Trial reportDiabetes, obesity & metabolism2017

Efficacy and safety of gemigliptin, a dipeptidyl peptidase-4 inhibitor, in patients with type 2 diabetes mellitus inadequately controlled with combination treatment of metformin and sulphonylurea: a 24-week, multicentre, randomized, double-blind, placebo-controlled study (TROICA study).

Chang Ho Ahn, Kyung Ah Han, Jae Myung Yu, Joo Young Nam, Kyu Jeung Ahn, Tae Keun Oh, Hyoung Woo Lee, Dae Ho Lee, Jaetaek Kim, Choon Hee Chung and 12 more

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2017. The graph read 4 numbers from its abstract, feeding 6 cells of the map: it supports the treatment in 6. Cited by 9 papers, 3 of them syntheses that pooled it.

4numbers the graph read from it
6cells of the map it votes in
9citing papers in PubMed, 3 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.

← favours the treatmentfavours the comparator →
-1.500 · no effect
Total cholesterolgemigliptin added to metformin and glimepiride vs placebo added to metformin and glimepiridefavours the treatment · t2dfeeds 3 cells of the map
Δ -0.21-0.38 to -0.03
Total cholesterol and LDL cholesterol were modestly but significantly reduced in the gemigliptin group compared with the placebo group (-0.21 mmol/L, 95% CI -0.38 to -0.03 mmol/L for total cholesterol, -0.18 mmol/L, 95% CI -0.34 to -0.01 mmol/L for LDL cholesterol).
LDL cholesterolgemigliptin added to metformin and glimepiride vs placebo added to metformin and glimepiridefavours the treatment · t2dfeeds 3 cells of the map
Δ -0.18-0.34 to -0.01
Total cholesterol and LDL cholesterol were modestly but significantly reduced in the gemigliptin group compared with the placebo group (-0.21 mmol/L, 95% CI -0.38 to -0.03 mmol/L for total cholesterol, -0.18 mmol/L, 95% CI -0.34 to -0.01 mmol/L for LDL cholesterol).
HbA1c levelgemigliptin added to metformin and glimepiride vs placebo added to metformin and glimepiridefavours the treatment · t2dfeeds 3 cells of the map
Δ -0.87-1.09 to -0.64
The addition of gemigliptin to metformin and glimepiride significantly reduced HbA1c levels at week 24 compared with placebo (between-group difference in adjusted mean change -0.87%, 95% confidence interval [CI] -1.09% to -0.64%).
Fasting plasma glucose levelgemigliptin added to metformin and glimepiride vs placebo added to metformin and glimepiridefavours the treatment · t2dfeeds 3 cells of the map
Δ -0.93-1.50 to -0.35
Fasting plasma glucose level was also significantly reduced with gemigliptin (-0.93 mmol/L, 95% CI -1.50 to -0.35 mmol/L), and a higher proportion of participants achieved an HbA1c level of <7% (39.3% vs 5.5%; P <.001) in the gemigliptin group than in the placebo group.

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×lipids

SupportsOpen on the map →What to test next →

9 readable studies in this cell: 2 favour the treatment, 5 find no difference, 2 favour the comparator.

Belief with this paper
1.00replicated · 2 families support, 0 contradict · against placebo
Without it
0.50This paper moves it by +0.50. It would be one trial.
← favours the treatmentfavours the comparator →
0 · no effect
This paper · 2017
Δ -0.21-0.38 to -0.03
NCT011066771,284 enrolled · 2010
Δ 2.30-3.90 to 8.50
NCT00676338820 enrolled · 2008
Δ -0.22-0.41 to -0.03
NCT00432276803 enrolled · 2007
Δ -4.20-8.60 to 0.10
NCT01137812756 enrolled · 2010
Δ -2.30-9.80 to 5.30
NCT01106690344 enrolled · 2010
Δ -12.1-12.1 to -0.90
NCT01678820299 enrolled · 2012
Δ 0.40-4.80 to 5.60
NCT0220216170 enrolled · 2014
Δ 0.970.90 to 1.05
decrease -0.10

DPP-4 inhibitors×glycemic control

SupportsOpen on the map →What to test next →

40 readable studies in this cell: 59 favour the treatment, 19 find no difference, 24 favour the comparator.

Belief with this paper
0.82replicated · 56 families support, 12 contradict · against placebo
Without it
0.82This paper does not move the number.
← favours the treatmentfavours the comparator →
0 · no effect
This paper · 2017
Δ -0.87-1.09 to -0.64
NCT015282542,004 enrolled · 2012
Slope -0.02-0.05 to 0.00
NCT026078651,864 enrolled · 2016
Δ -0.50-0.60 to -0.40
NCT001216671,462 enrolled · 2005
Δ -0.73-0.92 to -0.53
NCT040178321,441 enrolled · 2019
Δ -0.20-0.30 to -0.10
NCT011066771,284 enrolled · 2010
Δ -0.62-0.76 to -0.48
NCT016060071,282 enrolled · 2012
Δ -0.27-0.48 to -0.05
NCT004827291,246 enrolled · 2007
Δ -0.60-0.78 to -0.43
NCT020991101,233 enrolled · 2014
Δ -0.46-0.63 to -0.30
NCT019301881,231 enrolled · 2013
Δ -1.06-1.21 to -0.91
NCT007344741,202 enrolled · 2008
Δ -0.71-0.87 to -0.55
NCT022730501,136 enrolled · 2014
Δ -0.21-0.41 to -0.02
NCT004499301,050 enrolled · 2007
Δ 0.140.06 to 0.21

