Further improvement in postprandial glucose control with addition of exenatide or sitagliptin to combination therapy with insulin glargine and metformin: a proof-of-concept study.

Arnolds S, Dellweg S, Clair J, Dain MP, Nauck MA, Rave K, Kapitza C

Diabetes care31 Mar 2010Cited by 131 (Europe PMC)

PMID20357372PMCIDPMC2890351DOI10.2337/dc09-2191PepBankPUB-20357372

Read at source PubMedAsk about this study

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-ND. Results still quote short attributed sentences.

Results from this study12

12 results from studies that gave the peptide. 12 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, adding exenatide to glargine and metformin reduced postprandial glucose excursions versus glargine and metformin alone.
In plain wordsIn people with diabetes, adding exenatide reduced glucose rises after meals compared with glargine and metformin alone.
Peptide
Exenatide (exendin-4)
Outcome
DecreasePostprandial blood glucose excursion
Study
n: not reported in source
Comparator
insulin glargine plus metformin
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5-10 microg b.i.d. · 4 weeksAs given in this study (human).
Measurements
Glucose excursion
606 mg/dl/h
GLAR + MET + EXE
Glucose excursion
728 mg/dl/h
GLAR + MET
Source sentences
Summary
The unadjusted 6-h postprandial blood glucose excursion of both GLAR + MET + EXE and GLAR + MET + SITA was statistically significantly smaller than that of GLAR + MET (606 +/- 104 vs. 612 +/- 133 vs. 728 +/- 132 mg/dl/h; P = 0.0036 and 0.0008).
2 context sentences(design, population, supporting numbers)
Summary · context
To assess the effect of a 4-week adjunctive therapy of exenatide (EXE) (5-10 microg b.i.d.) or sitagliptin (SITA) (100 mg once daily) in response to a standardized breakfast meal challenge in 48 men or women with type 2 diabetes receiving insulin glargine (GLAR) + metformin (MET).
Summary · context
This was a single-center, randomized, open-label, active comparator-controlled study with a three-arm parallel group design, consisting of: screening, 4- to 8-week run-in period, 4-week treatment period, and follow-up.
Report a problemFND-2035737201
02HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, adding exenatide to glargine and metformin reduced A1C more than glargine and metformin alone.
In plain wordsIn people with diabetes, adding exenatide reduced A1C more than glargine and metformin alone.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseA1C reduction
Study
n: not reported in source
Comparator
insulin glargine plus metformin
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5-10 microg b.i.d. · 4 weeksAs given in this study (human).
Measurements
A1C change
−1.9 percentage points
GLAR + MET + EXE
A1C change
−1.2 percentage points
GLAR + MET
Source sentences
Summary
A1C significantly decreased in all three groups (P < 0.0001), with the greatest reduction of -1.9 +/- 0.7 under GLAR + MET + EXE (GLAR + MET + SITA -1.5 +/- 0.7; GLAR + MET -1.2 +/- 0.5%-points; GLAR + MET + EXE vs. GLAR + MET P = 0.0154).
2 context sentences(design, population, supporting numbers)
Summary · context
To assess the effect of a 4-week adjunctive therapy of exenatide (EXE) (5-10 microg b.i.d.) or sitagliptin (SITA) (100 mg once daily) in response to a standardized breakfast meal challenge in 48 men or women with type 2 diabetes receiving insulin glargine (GLAR) + metformin (MET).
Summary · context
This was a single-center, randomized, open-label, active comparator-controlled study with a three-arm parallel group design, consisting of: screening, 4- to 8-week run-in period, 4-week treatment period, and follow-up.
Report a problemFND-2035737202
03HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, A1C below 7.0% occurred in 80.0% with adjunctive exenatide versus 62.5% with glargine and metformin alone.
In plain wordsIn people with diabetes, more reached the A1C target with added exenatide than with glargine and metformin alone.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseA1C target attainment
Study
n: not reported in source
Comparator
insulin glargine plus metformin
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5-10 microg b.i.d. · 4 weeksAs given in this study (human).
Measurements
Target attainment
80%
GLAR + MET + EXE
Target attainment
62.5%
GLAR + MET
Source sentences
Summary
The American Diabetes Association A1C target of <7.0% was reached by 80.0, 87.5, and 62.5% of subjects, respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
The unadjusted 6-h postprandial blood glucose excursion of both GLAR + MET + EXE and GLAR + MET + SITA was statistically significantly smaller than that of GLAR + MET (606 +/- 104 vs. 612 +/- 133 vs. 728 +/- 132 mg/dl/h; P = 0.0036 and 0.0008).
