insulin-glulisine and Hyperglycemia

To evaluate the glycaemic control achieved by prandial once-daily insulin glulisine injection timing adjustment, based on a continuous glucose monitoring sensor, in comparison to once-daily insulin glulisine injection before breakfast in patients with type 2 diabetes who are uncontrolled with once-daily basal insulin glargine.. This was a 24-week open-label, randomized, controlled, multicentre trial. At the end of an 8-week period of basal insulin optimization, patients with HbA1c ≥ 7.5% and FPG < 130 mg/dL were randomized (1:1) to either arm A (no sensor) or arm B (sensor) to receive 16-week intensified prandial glulisine treatment. Patients in arm A received pre-breakfast glulisine, and patients in arm B received glulisine before the meal with the highest glucose elevation based on sensor data. The primary outcome was mean HbA1c at week 24 and secondary outcomes included rates of hypoglycaemic events and insulin dosage.. A total of 121 patients were randomized to arm A (n = 61) or arm B (n = 60). There was no difference in mean HbA1c at week 24 between arms A and B (8.5% ± 1.2% vs 8.4% ± 1.0%; P = .66). The prandial insulin glulisine dosage for arm A and arm B was 9.3 and 10.1 units, respectively (P = .39). The frequency of hypoglycaemic events did not differ between study arms (36.1% vs 51.7%; P = .08).. Using a CGM sensor to identify the meal with the highest glucose excursion and adjusting the timing of prandial insulin treatment did not show any advantage in terms of glycaemic control or safety in our patients.

Topics: Aged; Blood Glucose; Diabetes Mellitus, Type 2; Drug Administration Schedule; Drug Monitoring; Drug Therapy, Combination; Female; Humans; Hyperglycemia; Hypoglycemia; Hypoglycemic Agents; Insulin; Insulin Glargine; Insulin Resistance; Intention to Treat Analysis; Lost to Follow-Up; Male; Meals; Middle Aged; Monitoring, Ambulatory; Patient Dropouts; Pilot Projects

To use continuous glucose monitoring to examine the effects of insulin initiation with glargine, with or without glulisine, on glycaemic variability and glycaemia in a cohort of people with Type 2 diabetes receiving maximum oral hypoglycaemic agents in primary healthcare.. We conducted a post hoc analysis of continuous glucose monitoring data from 89 participants at baseline and at 24 weeks after insulin commencement. Indicators of glycaemic variability (standard deviation, J-index and mean amplitude of glycaemic excursion) and glycaemia (HbA1c , mean glucose, area under the glucose-time curve) were assessed. Multi-level regression analysis was used to identify the predictors of change.. Complete glycaemic variability data were available for 78 participants. Of these participants, 41% were women, their mean (sd) age was 59.2 (10.4) years, the median (interquartile range) diabetes duration was 10.4 (6.5, 13.3) years and the median (interquartile range) baseline HbA1c was 82.5 (71.6, 96.7) mmol/mol [9.7 (8.7, 11.0)%]. At baseline, BMI correlated negatively with standard deviation (r = -0.30) and mean amplitude of glycaemic excursion (r = -0.26), but not with J-index; HbA1c correlated with J-index (r = 0.61) but not with mean amplitude of glycaemic excursion and standard deviation. After insulin initiation the mean (sd) glucose level decreased [from 12.0 (3.0) to 8.5 (1.6) mmol/l; P < 0.001], as did the median (interquartile range) J-index [from 66.9 (47.7, 95.1) to 36.9 (27.6, 49.8) mmol/l; P < 0.001]. Baseline HbA1c correlated with a greater J-index reduction (r = -0.45; P < 0.001). The mean amplitude of glycaemic excursion and standard deviation values were unchanged. The baseline temporal profile, showing elevated postprandial morning glucose levels, was unchanged after insulin initiation, despite an overall reduction in glycaemia.. Insulin initiation reduced hyperglycaemia but did not alter glycaemic variability in adults with Type 2 diabetes receiving maximum oral hypoglycaemic agents. The most significant postprandial excursions were seen in the morning, which identifies prebreakfast as the most effective target for short-acting insulin therapy.

