CompletedPhase 3Results posted

An Evaluation of Exenatide and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus

An Evaluation of the Metabolic Effects of Exenatide, Rosiglitazone, and Exenatide Plus Rosiglitazone in Subjects With Type 2 Diabetes Mellitus Treated With Metformin

Lead sponsor

AstraZeneca

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

137

Study population

Type 2 diabetes

Eligibility highlights

•BMI 25-40•HbA1c 6.8-10%

Primary endpoint

•C-peptide AUC

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00135330

Org study IDH8O-US-GWAY

Timeline

Milestones

Study first posted2005-08-26estimated

Results first posted2009-08-28estimated

Last update posted2015-04-07estimated

Study start2005-10 (month precision)

Primary completion2008-07actual (month precision)

Study completion2008-07actual (month precision)

Assets

Investigational agents

Exenatide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•HbA1c of 6.8% to 10.0%, inclusive.

•Body mass index (BMI) of 25 kg/m^2 to 40 kg/m^2, inclusive.

Exclusion criteria

•Have participated in this study previously, or have received exenatide, pramlintide acetate, GLP-1 analogs, or dipeptidyl peptidase-IV (DPP-IV) inhibitors

•Have participated in an interventional, medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of study start. This criterion includes drugs that have not received regulatory approval for any indication at the time of study start.

•Treated with any of the following medications:

-Thiazolidinedione within 5 months of screening;

-Sulfonylurea within 3 months of screening;

-Metformin/sulfonylurea combination therapy within 3 months of screening;

-Alpha-glucosidase inhibitor within 3 months of screening;

-Meglitinide within 3 months of screening;

-Insulin for more than 1 week within the 3 months prior to screening.

-Symlin (pramlintide acetate) injection or Byetta (exenatide) injection at any time

-Chronic (more than 2 weeks) or recent (within 4 weeks of study start) use of a drug that directly affects gastrointestinal motility

-Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding study start

-Regular use of a medication with addictive potential such as an opiate, narcotic, or tranquilizer

-Systemic antineoplastic agent

-Systemic transplantation medication

-Drugs for weight loss, including over-the-counter medications, within the 4 months prior to study start

Endpoints (29)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Weight & body composition

Cardiometabolic biomarkers

Safety / tolerability / PK

Weight & body composition

7 endpoints

Secondary/protocol endpoint

Change in Body Weight

Time frame:Week 20

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Least-squares mean · kg	95% CI
ExenatideBaseline body weight	93.05	-
Change in body weight at week 20	-2.82	-
Exenatide Plus RosiglitazoneBaseline body weight	93.76	-
Change in body weight at week 20	-1.21	-
RosiglitazoneBaseline body weight	91.78	-
Change in body weight at week 20	1.48	-

p<0.001MMRM

Secondary/protocol endpoint

Change in Percent Body Fat During a Meal Challenge Test (MCT)

Time frame:20 weeks

change from baseline, improvement

Posted result

Group	Least-squares mean · percentage	95% CI
ExenatideBaseline percent body fat	33.42	-
Change in percent body fat at week 20	-1.40	-
Exenatide Plus RosiglitazoneBaseline percent body fat	34.07	-
Change in percent body fat at week 20	-0.347	-
RosiglitazoneBaseline percent body fat	32.50	-
Change in percent body fat at week 20	-1.18	-

p0.581ANCOVA

Secondary/protocol endpoint

Change in Body Fat Mass During a Meal Challenge Test (MCT)

Time frame:20 weeks

Total fat mass

change from baseline, improvement

Posted result

Group	Least-squares mean · kg	95% CI
ExenatideBaseline body fat mass	32.05	-
Change in body fat mass at week 20	-2.76	-
Exenatide Plus RosiglitazoneBaseline body fat mass	32.55	-
Change in body fat mass at week 20	-1.06	-
RosiglitazoneBaseline body fat mass	30.54	-
Change in body fat mass at week 20	-1.99	-

p0.631ANCOVA

Secondary/protocol endpoint

Change in Lean Body Mass During a Meal Challenge Test (MCT)