Metformin×lipids

SupportsOpen on the map →What to test next →

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

Belief with this paper
0.50contested · 3 families support, 1 contradict · against placebo
Without it
0.50This paper does not move the number.
← favours the treatmentfavours the comparator →
0 · no effect
This paper · 2017
Δ -0.21-0.38 to -0.03
NCT00676338820 enrolled · 2008
Δ -0.01-0.18 to 0.15
NCT00386100688 enrolled · 2006
Δ -11.3-20.6 to -0.90
NCT00727857600 enrolled · 2007
Δ 23.4-44.6 to 91.4
NCT00868790118 enrolled · 2009
Δ -3.90-10.2 to 2.30
NCT0158944577 enrolled · 2008
Δ -9.06-88.0 to 118

Metformin×glycemic control

SupportsOpen on the map →What to test next →

40 readable studies in this cell: 41 favour the treatment, 13 find no difference, 7 favour the comparator.

Belief with this paper
0.84replicated · 32 families support, 6 contradict · against placebo
Without it
0.84This paper does not move the number.
← favours the treatmentfavours the comparator →
0 · no effect
This paper · 2017
Δ -0.87-1.09 to -0.64
NCT017190031,413 enrolled · 2012
Adjusted mean -0.72-0.95 to -0.48
NCT018093271,186 enrolled · 2013
Δ -0.40-0.59 to -0.21
NCT022730501,136 enrolled · 2014
Δ -0.89-1.08 to -0.69
NCT008598981,093 enrolled · 2009
Δ -0.53-0.74 to -0.32
Δ -0.85-43.8 to 26.7
NCT00643851994 enrolled · 2008
Δ -0.86-1.11 to -0.62
NCT01708902876 enrolled · 2012
Δ -1.00-1.23 to -0.78
NCT00676338820 enrolled · 2008
Δ -0.05-0.26 to 0.17
NCT01126580807 enrolled · 2010
Δ -0.22-0.36 to -0.08
NCT01023581784 enrolled · 2009
Δ -0.67-0.96 to -0.37
NCT01076088744 enrolled · 2010
Δ -0.84-1.15 to -0.52
NCT00386100688 enrolled · 2006
Δ -0.49-0.67 to -0.30

Sulfonylureas & glinides×lipids

SupportsOpen on the map →What to test next →

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

Belief with this paper
0.50one trial · 1 family supports, 0 contradict · against placebo
Without it
0.25This paper moves it by +0.25. It would be no deciding trial.
← favours the treatmentfavours the comparator →
0 · no effect
This paper · 2017
Δ -0.21-0.38 to -0.03
NCT00770653305 enrolled · 2007
Δ 3.271.23 to 5.31
NCT0062028249 enrolled · 2008
Least squares mean 1.91-13.2 to 17.0

Sulfonylureas & glinides×glycemic control

SupportsOpen on the map →What to test next →

31 readable studies in this cell: 7 favour the treatment, 13 find no difference, 11 favour the comparator.

Belief with this paper
0.83established · 5 families support, 1 contradict · against placebo
Without it
0.80This paper moves it by +0.03.
← favours the treatmentfavours the comparator →
0 · no effect
This paper · 2017
Δ -0.87-1.09 to -0.64
NCT017093055,570 enrolled · 2012
Δ 0.190.02 to 0.36
NCT009688121,452 enrolled · 2009
Δ -0.01-0.11 to 0.09
NCT006609071,217 enrolled · 2008
Δ 0.00-0.11 to 0.11
NCT003184611,091 enrolled · 2006
Δ -0.02-0.19 to 0.15
NCT008389031,049 enrolled · 2009
Δ -0.27-0.45 to -0.09
Δ 0.640.33 to 0.95
NCT03332771954 enrolled · 2017
Δ 0.12-0.12 to 0.36
NCT02471404939 enrolled · 2015
Δ 0.160.03 to 0.30
NCT00614120929 enrolled · 2008
Δ -0.06-0.23 to 0.11
NCT00575588891 enrolled · 2007
Δ 0.06-0.05 to 0.16
NCT01682759751 enrolled · 2012
Δ 0.180.06 to 0.30
NCT00294723746 enrolled · 2006
Δ -0.62-0.83 to -0.42
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.

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

5 · Its place in the literature

Who cites it

9 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Metformin for the Treatment of Type 2 Diabetes in Asian Adults: A Systematic Review.Diabetes, metabolic syndrome and obesity : targets and therapy · 2025
    Review
  7. Review
  8. Review
  9. Gemigliptin: Newer Promising Gliptin for Type 2 Diabetes Mellitus.Indian journal of endocrinology and metabolism
    Review
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

22 authors.

