Primary outcome
What NCT01584232 measured first
| LY2189265 + OAMn=178 | Insulin Glargine + OAMn=179 |
|---|---|
| -1.44(0.05) | -0.90(0.05) |
Phase 3 · Dulaglutide
NCT01584232 trial results
A Phase 3 Study of LY2189265 Compared to Insulin Glargine in Patients With Type 2 Diabetes Mellitus on a Sulfonylurea and/or Biguanide
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks (percentage of HbA1c), Baseline, 26 weeks. LY2189265 + OAM: -1.44; Insulin Glargine + OAM: -0.90.
- Participants
- 361
- Status
- completed
- Completed
- 2013-07
- Sponsor
- Eli Lilly and Company
As posted on ClinicalTrials.gov (NCT01584232), updated at source Oct 20, 2014. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Side effects by arm
Side effects in NCT01584232
Percent of participants affected. The most common events the registry lists.
| Event | LY2189265 + OAM | Insulin Glargine + OAM |
|---|---|---|
| Any serious event | 5% | 1.7% |
| Nasopharyngitis | 27.1% | 25.6% |
| Diarrhoea | 12.2% | 2.2% |
| Nausea | 9.4% | 1.1% |
| Constipation | 8.8% | 3.3% |
| Vomiting | 5% | 1.1% |
| Lipase increased | 5% | 0.6% |
| Bronchitis | 2.2% | 3.9% |
| Influenza | 3.3% | 1.1% |
| Hypertension | 3.3% | 3.3% |
| Decreased appetite | 2.8% | 0% |
| Back pain | 2.8% | 2.8% |
| Eczema | 2.8% | 2.2% |
| Diabetic retinopathy | 2.2% | 1.1% |
| Abdominal distension | 2.2% | 0.6% |
| Dental caries | 1.7% | 2.2% |
| Dyspepsia | 2.2% | 0% |
| Gastritis | 1.1% | 2.2% |
| Gastroenteritis | 2.2% | 1.7% |
| Pharyngitis | 2.2% | 2.2% |
| Ligament sprain | 0.6% | 2.2% |
| Endometriosis | 1.8% | 0% |
| Abdominal pain | 1.7% | 0% |
| Abdominal pain upper | 1.7% | 0% |
| Toothache | 0.6% | 1.7% |
| Hepatic steatosis | 1.7% | 1.7% |
Secondary outcomes
What else it measured
| Measure | LY2189265 + OAMn=178 | Insulin Glargine + OAMn=179 |
|---|---|---|
| HbA1c <=6.5% | 51.1 | 24.0 |
| HbA1c <7% | 71.3 | 45.8 |
| LY2189265 + OAMn=176 | Insulin Glargine + OAMn=176 |
|---|---|
| -34.3(1.9) | -37.8(1.9) |
| Measure | LY2189265 + OAMn=178 | Insulin Glargine + OAMn=179 |
|---|---|---|
| Pre-morning meal (n=178, 179) | -33.49(1.65) | -38.66(1.64) |
| 2 hours post-morning meal (n=178, 179) | -49.54(3.33) | -36.14(3.31) |
| Pre-midday meal (n=178, 179) | -36.16(2.68) | -27.94(2.66) |
| 2 hours post-midday meal (n=178, 179) | -43.51(3.27) | -20.30(3.25) |
| Pre-evening meal (n=178, 179) | -31.14(2.77) | -17.50(2.75) |
| 2 hours post-evening meal (n=177, 178) | -46.68(3.05) | -15.55(3.03) |
| Bedtime (n=177, 172) | -41.53(2.95) | -17.79(2.96) |
| Second pre-morning meal (n=178, 179) | -30.81(1.60) | -37.02(1.59) |
| LY2189265 + OAMn=180 | Insulin Glargine + OAMn=180 |
|---|---|
| -0.48(0.17) | 0.94(0.17) |
| LY2189265 + OAMn=181 | Insulin Glargine + OAMn=180 |
|---|---|
| 26.0 | 47.8 |
The trial
How NCT01584232 was run
The purpose of this trial is to examine the efficacy and safety of once-weekly LY2189265 (dulaglutide) in participants with type 2 diabetes mellitus taking an oral antihyperglycemic medication (OAM).
- LY2189265 + OAM: LY2189265: 0.75 milligrams (mg), administered subcutaneously (SC), once weekly for 26 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).
- Insulin glargine + OAM: Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin).
Who could join the trial
Inclusion Criteria: * Participants who have had a diagnosis of type 2 diabetes mellitus for at least 6 months before screening * Participants who have been taking sulfonylurea (glibenclamide, gliclazide, or glimepiride) and/or biguanide (metformin or buformin). The dose of the drug(s) during the 8 weeks before screening must be stable * Participants who have a qualifying glycosylated hemoglobin (HbA1c) value of 7.0% to 10.0% at screening * Participants who have a body mass index (BMI) of 18.5 to 35.0 kilograms per meter squared (kg/m\^2) Exclusion Criteria: * Participants who have a diagnosis of type 1 diabetes * Participants who have previously been treated with any other glucagon-like peptide 1 (GLP-1) analog * Participants who have received therapy with an alpha-glucosidase inhibitor (a-GI), thiazolidinedione (TZD), glinide, or dipeptidyl peptidase-IV (DPP-IV) inhibitor within 3 months before screening * Participants who have been currently taking insulin or have had previous insulin treatment within 3 months before screening * Participants who have obvious clinical signs or symptoms of pancreatitis, a history of chronic pancreatitis, or acute pancreatitis at screening, as determined by the investigator. Participants who have a serum amylase concentration ≥ 3 times the upper limit of the reference range and/or a serum lipase concentration ≥ 2 times the upper limit of the reference range, as determined by the central laboratory at screening * Participants who have self or family history of medullary C-cell hyperplasia, focal hyperplasia, or medullary thyroid carcinoma (MTC)
Published papers
Papers from NCT01584232
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
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