Prediction and validation of exenatide risk marker effects on progression of renal disease: Insights from EXSCEL.

Idzerda NMA, Clegg LE, Hernandez AF, Bakris G, Penland RC, Boulton DW, Bethel MA, Holman RR, Heerspink HJL

Diabetes, obesity & metabolism3 Feb 2020Cited by 14 (Europe PMC)

PMID31912603PMCIDPMC7187441DOI10.1111/dom.13958PepBankPUB-31912603

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study9

7 results from studies that gave the peptide. 7 results from people.

01HumanOther designEfficacy outcome
In EXSCEL participants with diabetes, exenatide lowered mean HbA1c at 6 months compared with placebo.
In plain wordsIn EXSCEL participants with diabetes, exenatide lowered HbA1c compared with placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseHbA1c
Study
n: not reported in source
Comparator
Placebo
Outcome group
Glycemic control · Metabolic and weight
Studied dose
Dose not stated · 6 monthsAs given in this study (human).
Source sentences
Summary
Compared with placebo, mean HbA1c, BMI, SBP and total cholesterol were lower at 6 months with exenatide, as was the incidence of new microalbuminuria.
3 context sentences(design, population, supporting numbers)
Summary · context
Changes from baseline to 6 months in HbA1c, systolic blood pressure (SBP), body mass index (BMI), haemoglobin, total cholesterol, and new micro- or macroalbuminuria were evaluated.
Summary · context
The renal outcomes were defined as a composite of a sustained 30% or 40% decline in estimated glomerular filtration rate (eGFR) or end-stage renal disease (ESRD).
Summary · context
Relationships between risk markers and long-term renal outcomes were determined in patients with type 2 diabetes from the ALTITUDE study using multivariable Cox regression analysis, and then applied to short-term changes in risk markers observed in EXSCEL to predict the exenatide-induced impact on renal outcomes.
Report a problemFND-3191260301
02HumanOther designEfficacy outcome
In EXSCEL participants with diabetes, exenatide lowered mean BMI at 6 months compared with placebo.
In plain wordsIn EXSCEL participants with diabetes, exenatide lowered BMI compared with placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseBody mass index
Study
n: not reported in source
Comparator
Placebo
Outcome group
Body weight · Metabolic and weight
Studied dose
Dose not stated · 6 monthsAs given in this study (human).
Source sentences
Summary
Compared with placebo, mean HbA1c, BMI, SBP and total cholesterol were lower at 6 months with exenatide, as was the incidence of new microalbuminuria.
3 context sentences(design, population, supporting numbers)
Summary · context
Changes from baseline to 6 months in HbA1c, systolic blood pressure (SBP), body mass index (BMI), haemoglobin, total cholesterol, and new micro- or macroalbuminuria were evaluated.
Summary · context
The renal outcomes were defined as a composite of a sustained 30% or 40% decline in estimated glomerular filtration rate (eGFR) or end-stage renal disease (ESRD).
Summary · context
Relationships between risk markers and long-term renal outcomes were determined in patients with type 2 diabetes from the ALTITUDE study using multivariable Cox regression analysis, and then applied to short-term changes in risk markers observed in EXSCEL to predict the exenatide-induced impact on renal outcomes.
Report a problemFND-3191260302
03HumanOther designEfficacy outcome
In EXSCEL participants with diabetes, exenatide lowered mean systolic blood pressure at 6 months compared with placebo.
In plain wordsIn EXSCEL participants with diabetes, exenatide lowered systolic blood pressure compared with placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseSystolic blood pressure
Study
n: not reported in source
Comparator
Placebo
Outcome group
Blood pressure · Cardiovascular
Studied dose
Dose not stated · 6 monthsAs given in this study (human).
Source sentences
Summary
Compared with placebo, mean HbA1c, BMI, SBP and total cholesterol were lower at 6 months with exenatide, as was the incidence of new microalbuminuria.
3 context sentences(design, population, supporting numbers)
Summary · context
Changes from baseline to 6 months in HbA1c, systolic blood pressure (SBP), body mass index (BMI), haemoglobin, total cholesterol, and new micro- or macroalbuminuria were evaluated.
Summary · context
The renal outcomes were defined as a composite of a sustained 30% or 40% decline in estimated glomerular filtration rate (eGFR) or end-stage renal disease (ESRD).
Summary · context
Relationships between risk markers and long-term renal outcomes were determined in patients with type 2 diabetes from the ALTITUDE study using multivariable Cox regression analysis, and then applied to short-term changes in risk markers observed in EXSCEL to predict the exenatide-induced impact on renal outcomes.
Report a problemFND-3191260303
04HumanOther designEfficacy outcome
In EXSCEL participants with diabetes, exenatide lowered mean total cholesterol at 6 months compared with placebo.
In plain wordsIn EXSCEL participants with diabetes, exenatide lowered total cholesterol compared with placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseTotal cholesterol
Study
n: not reported in source
Comparator
Placebo
Outcome group
Lipids · Metabolic and weight
Studied dose
Dose not stated · 6 monthsAs given in this study (human).
Source sentences
Summary
Compared with placebo, mean HbA1c, BMI, SBP and total cholesterol were lower at 6 months with exenatide, as was the incidence of new microalbuminuria.
3 context sentences(design, population, supporting numbers)