Chang Ho AhnDepartment of Internal Medicine, Seoul National University Hospital, Seoul, Korea.
Kyung Ah HanDepartment of Internal Medicine, Eulji General Hospital, Seoul, Korea.
Jae Myung YuDepartment of Internal Medicine, Hallym University Kangnam Sacred Heart Hospital, Seoul, Korea.
Joo Young NamDepartment of Internal Medicine, National Health Insurance Service Ilsan Hospital, Goyang, Korea.
Kyu Jeung AhnDepartment of Endocrinology and Metabolism, Kyung Hee University Hospital at Gangdong, Seoul, Korea.
Tae Keun OhDepartment of Internal Medicine, Chungbuk National University Hospital, Cheongju, Korea.
Hyoung Woo LeeDepartment of Internal Medicine, Yeungnam University Medical Centre, Daegu, Korea.
Dae Ho LeeDepartment of Internal Medicine, Wonkwang University School of Medicine and Hospital, Iksan, Korea.
Jaetaek KimDepartment of Internal Medicine, Chung-Ang University Hospital, Seoul, Korea.
Choon Hee ChungDepartment of Internal Medicine, Yonsei University Wonju Severance Christian Hospital, Wonju, Korea.
Tae Sun ParkDepartment of Internal Medicine, Chonbuk National University Hospital, Jeonju, Korea.
Byung Joon KimDepartment of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea.
Seok Won ParkDepartment of Internal Medicine, CHA Bundang Medical Center, Seongnam, Korea.
Hyeong Kyu ParkDepartment of Internal Medicine, Soonchunhyang University Hospital, Seoul, Korea.
Kwang Jae LeeDepartment of Internal Medicine, Daedong General Hospital, Busan, Korea.
Sang-Wook KimDepartment of Internal Medicine, Kangwon National University Hospital, Chuncheon, Korea.
Jeong Hyun ParkDepartment of Internal Medicine, Inje University Busan Paik Hospital, Busan, Korea.
Kwan Pyo KoDepartment of Internal Medicine, Jeju National University Hospital, Jeju, Korea.
Chong Hwa KimDepartment of Internal Medicine, Sejong General Hospital, Bucheon, Korea.
Hyunjin LeeLG Life Sciences, Seoul, Korea.
Hak Chul JangDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Kyong Soo ParkDepartment of Internal Medicine, Seoul National University Hospital, Seoul, Korea.

Funding

No grant is acknowledged in the PubMed record.

8 · The paper itself

Abstract

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

aimsTo assess the efficacy and safety of gemigliptin, a dipeptidyl peptidase-4 inhibitor, added to metformin and sulphonylurea in patients with type 2 diabetes (T2DM). MATERIALS AND

methodsWe conducted a randomized, double-blind, placebo-controlled trial in 219 Korean patients inadequately controlled with metformin and glimepiride. Participants were randomized to gemigliptin 50 mg once daily or placebo added to metformin and glimepiride. The primary endpoint was change in glycated haemoglobin (HbA1c) level from baseline to week 24.

resultsThe baseline HbA1c was 8.2% in both groups. The addition of gemigliptin to metformin and glimepiride significantly reduced HbA1c levels at week 24 compared with placebo (between-group difference in adjusted mean change -0.87%, 95% confidence interval [CI] -1.09% to -0.64%). Fasting plasma glucose level was also significantly reduced with gemigliptin (-0.93 mmol/L, 95% CI -1.50 to -0.35 mmol/L), and a higher proportion of participants achieved an HbA1c level of <7% (39.3% vs 5.5%; P <.001) in the gemigliptin group than in the placebo group. Total cholesterol and LDL cholesterol were modestly but significantly reduced in the gemigliptin group compared with the placebo group (-0.21 mmol/L, 95% CI -0.38 to -0.03 mmol/L for total cholesterol, -0.18 mmol/L, 95% CI -0.34 to -0.01 mmol/L for LDL cholesterol). The incidence of hypoglycaemia was 9.4% in the gemigliptin group and 2.7% in the placebo group.

conclusionsGemigliptin significantly improved glycaemic control in patients with T2DM inadequately controlled with metformin and sulphonylurea. The incidence of hypoglycaemia was higher with gemigliptin than with placebo, which highlights the importance of optimal dose adjustment for sulphonylurea.

Indexed as

Drug ResistanceAgedDiabetes Mellitus, Type 2Dipeptidyl-Peptidase IV InhibitorsDouble-Blind MethodDrug MonitoringDrug Therapy, CombinationFemaleGlycated HemoglobinHumansHyperglycemiaHypoglycemiaHypoglycemic AgentsIncidenceMaleMetforminDipeptidyl-Peptidase IV InhibitorsGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsLC15-0444MetforminPiperidonesPyrimidinesSulfonylurea Compoundsclinical trialDPP-4 inhibitorphase III study

Identifiers

PMID28026912

What Socratic holds

Texttitle and abstract
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.