Evidence map›DPP-4 inhibitors × body weight & composition›PMID 18201203›Full record

Trial reportDiabetes, obesity & metabolism2008

Efficacy and safety of sitagliptin when added to ongoing metformin therapy in patients with type 2 diabetes.

R Scott, T Loeys, M J Davies, S S Engel, Sitagliptin Study 801 Group

3 registry-linked trialsAbstract readComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2008. The graph read 1 number from its abstract, feeding 2 cells of the map: it favours the comparator in 2. It reports registered trial NCT00541775. Cited by 88 papers, 20 of them syntheses that pooled it.

1number the graph read from it
2cells of the map it votes in
88citing papers in PubMed, 20 pooled it
19.0field-weighted citation impact, top 1% 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 treatmentfavours the comparator →
2.500 · no effect
Body weight & compositionfavours the comparator · against placebo · obesity, dyslipidemiafeeds 2 cells of the map
Δ 1.901.30 to 2.50
The difference in body weight between the sitagliptin and rosiglitazone groups was 1.9 kg (95% CI: 1.3-2.5).
FeedsDPP-4 inhibitors×body weight & compositionThiazolidinediones×body weight & composition

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×body weight & composition

ContradictsOpen on the map →What to test next →

29 readable studies in this cell: 8 favour the treatment, 8 find no difference, 13 favour the comparator.

Belief with this paper
0.50contested · 4 families support, 4 contradict · against placebo
Without it
0.50This paper does not move the number.
← favours the treatmentfavours the comparator →
0 · no effect
This paper · 2008
Δ 1.901.30 to 2.50
NCT026078651,864 enrolled · 2016
Δ -2.50-3.00 to -2.00
NCT011066771,284 enrolled · 2010
Δ -2.40-3.00 to -1.80
NCT007344741,202 enrolled · 2008
Δ -1.70-2.27 to -1.14
NCT007010901,035 enrolled · 2008
Δ -2.00-2.30 to -1.60
NCT00575588891 enrolled · 2007
Δ -2.20-2.70 to -1.70
NCT00676338820 enrolled · 2008
Δ -1.28-1.92 to -0.63
NCT00432276803 enrolled · 2007
Δ -0.50-1.03 to 0.04
NCT01137812756 enrolled · 2010
Δ -2.80-3.30 to -2.20
NCT01682759751 enrolled · 2012
IRR -3.70-10.6 to 3.30
NCT01438814689 enrolled · 2011
Δ 0.620.25 to 0.98
NCT02849080504 enrolled · 2016
Δ -1.90-2.60 to -1.20
NCT00642278451 enrolled · 2008
Δ 0.40-0.50 to 1.40

Thiazolidinediones×body weight & composition

ContradictsOpen on the map →What to test next →

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

Belief with this paper
0.00contested · 0 families support, 1 contradict · against placebo
Without itThis paper is the only evidence family behind the claim. Without it there is no number.
← favours the treatmentfavours the comparator →
0 · no effect
This paper · 2008
Δ 1.901.30 to 2.50
NCT00676338820 enrolled · 2008
Δ -3.56-4.21 to -2.90
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.

NCT00541775 phase3completed

A Multicenter, Double-Blind, Placebo and Active Controlled, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin 100 mg Once Daily in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy

Ran2006Enrolled273Registered outcomes3Posted comparisons3ConditionsType 2 Diabetes MellitusArmsComparator: Metformin, Comparator: Placebo, Comparator: Rosiglitazone, Sitagliptin
Open the trial in the graph
NCT00684528 phase3unknown status

A Double-Blind, Randomized, Active-Comparator (Metformin) Controlled, Clinical Trial to Study the Efficacy and Safety of the Strategy to Start Patients With Type 2 Diabetes Mellitus on Janumet™ Compared to Metformin

Ran2008Enrolled1,000Registered outcomes2Posted comparisons0ConditionsDiabetes Type 2ArmsMetformin 1500 mg daily, Metformin + Janufer (Janumet)
PMID 18353996other papers from this trial
Open the trial in the graph
NCT05556291 completednot on this mapstarted 2022, after this paper: background citation

Efficacy, Safety & Tolerability of Combination of Ertugliflozin and Sitagliptin in Patients With Type II Diabetes Mellitus

TypeobservationalSponsorGetz PharmaRan2022 to 2024Enrolled190ConditionsEfficacy, Safety, TolerabilityArmsCombinations of Oral Blood Glucose Lowering Drugs
5 · Its place in the literature

Who cites it

88 citing papers in PubMed, 20 syntheses or guidelines pooled it, 223 citations in OpenAlex.

