CompletedNCT00729326Updated Apr 9, 2015Results posted

Comparison of the Effect of Exenatide Versus Sitagliptin on 24-hour Average Glucose in Patients With Type 2 Diabetes on Metformin or a Thiazolidinedione

A Phase 4 interventional study of exenatide and sitagliptin in Type 2 Diabetes Mellitus, sponsored by AstraZeneca. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-04-09.

Sponsored by AstraZeneca · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 83
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study summary

This study is designed to compare the short-term effects and mechanisms of action of exenatide with those of sitagliptin when either is added to an oral agent(metformin or a thiazolidinedione [TZD]) in adult patients with type 2 diabetes mellitus(T2DM) with inadequate glycemic control.

Conditions studied

Type 2 Diabetes Mellitus

Browse trials for

Keywords

diabetes
exenatide
sitagliptin
Amylin
Lilly
metformin
thiazolidinedione

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 83 is close to the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Have type 2 diabetes
Has HbA1c 7.0% to 11.0%, at or within 4 weeks prior to Visit 1.
Have a fasting glucose concentration \<280 mg/dL at Visit 1
Have been treated with a stable dose of immediate or extended release metformin for at least 60 days prior to screening OR TZD (rosiglitazone or pioglitazone) for at least 120 days prior to screening.
Are between 18 and 70 years of age, inclusive.
Have body mass index ≥25 kg/m2 and ≤45 kg/m2.
Have a history of stable body weight (not varying by >10% for at least 3 months prior to screening).
Can swallow oral study drug capsule, without splitting or crushing.

Exclusion criteria

Exclusion Criteria:

Female patients of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopause) who meet any of the following criteria:
- Are breastfeeding.
- Test positive for pregnancy at the time of screening.
- Intend to become pregnant during the study.
- Have not practiced a reliable method of birth control (for example, use of oral contraceptives or Norplant®; diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices; partner with vasectomy; or abstinence) for 3 months prior to screening.
Treated with any of the following medications:
- Insulin, exenatide, pramlintide, sulfonylureas or meglitinides within 3 months of screening
- Alpha-glucosidase inhibitor within 2 months of screening.
- Drugs that directly affect gastrointestinal motility, including, but not limited to metoclopramide, cisapride, and chronic macrolide antibiotics.
- Use of a drug for weight loss (for example, prescription drugs such as orlistat, sibutramine, phentermine, or similar over-the-counter medications) within 3 months prior to Visit 1.
- Systemic corticosteroids by oral, intravenous, or intramuscular route within 2 months of screening.
Have a history of renal transplantation or are currently receiving renal dialysis.
Have obvious clinical signs or symptoms of liver disease or acute or chronic hepatitis.
Have known active proliferative retinopathy or macular edema expected to need treatment with focal photocoagulation within 3 months.
Have an active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
Have had organ transplantation.
Have received GLP-1 analogs other than exenatide or DPP-4 inhibitors within the previous 3 months.
Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 83 participants (actual)

Study arms

Experimental
Sequence A
Drug: exenatide · Drug: sitagliptin · Drug: placebo
Experimental
Sequence B
Drug: exenatide · Drug: sitagliptin · Drug: placebo

Interventions

Drugexenatide
subcutaneous injection (5mcg or 10mcg), twice a day
Also known as: Byetta
Drugsitagliptin
oral administration (100mg), once a day in the morning
Also known as: Januvia
Drugplacebo
subcutaneous injection (5mcg or 10mcg), twice a day
Drugplacebo
oral administration (100mg), once a day in the morning

What researchers measure

Primary outcomes

Change in Time-averaged Glucose During a 24 Hour Period
Change in time-averaged glucose during a 24-hour period from baseline to endpoint (i.e., time-averaged glucose over 24 hours at endpoint minus time-averaged glucose over 24 hours at baseline).
Time frame: baseline and 8 Weeks