Time frame:20 weeks

Lean mass

change from baseline, improvement

Posted result

Group	Least-squares mean · kg	95% CI
ExenatideBaseline lean body mass	64.62	-
Change in lean body mass at week 20	-2.99	-
Exenatide Plus RosiglitazoneBaseline lean body mass	60.94	-
Change in lean body mass at week 20	0.532	-
RosiglitazoneBaseline lean body mass	61.09	-
Change in lean body mass at week 20	1.23	-

p0.724ANCOVA

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:20 weeks

Waist circumference, change

change from baseline, improvement

Posted result

Group	Least-squares mean · cm	95% CI
ExenatideBaseline waist circumference	105.98	-
Change in waist circumference at Week 20	-2.95	-
Exenatide Plus RosiglitazoneBaseline waist circumference	106.85	-
Change in waist circumference at Week 20	-2.38	-
RosiglitazoneBaseline waist circumference	105.34	-
Change in waist circumference at Week 20	-0.225	-

p0.117MMRM

Secondary/protocol endpoint

Change in Hip Circumference

Time frame:20 weeks

change from baseline, improvement

Posted result

Group	Least-squares mean · cm	95% CI
ExenatideBaseline hip circumference	113.29	-
Change in hip circumference at week 20	-1.28	-
Exenatide Plus RosiglitazoneBaseline hip circumference	112.12	-
Change in hip circumference at week 20	0.147	-
RosiglitazoneBaseline hip circumference	111.90	-
Change in hip circumference at week 20	1.51	-

p0.251MMRM

Secondary/protocol endpoint

Change in Waist-to-hip Ratio

Time frame:20 weeks

change from baseline, improvement

Posted result

Group	Least-squares mean · ratio (cm/cm)	95% CI
ExenatideBaseline waist-to-hip ratio	0.939	-
Change in waist-to-hip ratio at week 20	-0.016	-
Exenatide Plus RosiglitazoneBaseline waist-to-hip ratio	0.957	-
Change in waist-to-hip ratio at week 20	-0.022	-
RosiglitazoneBaseline waist-to-hip ratio	0.943	-
Change in waist-to-hip ratio at week 20	-0.016	-

p0.710MMRM

Glycemic / diabetes

15 endpoints

Primary/protocol endpoint

Change in ASIiAUC During a Hyperglycemic Clamp Test.

Time frame:20 weeks

C-peptide AUC

change from baseline, improvement

Posted result

Group	Least-squares mean · uIU-min/ml	95% CI
ExenatideBaseline ASIiAUC	643.40	-
Change in ASIiAUC at week 20	747.26	-
Exenatide Plus RosiglitazoneBaseline ASIiAUC	686.41	-
Change in ASIiAUC at week 20	194.68	-
RosiglitazoneBaseline ASIiAUC	786.12	-
Change in ASIiAUC at week 20	-99.85	-

p0.282ANCOVA

The ratio of the ASI-iAUC at Week 20 to that at baseline was compared between the treatment groups.

Secondary/protocol endpoint

Change in AUC for Glucose During a Meal Challenge Test (MCT).

Time frame:Week 20

Postprandial glucose

change from baseline, improvement

Posted result

Group	Least-squares mean · mmol-min/L	95% CI
ExenatideBaseline glucose AUC during MCT	1782.86	-
Change in glucose AUC during MCT at week 20	-560.12	-
Exenatide Plus RosiglitazoneBaseline glucose AUC during MCT	1799.68	-
Change in glucose AUC during MCT at week 20	-635.24	-
RosiglitazoneBaseline glucose AUC during MCT	1741.87	-
Change in glucose AUC during MCT at week 20	-425.59	-

p0.004ANCOVA

Secondary/protocol endpoint

Change in Insulin Sensitivity Index as Measured by M-value.

Time frame:Week 20

change from baseline, improvement

Posted result

Group	Least-squares mean · mg/kg-min	95% CI
ExenatideM-Value at baseline	3.89	-
Change in M-Value from baseline at week 20	0.477	-
Exenatide Plus RosiglitazoneM-Value at baseline	2.49	-
Change in M-Value from baseline at week 20	2.07	-
RosiglitazoneM-Value at baseline	4.02	-
Change in M-Value from baseline at week 20	1.42	-

p0.308ANCOVA

Secondary/protocol endpoint/low confidence

Change in Insulin AUC in the First Stage From Baseline to Endpoint.

Time frame:Week 20

change from baseline, improvement

Posted result

Group	Least-squares mean · uIU-min/ml	95% CI
ExenatideBaseline insulin AUC	200.50	-
Change from baseline insulin AUC at week 20	134.88	-
Exenatide Plus RosiglitazoneBaseline insulin AUC	136.84	-
Change from baseline insulin AUC at week 20	32.12	-
RosiglitazoneBaseline insulin AUC	157.49	-
Change from baseline insulin AUC at week 20	-50.81	-

p0.079ANCOVA

Secondary/protocol endpoint

Change in Insulin iAUC From Baseline to Endpoint.