Topics: Administration, Oral; Adolescent; Adult; Aged; Aged, 80 and over; Blood Glucose; Blood Glucose Self-Monitoring; Cohort Studies; Diabetes Mellitus, Type 2; Female; Glycated Hemoglobin; Humans; Hyperglycemia; Hypoglycemic Agents; Insulin; Insulin Glargine; Male; Middle Aged; Treatment Outcome; Young Adult

To test the hypothesis that a 'basal plus' regimen--adding once-daily main-meal fast-acting insulin to basal insulin once daily--would be non-inferior to biphasic insulin twice daily as assessed by glycated haemoglobin (HbA1c) concentration (predefined as ≤0.4%), but would provide superior treatment satisfaction.. This open-label trial enrolled adults to an 8- or 12-week run-in period, during which oral therapies except metformin were stopped and insulin glargine dose was titrated. Those with fasting glucose <7 mmol/l but HbA1c >7% (53 mmol/mol) were randomized to insulin glargine/glulisine once daily (n = 170) or insulin aspart/aspart protamine 30/70 twice daily (n = 165) for 24 weeks, with dose titration to glucose targets using standardized algorithms.. For HbA1c, the basal plus regimen was non-inferior to biphasic insulin (least squares mean difference, 0.21%, upper 97.5% confidence limit 0.38%) meeting the predefined non-inferiority margin of 0.4%. Treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire change version and Insulin Treatment Satisfaction Questionnaire total scores) significantly favoured basal plus. No difference was observed between the basal plus and the biphasic insulin groups in responders (HbA1c <7%, 20.6 vs 27.9%; p = 0.12), weight gain (2.06 vs 2.50 kg; p = 0.2), diabetes-specific quality of life (Audit of Diabetes-Dependent Quality of Life average weighted impact (AWI) score) and generic health status (five-dimension European Quality of Life questionnaire). Overall hypoglycaemia rates were similar between groups (15.3 vs 18.2 events/patient-year; p = 0.22); nocturnal hypoglycaemia was higher with the basal plus regimen (5.7 vs 3.6 events/patient-year; p = 0.02).. In long-standing type 2 diabetes with suboptimal glycaemia despite oral therapies and basal insulin, the basal plus regimen was non-inferior to biphasic insulin for biomedical outcomes, with a similar overall hypoglycaemia rate but more nocturnal events.

Topics: Aged; Australia; Biphasic Insulins; Blood Glucose Self-Monitoring; Diabetes Mellitus, Type 2; Drug Administration Schedule; Drug Combinations; Drug Therapy, Combination; Female; Glycated Hemoglobin; Humans; Hyperglycemia; Hypoglycemia; Hypoglycemic Agents; Incidence; Insulin; Insulin Aspart; Insulin Glargine; Insulin, Isophane; Intention to Treat Analysis; Male; Middle Aged; Patient Dropouts; Quality of Life; United Kingdom

