Evidence mapPaperPMID 35917580Full record

Trial reportThe Journal of clinical endocrinology and metabolism2022

A Randomized Controlled Trial of R-Form Verapamil Added to Ongoing Metformin Therapy in Patients with Type 2 Diabetes.

Chih-Yuan Wang, Kuo-Chin Huang, Chia-Wen Lu, Chih-Hsun Chu, Chien-Ning Huang, Harn-Shen Chen, I-Te Lee, Jung-Fu Chen, Ching-Chu Chen, Chung-Sen Chen and 9 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
4.1field-weighted citation impact, top 5% 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

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Review
  6. Article
  7. Article
  8. Review
  9. Review
  10. Toward better diabetes care: Exploration and implementation.Journal of diabetes investigation · 2023
    Review
  11. Review
  12. Article
  13. 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

19 authors at 12 institutions in 1 country.

Chih-Yuan WangDivision of Endocrinology and Metabolism, Department of Internal Medicine, National Taiwan University Hospital, Taipei 100229, Taiwan.
Kuo-Chin HuangDepartment of Family Medicine, National Taiwan University Hospital, Taipei 100229, Taiwan.
Chia-Wen LuDepartment of Family Medicine, National Taiwan University Hospital, Taipei 100229, Taiwan.
Chih-Hsun ChuDivision of Endocrinology and Metabolism, Department of Internal Medicine, Kaohsiung Veterans General Hospital, Kaohsiung 813414, Taiwan.
Chien-Ning HuangInstitute of Medicine, Chung Shan Medical University & Hospital, Taichung 402306, Taiwan.
Harn-Shen ChenDivision of Endocrinology and Metabolism, Department of Medicine, Taipei Veterans General Hospital, Taipei 112201, Taiwan.
I-Te LeeDivision of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung 407219, Taiwan.
Jung-Fu ChenDivision of Metabolism, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung 833401, Taiwan.
Ching-Chu ChenDivision of Endocrinology and Metabolism, Department of Medicine, China Medical University Hospital, Taichung 404332, Taiwan.
Chung-Sen ChenDivision of Endocrinology and Metabolism, Department of Internal Medicine, Taipei City Hospital Zhongxiao Branch, Taipei 115006, Taiwan.
Chang-Hsun HsiehDivision of Endocrinology and Metabolism, Department of Internal Medicine, Tri-Service General Hospital, Taipei 114202, Taiwan.
Kai-Jen TienDivision of Endocrinology and Metabolism, Department of Internal Medicine, Chi Mei Medical Center, Tainan 710402, Taiwan.
Hung-Yu ChienDepartment of Endocrinology and Metabolism, Taipei City Hospital Renai Branch, Taipei 106243, Taiwan.
Yu-Yao HuangDivision of Endocrinology and Metabolism, Department of Internal Medicine, Chang Gung Memorial Hospital, Taoyuan 333423, Taiwan.
Jui-Pao HsuCenter Laboratories Inc., Taipei 115603, Taiwan.
Guang-Tzuu ShaneCenter Laboratories Inc., Taipei 115603, Taiwan.
Ai-Ching ChangLumosa Therapeutics Co., Ltd., Taipei 115603, Taiwan.
Yen-Chieh WuLumosa Therapeutics Co., Ltd., Taipei 115603, Taiwan.ORCID 0000-0002-9143-6533
Wayne Huey-Herng SheuDivision of Endocrinology and Metabolism, Department of Medicine, Taipei Veterans General Hospital, Taipei 112201, Taiwan.ORCID 0000-0002-8805-8340
National Taiwan University Hospital · TWChina Medical University · TWChang Gung Memorial Hospital · TWChang Gung University · TWChi Mei Medical Center · TWChung Shan Medical University Hospital · TWKaohsiung Veterans General Hospital · TWNational Yang Ming Chiao Tung University · TWTaichung Veterans General Hospital · TWTaipei City Hospital · TWTaipei Veterans General Hospital · TWTri-Service General Hospital · TW

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

contextThere is a medical need for effective insulin-independent antidiabetic drugs that can promote pancreatic β-cell function and have a low risk of hypoglycemia in type 2 diabetes mellitus (T2DM) patients. R-form verapamil (R-Vera), which is able to enhance the survival of β-cells and has higher cardiovascular safety margin compared with racemic verapamil, was developed as a novel approach for T2DM treatment.

objectiveThis randomized, double-blind, placebo-controlled clinical trial was designed to evaluate the efficacy and safety of 3 dosages of R-Vera added to ongoing metformin therapy in T2DM patients who had inadequate glycemic control on metformin alone.

methodsParticipants were randomly assigned in an equal ratio to receive R-Vera 450, 300, or 150 mg per day, or matching placebo, in combination with metformin. The primary endpoint was change in hemoglobin A1c (HbA1c) after 12 weeks of treatment.

resultsA total of 184 eligible participants were randomized to receive either R-Vera or placebo plus metformin. At week 12, significant reductions in HbA1c were observed for R-Vera 300 mg/day (-0.36, P = 0.0373) and 450 mg/day (-0.45, P = 0.0098) compared with placebo. The reduction in HbA1c correlated with decreasing fasting plasma glucose levels and improved HOMA2-β score. Treatment with R-Vera was well tolerated with no hypoglycemic episodes occurring during the trial.

conclusionAddition of R-Vera twice daily to ongoing metformin therapy significantly improved glycemic control in T2DM patients. The favorable efficacy and safety profile of R-Vera 300 mg/day can be considered as the appropriate dose for clinical practice.

Indexed as

Diabetes Mellitus, Type 2HypoglycemiaMetforminBlood GlucoseDouble-Blind MethodDrug Therapy, CombinationGlycated HemoglobinHumansHypoglycemic AgentsInsulinTreatment OutcomeVerapamilBlood GlucoseGlycated HemoglobinHypoglycemic AgentsInsulinMetforminVerapamilantidiabetic drugHbA1cmetforminR-form verapamiltype 2 diabetes

Identifiers

PMID35917580
PMCPMC9516171
OpenAlexW4289522373

What Socratic holds

Texttitle and abstract
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 Socratic graph.