Secondary outcomes

Change in Two-hour Postprandial Glucose After the Morning Meal
Change in 2 hour post-prandial glucose after the morning meal from baseline to endpoint (i.e., glucose level 2 hours after the morning meal at baseline minus glucose level 2 hours after the morning meal at endpoint)
Time frame: baseline and 8 Weeks
Change in Fasting Blood Glucose After the Morning Meal
Change in fasting blood glucose after the morning meal from baseline to endpoint (i.e., fasting blood glucose after the morning meal at baseline minus fasting blood glucose after the morning meal at endpoint)
Time frame: baseline and 8 Weeks
Change in Postprandial Glucagon Area Under the Concentration-time Curve (AUC) After the Morning Meal
Change in Postprandial Glucagon AUC after the morning meal (t=0 to 4 hours) (i.e., Glucagon AUC over the first 4 hours following the morning meal at baseline minus glucagon AUC over the first 4 hours following the morning meal at endpoint)
Time frame: baseline and 8 Weeks
Change in Postprandial Glucagon AUC Excursion After the Morning Meal
Change in postprandial glucagon AUC excursion after the morning meal (t=0 to 4 hours) (i.e., glucagon AUC excursion for 4 hours following the morning meal at baseline minus glucagon AUC excursion for 4 hours following the morning meal at endpoint)
Time frame: baseline and 8 Weeks
Change in Postprandial Triglyceride AUC After the Morning Meal
Change in postprandial triglyceride AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial triglyceride AUC after the morning meal at baseline minus postprandial triglyceride AUC after the morning meal at endpoint)
Time frame: baseline and 8 Weeks
Change in Postprandial Triglyceride AUC Excursion After the Morning Meal
Change in postprandial triglyceride AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial triglyceride AUC excursion after the morning meal at baseline minus postprandial triglyceride AUC excursion after the morning meal at endpoint)
Time frame: baseline and 8 Weeks
Change in Postprandial C-peptide AUC After the Morning Meal
Change in postprandial C-peptide AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial C-peptide AUC after the morning meal at baseline minus postprandial C-peptide AUC after the morning meal at endpoint)
Time frame: baseline and 8 Weeks
Change in Postprandial C-peptide AUC Excursion After the Morning Meal
Change in Postprandial C-peptide AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial C-peptide AUC excursion after the morning meal at baseline minus postprandial C-peptide AUC excursion after the morning meal at endpoint)
Time frame: baseline and 8 Weeks
Change in Postprandial Insulin AUC After the Morning Meal
Change in postprandial insulin AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial insulin AUC after the morning meal at baseline minus postprandial insulin AUC after the morning meal at endpoint)
Time frame: baseline and 8 Weeks
Change in Postprandial Insulin AUC Excursion After the Morning Meal
Change in Postprandial insulin AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial insulin AUC excursion after the morning meal at baseline minus postprandial insulin AUC excursion after the morning meal at endpoint)
Time frame: baseline and 8 Weeks
Change in Postprandial Active GLP-1 AUC After the Morning Meal
Change in Postprandial active GLP-1 AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial active GLP-1 AUC after the morning meal at baseline minus postprandial active GLP-1 AUC after the morning meal at endpoint)
Time frame: baseline and 8 Weeks
Change in Postprandial Active GLP-1 AUC Excursion After the Monrning Meal
Change in Postprandial active GLP-1 AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial active GLP-1 AUC excursion after the morning meal at baseline minus postprandial active GLP-1 AUC excursion after the morning meals at endpoint)
Time frame: baseline and 8 Weeks
Percentage of Patients Experiencing Hypoglycemia (Baseline to Week 4)
Percentage of patients experiencing minor hypoglycemia with a confirmed glucose \<54mg/dL
Time frame: 4 Weeks
Episodes of Hypoglycemia (Baseline to Week 4)
Number of episodes of hypoglycemia experienced during the first 4 weeks of the study
Time frame: 4 weeks
Percentage of Patients Experiencing Hypoglycemia (Week 4 to Week 8)
Percentage of patients experiencing minor hypoglycemia with a confirmed glucose \<54mg/dL
Time frame: 8 weeks
Episodes of Hypoglycemia (Week 4 to Week 8)
Number of episodes of hypoglycemia experienced between week 4 and week 8 of the study
Time frame: 8 weeks
Percentage of Patients Experiencing Hypoglycemia (Overall)
Percentage of patients experiencing minor hypoglycemia with a confirmed glucose \<54mg/dL
Time frame: 4 weeks and 8 weeks
Episodes of Hypoglycemia (Overall)
Number of episodes of hypoglycemia experienced overall during the study
Time frame: 4 weeks and 8 weeks