According to current knowledge, glulisine insulin (GLU) has a slightly faster onset of action than aspart (ASP) insulin. Therefore, GLU might lead to a better postprandial profile than ASP following the consumption of high-glycemic index (H-GI) meals. The aim of this study was to assess differences in the action of GLU and ASP after the consumption of a H-GI meal in type 1 diabetic children treated with insulin pumps.. FIFTY-SIX TYPE 1 DIABETIC CHILDREN OF MEAN AGE 14.72.0 YEARS WERE INCLUDED IN A RANDOMIZED, DOUBLE-BLIND, TWO-WAY CROSSOVER STUDY.. GLU-ASP and ASP-GLU. They were given a H-GI breakfast for two subsequent days.. The primary outcome was postprandial glycemia (PPG) based on continuous glucose monitoring system and self monitoring of blood glucose levels during 3 h of follow-up. The secondary outcomes were the frequency of hypoglycemia, glucose area under the curve, mean amplitude of glycemic excursion, and glycemic rise.. THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN THE GROUPS WITH REGARD TO PPG IN THE DETERMINED TIME INTERVALS AS WELL AS WITH RESPECT TO THE SECONDARY OUTCOMES. BETWEEN 60 AND 120MIN AFTER FOOD CONSUMPTION IN BOTH STUDY GROUPS, BLOOD GLUCOSE LEVELS WERE CLOSE TO OR ABOVE 10.0MMOL/L. GLUCOSE PEAKS WERE HIGHER IN THE GLUASP GROUP THAN IN THE ASPGLU GROUP (90MIN: P=0.065; 120 min: P=0.052). Most of the episodes of hypoglycemia were observed after the second hour of follow-up.. No statistically significant difference was found between GLU and ASP with regard to PPG after the consumption of a H-GI breakfast. Neither GLU nor ASP stabilized the glycemic profile after the consumption of a H-GI meal.

Topics: Adolescent; Blood Glucose; Child; Cross-Over Studies; Diabetes Mellitus, Type 1; Double-Blind Method; Female; Glycemic Index; Humans; Hyperglycemia; Hypoglycemic Agents; Insulin; Insulin Aspart; Male; Postprandial Period; Treatment Outcome

Basal and bolus insulin therapy is required for strict blood control in diabetic patients, which could lead to prevention of vascular complications in diabetes. However, the optimal combination regimen is not well established.. Fifty-nine diabetic patients (49 type 1 and 10 type 2; 52.9 ± 13.3 years old) whose blood glucose levels were uncontrolled (HbA1c  > 6.2%) by combination treatment of basal insulin glargine with multiple daily pre-meal injections of bolus short-acting insulin [aspart (n = 19), lispro (n = 37) and regular human insulin (n = 3)] for at least 8 weeks were enrolled in this study. We examined whether glycaemic control and vascular injury were improved by replacement of short-acting insulin with glulisine. Patient satisfaction was assessed with Diabetes Treatment Satisfaction Questionnaire.. Although bolus and basal insulin doses were almost unchanged before and after replacement therapy, switching to glulisine insulin for 24 weeks significantly decreased level of HbA1c , advanced glycation end products (AGEs), soluble receptor for AGEs (sRAGE), monocyte chemoattractant protein-1 (MCP-1) and urinary albumin excretion. In multiple stepwise regression analysis, change in MCP-1 values from baseline (ΔMCP-1) was a sole determinant of log urinary albumin excretion. ΔAGEs and ΔsRAGE were independently correlated with each other. The relationship between ΔMCP-1 and ΔsRAGE was marginally significant (p = 0.05). Replacement of short-acting insulin by glulisine significantly increased Diabetes Treatment Satisfaction Questionnaire scores.. Our present study suggests that combination therapy of glargine with multiple daily pre-meal injections of glulisine might show superior efficacy in controlling blood glucose, preventing vascular damage and improving treatment satisfaction in diabetic patients.

Topics: Adult; Aged; Biomarkers; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetic Angiopathies; Drug Administration Schedule; Drug Resistance; Drug Therapy, Combination; Female; Humans; Hyperglycemia; Hypoglycemia; Hypoglycemic Agents; Injections, Subcutaneous; Insulin; Insulin Glargine; Insulin, Long-Acting; Japan; Male; Middle Aged; Patient Satisfaction

