What NCT01126580 measured first
| 1.5 mg LY2189265n=265 | 0.75 mg LY2189265n=265 | Metforminn=265 |
|---|---|---|
| -0.78(0.06) | -0.71(0.06) | -0.56(0.06) |
The Impact of LY2189265 Versus Metformin on Glycemic Control in Early Type 2 Diabetes Mellitus (AWARD-3: Assessment of Weekly AdministRation of LY2189265 in Diabetes-3)
Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c) (percentage of glycosylated hemoglobin), Baseline, 26 weeks. 1.5 mg LY2189265: -0.78; 0.75 mg LY2189265: -0.71; Metformin: -0.56.
As posted on ClinicalTrials.gov (NCT01126580), updated at source Jan 16, 2015. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
| 1.5 mg LY2189265n=265 | 0.75 mg LY2189265n=265 | Metforminn=265 |
|---|---|---|
| -0.78(0.06) | -0.71(0.06) | -0.56(0.06) |
Percent of participants affected. The most common events the registry lists.
| Event | 1.5 mg LY2189265 | 0.75 mg LY2189265 | Metformin |
|---|---|---|---|
| Any serious event | 5.6% | 7.4% | 6% |
| Nausea | 19.7% | 11.5% | 16% |
| Diarrhoea | 11.5% | 9.6% | 14.6% |
| Nasopharyngitis | 5.2% | 3.3% | 10.4% |
| Vomiting | 9.7% | 7.4% | 5.2% |
| Headache | 3.7% | 5.2% | 7.5% |
| Constipation | 6.7% | 4.4% | 1.1% |
| Decreased appetite | 6.7% | 4.4% | 4.5% |
| Upper respiratory tract infection | 5.9% | 6.3% | 3% |
| Abdominal distension | 4.8% | 4.8% | 3.7% |
| Dyspepsia | 4.5% | 3% | 2.2% |
| Back pain | 1.9% | 3.3% | 4.5% |
| Dizziness | 1.9% | 4.4% | 3.4% |
| Abdominal pain | 4.1% | 3.7% | 2.2% |
| Bronchitis | 2.6% | 4.1% | 3.4% |
| Influenza | 3.3% | 4.1% | 3% |
| Urinary tract infection | 3.7% | 4.1% | 2.2% |
| 1.5 mg LY2189265n=265 | 0.75 mg LY2189265n=265 | Metforminn=265 |
|---|---|---|
| -0.70(0.07) | -0.55(0.07) | -0.51(0.07) |
| Measure | 1.5 mg LY2189265n=265 | 0.75 mg LY2189265n=265 | Metforminn=265 |
|---|---|---|---|
| HbA1c less than 7%, 26 weeks | 61.5 | 62.6 | 53.6 |
| HbA1c less than or equal to 6.5%, 26 weeks | 46.0 | 40.0 | 29.8 |
| HbA1c less than 7%, 52 weeks | 60.0 | 53.2 | 48.3 |
| HbA1c less than or equal to 6.5%, 52 weeks | 42.3 | 34.7 | 28.3 |
| Measure | 1.5 mg LY2189265n=267 | 0.75 mg LY2189265n=265 | Metforminn=264 |
|---|---|---|---|
| 26 weeks (n=244, 247, 245) | -1.61(0.13) | -1.46(0.13) | -1.34(0.13) |
| 52 weeks (n=207, 210, 194) | -1.56(0.14) | -1.00(0.14) | -1.15(0.14) |
| Measure | 1.5 mg LY2189265n=211 | 0.75 mg LY2189265n=207 | Metforminn=218 |
|---|---|---|---|
| 26 weeks (n=195, 200, 211) | -1.98(0.15) | -1.75(0.14) | -1.68(0.14) |
| 52 weeks (n=197, 200, 212) | -1.99(0.16) | -1.71(0.16) | -1.58(0.15) |
| Measure | 1.5 mg LY2189265n=269 | 0.75 mg LY2189265n=270 | Metforminn=268 |
|---|---|---|---|
| 26 weeks (n=267, 269, 267) | -2.29(0.24) | -1.36(0.24) | -2.22(0.24) |
| 52 weeks (n=267, 269, 267) | -1.93(0.29) | -1.09(0.29) | -2.20(0.29) |
| Measure | 1.5 mg LY2189265n=267 | 0.75 mg LY2189265n=269 | Metforminn=267 |
|---|---|---|---|
| 26 weeks | -0.86(0.09) | -0.51(0.09) | -0.82(0.09) |
| 52 weeks | -0.73(0.11) | -0.42(0.10) | -0.83(0.11) |
| Measure | 1.5 mg LY2189265n=245 | 0.75 mg LY2189265n=242 | Metforminn=242 |
|---|---|---|---|
| HOMA2-%B, 26 weeks (n=207, 207, 215) | 36.55(3.42) | 28.96(3.44) | 14.11(3.37) |
| HOMA2-%B, 52 weeks (n=179, 185, 170) | 29.97(3.46) | 22.5(3.46) | 9.77(3.51) |
| HOMA2-%S, 26 weeks (n=207, 207, 215) | 0.95(2.29) | 2.71(2.29) | 9.99(2.25) |
| HOMA2-%S, 52 weeks (n=179, 185, 170) | 5.29(2.43) | 1.84(2.43) | 10.83(2.48) |
| Measure | 1.5 mg LY2189265n=266 | 0.75 mg LY2189265n=268 | Metforminn=266 |
|---|---|---|---|
| 26 weeks (n=247, 251, 247) | 0.09(0.33) | 0.19(0.32) | 0.02(0.32) |
| 52 weeks (n=247, 252, 248) | 0.39(0.33) | -0.05(0.33) | 0.28(0.33) |
| Measure | 1.5 mg LY2189265n=268 | 0.75 mg LY2189265n=270 | Metforminn=268 |
|---|---|---|---|
| 26 weeks (n=248, 254, 249) | 0.72(0.19) | 0.63(0.18) | 0.79(0.18) |
