which is considerably less than that found in many maturity-onset diabetics. The distinction between basal and meal insulin requirements simplifies rules of insulin therapy.
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IN BRIEF Basal insulin therapy is well established for glycemic control in patients with diabetes but often is not optimally implemented, leading to poor clinical outcomes and adherence. Primary care providers can and should work together with other members of the diabetes care team to allow for effective titration of basal insulin that involves patients and their caregivers. Adequate guidance and monitoring during the titration process can minimize some of the adverse effects caused by basal insulin administration, while improving glycemic control in a timely manner.
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