To evaluate basal and prandial insulin initiation and titration in people with type 2 diabetes mellitus (T2DM) in primary care and to explore the feasibility of retrospective-continuous glucose monitoring (r-CGM) in guiding insulin dosing. The new model of care features General Practitioners (GPs) and Practice Nurses (PNs) working in an expanded role, with Credentialed Diabetes Educator - Registered Nurse (CDE-RN) support.. Insulin-naïve T2DM patients (HbA1c >7.5% [>58 mmol/mol] despite maximal oral therapy) from 22 general practices in Victoria, Australia commenced insulin glargine, with glulisine added as required. Each was randomised to receive r-CGM or self-monitoring of blood glucose (SMBG). Glycaemic control (HbA1c) was benchmarked against specialist ambulatory patients referred for insulin initiation.. Ninety-two patients mean age (range) 59 (28-77) years; 40% female; mean (SD) diabetes duration 10.5 (6.1) years participated. HbA1c decreased from (median (IQR)) 9.9 (8.8, 11.2)%; 85 (73, 99) mmol/mol to 7.3 (6.9, 7.8)%; 56 (52, 62) mmol/mol at 24 weeks (p < 0.0001). Comparing r-CGM (n = 46) with SMBG (n = 42), there were no differences in major hypoglycaemia (p=0.17) or ΔHbA1c (p = 0.31). More r-CGM than SMBG participants commenced glulisine (26/48 vs. 7/44; p < 0.001). Results were comparable to 82 benchmark patients, with similar low rates of major hypoglycaemia (2/89 vs. 0/82; p = 0.17) and less loss to follow up in the INITIATION group (3/92 vs. 14/82; p = 0.002).. Insulin initiation and titration for T2DM patients in primary care was safe and improved HbA1c with low rates of major hypoglycaemia. CDE-RNs were effective in a new consultant role. r-CGM use in primary care was feasible and enhanced post-prandial hyperglycaemia recognition. Trial registration ACTRN12610000797077.

Topics: Adult; Aged; Australia; Blood Glucose; Blood Glucose Self-Monitoring; Diabetes Mellitus, Type 2; Dose-Response Relationship, Drug; Drug Administration Schedule; Feasibility Studies; Female; Glycated Hemoglobin; Humans; Hyperglycemia; Hypoglycemia; Hypoglycemic Agents; Insulin; Insulin Glargine; Insulin, Long-Acting; Male; Middle Aged; Patient Acceptance of Health Care; Postprandial Period; Primary Health Care; Retrospective Studies

Insulin glulisine (Glu) is a rapidly-acting insulin analog with a faster onset of action than the other insulin analogs of its class, which are insulin aspart (Asp) and insulin lispro (Lisp). While insulin Glu is usually injected just before meals, postprandial injection may help to avoid unexpected postprandial hypoglycemia or hyperglycemia by adjusting the insulin dosage according to food intake. However, the effect of postprandial insulin Glu on the glucose profile has not been evaluated. The aim of this study was to compare daily glucose excursion by continuous glucose monitoring (CGM) between multiple daily doses of preprandial insulin Asp or postprandial insulin Glu. In a randomized cross-over trial, we performed CGM to evaluate the 48-hour glucose profile during treatment with the same dosage of insulin Asp just before each meal in 12 hospitalized patients with type 2 diabetes. Patients also received the same dosage of long-acting insulin glargine at bedtime. The average glucose level, standard deviation of the glucose level, mean amplitude of glucose excursion, and daily glucose profile did not differ between preprandial Asp and postprandial Glu. The incidence of hypoglycemic episodes (glucose level<70 mg/dL with or without symptoms) and the area under the curve of glucose<70 mg/dL also did not differ between the two insulin regimens. Multiple daily injections of preprandial Asp and postprandial Glu achieved the same daily glucose excursion profile. Postprandial injection of Glu may provide greater flexibility for patients who require insulin therapy.

