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Insulin detemir in a twice daily insulin regimen versus a three times daily insulin regimen in the treatment of type 1 diabetes in children: A pilot randomized controlled trial.

ABSTRACT: BACKGROUND:Children with type 1 diabetes (DM1) often use three daily (TID) injections with intermediate acting insulin at breakfast and bedtime, and rapid acting insulin at breakfast and dinner. Substituting the evening intermediate acting insulin with a long acting insulin analogue (LAIA) at dinner in a twice daily (BID) injection regimen may be as effective as a TID regimen. The objective of this pilot study was to compare HbA1c in children with DM1 using a BID regimen with a LAIA at dinner (intervention) to those using a standard TID regimen (control) over 6 months. METHODS:Randomized controlled trial with main outcome measure being HbA1c at 0, 3 and 6 months. Secondary outcomes were frequency of adverse events (hypoglycemia, diabetic ketoacidosis, weight gain) and scores on the Diabetes Quality of Life Measure for Youth (DQOLY). RESULTS:18 subjects (10 control, 8 intervention). Mean years (standard deviations) for control and intervention respectively were: age at diagnosis of DM1 6.31 (2.91) vs 7.76 (3.22), duration of DM1 5.96 (4.95) vs 3.76 (3.37). No significant differences were seen in the mean HbA1c between control and intervention at 0 months [8.48(0.86) vs 8.57(1.13)], 3 months [8.47(0.50) vs 7.99(0.61)], or 6 months [8.42(0.63) vs 8.30(0.76)]. No significant differences were found between groups for frequency of adverse events or DQOLY. CONCLUSIONS:In this pilot study, incorporating LAIA in a BID regimen did not cause deterioration in HbA1c or increases in adverse events; suggesting that this may be a viable option for families where a more simplified insulin regimen would be beneficial and compliance may be improved. TRIAL REGISTRATION:ClinicalTrials.gov: NCT00522210.

SUBMITTER: Ho J

PROVIDER: S-EPMC3223134 | biostudies-literature | 2011 Nov

REPOSITORIES: biostudies-literature

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Insulin detemir in a twice daily insulin regimen versus a three times daily insulin regimen in the treatment of type 1 diabetes in children: A pilot randomized controlled trial.

Ho Josephine J Huang Carol C Nettel-Aguirre Alberto A Pacaud Danièle D

International journal of pediatric endocrinology 20111108 1

<h4>Background</h4>Children with type 1 diabetes (DM1) often use three daily (TID) injections with intermediate acting insulin at breakfast and bedtime, and rapid acting insulin at breakfast and dinner. Substituting the evening intermediate acting insulin with a long acting insulin analogue (LAIA) at dinner in a twice daily (BID) injection regimen may be as effective as a TID regimen. The objective of this pilot study was to compare HbA1c in children with DM1 using a BID regimen with a LAIA at d ...[more]

PMID: 22067102

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Project description:OBJECTIVE:To compare perinatal outcome and glycaemic control in two groups of pregnant diabetic patients receiving two insulin regimens. DESIGN:Randomised controlled open label study. SETTING:University affiliated hospital, Israel. PARTICIPANTS:138 patients with gestational diabetes mellitus and 58 patients with pregestational diabetes mellitus received insulin four times daily, and 136 patients with gestational diabetes and 60 patients with pregestational diabetes received insulin twice daily. INTERVENTION:Three doses of regular insulin before meals and an intermediate insulin dose before bedtime (four times daily regimen), and a combination of regular and intermediate insulin in the morning and evening (twice daily regimen). MAIN OUTCOME MEASURES:Maternal glycaemic control and perinatal outcome. RESULTS:Mean daily insulin concentration before birth was higher in the women receiving insulin four times daily compared with twice daily: by 22 units (95% confidence interval 12 to 32) in patients with gestational diabetes and by 28 units (15 to 41) in patients with pregestational diabetes. Glycaemic control was better with the four times daily regimen than with the twice daily regimen: in patients with gestational diabetes mean blood glucose concentrations decreased by 0.19 mmol/l (0.13 to 0.25), HbA(1c) by 0.3% (0.2% to 0.4%), and fructosamine by 41 micromol/l (37 to 45), and adequate glycaemic control (mean blood glucose concentration <5.8 mmol/l) was achieved in 17% (8% to 26%) more women; in patients with pregestational diabetes mean blood glucose concentration decreased by 0.44 mmol/l (0.28 to 0.60), HbA(1c) by 0.5% (0.2% to 0.8%), and fructosamine by 51 micromol/l (45 to 57), and adequate glycaemic control was achieved in 31% (15% to 47%) more women. Maternal severe hypoglycaemic events, caesarean section, preterm birth, macrosomia, and low Apgar scores were similar in both dose groups. In women with gestational diabetes the four times daily regimen resulted in a lower rate of overall neonatal morbidity than the twice daily regimen (relative risk 0.59, 0.38 to 0.92), and the relative risk for hyperbilirubinaemia and hypoglycaemia was lower (0.51, 0.29 to 0.91 and 0.12, 0.02 to 0.97 respectively). The relative risk of hypoglycaemia in newborn infants to mothers with pregestational diabetes was 0.17 (0.04 to 0.74). CONCLUSIONS:Giving insulin four times rather than twice daily in pregnancy improved glycaemic control and perinatal outcome without further risking the mother.

