Evidence mapPaperPMID 38738005Full record

ArticleCureus2024

Evaluating the Efficacy, Safety, and Tolerability of Combination Therapy of Dapagliflozin and Linagliptin Over Dapagliflozin and Vildagliptin in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin.

Mala Dharmalingam, Surendra Kumar Sharma, Ved Prakash, Animesh Maiti, Ritesh Kumar, Laxminarayanappa Sreenivasa S Murthy, Balamurugan Ramanathan, Sanjiv Maheshwari, Sunil Naik Kethavath, Dhananjay Ogale and 6 more

Abstract read
In one paragraph

Article in Cureus, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

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

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

  1. Guideline
  2. Article
  3. Article
  4. 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

16 authors.

Mala DharmalingamEndocrinology and Diabetes, Bangalore Endocrinology and Diabetes Research Centre, Bengaluru, IND.
Surendra Kumar SharmaDiabetes and Endocrinology, Thyroid and Endocrine Centre, Jaipur, IND.
Ved PrakashEndocrinology, Indira Gandhi Institute of Medical Sciences, Patna, IND.
Animesh MaitiMedicine, Kolkata Medical College, Kolkata, IND.
Ritesh KumarEndocrinology, Diabetes and Metabolism, Institute of Medical Sciences, Banaras Hindu University, Varanasi, IND.
Laxminarayanappa Sreenivasa S MurthyMedicine, Life Care Hospital and Research Centre, Bengaluru, IND.
Balamurugan RamanathanDiabetes and Endocrinology, Kovai Diabetes Specialty Centre, Coimbatore, IND.
Sanjiv MaheshwariMedicine, Jawaharlal Nehru Medical College, Ajmer, IND.
Sunil Naik KethavathMedicine, Government Medical College, Srikakulam, IND.
Dhananjay OgaleMedicine, Byramjee Jeejeebhoy Medical College, Pune, IND.
Prajapati Vipul Kumar BachubhaiInternal Medicine, GCS Medical College, Ahmedabad, IND.
Ashutosh B SonawaneMedicine, Vakratunda Hospital, Nashik, IND.
Vaishal ShahMedicine, Lifeline Multispeciality Hospital, Mumbai, IND.
Manjula SureshMedical Services, Micro Labs Limited, Bengaluru, IND.
Sisir ChakrabortyMedicine, Sagore Dutta Hospital, Kolkata, IND.
Krishna Kumar ManjunathMedical Services, Micro Labs Limited, Bengaluru, IND.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background Type 2 diabetes mellitus (T2DM) patients commonly undergo metformin monotherapy. This study aims to compare the efficacy, safety, and tolerability of combination therapy of dapagliflozin plus linagliptin versus dapagliflozin plus vildagliptin as add-on therapy in T2DM patients inadequately controlled on metformin. Methodology This was an 18-week, multicenter, randomized, double-blind, active-controlled, parallel-group, phase III clinical study. About 236 participants were randomly assigned to receive either a fixed-dose combination of dapagliflozin 10 mg plus linagliptin 5 mg tablets or a fixed-dose combination of dapagliflozin 10 mg plus vildagliptin SR 100 mg tablets added to metformin monotherapy. The primary outcome was the mean change in hemoglobin A1c (HbA1c) from baseline to the end of week 16. The key secondary endpoints were mean change in postprandial blood glucose (PPBG), fasting blood glucose (FBG), body weight, and the proportion of participants achieving HbA1c less than 7.0%. Results The dapagliflozin/linagliptin combination therapy showed a more significant change in HbA1c from baseline to the end of 16 weeks (mean reduction: -1.59% vs. -1.25%) compared to dapagliflozin/vildagliptin (p < 0.0001). Additionally, compared to the dapagliflozin/vildagliptin group, the dapagliflozin/linagliptin group demonstrated a significant reduction in both PPBG (mean reduction: -59.99 mg/dL vs. -55.34 mg/dL) and FPG (mean reduction: -32.91 mg/dL vs. -26.78 mg/dL). A total of 18 adverse events were reported in 17 (7.20%) participants, all of which were mild and resolved completely. There were no serious adverse events. Conclusions Compared to dapagliflozin and vildagliptin combination therapy, dapagliflozin and linagliptin fixed-dose combination provided clinically significant improvements in glycemic control. Because of its effectiveness, safety, and tolerability, the fixed-dose combination of dapagliflozin and linagliptin was a better option for treating T2DM patients who had previously only received metformin monotherapy.

Indexed as

dapagliflozinglycemic controllinagliptinmetformintype 2 diabetes mellitusvildagliptin

Identifiers

PMID38738005
PMCPMC11088817

What Socratic holds

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LicenceCC BY
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.