Summary · context
To assess the effect of a 4-week adjunctive therapy of exenatide (EXE) (5-10 microg b.i.d.) or sitagliptin (SITA) (100 mg once daily) in response to a standardized breakfast meal challenge in 48 men or women with type 2 diabetes receiving insulin glargine (GLAR) + metformin (MET).
Summary · context
This was a single-center, randomized, open-label, active comparator-controlled study with a three-arm parallel group design, consisting of: screening, 4- to 8-week run-in period, 4-week treatment period, and follow-up.
Report a problemFND-2035737203
04HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, A1C target attainment was 80.0% with the exenatide regimen versus 87.5% with the sitagliptin regimen.
In plain wordsIn people with diabetes, the exenatide regimen had lower A1C target attainment than the sitagliptin regimen.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseA1C target attainment versus sitagliptin
Study
n: not reported in source
Comparator
glargine plus metformin plus sitagliptin
Outcome group
Glycemic control · Metabolic and weight
Studied dose
5-10 microg b.i.d. · 4 weeksAs given in this study (human).
Measurements
Target attainment
80%
GLAR + MET + EXE
Target attainment
87.5%
GLAR + MET + SITA
Source sentences
Summary
The American Diabetes Association A1C target of <7.0% was reached by 80.0, 87.5, and 62.5% of subjects, respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
The unadjusted 6-h postprandial blood glucose excursion of both GLAR + MET + EXE and GLAR + MET + SITA was statistically significantly smaller than that of GLAR + MET (606 +/- 104 vs. 612 +/- 133 vs. 728 +/- 132 mg/dl/h; P = 0.0036 and 0.0008).
Summary · context
To assess the effect of a 4-week adjunctive therapy of exenatide (EXE) (5-10 microg b.i.d.) or sitagliptin (SITA) (100 mg once daily) in response to a standardized breakfast meal challenge in 48 men or women with type 2 diabetes receiving insulin glargine (GLAR) + metformin (MET).
Summary · context
This was a single-center, randomized, open-label, active comparator-controlled study with a three-arm parallel group design, consisting of: screening, 4- to 8-week run-in period, 4-week treatment period, and follow-up.
Report a problemFND-2035737204
05HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, adjunctive exenatide produced more adverse events than glargine and metformin alone.
In plain wordsIn people with diabetes, adding exenatide produced more adverse events than glargine and metformin alone.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseAdverse event count versus background therapy
Study
n: not reported in source
Comparator
insulin glargine plus metformin
Outcome group
Adverse events · Whole body
Studied dose
5-10 microg b.i.d. · 4 weeksAs given in this study (human).
Measurements
Adverse events
47 events
GLAR + MET + EXE
Adverse events
10 events
GLAR + MET
Source sentences
Summary
GLAR + MET + EXE had the highest number (47) of adverse events, mostly gastrointestinal (56%) with one dropout.
3 context sentences(design, population, supporting numbers)
Summary · context
GLAR + MET or GLAR + MET + SITA only had 10 and 12 adverse events, respectively, and no dropouts.
Summary · context
To assess the effect of a 4-week adjunctive therapy of exenatide (EXE) (5-10 microg b.i.d.) or sitagliptin (SITA) (100 mg once daily) in response to a standardized breakfast meal challenge in 48 men or women with type 2 diabetes receiving insulin glargine (GLAR) + metformin (MET).
Summary · context
This was a single-center, randomized, open-label, active comparator-controlled study with a three-arm parallel group design, consisting of: screening, 4- to 8-week run-in period, 4-week treatment period, and follow-up.
Report a problemFND-2035737205
06HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, the exenatide regimen produced more adverse events than the sitagliptin regimen.
In plain wordsIn people with diabetes, the exenatide regimen produced more adverse events than the sitagliptin regimen.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseAdverse event count versus sitagliptin
Study
n: not reported in source
Comparator
glargine plus metformin plus sitagliptin
Outcome group
Adverse events · Whole body
Studied dose
5-10 microg b.i.d. · 4 weeksAs given in this study (human).
Measurements
Adverse events
47 events
GLAR + MET + EXE
Adverse events
12 events
GLAR + MET + SITA
Source sentences
Summary
GLAR + MET + EXE had the highest number (47) of adverse events, mostly gastrointestinal (56%) with one dropout.
3 context sentences(design, population, supporting numbers)
Summary · context
