Therapy after single oral agent failure: adding a second oral agent or an insulin mixture?

Malone, James; Beattie, Scott; Campaigne, Barbara N.; Johnson, Patricia A.; Howard, Andrew S.; Miličević, Zvonko

doi:10.1016/j.diabres.2003.08.003

Cited by 21 publications

(11 citation statements)

References 12 publications

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“…The study populations had a median hemoglobin A1c of 8.7 percent (range: 7.3 to 10.7 percent), a median body mass index of 29.4 kg/m 2 (range: 24 to 37 kg/m 2 ), and a median duration of diabetes of 11 years (range: 4 to 16 years). Eleven trials enrolled insulin-naïve patients (9;18;19;27;29;33;34;36;38;43;44), 26 enrolled insulin-treated patients (23;25;28;32;34;35;37;39-42;45-55;57-60), and nine did not specify history of insulin treatment (17;20-22;24;26;30;31;56). …”

Section: Resultsmentioning

confidence: 99%

Systematic Review: Comparative Effectiveness and Safety of Premixed Insulin Analogues in Type 2 Diabetes

et al. 2008

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Background Evidence comparing premixed insulin analogues with other antidiabetic agents is urgently required to guide appropriate therapy. Purpose To summarize the English-language literature on the effectiveness and safety of premixed insulin analogues as compared with other antidiabetic agents in adults with type 2 diabetes. Data Sources We searched MEDLINE®, EMBASE®, CINAHL, and the Cochrane Central Register of Controlled Trials from inception to February 2008, and unpublished data from U.S. Food and Drug Administration, European Medicines Agency, and industry. Study Selection Studies with control arms that compared premixed insulin analogues to another antidiabetic medication in adults with type 2 diabetes Data Extraction Serial abstraction by 2 reviewers using standardized protocols Data Synthesis Evidence from clinical trials was inconclusive for clinical outcomes, such as mortality. Therefore, the review focused on intermediate outcomes. Premixed analogues were similar to premixed human insulin in lowering fasting glucose, hemoglobin A1c, and the incidence of hypoglycemia but were more effective in lowering postprandial glucose (mean difference = -1.1 mmol/L; 95% CI = -1.4 to -0.7 mmol/L [-19.2 mg/dL; 95% CI=-25.9 to -12.5 mg/dL]). As compared to long-acting insulin analogues, premixed analogues were superior in lowering postprandial glucose (mean difference= -1.5 mmol/L; 95%CI = -1.9 to -1.2 mmol/L [-27.9 mg/dL; 95% CI=-34.3 to -21.5 mg/dL]) and hemoglobin A1c (mean difference=-0.39%; 95% CI=-0.50% to -0.28%) but inferior in lowering fasting glucose (mean difference=0.7 mmol/L; 95%CI = 0.3 to 1.0 mmol/L [12.0 mg/dL; 95% CI=6.0 to 18.1 mg/dL]) and had higher incidence of hypoglycemia. When compared to noninsulin antidiabetic agents, premixed analogues were more effective in lowering fasting glucose (mean difference= -1.1mmol/L; 95%CI = -1.7 to 0.6 mmol/L [-20.5 mg/dL; 95% CI=-29.9 to -11.2 mg/dL]), postprandial glucose (mean difference= -2.1 mmol/L; 95%CI = -3.4 to -0.8 mmol/L [-37.4 mg/dL; 95% CI=-61.0 to -13.7 mg/dL]), and hemoglobin A1c (mean difference=-0.49%; 95% CI=-0.86% to -0.12%) but had higher incidence of hypoglycemia. Limitations Searching was restricted to studies published in English. Data on clinical outcomes was limited. The small number of studies for each comparison limited assessment of between-study heterogeneity. Conclusions Premixed insulin analogues provide glycemic control similar to premixed human insulin and may provide tighter glycemic control than long-acting insulin analogues and noninsulin antidiabetic agents.

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Section: Resultsmentioning

confidence: 99%

Systematic Review: Comparative Effectiveness and Safety of Premixed Insulin Analogues in Type 2 Diabetes

et al. 2008

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“…Although the pharmacokinetics of conventional INS given via the gastrointestinal route makes it virtually impossible to replicate the normal pattern of INS action, several studies have reported a hypoglycemic response to oral INS (20). In addition, the facts that INS is present in human and pig colostrum and mature milk and that INS receptors are present on both luminal and basolateral membranes of the enterocyte suggest its potential role in small intestinal growth and development (21).…”

Section: Discussionmentioning

confidence: 98%

Oral Insulin Enhances Intestinal Regrowth Following Massive Small Bowel Resection in Rat

et al. 2005

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Experimental studies have suggested that insulin (INS) plays an important role in small intestinal growth and development. In the present study we investigated the effect of oral INS on structural intestinal adaptation and enterocyte proliferation and loss via apoptosis in a rat model of short bowel syndrome (SBS). Male Sprague-Dawley rats were divided into three experimental groups: sham rats underwent bowel transection, SBS rats underwent 75% small bowel resection, and SBS-INS rats underwent bowel resection and were treated with oral INS given in the drinking water from the 3rd to the 15th postoperative day. Parameters of intestinal adaptation (bowel and mucosal weight, mucosal DNA and protein, villous height, and crypt depth), enterocyte proliferation, and apoptosis were determined on day 15. SBS-INS rats demonstrated a significant increase (vs SBS rats) in jejunal and ileal overall bowel and mucosal weight, ileal mucosal DNA and protein, ileal villous height, and crypt depth. SBS-INS rats also showed an increased cell proliferation index in jejunum and ileum and decreased apoptotic index in jejunum compared to SBS animals. In conclusion, in a rat model of SBS, oral INS strongly enhances intestinal adaptation. Possible mechanisms may include increased cell proliferation and decreased enterocyte loss via apoptosis.

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“…A post hoc analysis of pooled clinical trial data from 15 insulin trials (both published 8,10,[12][13][14][15][16][17][18][19][20][21][22] and unpublished [Lilly data on file]) in patients with type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM) was performed.…”

Section: Introductionmentioning

confidence: 99%

The Effect of Adjusting for Baseline Hypoglycemia when Analyzing Hypoglycemia Data: A Systematic Analysis of 15 Diabetes Clinical Trials

Luo

Jacober²,

Prince³

et al. 2013

Diabetes Technology & Therapeutics

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Therapy after single oral agent failure: adding a second oral agent or an insulin mixture?

Cited by 21 publications

References 12 publications

Systematic Review: Comparative Effectiveness and Safety of Premixed Insulin Analogues in Type 2 Diabetes

Systematic Review: Comparative Effectiveness and Safety of Premixed Insulin Analogues in Type 2 Diabetes

Oral Insulin Enhances Intestinal Regrowth Following Massive Small Bowel Resection in Rat

The Effect of Adjusting for Baseline Hypoglycemia when Analyzing Hypoglycemia Data: A Systematic Analysis of 15 Diabetes Clinical Trials

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