Results

Posted Jan 20, 2011

Participant flow

Participant flow — Overall Study
Milestone	Exenatide Followed By Sitagliptin	Sitagliptin Followed By Exenatide
Started	41	42
Completed	31	33
Not completed	10	9
Withdrew: Lost to follow-up	2	0
Withdrew: Physician decision	0	1
Withdrew: Protocol violation	3	2
Withdrew: Subject decision	4	4
Withdrew: Sponsor decision	1	2

Outcome measures

PrimaryChange in Time-averaged Glucose During a 24 Hour Period

Change in time-averaged glucose during a 24-hour period from baseline to endpoint (i.e., time-averaged glucose over 24 hours at endpoint minus time-averaged glucose over 24 hours at baseline).

Time frame:: baseline and 8 Weeks
Reported as:: Least squares mean · mg/dL

Change in Time-averaged Glucose During a 24 Hour Period
mg/dL	Exenatide	Sitagliptin
Change in Time-averaged Glucose During a 24 Hour Period	-41.65 ± 2.55	-29.56 ± 2.58

Statistical analysis

Exenatide vs Sitagliptin · ANCOVA · p = <.001 (The p-values were not adjusted. The primary measure was change in 24-hour glucose without multiplicity adjustments for other analyses.)Analyses for continuous variables adjusted for treatment, period, sequence, baseline of the continuous variable.Analysis method was Grizzle's model.

SecondaryChange in Two-hour Postprandial Glucose After the Morning Meal

Change in 2 hour post-prandial glucose after the morning meal from baseline to endpoint (i.e., glucose level 2 hours after the morning meal at baseline minus glucose level 2 hours after the morning meal at endpoint)

Time frame:: baseline and 8 Weeks
Reported as:: Least squares mean · mg/dL

Change in Two-hour Postprandial Glucose After the Morning Meal
mg/dL	Exenatide	Sitagliptin
Change in Two-hour Postprandial Glucose After the Morning Meal	-108.35 ± 4.36	-44.43 ± 4.40

Statistical analysis

Exenatide vs Sitagliptin · ANCOVA · p = <.001

SecondaryChange in Fasting Blood Glucose After the Morning Meal

Change in fasting blood glucose after the morning meal from baseline to endpoint (i.e., fasting blood glucose after the morning meal at baseline minus fasting blood glucose after the morning meal at endpoint)

Time frame:: baseline and 8 Weeks
Reported as:: Least squares mean · mg/dL

Change in Fasting Blood Glucose After the Morning Meal
mg/dL	Exenatide	Sitagliptin
Change in Fasting Blood Glucose After the Morning Meal	-28.93 ± 2.70	-28.22 ± 2.71

Statistical analysis

Exenatide vs Sitagliptin · ANCOVA · p = .766

SecondaryChange in Postprandial Glucagon Area Under the Concentration-time Curve (AUC) After the Morning Meal

Change in Postprandial Glucagon AUC after the morning meal (t=0 to 4 hours) (i.e., Glucagon AUC over the first 4 hours following the morning meal at baseline minus glucagon AUC over the first 4 hours following the morning meal at endpoint)

Time frame:: baseline and 8 Weeks
Reported as:: Least squares mean · pmol*hours/L

Change in Postprandial Glucagon Area Under the Concentration-time Curve (AUC) After the Morning Meal
pmol*hours/L	Exenatide	Sitagliptin
Change in Postprandial Glucagon Area Under the Concentration-time Curve (AUC) After the Morning Meal	-29.60 ± 2.91	-16.91 ± 2.93