Topics: Adult; Aged; Blood Glucose; Cross-Over Studies; Diabetes Complications; Diabetes Mellitus, Type 2; Drug Administration Schedule; Drug Therapy, Combination; Female; Glycated Hemoglobin; Humans; Hyperglycemia; Hypoglycemia; Hypoglycemic Agents; Insulin; Insulin Aspart; Insulin Glargine; Insulin, Long-Acting; Male; Middle Aged; Monitoring, Ambulatory

Renal insufficiency may increase the risk of hypoglycemia in hospitalized patients with diabetes who are treated with insulin. We randomized inpatients with type 2 diabetes and chronic renal failure to treatment with two different dose levels of insulin glargine and glulisine and studied control of hyperglycemia and the frequency of hypoglycemia.. We conducted a multicenter, prospective, randomized trial to compare the efficacy of once-daily glargine and three-times daily glulisine at 0.5 vs. 0.25 units/kg/day. A total of 107 subjects had type 2 diabetes for >1 year, had a glomerular filtration rate <45 mL/min but did not require dialysis, and had an initial blood glucose (BG) >180 mg/dL. Doses were adjusted based on four-times daily BG measurements for 6 days.. Mean BG on the first day was 196 ± 71 mg/dL in the group receiving 0.5 units/kg (0.5 group) and 197 ± 55 mg/dL in the group receiving 0.25 units/kg (0.25 group; P = 0.94). On days 2 to 6, mean BG was 174 ± 52 mg/dL in the 0.5 group and 174 ± 46 mg/dL in the 0.25 group (P = 0.96). There were no significant differences between groups in the percentage of BG values within the target range of 100 to 180 mg/dL on any of the 6 study days. In the 0.5 group, 30% experienced hypoglycemia (BG <70 mg/dL) compared with 15.8% of the 0.25 group (P = 0.08).. Reduction of initial glargine/glulisine insulin weight-based dosing in hospitalized patients with diabetes and renal insufficiency reduced the frequency of hypoglycemia by 50% without compromising the control of hyperglycemia.

Topics: Adult; Aged; Blood Glucose; Diabetes Mellitus, Type 2; Female; Hospitalization; Humans; Hyperglycemia; Hypoglycemia; Insulin; Insulin Glargine; Insulin, Long-Acting; Male; Middle Aged; Renal Insufficiency; Treatment Outcome

In a previous pilot study comparing insulin glulisine (GLU) with insulin aspart (ASP) administered by continuous subcutaneous insulin infusion (CSII), GLU-treated patients did show a trend toward fewer catheter occlusions compared with ASP-treated patients. Here we performed a randomized open-label, three-way crossover, controlled multicenter study comparing GLU with ASP and insulin lispro (LIS).. Subjects with type 1 diabetes were allocated to one of three treatment orders-GLU-ASP-LIS, ASP-LIS-GLU, or LIS-GLU-ASP-with each insulin used for 13 weeks. The study was designed to demonstrate the superiority of GLU over ASP and LIS on unexplained hyperglycemia and/or perceived infusion set occlusion. A prespecified P value of 0.025 was considered significant to correct for multiple testing.. Percentages of subjects with at least one unexplained hyperglycemia and/or infusion set occlusion were not significantly different between GLU and ASP (68.4% [62.7-74.1%] vs. 62.1% [56.2-68.1%], P = 0.04) and GLU and LIS (68.4% [62.7-74.1%] vs. 61.3% [55.4-67.3%], P = 0.03). No differences were seen in hemoglobin A1c at end point, most points of the seven-point glucose curves, severe hypoglycemia, and symptomatic ketoacidosis. The overall rate of hypoglycemia with a plasma glucose level below 70 mg/dL per patient-year was significantly different between GLU and ASP (73.84 vs. 65.01, P = 0.008) and GLU and LIS (73.84 vs. 62.69, P < 0.001). Insulin doses remained unchanged during the trial.. GLU was not superior to ASP and LIS with no significant difference seen among GLU, ASP, and LIS in CSII use with respect to unexplained hyperglycemia and/or perceived catheter set occlusion. GLU was associated with a higher frequency of symptomatic hypoglycemia, possibly because of slight overdosing, as previous trials suggested lower insulin requirements when GLU is initiated in type 1 diabetes.

