Evidence map›Paper›PMID 28921919›Full record

ArticleJournal of diabetes investigation2017

Oral glucose lowering with linagliptin and metformin compared with linagliptin alone as initial treatment in Asian patients with newly diagnosed type 2 diabetes and marked hyperglycemia: Subgroup analysis of a randomized clinical trial.

Ronald Cw Ma, Stefano Del Prato, Baptist Gallwitz, Vyankatesh K Shivane, Diane Lewis-D'Agostino, Zelie Bailes, Sanjay Patel, Jisoo Lee, Maximilian von Eynatten, Maximiliano Di Domenico and 1 more

Open access · goldAbstract read
In one paragraph

Article in Journal of diabetes investigation, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 19% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Article
  6. Dipeptidyl Peptidase-4 at the Interface Between Inflammation and Metabolism.Clinical medicine insights. Endocrinology and diabetes · 2020
    Review
  7. Review
  8. Review
  9. Observational
  10. 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

11 authors at 8 institutions in 8 countries.

Ronald Cw MaDepartment of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China.ORCID http://orcid.org/0000-0002-1227-803X
Stefano Del PratoSection of Diabetes, Department of Endocrinology and Metabolism, University of Pisa, Pisa, Italy.
Baptist GallwitzDepartment of Medicine IV, University Hospital Tübingen, Tübingen, Germany.
Vyankatesh K ShivaneDepartment of Endocrinology, Seth G. S. Medical College and KEM Hospital, Mumbai, India.
Diane Lewis-D'AgostinoBoehringer Ingelheim Pharmaceuticals Inc., Connecticut, USA.
Zelie BailesBoehringer Ingelheim Ltd, Bracknell, UK.
Sanjay PatelBoehringer Ingelheim Ltd, Bracknell, UK.
Jisoo LeeBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
Maximilian von EynattenBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
Maximiliano Di DomenicoBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
Stuart A RossUniversity of Calgary, LMC Endocrinology Centers, Alberta, Canada.
Boehringer Ingelheim (Germany) · DEBoehringer Ingelheim (United Kingdom) · GBBoehringer Ingelheim (Brazil) · BRChinese University of Hong Kong · HKKing Edward Memorial Hospital and Seth G.S. Medical College · INUniversity Children's Hospital Tübingen · DEUniversity of Calgary · CAUniversity of Pisa · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

AIMS/

introductionType 2 diabetes mellitus is an epidemic in Asia, yet clinical trials of glucose-lowering therapies often enroll predominantly Western populations. We explored the initial combination of metformin and linagliptin, a dipeptidyl peptidase-4 inhibitor, in newly diagnosed type 2 diabetes mellitus patients in Asia with marked hyperglycemia. MATERIALS AND

methodsThis was a post-hoc subgroup analysis of a multinational, parallel-group clinical trial in which 316 newly diagnosed type 2 diabetes mellitus patients with glycated hemoglobin A1c (HbA1c) 8.5-12.0% were randomized to double-blind oral treatment with linagliptin/metformin or linagliptin monotherapy. The primary end-point was the change from baseline in HbA1c at week 24. We evaluated data for the 125 participants from Asian countries.

resultsAfter 24 weeks, the mean ± standard error reduction from baseline in HbA1c (mean 10.0%) was -2.99 ± 0.18% with linagliptin/metformin and -1.84 ± 0.18% with linagliptin; a treatment difference of -1.15% (95% confidence interval -1.65 to -0.66, P < 0.0001). HbA1c <7.0% was achieved by 60% of participants receiving linagliptin/metformin. The mean bodyweight change after 24 weeks was -0.45 ± 0.41 kg and 1.33 ± 0.45 kg in the linagliptin/metformin and linagliptin groups, respectively (treatment difference -1.78 kg [95% confidence interval -2.99 to -0.57, P = 0.0043]). Drug-related adverse events occurred in 9.7% of participants receiving linagliptin/metformin and 4.8% of those receiving linagliptin. Hypoglycemia occurred in 6.5% and 4.8% of the linagliptin/metformin and linagliptin groups, respectively, with no severe episodes. Gastrointestinal disorders occurred in 12.9% and 12.7% of the linagliptin/metformin and linagliptin groups, respectively, with no associated treatment discontinuations.

conclusionsIn people from Asia with newly diagnosed type 2 diabetes mellitus and marked hyperglycemia, the initial combination of linagliptin and metformin substantially improved glycemic control without weight gain and with infrequent hypoglycemia. Initial oral combination therapy might be a viable treatment for such individuals.

Indexed as

AsiaDiabetes mellitus type 2Dipeptidyl peptidase-4 inhibitors

Identifiers

PMID28921919
PMCPMC5934255
OpenAlexW2756246648

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.