Statistical analysis

Exenatide vs Sitagliptin · ANCOVA · p = <.001

SecondaryChange in Postprandial Glucagon AUC Excursion After the Morning Meal

Change in postprandial glucagon AUC excursion after the morning meal (t=0 to 4 hours) (i.e., glucagon AUC excursion for 4 hours following the morning meal at baseline minus glucagon AUC excursion for 4 hours following the morning meal at endpoint)

Time frame:: baseline and 8 Weeks
Reported as:: Least squares mean · pmol*hours/L

Change in Postprandial Glucagon AUC Excursion After the Morning Meal
pmol*hours/L	Exenatide	Sitagliptin
Change in Postprandial Glucagon AUC Excursion After the Morning Meal	-30.94 ± 2.12	-14.93 ± 2.13

Statistical analysis

Exenatide vs Sitagliptin · ANCOVA · p = <.001

SecondaryChange in Postprandial Triglyceride AUC After the Morning Meal

Change in postprandial triglyceride AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial triglyceride AUC after the morning meal at baseline minus postprandial triglyceride AUC after the morning meal at endpoint)

Time frame:: baseline and 8 Weeks
Reported as:: Least squares mean · mg*hours/dL

Change in Postprandial Triglyceride AUC After the Morning Meal
mg*hours/dL	Exenatide	Sitagliptin
Change in Postprandial Triglyceride AUC After the Morning Meal	0.83 ± 0.03	0.87 ± 0.03

Statistical analysis

Exenatide vs Sitagliptin · ANCOVA · p = .117

SecondaryChange in Postprandial Triglyceride AUC Excursion After the Morning Meal

Change in postprandial triglyceride AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial triglyceride AUC excursion after the morning meal at baseline minus postprandial triglyceride AUC excursion after the morning meal at endpoint)

Time frame:: baseline and 8 Weeks
Reported as:: Least squares mean · mg*hours/dL

Change in Postprandial Triglyceride AUC Excursion After the Morning Meal
mg*hours/dL	Exenatide	Sitagliptin
Change in Postprandial Triglyceride AUC Excursion After the Morning Meal	-108.16 ± 8.38	-41.39 ± 8.45

Statistical analysis

Exenatide vs Sitagliptin · ANCOVA · p = <.001

SecondaryChange in Postprandial C-peptide AUC After the Morning Meal

Change in postprandial C-peptide AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial C-peptide AUC after the morning meal at baseline minus postprandial C-peptide AUC after the morning meal at endpoint)

Time frame:: baseline and 8 Weeks
Reported as:: Least squares mean · nmol*hours/L

Change in Postprandial C-peptide AUC After the Morning Meal
nmol*hours/L	Exenatide	Sitagliptin
Change in Postprandial C-peptide AUC After the Morning Meal	-1.78 ± 0.28	0.25 ± 0.28

Statistical analysis

Exenatide vs Sitagliptin · ANCOVA · p = <.001

SecondaryChange in Postprandial C-peptide AUC Excursion After the Morning Meal

Change in Postprandial C-peptide AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial C-peptide AUC excursion after the morning meal at baseline minus postprandial C-peptide AUC excursion after the morning meal at endpoint)

Time frame:: baseline and 8 Weeks
Reported as:: Least squares mean · nmol*hours/L

Change in Postprandial C-peptide AUC Excursion After the Morning Meal
nmol*hours/L	Exenatide	Sitagliptin
Change in Postprandial C-peptide AUC Excursion After the Morning Meal	-2.83 ± 0.29	0.14 ± 0.29

Statistical analysis

Exenatide vs Sitagliptin · ANCOVA · p = <.001

SecondaryChange in Postprandial Insulin AUC After the Morning Meal

Change in postprandial insulin AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial insulin AUC after the morning meal at baseline minus postprandial insulin AUC after the morning meal at endpoint)

Time frame:: baseline and 8 Weeks
Reported as:: Least squares mean · pmol*hours/L

