Phase 3 · Exenatide

NCT00135330 trial results

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

Participants: 137
Status: completed
Completed: 2008-07
Sponsor: AstraZeneca

As posted on ClinicalTrials.gov (NCT00135330), updated at source Apr 7, 2015. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT00135330 measured first

Change in ASIiAUC During a Hyperglycemic Clamp Test.uIU-min/ml · 20 weeks · least squares mean

Measure	Exenatiden=17	Exenatide Plus Rosiglitazonen=18	Rosiglitazonen=15
Baseline ASIiAUC	643.40(106.71)	686.41(103.70)	786.12(113.60)
Change in ASIiAUC at week 20	747.26(187.40)	194.68(181.59)	-99.85(200.04)

Side effects by arm

Side effects in NCT00135330

Percent of participants affected. The most common events the registry lists.

Event	Exenatide	Exenatide Plus Rosiglitazone	Rosiglitazone
Nausea	46.7%	46.8%	4.4%
Vomiting	22.2%	19.1%	0%
Diarrhoea	6.7%	21.3%	4.4%
Oedema peripheral	4.4%	10.6%	20%
Dizziness	13.3%	14.9%	6.7%
Headache	11.1%	8.5%	6.7%
Fatigue	11.1%	2.1%	4.4%
Contusion	6.7%	10.6%	4.4%
Upper respiratory tract infection	6.7%	2.1%	8.9%
Injection site bruising	6.7%	8.5%	0%
Anaemia	2.2%	2.1%	6.7%
Hunger	6.7%	2.1%	0%
Nasal congestion	6.7%	2.1%	0%
Pharyngolaryngeal pain	2.2%	0%	6.7%
Diverticulitis	0%	0%	6.7%
Oedema	0%	0%	6.7%
Asthenia	4.4%	6.4%	2.2%
Constipation	4.4%	6.4%	0%
Flatulence	4.4%	6.4%	0%

Secondary outcomes

What else it measured

Change in AUC for Glucose During a Meal Challenge Test (MCT).mmol-min/L · Week 20 · least squares mean

Measure	Exenatiden=34	Exenatide Plus Rosiglitazonen=35	Rosiglitazonen=34
Baseline glucose AUC during MCT	1782.86(60.47)	1799.68(59.60)	1741.87(60.47)
Change in glucose AUC during MCT at week 20	-560.12(50.95)	-635.24(50.25)	-425.59(51.02)

Change in Insulin Sensitivity Index as Measured by M-value.mg/kg-min · Week 20 · least squares mean

Measure	Exenatiden=16	Exenatide Plus Rosiglitazonen=16	Rosiglitazonen=15
M-Value at baseline	3.89(0.495)	2.49(0.495)	4.02(0.511)
Change in M-Value from baseline at week 20	0.477(0.425)	2.07(0.440)	1.42(0.442)

Change in Insulin AUC in the First Stage From Baseline to Endpoint.uIU-min/ml · Week 20 · least squares mean

Measure	Exenatiden=17	Exenatide Plus Rosiglitazonen=17	Rosiglitazonen=15
Baseline insulin AUC	200.50(50.40)	136.84(50.40)	157.49(53.66)
Change from baseline insulin AUC at week 20	134.88(31.71)	32.12(31.65)	-50.81(33.59)

Change in Insulin iAUC From Baseline to Endpoint.uIU-min/ml · Week 20 · least squares mean

Measure	Exenatiden=17	Exenatide Plus Rosiglitazonen=17	Rosiglitazonen=15
Baseline insulin iAUC	5.98(14.29)	-9.92(14.29)	23.09(15.21)
Change from baseline insulin iAUC at week 20	99.08(24.23)	53.71(24.54)	11.51(26.15)

Ratio (Value at Endpoint Divided by Value at Baseline) of AUC for Insulin During a Meal Challenge Test (MCT).uIU-min/ml · Week 20 · geometric mean

Measure	Exenatiden=34	Exenatide Plus Rosiglitazonen=35	Rosiglitazonen=33
Baseline AUC for insulin during MCT	5171.40(522.82)	4324.13(430.87)	5816.83(596.91)
Ratio(endpoint/baseline) of insulin AUC during MCT	0.806(0.063)	0.664(0.052)	0.722(0.058)

Change in AUC for C-peptide During a Meal Challenge Test (MCT).nmol-min/L · Week 20 · geometric mean

Measure	Exenatiden=34	Exenatide Plus Rosiglitazonen=34	Rosiglitazonen=32
Baseline C-peptide during a MCT	319.77(18.13)	310.51(17.61)	325.65(19.04)
Ratio(endpoint/baseline) of C-peptide during a MCT	0.908(0.040)	0.804(0.036)	0.854(0.039)

Change in Incremental for Postprandial Glucose During a Meal Challenge Test (MCT).mmol/L · Week 20 · least squares mean

Measure	Exenatiden=34	Exenatide Plus Rosiglitazonen=34	Rosiglitazonen=33
Baseline glucose at 15 min	0.950(0.138)	1.12(0.138)	0.828(0.142)
Change fr baseline glucose at 15 min at wk 20	-0.651(0.151)	-0.286(0.152)	0.150(0.157)
Baseline glucose at 30 min	2.39(0.218)	2.54(0.221)	2.23(0.221)
Change fr baseline glucose at 30 min at wk 20	-1.46(0.248)	-1.06(0.252)	-0.066(0.252)
Baseline glucose at 60 minutes	3.59(0.273)	3.88(0.273)	3.48(0.273)
Change fr baseline glucose at 60 min at wk 20	-2.56(0.329)	-2.46(0.330)	-0.720(0.329)
Baseline glucose at 90 minutes	3.24(0.231)	3.36(0.228)	3.48(0.239)
Change fr baseline glucose at 90 min at wk 20	-2.87(0.312)	-2.91(0.307)	-0.952(0.322)
Baseline glucose at 120 minutes	2.49(0.235)	2.24(0.238)	2.31(0.235)
Change fr baseline glucose at 120 min at wk 20	-2.24(0.271)	-2.52(0.275)	-0.912(0.271)
Baseline glucose at 150 minutes	1.62(0.230)	1.14(0.230)	1.25(0.230)
Change fr baseline glucose at 150 min at wk 20	-1.42(0.288)	-1.95(0.287)	-0.830(0.286)

