Evidence map›Paper›PMID 31423685›Full record

Trial reportDiabetes, obesity & metabolism2019

Superior HbA1c control with the fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with a maximum dose of 50 units of insulin degludec in Japanese individuals with type 2 diabetes in a phase 3, double-blind, randomized trial.

Hirotaka Watada, Shizuka Kaneko, Mitsuhisa Komatsu, Bue Ross Agner, Tomoyuki Nishida, Mattis Ranthe, Jiro Nakamura

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02911948. Cited by 21 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 3 pooled it
2.4field-weighted citation impact, top 11% of its field
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.

NCT02911948 phase3completed

A Double-blinded Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec Both in Combination With Metformin in Japanese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal or Pre-mix/Combination Insulin Therapy and Oral Anti-diabetic Drugs

Ran2016Enrolled210Registered outcomes28Posted comparisons1ConditionsDiabetes, Diabetes Mellitus, Type 2Armsinsulin degludec, insulin degludec/liraglutide
PMID 33595901other papers from this trial
Open the trial in the graph
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 3 syntheses or guidelines pooled it, 29 citations in OpenAlex.

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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

7 authors at 5 institutions in 2 countries.

Hirotaka WatadaDepartment of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, Tokyo, Japan.ORCID 0000-0001-5961-1816
Shizuka KanekoDivision of Diabetes/Endocrinology/Lifestyle-related Disease, Takatsuki Red Cross Hospital, Takatsuki, Japan.
Mitsuhisa KomatsuDepartment of Diabetes, Endocrinology and Metabolism, Division of Internal Medicine, Shinshu University School of Medicine, Matsumoto, Japan.
Bue Ross AgnerNovo Nordisk A/S, Søborg, Denmark.
Tomoyuki NishidaNovo Nordisk Pharma Ltd, Tokyo, Japan.
Mattis RantheNovo Nordisk A/S, Søborg, Denmark.
Jiro NakamuraDivision of Diabetes, Department of Internal Medicine, Aichi Medical University School of Medicine, Nagakute, Japan.
Novo Nordisk (Denmark) · DKAichi Medical University · JPJuntendo University · JPShinshu University · JPTakatsuki Red Cross Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo investigate the efficacy and safety of insulin degludec/liraglutide (IDegLira) compared with 50 U insulin degludec (degludec) or less in Japanese individuals with type 2 diabetes (T2D). MATERIALS AND

methodsIn this 26-week, double-blind, multicentre, treat-to-target trial, Japanese individuals with T2D that was uncontrolled with basal or pre-mix insulin (20-50 units) were randomized (1:1) to receive IDegLira or degludec, both with metformin. The maximum dose was 50 dose steps (IDegLira) or 50 units (degludec). The primary endpoint was change from baseline in HbA1c with IDegLira vs degludec after 26 weeks of treatment.

resultsIn total, 210 Japanese individuals were randomized to IDegLira or degludec and completion rates were 100% and 93%, respectively. IDegLira was superior to degludec with respect to change from baseline in HbA1c: estimated treatment difference (ETD) (95% confidence interval), -13.98 mmol/Mol (-16.41; -11.55); P < 0.0001. The change in mean HbA1c was from 70.6 by -21.3 mmol/Mol with IDegLira and from 70.1 by -7.1 mmol/Mol with degludec. Mean change in body weight was -0.7 kg with IDegLira and 0.7 kg with degludec: ETD (95% CI) -1.41 kg (-2.26; -0.56); P = 0.0012. Mean daily total insulin dose was significantly lower with IDegLira (37.6 U) as compared to that with degludec (41.2 U) at Week 26. Overall rates of severe or blood glucose-confirmed hypoglycaemia and adverse events were comparable between treatment groups.

conclusionsIDegLira provided superior reductions in HbA1c compared with ≤50 U degludec, with weight loss and similar hypoglycaemia rates and no unexpected safety or tolerability issues. These results suggest that this treatment could be an attractive intensification option for Japanese subjects with T2D that was uncontrolled with basal or pre-mixed insulin.

Indexed as

AgedBlood GlucoseDiabetes Mellitus, Type 2Double-Blind MethodFemaleGlycated HemoglobinHumansHypoglycemic AgentsInsulin, Long-ActingJapanLiraglutideMaleMiddle AgedBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic Agentsinsulin degludecInsulin, Long-ActingLiraglutidebasal insulinhypoglycaemialiraglutiderandomized trialtype 2 diabetes

Identifiers

PMID31423685
PMCPMC6900157
OpenAlexW2969317099

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC
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 Socratic graph.