Topics: Adult; Cross-Over Studies; Diabetes Mellitus, Type 1; Diabetic Ketoacidosis; Female; Glycated Hemoglobin; Humans; Hyperglycemia; Hypoglycemia; Hypoglycemic Agents; Insulin; Insulin Aspart; Insulin Infusion Systems; Insulin Lispro; Male; Middle Aged; Statistics as Topic; Time Factors

This twelve-week, European, multicenter, controlled, open-label, randomized (1 : 1), parallel-group trial compared the safety of insulin glulisine with insulin as part used in continuous subcutaneous insulin infusion. Patients with type 1 diabetes (n=59) and continuous subcutaneous insulin infusion experience (mean values: HbA1c 6.9 % [insulin glulisine: 6.8 % VS. insulin as part: 7.1 %]; age 45.8 years; body mass index 26.0 kg/m2) were enrolled. HbA1c levels at endpoint (insulin glulisine: 7.0 % VS. insulin as part: 7.2 %), daily insulin doses, blood glucose profiles and adverse event rates were similar in both groups. The median (minimum-maximum) catheter occlusion rate was low for insulin glulisine and insulin as part (0 [0 - 0.7] VS. 0 [0 - 1.1] occlusions/month. Unexplained hyperglycemia occurred in six insulin glulisine-treated patients and twelve insulin as part-treated patients. Patients were expected to change their catheters every 2 days (15 changes/month); the catheter change rate was similar for insulin glulisine and insulin as part (14.1 VS. 14.8 changes/month). The frequency of infusion site reactions and hypoglycemia, and the time between catheter changes were similar for both insulin forms. Diabetic ketoacidosis was not reported. This study supports the safety of insulin glulisine in continuous subcutaneous insulin infusion administered via an external pump in type 1 diabetes.

Topics: Adult; Catheters, Indwelling; Diabetes Mellitus, Type 1; Drug Administration Routes; Equipment Failure; Female; Humans; Hyperglycemia; Hypoglycemia; Infusion Pumps; Insulin; Insulin Aspart; Insulin Infusion Systems; Male; Middle Aged

Several studies have found improved glycemic control with continuous subcutaneous insulin infusion compared with multiple daily insulin injections for patients with type 1 diabetes, albeit for a relatively short-period of follow-up. This prospective study presents for the first time the optimization of glycemic control with insulin pumps in a cohort of Greek patients with type 1 diabetes for a 3-year follow-up period during the socioeconomic crisis in Greece.. Ninety-four patients, previously on intensified basal-bolus insulin therapy with poor glycemic control, were initially recruited. Glycosylated hemoglobin (HbA1c), hypoglycemic and diabetic ketoacidosis episodes, pump-related side effects, lipidemic profile, 24-h urine albumin excretion, body mass index, blood pressure, and total daily insulin requirements (bolus and basal) were recorded during the 3-year follow-up. Statistical analysis was initially conducted for the entire study population and after body mass index and gender stratification.. Seventy-nine patients completed the study. A statistically significant decrease of HbA1c level (P < 0.0001) was observed at the end of Year 1 and was retained for the following years for the whole population. Similarly, significantly fewer hypoglycemic episodes occurred during the follow-up period (P < 0.0001) compared with study entry. Insulin pump treatment was not accompanied with weight changes across all body mass index strata.. Continuous subcutaneous insulin infusion achieved almost optimal glycemic control, reduced the number of hypoglycemic episodes without weight gain, and was well tolerated for the whole study period. Finally, this therapeutic approach was accompanied with lower daily insulin requirements.

Topics: Adult; Cohort Studies; Diabetes Complications; Diabetes Mellitus, Type 1; Drug Monitoring; Female; Follow-Up Studies; Glycated Hemoglobin; Greece; Hospitals, Urban; Humans; Hyperglycemia; Hypoglycemia; Hypoglycemic Agents; Insulin; Insulin Aspart; Insulin Infusion Systems; Insulin Lispro; Male; Middle Aged; Outpatient Clinics, Hospital; Prospective Studies

