Trial reportDiabetes, obesity & metabolism2019

Comparative effect of saxagliptin and glimepiride with a composite endpoint of adequate glycaemic control without hypoglycaemia and without weight gain in patients uncontrolled with metformin therapy: Results from the SPECIFY study, a 48-week, multi-centre, randomized, controlled trial.

Tianwei Gu, Jianhua Ma, Qiu Zhang, Liangying Zhu, Hong Zhang, Lan Xu, Jinluo Cheng, Bimin Shi, Dongmei Li, Jiaqing Shao and 4 more

Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2019. The graph read 1 number from its abstract, feeding 3 cells of the map: it supports the treatment in 3. It is linked to trial NCT02280486 (Efficacy and Safety of Saxagliptin and Glimepiride in Chinese Patients With Type 2 Diabetes Controlled Inadequately With Metformin Monotherapy), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

1number the graph read from it
3cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 35% 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.

← favours the comparatorfavours the treatment →
21 · no effect
Cardiovascular eventsfavours the treatment · against placebo · obesity, t2dfeeds 3 cells of the map
OR 1.381.05 to 1.82P = 0.019
RESULTS: Over 48 weeks, a greater proportion of patients achieved the primary endpoint with saxagliptin compared with glimepiride (43.3% vs 31.3%; odds ratio, 1.38, 95% CI, 1.05-1.82; P = 0.019), especially among patients with baseline HbA1c <8.0%, duration <5 years or baseline BMI ≥25 kg/m CONCLUSIONS: This study provides evidence that, compared to glimepiride, saxagliptin more effectively achieves a composite endpoint of adequate glycaemic control without hypoglycaemia and without weight gain in T2D patients who are inadequately controlled with metformin monotherapy, especially in overweight patients with moderate hyperglycaemia and a relatively short duration of diabetes.

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

DPP-4 inhibitors×cardiovascular events

SupportsOpen on the map →What to test next →

3 readable studies in this cell: 2 favour the treatment, 1 find no difference, 0 favour the comparator.

Belief with this paper
0.99replicated · 2 families support, 0 contradict · against placebo
Without it
0.50This paper moves it by +0.49. It would be one trial.
← favours the comparatorfavours the treatment →
1 · no effect
This paper · 2019
OR 1.381.05 to 1.82
NCT01438814689 enrolled · 2011
OR 0.960.67 to 1.37

Metformin×cardiovascular events

SupportsOpen on the map →What to test next →

5 readable studies in this cell: 4 favour the treatment, 1 find no difference, 0 favour the comparator.

Belief with this paper
0.50contested · 4 families support, 2 contradict · against placebo
Without it
0.50This paper does not move the number.
← favours the comparatorfavours the treatment →
1 · no effect
This paper · 2019
OR 1.381.05 to 1.82

Sulfonylureas & glinides×cardiovascular events

SupportsOpen on the map →What to test next →

3 readable studies in this cell: 2 favour the treatment, 1 find no difference, 0 favour the comparator.

Belief with this paper
0.96replicated · 2 families support, 0 contradict · against placebo
Without it
0.50This paper moves it by +0.46. It would be one trial.
← favours the comparatorfavours the treatment →
1 · no effect
This paper · 2019
OR 1.381.05 to 1.82
4 · 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.

NCT02280486 phase4completednot on this map

Efficacy and Safety of Saxagliptin and Glimepiride in Chinese Patients With Type 2 Diabetes Controlled Inadequately With Metformin Monotherapy (SPECIFY Study) : a 48-week, Multi-center, Randomized, Open-label Trial

TypeinterventionalSponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolRan2015 to 2017Enrolled388ConditionsType 2 DiabetesArmsSaxagliptin, Glimepiride
5 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
6 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

7 · Who and what money

Authors and funding

14 authors at 11 institutions in 1 country.

Tianwei GuDepartment of Endocrinology, Drum Tower Hospital Affiliated to Nanjing University Medical School, Nanjing, China.ORCID 0000-0002-2320-5100
Jianhua MaDepartment of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.
Qiu ZhangDepartment of Endocrinology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.
Liangying ZhuDepartment of Endocrinology, Drum Tower Hospital Affiliated to Nanjing University Medical School, Nanjing, China.
Hong ZhangDepartment of Endocrinology, Huai'an First People's Hospital, Huai'an, China.
Lan XuDepartment of Endocrinology, Wuxi First People's Hospital, Wuxi, China.
Jinluo ChengDepartment of Endocrinology, Changzhou Second People's Hospital affiliated to Nanjing Medical University, Changzhou, China.
Bimin ShiDepartment of Endocrinology, The First Affiliated Hospital of Soochow University, Suzhou, China.
Dongmei LiDepartment of Endocrinology, Nanjing Pukou District Central Hospital, Nanjing, China.
Jiaqing ShaoDepartment of Endocrinology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.
Zilin SunDepartment of Endocrinology, Zhongda Hospital, Institute of Diabetes, School of Medicine, Southeast University, Nanjing, China.
Shao ZhongDepartment of Endocrinology, Kunshan First People's Hospital, Suzhou, China.
Yan BiDepartment of Endocrinology, Drum Tower Hospital Affiliated to Nanjing University Medical School, Nanjing, China.ORCID 0000-0003-3914-7854
Dalong ZhuDepartment of Endocrinology, Drum Tower Hospital Affiliated to Nanjing University Medical School, Nanjing, China.
Nanjing Drum Tower Hospital · CNAnhui Medical University · CNChangzhou No.2 People's Hospital · CNHuaian First People’s Hospital · CNJiangsu Province Hospital · CNJiangsu University · CNNanjing General Hospital of Nanjing Military Command · CNNanjing Medical University · CNSoochow University · CNWuxi People's Hospital · CNZhongda Hospital Southeast University · CN

Funding

AstraZeneca
8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

aimsTo compare the efficacy and safety of saxagliptin and glimepiride in type 2 diabetes (T2D) patients who are inadequately controlled with metformin monotherapy. MATERIALS AND

methodsIn this 48-week, multi-centre, open-label, randomized, parallel trial (NCT02280486, clinicaltrials.gov), a total of 388 T2D patients were randomized 1:1 to saxagliptin or glimepiride groups. The primary endpoint was achievement of HbA1c <7.0%, without hypoglycaemia, defined as blood glucose <3.9 mmol/L and weight gain <3.0% after 48 weeks of treatment.

resultsOver 48 weeks, a greater proportion of patients achieved the primary endpoint with saxagliptin compared with glimepiride (43.3% vs 31.3%; odds ratio, 1.38, 95% CI, 1.05-1.82; P = 0.019), especially among patients with baseline HbA1c <8.0%, duration <5 years or baseline BMI ≥25 kg/m

conclusionsThis study provides evidence that, compared to glimepiride, saxagliptin more effectively achieves a composite endpoint of adequate glycaemic control without hypoglycaemia and without weight gain in T2D patients who are inadequately controlled with metformin monotherapy, especially in overweight patients with moderate hyperglycaemia and a relatively short duration of diabetes.

Indexed as

AdamantaneAdultAgedBlood GlucoseBody WeightDiabetes Mellitus, Type 2DipeptidesFemaleGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsInsulin ResistanceInsulin-Secreting CellsInsulin SecretionMaleAdamantaneBlood GlucoseDipeptidesglimepirideGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsMetforminsaxagliptinSulfonylurea CompoundsDPP-IV inhibitorrandomized trialsulfonylureatype 2 diabetes

Identifiers

PMID30520221
OpenAlexW2904482309

What Socratic holds

Texttitle and abstract
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.