Time frame:Week 20

change from baseline, improvement

Posted result

Group	Least-squares mean · uIU-min/ml	95% CI
ExenatideBaseline insulin iAUC	5.98	-
Change from baseline insulin iAUC at week 20	99.08	-
Exenatide Plus RosiglitazoneBaseline insulin iAUC	-9.92	-
Change from baseline insulin iAUC at week 20	53.71	-
RosiglitazoneBaseline insulin iAUC	23.09	-
Change from baseline insulin iAUC at week 20	11.51	-

p0.252ANCOVA

Secondary/protocol endpoint/low confidence

Ratio (Value at Endpoint Divided by Value at Baseline) of AUC for Insulin During a Meal Challenge Test (MCT).

Time frame:Week 20

ratio, improvement

Posted result

Group	Geometric mean · uIU-min/ml	95% CI
ExenatideBaseline AUC for insulin during MCT	5171.40	-
Ratio(endpoint/baseline) of insulin AUC during MCT	0.806	-
Exenatide Plus RosiglitazoneBaseline AUC for insulin during MCT	4324.13	-
Ratio(endpoint/baseline) of insulin AUC during MCT	0.664	-
RosiglitazoneBaseline AUC for insulin during MCT	5816.83	-
Ratio(endpoint/baseline) of insulin AUC during MCT	0.722	-

p0.465ANCOVA

Secondary/protocol endpoint

Change in AUC for C-peptide During a Meal Challenge Test (MCT).

Time frame:Week 20

C-peptide AUC

ratio, improvement

Posted result

Group	Geometric mean · nmol-min/L	95% CI
ExenatideBaseline C-peptide during a MCT	319.77	-
Ratio(endpoint/baseline) of C-peptide during a MCT	0.908	-
Exenatide Plus RosiglitazoneBaseline C-peptide during a MCT	310.51	-
Ratio(endpoint/baseline) of C-peptide during a MCT	0.804	-
RosiglitazoneBaseline C-peptide during a MCT	325.65	-
Ratio(endpoint/baseline) of C-peptide during a MCT	0.854	-

p0.348ANCOVA

Secondary/protocol endpoint

Change in Incremental for Postprandial Glucose During a Meal Challenge Test (MCT).

Time frame:Week 20

Postprandial glucose

change from baseline, improvement

Posted result

Group	Least-squares mean · mmol/L	95% CI
ExenatideBaseline glucose at 15 min	0.950	-
Change fr baseline glucose at 15 min at wk 20	-0.651	-
Baseline glucose at 30 min	2.39	-
Change fr baseline glucose at 30 min at wk 20	-1.46	-
Baseline glucose at 60 minutes	3.59	-
Change fr baseline glucose at 60 min at wk 20	-2.56	-
Baseline glucose at 90 minutes	3.24	-
Change fr baseline glucose at 90 min at wk 20	-2.87	-
Baseline glucose at 120 minutes	2.49	-
Change fr baseline glucose at 120 min at wk 20	-2.24	-
Baseline glucose at 150 minutes	1.62	-
Change fr baseline glucose at 150 min at wk 20	-1.42	-
Baseline glucose at 180 minutes	0.461	-
Change fr baseline glucose at 180 min at wk 20	-0.583	-
Exenatide Plus RosiglitazoneBaseline glucose at 15 min	1.12	-
Change fr baseline glucose at 15 min at wk 20	-0.286	-
Baseline glucose at 30 min	2.54	-
Change fr baseline glucose at 30 min at wk 20	-1.06	-
Baseline glucose at 60 minutes	3.88	-
Change fr baseline glucose at 60 min at wk 20	-2.46	-
Baseline glucose at 90 minutes	3.36	-
Change fr baseline glucose at 90 min at wk 20	-2.91	-
Baseline glucose at 120 minutes	2.24	-
Change fr baseline glucose at 120 min at wk 20	-2.52	-
Baseline glucose at 150 minutes	1.14	-
Change fr baseline glucose at 150 min at wk 20	-1.95	-
Baseline glucose at 180 minutes	0.036	-
Change fr baseline glucose at 180 min at wk 20	-0.995	-
RosiglitazoneBaseline glucose at 15 min	0.828	-
Change fr baseline glucose at 15 min at wk 20	0.150	-
Baseline glucose at 30 min	2.23	-
Change fr baseline glucose at 30 min at wk 20	-0.066	-
Baseline glucose at 60 minutes	3.48	-
Change fr baseline glucose at 60 min at wk 20	-0.720	-
Baseline glucose at 90 minutes	3.48	-
Change fr baseline glucose at 90 min at wk 20	-0.952	-
Baseline glucose at 120 minutes	2.31	-
Change fr baseline glucose at 120 min at wk 20	-0.912	-
Baseline glucose at 150 minutes	1.25	-
Change fr baseline glucose at 150 min at wk 20	-0.830	-
Baseline glucose at 180 minutes	0.279	-
Change fr baseline glucose at 180 min at wk 20	-0.481	-

