Trial reportDiabetes care2009

Treatment with the human once-weekly glucagon-like peptide-1 analog taspoglutide in combination with metformin improves glycemic control and lowers body weight in patients with type 2 diabetes inadequately controlled with metformin alone: a double-blind placebo-controlled study.

Michael A Nauck, Robert E Ratner, Christoph Kapitza, Rachele Berria, Mark Boldrin, Raffaella Balena

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Diabetes care, 2009. The graph read 3 numbers from its abstract, feeding 2 cells of the map: it supports the treatment in 2. Cited by 38 papers, 5 of them syntheses that pooled it.

3numbers the graph read from it
2cells of the map it votes in
38citing papers in PubMed, 5 pooled it
16.4field-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 →
-2.000 · no effect
Change in A1C (percent) from baselinetaspoglutide 10 mg once every 2 weeks vs placebofavours the treatment · t2d, dyslipidemiafeeds one cell of the map
Δ -0.70<0.0001
RESULTS: Significantly greater (P < 0.0001) reductions in A1C from a mean +/- SD baseline of 7.9 +/- 0.7% were observed in all taspoglutide groups compared with placebo after 8 weeks of treatment: -1.0 +/- 0.1% (5 mg once weekly), -1.2 +/- 0.1% (10 mg once weekly), -1.2 +/- 0.1% (20 mg once weekly), -0.9 +/- 0.1% (10 mg Q2W), and -1.0 +/- 0.1% (20 mg Q2W) vs. -0.2 +/- 0.1% with placebo.
Body weight losstaspoglutide 20 mg once weekly vs placebofavours the treatment · t2d, dyslipidemiafeeds one cell of the map
Δ -2.00<0.0001
After 8 weeks, body weight loss was significantly greater in the 10 mg (-2.1 +/- 0.3 kg, P = 0.0035 vs. placebo) and 20 mg (-2.8 +/- 0.3 kg, P < 0.0001) once-weekly groups and the 20 mg once every 2 weeks (-1.9 +/- 0.3 kg, P = 0.0083) group than with placebo (-0.8 +/- 0.3 kg).
Change in A1C (percent) from baselinetaspoglutide 10 mg once weekly vs placebofavours the treatment · t2d, dyslipidemiafeeds one cell of the map
Δ -1.00<0.0001
RESULTS: Significantly greater (P < 0.0001) reductions in A1C from a mean +/- SD baseline of 7.9 +/- 0.7% were observed in all taspoglutide groups compared with placebo after 8 weeks of treatment: -1.0 +/- 0.1% (5 mg once weekly), -1.2 +/- 0.1% (10 mg once weekly), -1.2 +/- 0.1% (20 mg once weekly), -0.9 +/- 0.1% (10 mg Q2W), and -1.0 +/- 0.1% (20 mg Q2W) vs. -0.2 +/- 0.1% with placebo.

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.

Investigational compounds×glycemic control

SupportsOpen on the map →What to test next →

21 readable studies in this cell: 10 favour the treatment, 8 find no difference, 3 favour the comparator.

Belief with this paper
0.78replicated · 14 families support, 4 contradict · against placebo
Without it
0.76This paper moves it by +0.01.
← favours the treatmentfavours the comparator →
0 · no effect
This paper · 2009
Δ -0.70
NCT004798822,414 enrolled · 2007
Δ -0.20-0.90 to 0.50
NCT002899002,340 enrolled · 2006
Δ 0.10-0.30 to 0.90
NCT03214380933 enrolled · 2017
Δ 0.06-0.05 to 0.16
NCT03235050834 enrolled · 2017
Δ -0.83-1.06 to -0.59
NCT00767000813 enrolled · 2008
Δ -0.51-0.80 to -0.22
NCT02119819420 enrolled · 2014
Δ -0.78-1.05 to -0.52
NCT04153929413 enrolled · 2020
Δ -1.53-1.84 to -1.22
NCT05048719383 enrolled · 2021
Δ -0.77-1.13 to -0.40
NCT00479466342 enrolled · 2007
Δ -30.6-44.0 to -17.3
NCT02973321296 enrolled · 2016
Δ -0.96-1.36 to -0.55
NCT04867785281 enrolled · 2021
Δ -0.38-0.94 to 0.18
NCT02492763176 enrolled · 2015
Δ -0.39-0.88 to 0.11

Investigational compounds×body weight & composition

SupportsOpen on the map →What to test next →

12 readable studies in this cell: 8 favour the treatment, 3 find no difference, 1 favour the comparator.