Summary · context
Changes from baseline to 6 months in HbA1c, systolic blood pressure (SBP), body mass index (BMI), haemoglobin, total cholesterol, and new micro- or macroalbuminuria were evaluated.
Summary · context
The renal outcomes were defined as a composite of a sustained 30% or 40% decline in estimated glomerular filtration rate (eGFR) or end-stage renal disease (ESRD).
Summary · context
Relationships between risk markers and long-term renal outcomes were determined in patients with type 2 diabetes from the ALTITUDE study using multivariable Cox regression analysis, and then applied to short-term changes in risk markers observed in EXSCEL to predict the exenatide-induced impact on renal outcomes.
Report a problemFND-3191260304
05HumanOther designEfficacy outcome
In EXSCEL participants with diabetes, exenatide lowered new microalbuminuria incidence at 6 months compared with placebo.
In plain wordsIn EXSCEL participants with diabetes, exenatide reduced new small urine albumin leaks compared with placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseNew microalbuminuria
Study
n: not reported in source
Comparator
Placebo
Outcome group
Kidney function · Kidney and urinary
Studied dose
Dose not stated · 6 monthsAs given in this study (human).
Source sentences
Summary
Compared with placebo, mean HbA1c, BMI, SBP and total cholesterol were lower at 6 months with exenatide, as was the incidence of new microalbuminuria.
3 context sentences(design, population, supporting numbers)
Summary · context
Changes from baseline to 6 months in HbA1c, systolic blood pressure (SBP), body mass index (BMI), haemoglobin, total cholesterol, and new micro- or macroalbuminuria were evaluated.
Summary · context
The renal outcomes were defined as a composite of a sustained 30% or 40% decline in estimated glomerular filtration rate (eGFR) or end-stage renal disease (ESRD).
Summary · context
Relationships between risk markers and long-term renal outcomes were determined in patients with type 2 diabetes from the ALTITUDE study using multivariable Cox regression analysis, and then applied to short-term changes in risk markers observed in EXSCEL to predict the exenatide-induced impact on renal outcomes.
Report a problemFND-3191260305
06HumanOther designEfficacy outcome
In EXSCEL participants, observed risk of the renal composite with 30% eGFR decline or ESRD was lower with exenatide versus placebo.
In plain wordsIn EXSCEL participants, exenatide reduced the observed combined kidney outcome risk versus placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseObserved renal composite with thirty-percent eGFR decline
Study
n: not reported in source
Comparator
Placebo
Outcome group
Kidney function · Kidney and urinary
Studied dose
Dose not stated
Measurements
Observed relative risk reduction
12.7%
30% eGFR decline plus ESRD
Observed hazard ratio
0.87 ratio
30% eGFR decline plus ESRD
Source sentences
Summary
The PRE score predicted a relative risk reduction for the 30% eGFR decline + ESRD endpoint of 11.3% (HR 0.89; 95% CI 0.83-0.94), compared with 12.7% (HR 0.87; 0.77-0.99) observed risk reduction.
3 context sentences(design, population, supporting numbers)
Summary · context
Changes from baseline to 6 months in HbA1c, systolic blood pressure (SBP), body mass index (BMI), haemoglobin, total cholesterol, and new micro- or macroalbuminuria were evaluated.
Summary · context
The renal outcomes were defined as a composite of a sustained 30% or 40% decline in estimated glomerular filtration rate (eGFR) or end-stage renal disease (ESRD).
Summary · context
Relationships between risk markers and long-term renal outcomes were determined in patients with type 2 diabetes from the ALTITUDE study using multivariable Cox regression analysis, and then applied to short-term changes in risk markers observed in EXSCEL to predict the exenatide-induced impact on renal outcomes.
Report a problemFND-3191260307
07HumanOther designEfficacy outcome
In EXSCEL participants, the exenatide versus placebo estimate for the renal composite with 40% eGFR decline or ESRD included no effect.
In plain wordsIn EXSCEL participants, the larger-decline kidney outcome estimate for exenatide versus placebo did not exclude no effect.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeObserved renal composite with forty-percent eGFR decline
Study
n: not reported in source
Comparator
Placebo
Outcome group
Kidney function · Kidney and urinary
Studied dose
Dose not stated
Measurements
Observed relative risk reduction
13.7%
40% eGFR decline plus ESRD
Observed hazard ratio
0.86 ratio
40% eGFR decline plus ESRD
Source sentences
Summary
For the 40% eGFR decline + ESRD endpoint, the predicted and observed risk reductions were 11.0% (HR 0.89; 0.82-0.97) and 13.7% (HR 0.86, 0.72-1.04), respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
Changes from baseline to 6 months in HbA1c, systolic blood pressure (SBP), body mass index (BMI), haemoglobin, total cholesterol, and new micro- or macroalbuminuria were evaluated.
Summary · context
The renal outcomes were defined as a composite of a sustained 30% or 40% decline in estimated glomerular filtration rate (eGFR) or end-stage renal disease (ESRD).
Summary · context
Relationships between risk markers and long-term renal outcomes were determined in patients with type 2 diabetes from the ALTITUDE study using multivariable Cox regression analysis, and then applied to short-term changes in risk markers observed in EXSCEL to predict the exenatide-induced impact on renal outcomes.
Report a problemFND-3191260309

