Phase 3
Completed N=361
A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01584232 ↗Enrolled (actual)
361
Serious AEs
3.3%
Results posted
Oct 2014
Primary outcomePrimary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks — -1.44; -0.90 percentage of HbA1c — p=<0.001
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks |
-1.44; -0.90 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieved Glycosylated Hemoglobin (HbA1c) <=6.5% or <7% at 26 Weeks |
51.1; 24.0; 71.3; 45.8 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks |
-34.3; -37.8 | 0.183 |
| SECONDARY Change From Baseline in 8-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks |
-33.49; -38.66; -49.54; -36.14; -36.16; -27.94 | 0.022 sig |
| SECONDARY Change From Baseline in Body Weight at 26 Weeks |
-0.48; 0.94 | <0.001 sig |
| SECONDARY Percentage of Participants With Hypoglycemic Episodes |
26.0; 47.8 | <0.001 sig |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01584232). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.