What NCT00765817 measured first
| Exenatide Armn=112 | Placebo Armn=100 |
|---|---|
| -1.71(0.09) | -1.00(0.09) |
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.
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.
| Exenatide Armn=112 | Placebo Armn=100 |
|---|---|
| -1.71(0.09) | -1.00(0.09) |
Percent of participants affected. The most common events the registry lists.
| Event | Exenatide Arm | Placebo Arm |
|---|---|---|
| Any serious event | 5.8% | 9% |
| Nausea | 40.6% | 8.1% |
| Diarrhea | 18.1% | 8.1% |
| Vomiting | 18.1% | 4.1% |
| Headache | 13.8% | 4.1% |
| Constipation | 10.1% | 1.6% |
| Upper Respiratory Tract Infection | 8% | 7.3% |
| Back Pain | 6.5% | 1.6% |
| Dyspepsia | 6.5% | 1.6% |
| Nasopharyngitis | 5.8% | 4.9% |
| Cough | 5.1% | 5.7% |
| Dizziness | 4.3% | 5.7% |
| Asthenia | 5.1% | 0.8% |
| Exenatide Armn=127 | Placebo Armn=106 |
|---|---|
| 58.3 | 31.1 |
| Exenatide Armn=131 | Placebo Armn=113 |
|---|---|
| 42.0 | 13.3 |
| Exenatide Armn=111 | Placebo Armn=98 |
|---|---|
| -1.28(0.2) | -0.87(0.2) |
| Measure | Exenatide Armn=108 | Placebo Armn=89 |
|---|---|---|
| Pre-breakfast: baseline | 7.89(0.2) | 8.27(0.2) |
| Pre-breakfast: change at week 30 | -1.58(0.1) | -1.48(0.1) |
| 2 hour post-breakfast: baseline | 10.89(0.2) | 11.82(0.2) |
| 2 hour post-breakfast: change at week 30 | -3.56(0.2) | -1.72(0.2) |
| Pre-lunch: baseline | 8.95(0.2) | 9.77(0.2) |
| Pre-lunch: change at week 30 | -2.23(0.2) | -1.15(0.2) |
| 2 hour post-lunch: baseline | 11.35(0.2) | 11.70(0.2) |
| 2 hour post-lunch: change at week 30 | -2.74(0.2) | -1.38(0.2) |
| Pre-dinner: baseline | 9.85(0.2) | 9.99(0.2) |
| Pre-dinner: change at week 30 | -2.25(0.2) | -1.33(0.2) |
| 2 hour post-dinner: baseline | 12.03(0.3) | 11.86(0.3) |
| 2 hour post-dinner: change at week 30 | -3.87(0.2) | -1.34(0.3) |
| Exenatide Armn=110 | Placebo Armn=98 |
|---|---|
| -0.16(0.08) | -0.02(0.09) |
| Exenatide Armn=102 | Placebo Armn=97 |
|---|---|
| -0.19(0.07) | -0.00(0.07) |
| Exenatide Armn=110 | Placebo Armn=98 |
|---|---|
| 0.01(0.02) | 0.00(0.02) |
| Exenatide Armn=110 | Placebo Armn=98 |
|---|---|
| -0.02(0.09) | -0.03(0.09) |
| Exenatide Armn=112 | Placebo Armn=101 |
|---|---|
| -1.78(0.3) | 0.96(0.3) |
| Exenatide Armn=137 | Placebo Armn=120 |
|---|---|
| -1.08(0.52) | -0.25(0.55) |
| Exenatide Armn=110 | Placebo Armn=100 |
|---|---|
| 13.19(2.02) | 19.71(2.11) |
| Exenatide Armn=110 | Placebo Armn=100 |
|---|---|
| 0.15(0.02) | 0.20(0.02) |
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.
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.
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.