Studies that did not test the peptide alone2

In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Exenatide (exendin-4).

08Computer modelNot a test of Exenatide (exendin-4) aloneIn silicoOther
In computer modelling using EXSCEL risk-marker changes, the PRE score predicted lower renal composite risk with exenatide versus placebo.
In plain wordsIn computer modelling, the PRE score predicted lower kidney outcome risk with exenatide than placebo.
Peptide
Exenatide (exendin-4)
Outcome
DecreasePredicted renal composite with thirty-percent eGFR decline
Study
n: not reported in source
Comparator
Placebo
Outcome group
Kidney function · Kidney and urinary
Measurements
Predicted relative risk reduction
11.3%
30% eGFR decline plus ESRD
Predicted hazard ratio
0.89 ratio
30% eGFR decline plus ESRD
Source sentences
Summary
The PRE score predicted a relative risk reduction for the 30% eGFR decline + ESRD endpoint of 11.3% (HR 0.89; 95% CI 0.83-0.94), compared with 12.7% (HR 0.87; 0.77-0.99) observed risk reduction.
3 context sentences(design, population, supporting numbers)
Summary · context
Changes from baseline to 6 months in HbA1c, systolic blood pressure (SBP), body mass index (BMI), haemoglobin, total cholesterol, and new micro- or macroalbuminuria were evaluated.
Summary · context
The renal outcomes were defined as a composite of a sustained 30% or 40% decline in estimated glomerular filtration rate (eGFR) or end-stage renal disease (ESRD).
Summary · context
Relationships between risk markers and long-term renal outcomes were determined in patients with type 2 diabetes from the ALTITUDE study using multivariable Cox regression analysis, and then applied to short-term changes in risk markers observed in EXSCEL to predict the exenatide-induced impact on renal outcomes.
In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).
Report a problemFND-3191260306
09Computer modelNot a test of Exenatide (exendin-4) aloneIn silicoOther
In computer modelling using EXSCEL risk-marker changes, the PRE score predicted lower risk of the larger-decline renal composite with exenatide versus placebo.
In plain wordsIn computer modelling, exenatide had lower predicted kidney outcome risk than placebo for the larger-decline endpoint.
Peptide
Exenatide (exendin-4)
Outcome
DecreasePredicted renal composite with forty-percent eGFR decline
Study
n: not reported in source
Comparator
Placebo
Outcome group
Kidney function · Kidney and urinary
Measurements
Predicted relative risk reduction
11%
40% eGFR decline plus ESRD
Predicted hazard ratio
0.89 ratio
40% eGFR decline plus ESRD
Source sentences
Summary
For the 40% eGFR decline + ESRD endpoint, the predicted and observed risk reductions were 11.0% (HR 0.89; 0.82-0.97) and 13.7% (HR 0.86, 0.72-1.04), respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
Changes from baseline to 6 months in HbA1c, systolic blood pressure (SBP), body mass index (BMI), haemoglobin, total cholesterol, and new micro- or macroalbuminuria were evaluated.
Summary · context
The renal outcomes were defined as a composite of a sustained 30% or 40% decline in estimated glomerular filtration rate (eGFR) or end-stage renal disease (ESRD).
Summary · context
Relationships between risk markers and long-term renal outcomes were determined in patients with type 2 diabetes from the ALTITUDE study using multivariable Cox regression analysis, and then applied to short-term changes in risk markers observed in EXSCEL to predict the exenatide-induced impact on renal outcomes.
In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).
Report a problemFND-3191260308

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Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
22 Oct 2026, 02:26 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

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