Belief with this paper
1.00established · 9 families support, 0 contradict · against placebo
Without it
1.00This paper does not move the number.
← favours the treatmentfavours the comparator →
0 · no effect
This paper · 2009
Δ -2.00
NCT03235050834 enrolled · 2017
Δ -2.00-3.08 to -0.91
NCT05616013507 enrolled · 2022
Δ -14.5-18.0 to -11.0
NCT03486392474 enrolled · 2018
Δ -6.75-9.31 to -4.19
NCT04153929413 enrolled · 2020
Δ -7.68-9.52 to -5.83
NCT02973321296 enrolled · 2016
Δ -3.57-5.31 to -1.83
NCT04867785281 enrolled · 2021
Δ -0.49-2.07 to 1.08
NCT02492763176 enrolled · 2015
Δ -0.70-2.00 to 0.60
decrease -24.2
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

38 citing papers in PubMed, 5 syntheses or guidelines pooled it, 117 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Glucagon-like peptide analogues for type 2 diabetes mellitus.The Cochrane database of systematic reviews · 2011 · on this map
    Pooled it
  5. 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
  6. Trial
  7. Trial
  8. Trial
  9. Utilization of model-based meta-analysis to delineate the net efficacy of taspoglutide from the response of placebo in clinical trials.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2015
    Article
  10. Review
  11. Review
  12. Glucagon-like peptide-1 analogues: An overview.Indian journal of endocrinology and metabolism · 2013
    Article
  13. Pharmacotherapy for childhood obesity: present and future prospects.International journal of obesity (2005) · 2013
    Review
  14. Efficacy and safety of taspoglutide versus sitagliptin for type 2 diabetes mellitus (T-emerge 4 trial).Diabetes therapy : research, treatment and education of diabetes and related disorders · 2012
    Article
  15. Incretin-based therapies.Journal of diabetes · 2012 · on this map
    Review
  16. Review
  17. Article
  18. Incretin-based therapy: a powerful and promising weapon in the treatment of type 2 diabetes mellitus.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2011
    Article
  19. Article
  20. 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

6 authors at 5 institutions in 3 countries.

Michael A NauckDiabeteszentrum, Bad Lauterberg im Harz, Germany.
Robert E Ratner
Christoph Kapitza
Rachele Berria
Mark Boldrin
Raffaella Balena
La Roche College · USDiabeteszentrum Bad Lauterberg · DEMedStar Health · USProfil Institute for Metabolic Research · DERoche (Switzerland) · CH

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.

objectiveTo evaluate the efficacy and safety of taspoglutide (R1583/BIM51077), a human once-weekly glucagon-like peptide-1 analog, in patients with type 2 diabetes inadequately controlled with metformin. RESEARCH DESIGN AND

methodsType 2 diabetic (n = 306) patients who failed to obtain glycemic control (A1C 7-9.5%) despite 1,500 mg metformin daily were randomly assigned to 8 weeks of double-blind subcutaneous treatment with placebo or taspoglutide, either 5, 10, or 20 mg once weekly or 10 or 20 mg once every 2 weeks, and followed for 4 additional weeks. All patients received their previously established dose of metformin throughout the study. Glycemic control was assessed by change in A1C (percent) from baseline.

resultsSignificantly greater (P < 0.0001) reductions in A1C from a mean +/- SD baseline of 7.9 +/- 0.7% were observed in all taspoglutide groups compared with placebo after 8 weeks of treatment: -1.0 +/- 0.1% (5 mg once weekly), -1.2 +/- 0.1% (10 mg once weekly), -1.2 +/- 0.1% (20 mg once weekly), -0.9 +/- 0.1% (10 mg Q2W), and -1.0 +/- 0.1% (20 mg Q2W) vs. -0.2 +/- 0.1% with placebo. After 8 weeks, body weight loss was significantly greater in the 10 mg (-2.1 +/- 0.3 kg, P = 0.0035 vs. placebo) and 20 mg (-2.8 +/- 0.3 kg, P < 0.0001) once-weekly groups and the 20 mg once every 2 weeks (-1.9 +/- 0.3 kg, P = 0.0083) group than with placebo (-0.8 +/- 0.3 kg). The most common adverse event was dose-dependent, transient, mild-to-moderate nausea; the incidence of hypoglycemia was very low.

conclusionsTaspoglutide used in combination with metformin significantly improves fasting and postprandial glucose control and induces weight loss, with a favorable tolerability profile.

Indexed as

Diabetes Mellitus, Type 2Double-Blind MethodDrug Administration ScheduleFemaleGlycated HemoglobinHumansHypoglycemic AgentsInsulinLipidsMaleMetforminPeptidesPostmenopauseSafetySterilization, ReproductiveGlycated HemoglobinHypoglycemic AgentsInsulinLipidsMetforminPeptidestaspoglutide

Identifiers

PMID19366970
PMCPMC2699710
OpenAlexW1994636940

What Socratic holds

Texttitle and abstract
LicenceCC BY-NC-ND
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.