GLAR + MET or GLAR + MET + SITA only had 10 and 12 adverse events, respectively, and no dropouts.
Summary · context
To assess the effect of a 4-week adjunctive therapy of exenatide (EXE) (5-10 microg b.i.d.) or sitagliptin (SITA) (100 mg once daily) in response to a standardized breakfast meal challenge in 48 men or women with type 2 diabetes receiving insulin glargine (GLAR) + metformin (MET).
Summary · context
This was a single-center, randomized, open-label, active comparator-controlled study with a three-arm parallel group design, consisting of: screening, 4- to 8-week run-in period, 4-week treatment period, and follow-up.
Report a problemFND-2035737206
07HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes receiving adjunctive exenatide, gastrointestinal events comprised 56% of adverse events.
In plain wordsIn people with diabetes receiving added exenatide, most adverse events affected the digestive system.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableGastrointestinal adverse events
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
5-10 microg b.i.d. · 4 weeksAs given in this study (human).
Measurements
Gastrointestinal share of events
56%
GLAR + MET + EXE
Source sentences
Summary
GLAR + MET + EXE had the highest number (47) of adverse events, mostly gastrointestinal (56%) with one dropout.
2 context sentences(design, population, supporting numbers)
Summary · context
To assess the effect of a 4-week adjunctive therapy of exenatide (EXE) (5-10 microg b.i.d.) or sitagliptin (SITA) (100 mg once daily) in response to a standardized breakfast meal challenge in 48 men or women with type 2 diabetes receiving insulin glargine (GLAR) + metformin (MET).
Summary · context
This was a single-center, randomized, open-label, active comparator-controlled study with a three-arm parallel group design, consisting of: screening, 4- to 8-week run-in period, 4-week treatment period, and follow-up.
Report a problemFND-2035737207
08HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, one dropout occurred with adjunctive exenatide versus none with glargine and metformin alone.
In plain wordsIn people with diabetes, one stopped with added exenatide versus none with glargine and metformin alone.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseDropout versus background therapy
Study
n: not reported in source
Comparator
insulin glargine plus metformin
Outcome group
Adverse events · Whole body
Studied dose
5-10 microg b.i.d. · 4 weeksAs given in this study (human).
Measurements
Dropouts
1 participants
GLAR + MET + EXE
Source sentences
Summary
GLAR + MET + EXE had the highest number (47) of adverse events, mostly gastrointestinal (56%) with one dropout.
3 context sentences(design, population, supporting numbers)
Summary · context
GLAR + MET or GLAR + MET + SITA only had 10 and 12 adverse events, respectively, and no dropouts.
Summary · context
To assess the effect of a 4-week adjunctive therapy of exenatide (EXE) (5-10 microg b.i.d.) or sitagliptin (SITA) (100 mg once daily) in response to a standardized breakfast meal challenge in 48 men or women with type 2 diabetes receiving insulin glargine (GLAR) + metformin (MET).
Summary · context
This was a single-center, randomized, open-label, active comparator-controlled study with a three-arm parallel group design, consisting of: screening, 4- to 8-week run-in period, 4-week treatment period, and follow-up.
Report a problemFND-2035737208
09HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, one dropout occurred with the exenatide regimen versus none with the sitagliptin regimen.
In plain wordsIn people with diabetes, one stopped with the exenatide regimen versus none with the sitagliptin regimen.
Peptide
Exenatide (exendin-4)
Outcome
IncreaseDropout versus sitagliptin
Study
n: not reported in source
Comparator
glargine plus metformin plus sitagliptin
Outcome group
Adverse events · Whole body
Studied dose
5-10 microg b.i.d. · 4 weeksAs given in this study (human).
Measurements
Dropouts
1 participants
GLAR + MET + EXE
Source sentences
Summary
GLAR + MET + EXE had the highest number (47) of adverse events, mostly gastrointestinal (56%) with one dropout.
3 context sentences(design, population, supporting numbers)
Summary · context
GLAR + MET or GLAR + MET + SITA only had 10 and 12 adverse events, respectively, and no dropouts.
Summary · context
To assess the effect of a 4-week adjunctive therapy of exenatide (EXE) (5-10 microg b.i.d.) or sitagliptin (SITA) (100 mg once daily) in response to a standardized breakfast meal challenge in 48 men or women with type 2 diabetes receiving insulin glargine (GLAR) + metformin (MET).
Summary · context
