Evidence map›Paper›PMID 19684847›Full record

ArticleArchives of drug information2009

Improved Glycaemic Control with Biphasic Insulin Aspart 30 in Type 2 Diabetes Patients Failing Oral Antidiabetic Drugs: PRESENT Study Results.

Serdar Güler, Surendra Kumar Sharma, Majeed Almustafa, Chong Hwa Kim, Sami Azar, Rucsandra Danciulescu, Marina Shestakova, Duma Khutsoane, Ole Molskov Bech

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Archives of drug information, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01536600 (A Multi-center, Prospective, Non-interventional Evaluation of Efficacy, Safety and Convenience of Using NovoMix 30 as Monotherapy, or in Combination With OHAs, in the Treatment of Type 2 Diabetic Patients in Routine Clinical Practice), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01536600 completednot on this map

A Multi-center, Prospective, Non-interventional Evaluation of Efficacy, Safety and Convenience of Using NovoMix 30 as Monotherapy, or in Combination With OHAs, in the Treatment of Type 2 Diabetic Patients in Routine Clinical Practice

TypeobservationalSponsorNovo Nordisk A/SRan2004 to 2006Enrolled33,010ConditionsDiabetes, Diabetes Mellitus, Type 2Armsbiphasic insulin aspart 30
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Serdar Güler
Surendra Kumar Sharma
Majeed Almustafa
Chong Hwa Kim
Sami Azar
Rucsandra Danciulescu
Marina Shestakova
Duma Khutsoane
Ole Molskov Bech

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThis paper presents the treatment outcomes for patients intiated on biphasic insulin aspart 30 (BIAsp 30) treatment: BIAsp 30-only, BIAsp 30 + sulphonylureas (SU), BIAsp 30 + biguanides (BI), BIAsp 30 + SU + BI, BIAsp 30 + alpha-glucosidase inhibitors (GI), and BIAsp 30 + BI + thiazolidinediones (TZD) after failing oral antidiabetic drugs (OADs) treatment.

methodsThis was a multi-national, multi-centre, six-month, prospective, open-labelled, uncontrolled, clinical experience evaluation study, with the exception of a three-month study in one country (China) ("all exclude China" and "China"). Initiation and discontinuation of BIAsp 30 treatment were entirely at the discretion of the attending physicians.

resultsMean HbA(1c), FPG and PPPG were significantly reduced from baseline at three and six months in all groups (P < 0.001). In "all exclude China", reductions in mean HbA(1c), FPG and PPPG at six months were as follows: BIAsp 30-only group (-2.12 +/- 1.76% points; -4.82 +/- 3.86 mmol/L; -6.89 +/- 4.74 mmol/L), BIAsp 30 + BI group (-2.24 +/- 1.77% points; -4.48 +/- 3.68 mmol/L; -6.66 +/- 4.55 mmol/L), BIAsp 30 + SU group (-1.95 +/- 1.59% points; -3.98 +/- 3.19 mmol/L; -6.25 +/- 4.45 mmol/L) and BIAsp 30 + SU + BI group (-1.78 +/- 1.20% points; -3.57 +/- 2.78 mmol/L; -5.89 +/- 3.98 mmol/L). The only serious adverse drug reaction was reported by the BIAsp 30-only group. In the "China" group, reductions in mean HbA(1c), FPG and PPPG at three months were: BIAsp 30-only group (-2.16 +/- 1.52% points; -3.34 +/- 2.49 mmol/L; -6.29 +/- 3.92 mmol/L), BIAsp 30 + BI group (-2.44 +/- 1.52% points; -4.01 +/- 2.50 mmol/L; -7.10 +/- 3.96 mmol/L), BIAsp 30 + GI group (-2.33 +/- 1.41% points; -4.34 +/- 2.52 mmol/L; -7.97 +/- 3.99 mmol/L) and BIAsp 30 + BI + TZD group (-1.21 +/- 1.60% points; -3.50 +/- 2.29 mmol/L; -5.97 +/- 3.39 mmol/L). No serious ADR were reported in China. The most frequent hypoglycaemic episodes were diurnal and minor in nature.

conclusionsBIAsp 30 treatment in a clinical setting improved glycaemic control in type 2 diabetes patients failing OADs.

Identifiers

PMID19684847
PMCPMC2721962

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.