Evidence map›Paper›PMID 19864452›Full record

Trial reportThe Journal of clinical endocrinology and metabolism2009

Saxagliptin added to a thiazolidinedione improves glycemic control in patients with type 2 diabetes and inadequate control on thiazolidinedione alone.

Priscilla Hollander, Jia Li, Elsie Allen, Roland Chen, CV181-013 Investigators

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00295633. Cited by 71 papers, 16 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
71citing papers in PubMed, 16 pooled it
19.9field-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.

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.

NCT00295633 phase3completed

A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase III Trial to Evaluate the Efficacy and Safety of Saxagliptin (BMS477118) in Combination With Thiazolidinedione Therapy in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control on Thiazolidinedione Therapy Alone

Ran2006Enrolled565Registered outcomes4Posted comparisons0ConditionsDiabetes Mellitus, Type 2ArmsMetformin, Pioglitazone, Placebo, Rosiglitazone, Saxagliptin
Open the trial in the graph
3 · Its place in the literature

Who cites it

71 citing papers in PubMed, 16 syntheses or guidelines pooled it, 208 citations in OpenAlex.

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

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

5 authors at 2 institutions in 1 country.

Priscilla HollanderBaylor University Medical Center, Department of Endocrinology, 3600 Gaston Avenue, Wadley 656, Dallas, Texas 75246, USA. priscilh@BaylorHealth.edu
Jia Li
Elsie Allen
Roland Chen
CV181-013 Investigators
Bristol-Myers Squibb (United States) · USBaylor University Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

contextDue to the natural progression of type 2 diabetes (T2D), most patients require combination therapy to maintain glycemic control.

objectiveOur objective was to evaluate efficacy and safety of saxagliptin plus thiazolidinedione (TZD) in patients with T2D and inadequate glycemic control on TZD monotherapy.

designThe study was a multicenter, randomized, double-blind, placebo (PBO)-controlled phase 3 trial conducted from March 13, 2006, to October 15, 2007.

settingPatients were recruited from 172 outpatient centers. PATIENTS: Patients with inadequately controlled T2D [glycosylated hemoglobin (HbA(1c)) 7.0-10.5%], 18-77 yr, receiving stable TZD monotherapy (pioglitazone 30 or 45 mg or rosiglitazone 4 or 8 mg) for at least 12 wk before screening were eligible.

interventionsA total of 565 patients were randomized and treated with saxagliptin (2.5 or 5 mg) or PBO, once daily, plus stable TZD dose for 24 wk.

main outcome measuresPrimary outcome was change in HbA(1c) from baseline to wk 24. Secondary outcomes were change from baseline to wk 24 in fasting plasma glucose, proportion of patients achieving HbA(1c) less than 7.0%, and postprandial glucose area under the curve.

resultsAt 24 wk, saxagliptin (2.5 and 5 mg) plus TZD demonstrated statistically significant adjusted mean decreases vs. PBO in HbA(1c) [-0.66% (P = 0.0007) and -0.94% (P < 0.0001) vs. -0.30%] and fasting plasma glucose [-0.8 mmol/liter (P = 0.0053) and -1 mmol/liter (P = 0.0005) vs. -0.2 mmol/liter]. Proportion of patients achieving HbA(1c) less than 7.0% was greater for saxagliptin (2.5 and 5 mg) plus TZD vs. PBO [42.2% (P = 0.001) and 41.8% (P = 0.0013) vs. 25.6%]. Postprandial glucose area under the curve was significantly reduced [-436 mmol x min/liter (saxagliptin 2.5 mg plus TZD) and -514 mmol x min/liter (saxagliptin 5 mg plus TZD) vs. -149 mmol x min/liter (PBO)]. Saxagliptin was generally well tolerated; adverse event occurrence and reported hypoglycemic events were similar across all groups.

conclusionsSaxagliptin added to TZD provided statistically significant improvements in key parameters of glycemic control vs. TZD monotherapy and was generally well tolerated.

Indexed as

AdamantaneAdolescentAdultAgedArea Under CurveBlood GlucoseDiabetes Mellitus, Type 2DipeptidesDose-Response Relationship, DrugDouble-Blind MethodDrug Therapy, CombinationEndpoint DeterminationFemaleGlycated HemoglobinHumansHypoglycemic AgentsAdamantaneBlood GlucoseDipeptidesGlycated HemoglobinHypoglycemic AgentsPioglitazoneRosiglitazonesaxagliptinThiazolidinediones

Identifiers

PMID19864452
OpenAlexW2045063167

What OpenQuestion holds

Textmetadata
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 OpenQuestion graph.