Evidence map›Paper›PMID 25048824›Full record

Observational studyBMC endocrine disorders2014

Lower risk of hypoglycaemia and greater odds for weight loss with initiation of insulin detemir compared with insulin glargine in Turkish patients with type 2 diabetes mellitus: local results of a multinational observational study.

Taner Damci, Rifat Emral, Anne Louise Svendsen, Tanzer Balkir, Jiten Vora, SOLVE™ study group

2 registry-linked trialsAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in BMC endocrine disorders, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT00740519 completednot on this map

Evaluation on Safety of Self-titration in Insulin naïve People With Type 2 Diabetes Treated With Levemir® (Insulin Detemir) and Oral Antidiabetic Agents

TypeobservationalSponsorNovo Nordisk A/SRan2008 to 2011Enrolled882ConditionsDiabetes, Diabetes Mellitus, Type 2Armsinsulin detemir
NCT00825643 completednot on this map

A Multicentre, Open Label, Observational 24-week Study to Evaluate Safety of Initiating Insulin Therapy With Levemir® (Insulin Detemir) Once-daily in Oral Antidiabetic Drug-treated Patients With Type 2 Diabetes

TypeobservationalSponsorNovo Nordisk A/SRan2008 to 2011Enrolled18,481ConditionsDiabetes, Diabetes Mellitus, Type 2Armsinsulin detemir
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Article
  3. Article
  4. Practical combination therapy based on pathophysiology of type 2 diabetes.Diabetes, metabolic syndrome and obesity : targets and therapy · 2016
    Review
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

6 authors.

Taner DamciDepartment of Endocrinology, Diabetes and Metabolism, Cerrahpasa Medical School, Istanbul University, 34363 Istanbul, Turkey. tdamci@gmail.com.
Rifat Emral
Anne Louise Svendsen
Tanzer Balkir
Jiten Vora
SOLVE™ study group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe purpose of this analysis is to evaluate the safety and effectiveness of insulin initiation with once-daily insulin detemir (IDet) or insulin glargine (IGlar) in real-life clinical practice in Turkish patients with type 2 diabetes mellitus (T2DM).

methodsThis was a 24-week multinational observational study of insulin initiation in patients with T2DM.

resultsThe Turkish cohort (n = 2886) included 2395 patients treated with IDet and 491 with IGlar. The change in glycosylated haemoglobin (HbA1c) from the pre-insulin levels was -2.21% [95% confidence interval (CI) -2.32, -2.09] in the IDet group and -1.88% [95% CI -2.17, -1.59] in the IGlar group at the final visit. The incidence rate of minor hypoglycaemia increased in both groups from the pre-insulin to the final visit (+0.66 and +2.23 events per patient year in the IDet and IGlar groups, respectively). Weight change in the IDet group was -0.23 kg [95% CI -0.49, 0.02 kg], and +1.55 kg [95% CI 1.11, 2.00 kg] in the IGlar group. Regression analysis with adjustment for previously identified confounders (age, gender, duration of diabetes, body mass index, previous history of hypoglycaemia, microvascular disease, number and change in oral anti-diabetic drug therapy, HbA1c at baseline and insulin dose) identified an independent effect of insulin type (IDet versus IGlar) with a risk of at least one episode of hypoglycaemia (odds ratio (OR): 0.33 [95% CI 0.21, 0.52], p <0.0001), and weight loss ≥1 kg (OR: 1.75 [95% CI 1.18, 2.59], p = 0.005), but not on HbA1c (+0.05% [95% CI -0.15, 0.25%], p = 0.6).

conclusionsInitiation of basal insulin analogues, IDet and IGlar, were associated with clinically significant glycaemic improvements. A lower risk of minor hypoglycaemia and greater odds of weight loss ≥1 kg was observed with IDet compared with IGlar.

trial registrationNCT00825643 and NCT00740519.

Indexed as

AgedBlood GlucoseDiabetes Mellitus, Type 2FemaleFollow-Up StudiesHumansHypoglycemiaHypoglycemic AgentsInsulin DetemirInsulin GlargineInsulin, Long-ActingInternational AgenciesMaleMiddle AgedPrognosisProspective StudiesBlood GlucoseHypoglycemic AgentsInsulin DetemirInsulin GlargineInsulin, Long-Acting

Identifiers

PMID25048824
PMCPMC4223563

What OpenQuestion holds

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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.