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  19. Risk of fatal and nonfatal lactic acidosis with metformin use in type 2 diabetes mellitus.The Cochrane database of systematic reviews · 2010 · on this map
    Pooled it
  20. Dipeptidyl peptidase-4 (DPP-4) inhibitors for type 2 diabetes mellitus.The Cochrane database of systematic reviews · 2008
    Pooled it

28 more citing papers are in PubMed but not listed here.

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

5 authors at 2 institutions in 2 countries.

R ScottLipid and Diabetes Research Group, Christchurch School of Medicine, Christchurch, New Zealand.
T Loeys
M J Davies
S S Engel
Sitagliptin Study 801 Group
Merck & Co., Inc., Rahway, NJ, USA (United States) · USChristchurch Clinical Studies Trust · NZ

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.

aimTo assess the addition of sitagliptin to ongoing metformin therapy in patients with type 2 diabetes who were inadequately controlled [haemoglobin A(1c) (HbA(1c)) 7-11%] on metformin monotherapy.

methodsPatients (n = 273) on metformin (>/=1500 mg/day) were randomized to receive the addition of once-daily placebo, sitagliptin 100 mg or rosiglitazone 8 mg in a 1 : 1 : 1 ratio for 18 weeks. The efficacy analysis was based on the all-patients-treated population using an analysis of co-variance with change in HbA(1c) from baseline as the primary endpoint.

resultsThe mean baseline HbA(1c) was 7.7% for the entire cohort. After 18 weeks, both active add-on therapies led to greater improvements in HbA(1c) from baseline: -0.73% for sitagliptin (p < 0.001 vs. placebo) and -0.79% for rosiglitazone compared with -0.22% for placebo. No difference was observed between the sitagliptin and rosiglitazone treatments (0.06% [95% confidence interval (CI): -0.14 to 0.25]). The proportion of patients achieving an HbA(1c) < 7% was greater with sitagliptin (55%) and rosiglitazone (63%) compared with placebo (38%). Body weight increased from baseline with rosiglitazone (1.5 kg) compared with body weight reduction with sitagliptin (-0.4 kg) and placebo (-0.8 kg). The difference in body weight between the sitagliptin and rosiglitazone groups was 1.9 kg (95% CI: 1.3-2.5). In a prespecified analysis, the proportion of patients experiencing a greater than 3-kg increase in body weight was 21% in the rosiglitazone group compared with 2% in both the sitagliptin and placebo groups. Both active treatments were generally well tolerated, with no increased risk of hypoglycaemia or gastrointestinal adverse events compared with placebo.

conclusionsIn this 18-week study, the addition of sitagliptin was effective and well tolerated in patients with type 2 diabetes inadequately controlled with metformin monotherapy. Treatment with sitagliptin produced similar reductions in HbA(1c) compared with the addition of rosiglitazone.

Indexed as

Analysis of VarianceBiomarkersBlood GlucoseBody WeightCholesterol, LDLDiabetes Mellitus, Type 2Double-Blind MethodDrug Therapy, CombinationFemaleGlycated HemoglobinHumansHypoglycemic AgentsInsulinLipidsMaleMetforminBiomarkersBlood GlucoseCholesterol, LDLGlycated HemoglobinHypoglycemic AgentsInsulinLipidsMetforminPyrazinesRosiglitazoneSitagliptin PhosphateThiazolidinedionesTriazolesTriglycerides

Identifiers

PMID18201203
OpenAlexW2158727328

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.