This was a single-center, randomized, open-label, active comparator-controlled study with a three-arm parallel group design, consisting of: screening, 4- to 8-week run-in period, 4-week treatment period, and follow-up.
Report a problemFND-2035737209
10HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, hypoglycemia rates were low and comparable with adjunctive exenatide and glargine plus metformin alone.
In plain wordsIn people with diabetes, low blood glucose rates were similar with added exenatide and glargine plus metformin alone.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeHypoglycemia versus background therapy
Study
n: not reported in source
Comparator
insulin glargine plus metformin
Outcome group
Adverse events · Metabolic and weight
Studied dose
5-10 microg b.i.d. · 4 weeksAs given in this study (human).
Source sentences
Summary
Hypoglycemia (blood glucose <50 mg/dl) rates were low and comparable among groups.
2 context sentences(design, population, supporting numbers)
Summary · context
To assess the effect of a 4-week adjunctive therapy of exenatide (EXE) (5-10 microg b.i.d.) or sitagliptin (SITA) (100 mg once daily) in response to a standardized breakfast meal challenge in 48 men or women with type 2 diabetes receiving insulin glargine (GLAR) + metformin (MET).
Summary · context
This was a single-center, randomized, open-label, active comparator-controlled study with a three-arm parallel group design, consisting of: screening, 4- to 8-week run-in period, 4-week treatment period, and follow-up.
Report a problemFND-2035737210
11HumanRandomized controlled trialSafety outcome
In adults with type 2 diabetes, hypoglycemia rates were low and comparable with the exenatide and sitagliptin regimens.
In plain wordsIn people with diabetes, low blood glucose rates were similar with the exenatide and sitagliptin regimens.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeHypoglycemia versus sitagliptin
Study
n: not reported in source
Comparator
glargine plus metformin plus sitagliptin
Outcome group
Adverse events · Metabolic and weight
Studied dose
5-10 microg b.i.d. · 4 weeksAs given in this study (human).
Source sentences
Summary
Hypoglycemia (blood glucose <50 mg/dl) rates were low and comparable among groups.
2 context sentences(design, population, supporting numbers)
Summary · context
To assess the effect of a 4-week adjunctive therapy of exenatide (EXE) (5-10 microg b.i.d.) or sitagliptin (SITA) (100 mg once daily) in response to a standardized breakfast meal challenge in 48 men or women with type 2 diabetes receiving insulin glargine (GLAR) + metformin (MET).
Summary · context
This was a single-center, randomized, open-label, active comparator-controlled study with a three-arm parallel group design, consisting of: screening, 4- to 8-week run-in period, 4-week treatment period, and follow-up.
Report a problemFND-2035737211
12HumanRandomized controlled trialEfficacy outcome
In adults with type 2 diabetes, adjunctive exenatide reduced weight compared with glargine and metformin alone.
In plain wordsIn people with diabetes, added exenatide reduced weight compared with glargine and metformin alone.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseBody weight
Study
n: not reported in source
Comparator
insulin glargine plus metformin
Outcome group
Body weight · Metabolic and weight
Studied dose
5-10 microg b.i.d. · 4 weeksAs given in this study (human).
Measurements
Weight change
−0.9 kg
GLAR + MET + EXE
Weight change
0.4 kg
GLAR + MET
Source sentences
Summary
Weight decreased with GLAR + MET + EXE (-0.9 +/- 1.7 kg; P = 0.0396) and increased slightly with GLAR + MET (0.4 +/- 1.5 kg; NS; GLAR + MET + EXE vs. GLAR + MET P = 0.0377).
2 context sentences(design, population, supporting numbers)
Summary · context
To assess the effect of a 4-week adjunctive therapy of exenatide (EXE) (5-10 microg b.i.d.) or sitagliptin (SITA) (100 mg once daily) in response to a standardized breakfast meal challenge in 48 men or women with type 2 diabetes receiving insulin glargine (GLAR) + metformin (MET).
Summary · context
This was a single-center, randomized, open-label, active comparator-controlled study with a three-arm parallel group design, consisting of: screening, 4- to 8-week run-in period, 4-week treatment period, and follow-up.
Report a problemFND-2035737212

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 1NCT00971659

Adjunctive Therapy of Exenatide or Sitagliptin to Insulin Glargine in Type 2 Diabetes

Profil Institut für Stoffwechselforschung GmbHn = 48Jan 2008 to Nov 2008

Type 2 Diabetes

Trial page ClinicalTrials.govUpdated 4 Sept 2009

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

Subjects

Terms as the source lists them.

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