A randomized controlled trial examining combinations of repaglinide, metformin and NPH insulin

Davies, Melanie J.; Tringham, Jennifer; Howe, J; Jarvis, Janet; Johnston, V.; Kitchener, Dl L.; Skinner, Timothy; McNally, PG; Lawrence, IG

doi:10.1111/j.1464-5491.2007.02128.x

Cited by 15 publications

(5 citation statements)

References 40 publications

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“…In contrast to our findings, Duran et al showed statistically significant decrease in HbA 1c levels due to administration of repaglinide against acarbose concomitant consumption with glargine insulin (11). In contrast of our study, episodes of hypoglycemia were not reduced in Davies et al trial which was handled by insulin use through repaglinide and metformin administration (12). Totally, albumin excretion rates were slightly diminished and changes were dependent on the administration route of drugs.…”

Section: Discussioncontrasting

confidence: 99%

Oral repaglinide versus insulin injection in type II diabetes mellitus; a randomized clinical trial

Chiti¹,

Manjili²,

Pezeshgi³

et al. 2017

J Nephropharmacol

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Section: Discussioncontrasting

confidence: 99%

Oral repaglinide versus insulin injection in type II diabetes mellitus; a randomized clinical trial

Chiti¹,

Manjili²,

Pezeshgi³

et al. 2017

J Nephropharmacol

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“…Moderate grade evidence showed a modestly lower risk of hypoglycemia when metformin was combined with basal insulin or glargine, rather than a premixed insulin such as lispro 75/25 or aspart 70/30 (but not lispro 50/50), which was associated with an increased risk of mild-to-moderate hypoglycemia compared with metformin. [133][134][135][136][137][138] Comparative Effects of Combination Therapies on Other Adverse Events Among several RCTs, no adverse events related to the liver were noted for treatment with various drug combinations including metformin combined with sulfonylureas or thiazolidinediones, or the thiazolidinediones combined with sulfonylureas. 70,109,110 The RECORD study found that patients taking rosiglitazone in combination with either a sulfonylurea or metformin had double the risk of CHF compared with patients receiving a combination of sulfonylurea and metformin.…”

Section: Comparative Effects Of Combination Therapies On Hypoglycemiamentioning

confidence: 99%

AHRQ’s Comparative Effectiveness Research on Oral Medications for Type 2 Diabetes: A Summary of the Key Findings

Bennett¹,

Balfe²,

Faysal³

2012

JMCP

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Type 2 diabetes mellitus is a major public health burden. Since the 2007 AHRQ systematic review of oral medications for type 2 diabetes, the FDA has approved several new drug classes. Therefore, in 2011, the original systematic review was updated with comparisons including the newer oral diabetes medications. The updated report expands beyond the scope of the original 2007 review by including comparisons of 2-drug combinations and the addition of more head-to-head comparisons, as well as additional adverse outcomes. A high strength of evidence showed that most medications were similarly efficacious at lowering hemoglobin A1c by about 1 absolute percentage point compared with baseline values. The addition of most oral medications to initial monotherapy further improved glycemiccontrol by lowering A1c by another 1 percentage point. The only exception was the DPP-4 inhibitor class, which did not lower A1c to the same extent as metformin when used as monotherapy. Overall, metformin was found to have a more favorable effect on body weight when compared with other medications. Two-drug combinations compared with each other demonstrated similar reductions in A1c levels. Metformin decreased low-density lipoprotein cholesterol (LDL-C) relative to pioglitazone, sulfonylureas,and DPP-4 inhibitors. Sulfonylureas had a 4-fold higher risk of mild-to-moderate hypoglycemia compared with metformin alone, and, in combination with metformin, had more than a 5-fold increased risk compared with metformin plus a thiazolidinedione. Thiazolidinediones had an increased risk of congestive heart failure relative to sulfonylureas, and an increased risk for bone fractures relative to metformin. Diarrhea occurred more often for metformin users compared with thiazolidinedione users. Although the long-term risks and benefits of diabetes medications remain unclear, the evidence supports the use of metformin as a first-line agent.

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“…Davies et al9 defined it as an episode occurring between evening injection and breakfast. Diamant et al10 defined it as an episode between bedtime and breakfast.…”

Section: Resultsmentioning

confidence: 99%

Hypoglycemia: a review of definitions used in clinical trials evaluating antihyperglycemic drugs for diabetes

Balijepalli¹,

Druyts²,

Siliman³

et al. 2017

CLEP

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ObjectiveTo understand the severity and potential impact of heterogeneity in definitions of hypoglycemia used in diabetes research, we aimed to review the hypoglycemia definitions adopted in randomized controlled trials (RCTs).MethodsWe reviewed 109 RCTs included in the Canadian Agency for Drugs and Technologies in Health reports for the second- and third-line therapy for the patients with type 2 diabetes (T2D).ResultsNearly 60% (n=66) of the studies reviewed presented the definitions for overall hypoglycemia, and another 20% (n=22) of the studies reported the results for hypoglycemia but did not report a definition. Among these 66 studies, only 9 (14%) followed the American Diabetes Association/European Medicines Agency specified guidelines to define hypoglycemia, with an exact threshold of plasma glucose ≤3.9 mmol/L. Fifty-two of the 66 studies (79%) used a threshold considerably lower than the recommended ≤3.9 mmol/L, and 16 studies used a threshold between 3.8 and 4.0 mmol/L. The proportion of the trials that used a cutoff value of <3.1 mmol/L appeared to be slightly similar among the more commonly used non-insulin treatments, GLP-1s (7 of 18 [39%]), thiazolidinediones (TZDs; 6 of 11 [55%]), DPP-4s (12 of 19 [64%]), and sulfonylureas (11 of 20 [55%]). Among trials with intermediate-long-acting insulins (neutral protamine Hagedorn insulin, detemir, glargine), 7 of 26 trials (27%) used a cutoff of <3.1 mmol/L. The definition of severe hypoglycemia was also subject to substantial heterogeneity, in both the utilized threshold and accompanying soft definitions.ConclusionThis review demonstrates that substantial heterogeneity exists in the definition of overall, severe/major, and nocturnal hypoglycemia across RCTs investigating T2D interventions.

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A randomized controlled trial examining combinations of repaglinide, metformin and NPH insulin

Abstract: The approach using repaglinide, metformin and NPH insulin improved glycaemic control with a similar safety profile to conventional insulin initiation in T2DM and produced final glycaemic control similar to metformin and a twice daily biphasic insulin mixture.

Cited by 15 publications

References 40 publications

Oral repaglinide versus insulin injection in type II diabetes mellitus; a randomized clinical trial

Oral repaglinide versus insulin injection in type II diabetes mellitus; a randomized clinical trial

AHRQ’s Comparative Effectiveness Research on Oral Medications for Type 2 Diabetes: A Summary of the Key Findings

Hypoglycemia: a review of definitions used in clinical trials evaluating antihyperglycemic drugs for diabetes

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