Secondary/protocol endpoint

Change in Incremental for Postprandial Insulin During Meal Challenge Test (MCT).

Time frame:Week 20

change from baseline, improvement

Posted result

Group	Least-squares mean · mmol/L	95% CI
ExenatideBaseline insulin at 15 min	9.97	-
Change fr baseline insulin at 15 min at wk 20	-1.71	-
Baseline insulin at 30 min	19.81	-
Change fr baseline insulin at 30 min at wk 20	-3.00	-
Baseline insulin at 60 min	27.92	-
Change fr baseline insulin at 60 min at wk 20	-11.04	-
Baseline insulin at 90 min	26.06	-
Change fr baseline insulin at 90 min at wk 20	-9.42	-
Baseline insulin at 120 min	19.56	-
Change fr baseline insulin at 120 min at wk 20	-11.26	-
Baseline insulin at 150 min	15.67	-
Change fr baseline insulin at 150 min at wk 20	-7.48	-
Baseline insulin at 180 min	10.58	-
Change fr baseline insulin at 180 min at wk 20	0.031	-
Exenatide Plus RosiglitazoneBaseline insulin at 15 min	8.09	-
Change fr baseline insulin at 15 min at wk 20	-1.84	-
Baseline insulin at 30 min	14.79	-
Change fr baseline insulin at 30 min at wk 20	-2.63	-
Baseline insulin at 60 min	27.67	-
Change fr baseline insulin at 60 min at wk 20	-7.47	-
Baseline insulin at 90 min	21.85	-
Change fr baseline insulin at 90 min at wk 20	-9.27	-
Baseline insulin at 120 min	17.52	-
Change fr baseline insulin at 120 min at wk 20	-8.69	-
Baseline insulin at 150 min	12.74	-
Change fr baseline insulin at 150 min at wk 20	-8.13	-
Baseline insulin at 180 min	8.18	-
Change fr baseline insulin at 180 min at wk 20	-5.26	-
RosiglitazoneBaseline insulin at 15 min	7.53	-
Change fr baseline insulin at 15 min at wk 20	-0.455	-
Baseline insulin at 30 min	18.83	-
Change fr baseline insulin at 30 min at wk 20	-1.04	-
Baseline insulin at 60 min	32.09	-
Change fr baseline insulin at 60 min at wk 20	-7.42	-
Baseline insulin at 90 min	32.25	-
Change fr baseline insulin at 90 min at wk 20	-6.19	-
Baseline insulin at 120 min	25.47	-
Change fr baseline insulin at 120 min at wk 20	-6.43	-
Baseline insulin at 150 min	18.11	-
Change fr baseline insulin at 150 min at wk 20	-5.57	-
Baseline insulin at 180 min	10.74	-
Change fr baseline insulin at 180 min at wk 20	-4.04	-

Secondary/protocol endpoint

Change in Incremental for Postprandial C-peptide During Meal Challenge Test (MCT).