Change in Incremental for Postprandial Insulin During Meal Challenge Test (MCT).mmol/L · Week 20 · least squares mean

Measure	Exenatiden=34	Exenatide Plus Rosiglitazonen=35	Rosiglitazonen=32
Baseline insulin at 15 min	9.97(1.71)	8.09(1.71)	7.53(1.79)
Change fr baseline insulin at 15 min at wk 20	-1.71(1.45)	-1.84(1.45)	-0.455(1.52)
Baseline insulin at 30 min	19.81(2.28)	14.79(2.25)	18.83(2.35)
Change fr baseline insulin at 30 min at wk 20	-3.00(1.90)	-2.63(1.89)	-1.04(1.96)
Baseline insulin at 60 min	27.92(4.68)	27.67(4.61)	32.09(4.75)
Change fr baseline insulin at 60 min at wk 20	-11.04(2.63)	-7.47(2.59)	-7.42(2.67)
Baseline insulin at 90 min	26.06(4.10)	21.85(4.10)	32.25(4.36)
Change fr baseline insulin at 90 min at wk 20	-9.42(2.72)	-9.27(2.74)	-6.19(2.92)
Baseline insulin at 120 min	19.56(2.99)	17.52(2.99)	25.47(3.04)
Change fr baseline insulin at 120 min at wk 20	-11.26(1.99)	-8.69(2.00)	-6.43(2.04)
Baseline insulin at 150 min	15.67(2.47)	12.74(2.43)	18.11(2.51)
Change fr baseline insulin at 150 min at wk 20	-7.48(1.74)	-8.13(1.73)	-5.57(1.78)

Change in Incremental for Postprandial C-peptide During Meal Challenge Test (MCT).mmol/L · Week 20 · least squares mean

Measure	Exenatiden=34	Exenatide Plus Rosiglitazonen=34	Rosiglitazonen=32
Baseline C-peptide at 15 min	0.238(0.049)	0.259(0.049)	0.206(0.051)
Change fr baseline C-peptide at 15 min at week 20	-0.006(0.045)	0.016(0.046)	0.087(0.047)
Baseline C-peptide at 30 min	0.521(0.059)	0.517(0.059)	0.560(0.061)
Change fr baseline C-peptide at 30 min at week 20	-0.071(0.056)	-0.036(0.056)	0.099(0.058)
Baseline C-peptide at 60 min	0.818(0.110)	0.871(0.110)	0.881(0.114)
Change fr baseline C-peptide at 60 min at week 20	-0.148(0.090)	-0.025(0.090)	0.054(0.093)
Baseline C-peptide at 90 min	0.895(0.100)	0.953(0.101)	1.03(0.106)
Change fr baseline C-peptide at 90 min at week 20	-0.185(0.099)	-0.117(0.101)	-0.052(0.106)
Baseline C-peptide at 120 min	0.817(0.112)	0.828(0.114)	0.972(0.114)
Change fr baseline C-peptide at 120 min at week 20	-0.259(0.100)	-0.134(0.102)	-0.016(0.102)
Baseline C-peptide at 150 min	0.843(0.091)	0.651(0.091)	0.813(0.092)
Change fr baseline C-peptide at 150 min at week 20	-0.251(0.095)	-0.254(0.095)	-0.093(0.096)

Change in HbA1cPercentage · Week 20 · least squares mean

Measure	Exenatiden=35	Exenatide Plus Rosiglitazonen=36	Rosiglitazonen=34
Baseline HbA1c	7.79(0.116)	7.84(0.115)	7.92(0.116)
Change from baseline HbA1c at week 20	-0.908(0.118)	-1.31(0.116)	-0.968(0.118)

Change in Fasting Serum Glucose Concentration.mmol/L · Week 20 · least squares mean

Measure	Exenatiden=34	Exenatide Plus Rosiglitazonen=35	Rosiglitazonen=34
Baseline fasting serum glucose	8.42(0.278)	8.43(0.271)	8.48(0.274)
Change fr baseline fasting serum glucose at wk 20	-1.46(0.250)	-1.60(0.244)	-1.80(0.250)

Change in Fasting InsulinuIU/ml · Week 20 · geometric mean

Measure	Exenatiden=35	Exenatide Plus Rosiglitazonen=35	Rosiglitazonen=31
Baseline fasting insulin	12.84(1.55)	10.96(1.33)	12.77(1.54)
Ratio (wk20/baseline)of fasting insulin	0.980(0.096)	0.599(0.059)	0.755(0.078)

The trial

How NCT00135330 was run

This protocol is designed to evaluate the metabolic effects of adding exenatide, rosiglitazone, or both to an existing regimen of metformin in subjects with inadequate glycemic control.

Exenatide Arm
Exenatide plus Rosiglitazone Arm
Rosiglitazone Arm

Who could join the trial

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

Published papers

Papers from NCT00135330

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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