Project description:BackgroundChronically elevated blood glucose levels are associated with significant morbidity and mortality. Many diabetes patients will eventually require insulin treatment to maintain good glycaemic control. There are still uncertainties about the optimal insulin treatment regimens for type 2 diabetes, but the long-acting insulin analogues seem beneficial. Several reviews have compared either insulin detemir or insulin glargine to NPH insulin, but research directly comparing both insulin analogues is limited.ObjectivesTo assess the effects of insulin detemir and insulin glargine compared with each other in the treatment of type 2 diabetes mellitus.Search strategyWe searched MEDLINE, EMBASE, The Cochrane Library, online registries of ongoing trials and abstract books. Date of last search was January 2011.Selection criteriaAll randomised controlled trials comparing insulin detemir with insulin glargine with a duration of 12 weeks or longer were included.Data collection and analysisTwo authors independently selected the studies and extracted the data. Pooling of studies by means of random-effects meta-analysis was performed.Main resultsThis review examined four trials lasting 24 to 52 weeks involving 2250 people randomised to either insulin detemir or glargine. Overall, risk of bias of the evaluated studies was high. Insulin glargine was dosed once-daily in the evening. Insulin detemir was initiated once-daily in the evening with the option of an additional dose in the morning in three studies and initiated twice-daily in one study. Of randomised patients 13.6% to 57.2% were injecting insulin detemir twice-daily at the end of trial.Glycaemic control, measured by glycosylated haemoglobin A1c (HbA1c) and HbA1c equal to or less than 7% with or without hypoglycaemia, did not differ statistically significantly between treatment groups.The results showed no significant differences in overall, nocturnal and severe hypoglycaemia between treatment groups.Insulin detemir was associated with less weight gain. Treatment with insulin glargine resulted in a lower daily basal insulin dose and a lower number of injection site reactions.There was no significant difference in the variability of FPG or glucose values in 24-hour profiles between treatment groups. It was not possible to draw conclusions on quality of life, costs or mortality. Only one trial reported results on health-related quality of life and showed no significant differences between treatment groups.Authors' conclusionsOur analyses suggest that there is no clinically relevant difference in efficacy or safety between insulin detemir and insulin glargine for targeting hyperglycaemia. However, to achieve the same glycaemic control insulin detemir was often injected twice-daily in a higher dose but with less weight gain, while insulin glargine was injected once-daily, with somewhat fewer injection site reactions.

Project description:AimTo compare the efficacy and safety of basal insulin glargine 100 units/ml (Gla) + 2-3 oral antihyperglycaemic drugs (OADs) with twice-daily premixed insulin aspart 70/30 (Asp30) + metformin (MET) after short-term intensive insulin therapy in adults with type 2 diabetes in China.Materials and methodsThis open-label trial enrolled insulin-naïve adults with type 2 diabetes and an HbA1c of 7.5%-11.0% (58-97 mmol/mol) despite treatment with 2-3 OADs. All participants stopped previous OADs except MET, then received short-term intensive insulin therapy during the run-in period, when those with a fasting plasma glucose of less than 7.0 mmol/L and 2-hour postprandial glucose of less than 10.0 mmol/L were randomized to Gla + MET + a dipeptidyl peptidase-4 inhibitor or twice-daily Asp30 + MET. If HbA1c was more than 7.0% (>53 mmol/mol) at week 12, participants in the Gla group were added repaglinide or acarbose, at the physician's discretion, and participants in the Asp30 group continued to titrate insulin dose. The change in HbA1c from baseline to week 24 was assessed in the per protocol (PP) population (primary endpoint).ResultsThere were 384 enrollees (192 each to Gla and Asp30); 367 were included in the PP analysis. The threshold for non-inferiority of Gla + OADs versus Asp30 + MET was met, with a least squares mean change from baseline in HbA1c of -1.72% and -1.70% (-42.2 and -42.1 mmol/mol), respectively (estimated difference -0.01%; 95% CI -0.20%, 0.17% [-0.1 mmol/mol; 95% CI -2.2, 1.9]). Achievement of HbA1c less than 7.0% (<53 mmol/mol) was comparable between the groups (60% vs. 57%). The proportion of participants with any (24% vs. 38%; P = .003), symptomatic (19% vs. 31%; P = .007) or confirmed hypoglycaemia (18% vs. 33%; P < .001) was lower in the Gla + OADs group.ConclusionsCompared with Asp30 + MET, Gla + 2-3 OADs showed similar efficacy but a lower hypoglycaemia risk in Chinese individuals with type 2 diabetes who had undergone short-term intensive insulin therapy.

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Insulin detemir in a twice daily insulin regimen versus a three times daily insulin regimen in the treatment of type 1 diabetes in children: A pilot randomized controlled trial.

Publications

Insulin detemir in a twice daily insulin regimen versus a three times daily insulin regimen in the treatment of type 1 diabetes in children: A pilot randomized controlled trial.

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