Time frame:Week 20

C-peptide AUC

change from baseline, improvement

Posted result

Group	Least-squares mean · mmol/L	95% CI
ExenatideBaseline C-peptide at 15 min	0.238	-
Change fr baseline C-peptide at 15 min at week 20	-0.006	-
Baseline C-peptide at 30 min	0.521	-
Change fr baseline C-peptide at 30 min at week 20	-0.071	-
Baseline C-peptide at 60 min	0.818	-
Change fr baseline C-peptide at 60 min at week 20	-0.148	-
Baseline C-peptide at 90 min	0.895	-
Change fr baseline C-peptide at 90 min at week 20	-0.185	-
Baseline C-peptide at 120 min	0.817	-
Change fr baseline C-peptide at 120 min at week 20	-0.259	-
Baseline C-peptide at 150 min	0.843	-
Change fr baseline C-peptide at 150 min at week 20	-0.251	-
Baseline C-peptide at 180 min	0.610	-
Change fr baseline C-peptide at 180 min at week 20	-0.075	-
Exenatide Plus RosiglitazoneBaseline C-peptide at 15 min	0.259	-
Change fr baseline C-peptide at 15 min at week 20	0.016	-
Baseline C-peptide at 30 min	0.517	-
Change fr baseline C-peptide at 30 min at week 20	-0.036	-
Baseline C-peptide at 60 min	0.871	-
Change fr baseline C-peptide at 60 min at week 20	-0.025	-
Baseline C-peptide at 90 min	0.953	-
Change fr baseline C-peptide at 90 min at week 20	-0.117	-
Baseline C-peptide at 120 min	0.828	-
Change fr baseline C-peptide at 120 min at week 20	-0.134	-
Baseline C-peptide at 150 min	0.651	-
Change fr baseline C-peptide at 150 min at week 20	-0.254	-
Baseline C-peptide at 180 min	0.482	-
Change fr baseline C-peptide at 180 min at week 20	-0.238	-
RosiglitazoneBaseline C-peptide at 15 min	0.206	-
Change fr baseline C-peptide at 15 min at week 20	0.087	-
Baseline C-peptide at 30 min	0.560	-
Change fr baseline C-peptide at 30 min at week 20	0.099	-
Baseline C-peptide at 60 min	0.881	-
Change fr baseline C-peptide at 60 min at week 20	0.054	-
Baseline C-peptide at 90 min	1.03	-
Change fr baseline C-peptide at 90 min at week 20	-0.052	-
Baseline C-peptide at 120 min	0.972	-
Change fr baseline C-peptide at 120 min at week 20	-0.016	-
Baseline C-peptide at 150 min	0.813	-
Change fr baseline C-peptide at 150 min at week 20	-0.093	-
Baseline C-peptide at 180 min	0.619	-
Change fr baseline C-peptide at 180 min at week 20	-0.092	-

Secondary/protocol endpoint

Change in HbA1c

Time frame:Week 20

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Least-squares mean · Percentage	95% CI
ExenatideBaseline HbA1c	7.79	-
Change from baseline HbA1c at week 20	-0.908	-
Exenatide Plus RosiglitazoneBaseline HbA1c	7.84	-
Change from baseline HbA1c at week 20	-1.31	-
RosiglitazoneBaseline HbA1c	7.92	-
Change from baseline HbA1c at week 20	-0.968	-

p0.039Mixed Model Repeated Measures (MMRM)

Secondary/protocol endpoint

Change in Fasting Serum Glucose Concentration.

Time frame:Week 20

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Least-squares mean · mmol/L	95% CI
ExenatideBaseline fasting serum glucose	8.42	-
Change fr baseline fasting serum glucose at wk 20	-1.46	-
Exenatide Plus RosiglitazoneBaseline fasting serum glucose	8.43	-
Change fr baseline fasting serum glucose at wk 20	-1.60	-
RosiglitazoneBaseline fasting serum glucose	8.48	-
Change fr baseline fasting serum glucose at wk 20	-1.80	-

p0.555MMRM

Secondary/protocol endpoint

Change in Fasting C-peptide

Time frame:Week 20

C-peptide AUC

change from baseline, improvement

Secondary/protocol endpoint

Change in Fasting Insulin

Time frame:Week 20

change from baseline, improvement

Posted result

Group	Geometric mean · uIU/ml	95% CI
ExenatideBaseline fasting insulin	12.84	-
Ratio (wk20/baseline)of fasting insulin	0.980	-
Exenatide Plus RosiglitazoneBaseline fasting insulin	10.96	-
Ratio (wk20/baseline)of fasting insulin	0.599	-
RosiglitazoneBaseline fasting insulin	12.77	-
Ratio (wk20/baseline)of fasting insulin	0.755	-

p0.106MMRM

Secondary/protocol endpoint/low confidence

Change in Fasting Proinsulin

Time frame:Week 20

ratio, improvement

Posted result

Group	Geometric mean · pmol/L	95% CI
ExenatideBaseline fasting proinsulin	4.32	-
Ratio(wk20/baseline)of fasting proinsulin	0.663	-
Exenatide Plus RosiglitazoneBaseline fasting proinsulin	3.80	-
Ratio(wk20/baseline)of fasting proinsulin	0.538	-
RosiglitazoneBaseline fasting proinsulin	3.56	-
Ratio(wk20/baseline)of fasting proinsulin	0.623	-

p0.341MMRM

Cardiometabolic biomarkers

4 endpoints

Secondary/protocol endpoint

Change in Fasting Total Cholesterol.