This study determined the optimal timing of insulin bolus administration in relation to meal consumption in adolescents and adults with type 1 diabetes.. Twenty-three subjects participated in this crossover study consisting of three treatment arms: delivering an insulin glulisine bolus by insulin pump 20 min prior to a meal ("PRE"), immediately before the meal ("START"), and 20 min after meal initiation ("POST"). Blood glucose levels were measured every 30 min for a total of 240 min post-meal initiation. Mean blood glucose levels at 1 and 2 h after meal initiation, blood glucose area under the curve (AUC), and maximum blood glucose levels were analyzed.. At both 60 and 120 min after meal initiation, the PRE arm showed significantly lower glycemic excursions than the START arm (P = 0.0029 and 0.0294, respectively) and the POST arm (P = 0.001 and 0.0408, respectively). Glycemic AUC was significantly less in the PRE arm versus both the START and POST arms (159.5 +/- 58.9 mg/dL vs. 187.0 +/- 43.1 mg/dL [P = 0.0297] and 184.5 +/- 33.2 mg/dL [P = 0.0463], respectively). Peak blood glucose levels were significantly lower in the PRE arm compared to the START arm (P = 0.0039) and the POST arm (P = 0.0027).. A bolus of rapid-acting insulin 20 min prior to a meal results in significantly better postprandial glucose control than when the meal insulin bolus is given just prior to the meal or 20 min after meal initiation.

Topics: Adolescent; Adult; Blood Glucose; Child; Colorado; Cross-Over Studies; Diabetes Mellitus, Type 1; Drug Administration Schedule; Female; Humans; Hyperglycemia; Insulin; Insulin Infusion Systems; Male; Self Care; Young Adult

Premixed insulin regimens are commonly used for type 2 diabetes mellitus (T2DM) patients. However, there is limited information regarding next-step therapy options in cases where premixed insulin does not provide adequate glycaemic control. This 12-week observational study of everyday clinical practice evaluated the efficacy and safety of insulin glargine (glargine) plus oral antidiabetic drugs (OADs) in T2DM patients previously treated with premixed insulin.. Type 2 diabetes mellitus patients taking premixed insulin were identified from German clinics and were eligible to switch to glargine plus OADs at the physicians' and patients' discretion, as part of routine clinical practice. The study design and conduct was in accordance with German regulations. Fasting blood glucose (FBG), 2-h postprandial blood glucose (PPBG) and glycosylated haemoglobin (HbA(1c)) were measured at the start and after a 12-week observation period.. A total of 5045 patients were followed-up and received glargine plus OADs. FBG [start to end-point: 9.9 +/- 2.7 to 6.9 +/- 1.5 mmol/l (178 +/- 48 to 124 +/- 26 mg/dl); p < or = 0.001], 2-h PPBG [10.8 +/- 2.8 to 7.8 +/- 1.5 mmol/l (195 +/- 50 to 140 +/- 27 mg/dl)] and HbA(1c) (8.3 +/- 1.2 to 7.2 +/- 0.8%; p < or = 0.001) improved significantly from start to end-point, respectively. A total of 48.9%, 38.4% and 73.9% of patients had FBG < 6.7 mmol/l (< 120 mg/dl), 2-h PPBG < 7.2 mmol/l (< 130 mg/dl) or HbA(1c) < 7.5%, respectively, after 12 weeks. Significant reductions in body weight were observed between the start and end of the observation period. A total of 71 adverse events were reported by 38 patients. Hypoglycaemia was the most common event (n = 16).. This observational study shows that, in T2DM patients inadequately controlled with premixed insulin, switching therapy to glargine plus OADs is associated with significant improvements in FBG and HbA(1c), and is well tolerated in everyday clinical practice. Further intensification of insulin therapy, perhaps by adding one or more injections of prandial insulin, would help provide further improvements in glycaemic control in these patients.

Topics: Administration, Oral; Aged; Blood Glucose; Body Weight; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Female; Humans; Hyperglycemia; Hypoglycemic Agents; Insulin; Male; Middle Aged; Treatment Outcome