| 52 weeks (n=249, 255, 250) | 0.45(0.19) | 0.61(0.19) | 0.75(0.19) |
| Measure | 1.5 mg LY2189265n=266 | 0.75 mg LY2189265n=267 | Metforminn=267 |
|---|---|---|---|
| 26 weeks (n=244, 249, 241) | 1.93(0.39) | 1.81(0.38) | 2.04(0.39) |
| 52 weeks (n=245, 251, 244) | 1.82(0.44) | 1.29(0.43) | 1.94(0.44) |
| 1.5 mg LY2189265n=230 | 0.75 mg LY2189265n=235 | Metforminn=230 |
|---|---|---|
| 12.92(0.52) | 12.73(0.50) | 12.58(0.51) |
| Measure | 1.5 mg LY2189265n=267 | 0.75 mg LY2189265n=270 | Metforminn=267 |
|---|---|---|---|
| 26 weeks (n=245, 253, 248) | 0.24(0.36) | -0.16(0.35) | 0.41(0.35) |
| 52 weeks (n=247, 255, 249) | 0.49(0.39) | 0.42(0.39) | 0.59(0.39) |
The purpose of this study is to determine if LY2189265 is safe and effective in reducing glycosylated hemoglobin (HbA1c) as compared to metformin in participants with Type 2 Diabetes.
Inclusion Criteria: * Have type 2 diabetes for greater than or equal to 3 months and less than or equal to 5 years based on the disease diagnostic criteria (refer to the World Health Organization's \[WHO\] Classification of Diabetes). * Are treatment-naïve, not optimally controlled with diet and exercise alone, or are taking 1 oral antihyperglycemic medication (OAM) as monotherapy (excluding thiazolidinediones). For those on 1 OAM, the dose must be less than or equal to 50% the maximum authorized per local label. * Are able and willing to tolerate a minimum dose of 1500 milligrams per day (mg/day) or up to 2000 mg/day of metformin. * Have glycosylated hemoglobin (HbA1c) greater than or equal to 6.5% to less than or equal to 9.5%. * Females of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopausal) must: a) test negative for pregnancy at screening based on a serum pregnancy test, and b) agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug; or c) not be breastfeeding. * Have a stable weight (plus or minus 5%) greater than or equal to 3 months prior to screening. * Have a body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m\^2), inclusive. * Are well-motivated, capable, and willing to: a) perform self-monitored blood glucose (SMBG) testing; b) learn how to self-inject treatment (LY2189265 or placebo) and c) maintain a study diary. Exclusion Criteria: * Have type 1 diabetes mellitus. * Are being or have been treated with any of the following medications: a) chronically treated with insulin for the treatment of diabetes in the past; however, a short-term use of insulin more than 3 months prior to screening is allowable, b) glucagon-like peptide 1 (GLP-1) analogs within 3 months prior to this screening, c) drugs to cause weight loss within 3 months prior to screening, d) thiazolidinediones (TZDs) within 3 months prior to screening, e) chronically treated (greater than or equal to 14 days) with an oral glucocorticoid or have received this type of therapy within 4 weeks prior to screening, or f) illegal drugs. * Have had 1 or more cases of uncontrolled diabetes that required hospitalization in the 6 months prior to screening. * Have stomach problems, have chronically taken medication to increase movement in the digestive tract or slow down the emptying of the digestive tract, or have had gastric bypass (bariatric) surgery. * Have had problems with the heart or brain in the past 2 months prior to screening, such as a heart attack, chest pain, heart failure, heart bypass operation, angioplasty or stent insertion, a heart rhythm problem, or a stroke. * Have a serum creatinine result which shows a greater than or equal to 1.5 milligrams per deciliter (mg/dL) for men or greater than or equal to 1.4 mg/dL for women. * Have a problem with the liver or pancreas. * Have a creatinine clearance result which shows less than 60...
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.