Time frame:Week 20

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

Group	Least-squares mean · mmol/L	95% CI
ExenatideBaseline total cholesterol	4.42	-
Change fr baseline total cholesterol at week 20	-0.128	-
Exenatide Plus RosiglitazoneBaseline total cholesterol	4.41	-
Change fr baseline total cholesterol at week 20	0.258	-
RosiglitazoneBaseline total cholesterol	4.62	-
Change fr baseline total cholesterol at week 20	0.438	-

p0.276MMRM

Secondary/protocol endpoint

Change in Fasting HDL Cholesterol

Time frame:Week 20

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

Group	Least-squares mean · mmol/L	95% CI
ExenatideBaseline HDL	1.13	-
Change from baseline HDL at week 20	0.022	-
Exenatide Plus RosiglitazoneBaseline HDL	1.17	-
Change from baseline HDL at week 20	0.046	-
RosiglitazoneBaseline HDL	1.17	-
Change from baseline HDL at week 20	0.055	-

p0.840MMRM

Secondary/protocol endpoint

Change in Fasting LDL Cholesterol

Time frame:Week 20

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Posted result

Group	Least-squares mean · mmol/L	95% CI
ExenatideBaseline LDL	2.59	-
Change from baseline LDL at week 20	-0.049	-
Exenatide Plus RosiglitazoneBaseline LDL	2.57	-
Change from baseline LDL at week 20	0.096	-
RosiglitazoneBaseline LDL	2.71	-
Change from baseline LDL at week 20	0.334	-

p0.096MMRM

Secondary/protocol endpoint

Change in Fasting Triglycerides

Time frame:Week 20

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

Group	Geometric mean · mmol/L	95% CI
ExenatideBaseline triglyceride	1.56	-
Ratio (endpoint/baseline) for triglycerides	0.861	-
Exenatide Plus RosiglitazoneBaseline triglyceride	1.67	-
Ratio (endpoint/baseline) for triglycerides	0.977	-
RosiglitazoneBaseline triglyceride	1.76	-
Ratio (endpoint/baseline) for triglycerides	0.992	-

p0.875MMRM

Safety / tolerability / PK

3 endpoints

Secondary/protocol endpoint

Incidence of Hypoglycemia Events

Time frame:20 weeks

Documented hypoglycemia

event count, event

Posted result

Group	Number · participants	95% CI
Exenatide	8	-
Exenatide Plus Rosiglitazone	9	-
Rosiglitazone	6	-

p0.575Fisher Exact

Secondary/protocol endpoint

Hypoglycemia Rate Per 30 Days Per Patient

Time frame:20 weeks

Documented hypoglycemia

event count, event

Posted result

Group	Mean · hypoglycemia events / 30 days / patient	95% CI
Exenatide	0.391	-
Exenatide Plus Rosiglitazone	0.594	-
Rosiglitazone	0.853	-

p0.436ANOVA

Secondary/protocol endpoint

Pedal Edema Score

Time frame:20 weeks

descriptive

Posted result

Group	Number · participants	95% CI
ExenatideNo edema	37	-
Edema score: 1+	7	-
Edema score: 2+	1	-
Edema score: 3+	0	-
Exenatide Plus RosiglitazoneNo edema	34	-
Edema score: 1+	11	-
Edema score: 2+	3	-
Edema score: 3+	0	-
RosiglitazoneNo edema	30	-
Edema score: 1+	14	-
Edema score: 2+	6	-
Edema score: 3+	1	-

p0.168Generalized Linear Model

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment.
Diabetes, obesity & metabolism2012 Jun (month)PMID22236356doi:10.1111/j.1463-1326.2012.01561.xvia clinicaltrials gov reference derived + pubmed nct search
Effects of exenatide plus rosiglitazone on beta-cell function and insulin sensitivity in subjects with type 2 diabetes on metformin.
Diabetes care2010 May (month)PMID20107105doi:10.2337/dc09-1521via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.