Phase 3 · Exenatide

NCT00765817 trial results

A Randomized Trial Comparing Exenatide With Placebo in Subjects With Type 2 Diabetes on Insulin Glargine With or Without Oral Antihyperglycemic Medications

Change in Glycosylated Hemoglobin (HbA1c) (percentage of hemoglobin), baseline and 30 weeks. Exenatide Arm: -1.71; Placebo Arm: -1.00.

Participants
261
Status
completed
Completed
2010-01
Sponsor
AstraZeneca

As posted on ClinicalTrials.gov (NCT00765817), updated at source Oct 24, 2016. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT00765817 measured first

Change in Glycosylated Hemoglobin (HbA1c)percentage of hemoglobin · baseline and 30 weeks · least squares mean
Exenatide Armn=112Placebo Armn=100
-1.71(0.09)-1.00(0.09)
Side effects by arm

Side effects in NCT00765817

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

EventExenatide ArmPlacebo Arm
Any serious event5.8%9%
Nausea40.6%8.1%
Diarrhea18.1%8.1%
Vomiting18.1%4.1%
Headache13.8%4.1%
Constipation10.1%1.6%
Upper Respiratory Tract Infection8%7.3%
Back Pain6.5%1.6%
Dyspepsia6.5%1.6%
Nasopharyngitis5.8%4.9%
Cough5.1%5.7%
Dizziness4.3%5.7%
Asthenia5.1%0.8%
Secondary outcomes

What else it measured

Percentage of Patients Achieving HbA1c <=7%percentage · baseline and 30 weeks · number
Exenatide Armn=127Placebo Armn=106
58.331.1
Percentage of Patients Achieving HbA1c <=6.5%percentage · baseline and 30 weeks · number
Exenatide Armn=131Placebo Armn=113
42.013.3
Change in Fasting Serum Glucosemmol/L · baseline and 30 weeks · least squares mean
Exenatide Armn=111Placebo Armn=98
-1.28(0.2)-0.87(0.2)
Change in 7-point Self-monitored Blood Glucose (SMBG) Profilemmol/L · baseline and 30 weeks · least squares mean
MeasureExenatide Armn=108Placebo Armn=89
Pre-breakfast: baseline7.89(0.2)8.27(0.2)
Pre-breakfast: change at week 30-1.58(0.1)-1.48(0.1)
2 hour post-breakfast: baseline10.89(0.2)11.82(0.2)
2 hour post-breakfast: change at week 30-3.56(0.2)-1.72(0.2)
Pre-lunch: baseline8.95(0.2)9.77(0.2)
Pre-lunch: change at week 30-2.23(0.2)-1.15(0.2)
2 hour post-lunch: baseline11.35(0.2)11.70(0.2)
2 hour post-lunch: change at week 30-2.74(0.2)-1.38(0.2)
Pre-dinner: baseline9.85(0.2)9.99(0.2)
Pre-dinner: change at week 30-2.25(0.2)-1.33(0.2)
2 hour post-dinner: baseline12.03(0.3)11.86(0.3)
2 hour post-dinner: change at week 30-3.87(0.2)-1.34(0.3)
Change in Total Cholesterolmmol/L · baseline and 30 weeks · least squares mean
Exenatide Armn=110Placebo Armn=98
-0.16(0.08)-0.02(0.09)
Change in Low Density Lipoprotein (LDL) Cholesterolmmol/L · baseline and 30 weeks · least squares mean
Exenatide Armn=102Placebo Armn=97
-0.19(0.07)-0.00(0.07)
Change in High Density Lipoprotein (HDL) Cholesterolmmol/L · baseline and 30 weeks · least squares mean
Exenatide Armn=110Placebo Armn=98
0.01(0.02)0.00(0.02)
Change in Triglyceridesmmol/L · baseline and 30 weeks · least squares mean
Exenatide Armn=110Placebo Armn=98
-0.02(0.09)-0.03(0.09)
Change in Body Weightkg · baseline and 30 weeks · least squares mean
Exenatide Armn=112Placebo Armn=101
-1.78(0.3)0.96(0.3)
Change in Waist Circumferencecm · baseline and 30 weeks · least squares mean
Exenatide Armn=137Placebo Armn=120
-1.08(0.52)-0.25(0.55)
Change in Daily Insulin Doseinsulin units (U) · baseline and 30 weeks · least squares mean
Exenatide Armn=110Placebo Armn=100
13.19(2.02)19.71(2.11)
Change in Daily Insulin Dose (on a Per Body Weight Basis)insulin units per kg (U/kg) · baseline and 30 weeks · least squares mean
Exenatide Armn=110Placebo Armn=100
0.15(0.02)0.20(0.02)
The trial

How NCT00765817 was run

This study will compare the efficacy and safety of exenatide versus placebo in adults whose diabetes is not fully controlled by insulin glargine with or without metformin and/or pioglitazone.

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Who could join the trial

Inclusion Criteria: * Have type 2 diabetes. * Have been taking insulin glargine at a dose of ≥20 units/day for at least 3 months before entering the study. Have been taking insulin glargine alone or in combination with one of the following for at least 3 months before entering the study: 1. metformin (stable dose for 6 weeks) 2. pioglitazone (stable dose for 6 weeks) 3. a combination of metformin and pioglitazone (stable dose for 6 weeks) * Have HbA1C between 7.1% and 10.5%, inclusive. * Have a body mass index (BMI) ≤45 kg/m2. * Have a history of stable body weight (not varying by \>5% for at least 3 months prior to screening). Exclusion Criteria: * Have taken medications to lower blood sugar other than insulin glargine, pioglitazone, or metformin in the 3 months before entering the study for more than a 1-week period, or within 1 week of entering the study. * Have had more than one episode of major (severe) hypoglycemia in the 6 months before entering the study. * Are pregnant or intend to become pregnant during the study or are sexually active women not actively practicing birth control. * Women who are breastfeeding. * Have any significant diseases of the blood, heart, kidney, gastrointestinal system, or other significant diseases such as cancer. * Have had a kidney transplant or are currently on kidney dialysis. * Have a cancer that's never been treated, that's currently being treated, or that was diagnosed within the last 5 years. * Have had a bad reaction to exenatide in the past or have a condition that is not recommended to be exposed to exenatide or any of exenatide's other ingredients. * Have used a drug for weight loss in the 3 months before entering the study for more than a 1-week period, or within 1 month of entering the study. * Are currently on a weight-loss program or have been on one within 3 months of entering the study. * Have had a blood transfusion or severe blood loss within 3 months of entering the study. * Are taking systemic glucocorticoids or have received systemic glucocorticoids within 8 weeks of entering the study. * Have an irregular sleep cycle (for example, sleeping during the day and working during the night). * Have a history of pancreatitis. * Have received treatment with an experimental drug within 30 days of entering the study. * If on metformin, have a condition that is not recommended to be exposed to metformin, or any condition associated with hypoperfusion, hypoxemia, dehydration, or sepsis. * If on metformin, have had a radiologic contrast study performed within 48 hours of entering the study. * If on pioglitazone, have a condition that is not recommended to be exposed to pioglitazone, including congestive heart failure, or are taking pioglitazone at a dose that is not approved for use with insulin.

Published papers

Papers from NCT00765817

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

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