Change in Postprandial Insulin AUC After the Morning Meal
pmol*hours/L	Exenatide	Sitagliptin
Change in Postprandial Insulin AUC After the Morning Meal	-396.12 ± 56.79	-8.79 ± 57.32

Statistical analysis

Exenatide vs Sitagliptin · ANCOVA · p = <.001

SecondaryChange in Postprandial Insulin AUC Excursion After the Morning Meal

Change in Postprandial insulin AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial insulin AUC excursion after the morning meal at baseline minus postprandial insulin AUC excursion after the morning meal at endpoint)

Time frame:: baseline and 8 Weeks
Reported as:: Least squares mean · pmol*hours/L

Change in Postprandial Insulin AUC Excursion After the Morning Meal
pmol*hours/L	Exenatide	Sitagliptin
Change in Postprandial Insulin AUC Excursion After the Morning Meal	-525.01 ± 58.77	-34.83 ± 59.40

Statistical analysis

Exenatide vs Sitagliptin · ANCOVA · p = <.001

SecondaryChange in Postprandial Active GLP-1 AUC After the Morning Meal

Change in Postprandial active GLP-1 AUC after the morning meal (t=0 to 4 hours) (i.e., postprandial active GLP-1 AUC after the morning meal at baseline minus postprandial active GLP-1 AUC after the morning meal at endpoint)

Time frame:: baseline and 8 Weeks
Reported as:: Least squares mean · pmol*hours/L

Change in Postprandial Active GLP-1 AUC After the Morning Meal
pmol*hours/L	Exenatide	Sitagliptin
Change in Postprandial Active GLP-1 AUC After the Morning Meal	-14.28 ± 3.12	47.37 ± 3.15

Statistical analysis

Exenatide vs Sitagliptin · ANCOVA · p = <.001

SecondaryChange in Postprandial Active GLP-1 AUC Excursion After the Monrning Meal

Change in Postprandial active GLP-1 AUC excursion after the morning meal (t=0 to 4 hours) (i.e., postprandial active GLP-1 AUC excursion after the morning meal at baseline minus postprandial active GLP-1 AUC excursion after the morning meals at endpoint)

Time frame:: baseline and 8 Weeks
Reported as:: Least squares mean · pmol*hours/L

Change in Postprandial Active GLP-1 AUC Excursion After the Monrning Meal
pmol*hours/L	Exenatide	Sitagliptin
Change in Postprandial Active GLP-1 AUC Excursion After the Monrning Meal	-14.04 ± 3.28	23.53 ± 3.31

Statistical analysis

Exenatide vs Sitagliptin · ANCOVA · p = <.001

SecondaryPercentage of Patients Experiencing Hypoglycemia (Baseline to Week 4)

Percentage of patients experiencing minor hypoglycemia with a confirmed glucose \<54mg/dL

Time frame:: 4 Weeks
Reported as:: Number · Percentage of patients

Percentage of Patients Experiencing Hypoglycemia (Baseline to Week 4)
Percentage of patients	Exenatide	Sitagliptin
Percentage of Patients Experiencing Hypoglycemia (Baseline to Week 4)	2.9	2.7

SecondaryEpisodes of Hypoglycemia (Baseline to Week 4)

Number of episodes of hypoglycemia experienced during the first 4 weeks of the study

Time frame:: 4 weeks
Reported as:: Number · episodes of hypoglycemia

Episodes of Hypoglycemia (Baseline to Week 4)
episodes of hypoglycemia	Exenatide	Sitagliptin
Episodes of Hypoglycemia (Baseline to Week 4)	1	1

SecondaryPercentage of Patients Experiencing Hypoglycemia (Week 4 to Week 8)

Percentage of patients experiencing minor hypoglycemia with a confirmed glucose \<54mg/dL

Time frame:: 8 weeks
Reported as:: Number · Percentage of patients

Percentage of Patients Experiencing Hypoglycemia (Week 4 to Week 8)
Percentage of patients	Exenatide	Sitagliptin
Percentage of Patients Experiencing Hypoglycemia (Week 4 to Week 8)	5.7	0.0

SecondaryEpisodes of Hypoglycemia (Week 4 to Week 8)

Number of episodes of hypoglycemia experienced between week 4 and week 8 of the study

Time frame:: 8 weeks
Reported as:: Number · episodes of hypoglycemia

Episodes of Hypoglycemia (Week 4 to Week 8)
episodes of hypoglycemia	Exenatide	Sitagliptin
Episodes of Hypoglycemia (Week 4 to Week 8)	2	0

SecondaryPercentage of Patients Experiencing Hypoglycemia (Overall)

Percentage of patients experiencing minor hypoglycemia with a confirmed glucose \<54mg/dL

Time frame:: 4 weeks and 8 weeks
Reported as:: Number · Percentage of patients

Percentage of Patients Experiencing Hypoglycemia (Overall)
Percentage of patients	Exenatide	Sitagliptin
Percentage of Patients Experiencing Hypoglycemia (Overall)	4.3	1.4

SecondaryEpisodes of Hypoglycemia (Overall)

Number of episodes of hypoglycemia experienced overall during the study

Time frame:: 4 weeks and 8 weeks
Reported as:: Number · episodes of hypoglycemia

Episodes of Hypoglycemia (Overall)
episodes of hypoglycemia	Exenatide	Sitagliptin
Episodes of Hypoglycemia (Overall)	3	1

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Exenatide	—	2/73 (2.7%)	43/73 (58.9%)
Sitagliptin	—	0/73 (0%)	37/73 (50.7%)

Most frequent serious events

Most frequent serious events
Event	Exenatide	Sitagliptin
Anaphylactic reactionImmune system disorders	1/73	0/73
AngioedemaSkin and subcutaneous tissue disorders	1/73	0/73
Confusional statePsychiatric disorders	1/73	0/73

Most frequent other events

Showing 10 of 13

Most frequent other events
Event	Exenatide	Sitagliptin
NauseaGastrointestinal disorders	27/73	12/73
VomitingGastrointestinal disorders	15/73	4/73
HeadacheNervous system disorders	9/73	9/73
DiarrhoeaGastrointestinal disorders	7/73	8/73
DizzinessNervous system disorders	7/73	5/73
Back painMusculoskeletal and connective tissue disorders	6/73	5/73
CoughRespiratory, thoracic and mediastinal disorders	4/73	5/73
RhinorrhoeaRespiratory, thoracic and mediastinal disorders	3/73	5/73
Nasal congestionRespiratory, thoracic and mediastinal disorders	2/73	5/73
Abdominal discomfortGastrointestinal disorders	4/73	3/73

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Exenatide Followed By Sitagliptin	Sitagliptin Followed By Exenatide	Total
<=18 years	0	0	0
Between 18 and 65 years	34	37	71
>=65 years	7	5	12

Age, Continuous
Age, Continuous(years)	Exenatide Followed By Sitagliptin	Sitagliptin Followed By Exenatide	Total
Mean	54.7 ± 10.10	53.5 ± 9.49	54.1 ± 9.75

Sex: Female, Male
Sex: Female, Male(Participants)	Exenatide Followed By Sitagliptin	Sitagliptin Followed By Exenatide	Total
Female	19	29	48
Male	22	13	35

Study locations

1 site

Research Site
San Antonio, Texas, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 9, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00729326
Lead sponsor: AstraZeneca
Collaborators: Eli Lilly and Company
Responsible party: Sponsor
First posted: Aug 7, 2008
Start date: Aug 2008
Primary completion: Oct 2009
Completion: Oct 2009
Results posted: Jan 20, 2011
Last update: Apr 9, 2015

Study contacts

Chief Medical Officer, MD

study director · Eli Lilly and Company

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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Comparison of the Effect of Exenatide Versus Sitagliptin on 24-hour Average Glucose in Patients With Type 2 Diabetes on Metformin or a Thiazolidinedione

Study summary

Conditions studied

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Keywords

In context

Diabetes Mellitus

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Who can participate

✓Inclusion criteria

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Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

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Outcome measures

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Baseline characteristics

Study locations

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