Phase 3
Completed N=394
A Study of LY2189265 in Japanese Participants With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01468181 ↗Enrolled (actual)
394
Serious AEs
5.1%
Results posted
Dec 2014
Primary outcomePrimary: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) — 85.5; 83.6; 70.8; 80.3 percentage of participants
Summary
This was a 52-week, multicenter, non-randomized, open-label, Phase 3 long-term safety study in participants with type 2 diabetes mellitus who have inadequate glycemic control with monotherapy of oral antihyperglycemic medication (OAM).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) |
85.5; 83.6; 70.8; 80.3; 73.2 | — |
| PRIMARY Percentage of Participants With Hypoglycemic Episodes |
33.6; 3.3; 6.2; 6.1; 9.9 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) |
-1.93; -1.58; -1.67; -1.71; -1.80; -1.67 | <0.001 sig |
| SECONDARY Percentage of Participants Who Achieve HbA1c ≤6.5% or <7% |
35.1; 54.1; 72.3; 60.6; 53.5; 31.3 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose (FBG) |
-46.8; -37.9; -46.8; -42.1; -42.7; -43.2 | <0.001 sig |
| SECONDARY Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) |
-44.70; -34.60; -45.97; -35.40; -48.26; -42.93 | <0.001 sig |
| SECONDARY Change From Baseline in Body Weight |
0.02; -0.74; -1.22; 0.78; 0.19; 0.10 | <0.277 |
| SECONDARY Change From Baseline in Updated Homeostasis Model Assessment (HOMA2) |
29.10; 28.15; 30.88; 27.34; 26.93; 26.06 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Participants who have had a diagnosis of type 2 diabetes mellitus before screening
- Participants who have been taking SU (Glibenclamide, Gliclazide, Glimepiride), BG, TZD, a-GI or glinides monotherapy for at least 3 months before screening and have been on a stable dose for at least 8 weeks before screening
- Participants must have a qualifying HbA1c value of 7.0% to 11.0% 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 within the 3 months before screening
- Participants who are currently taking insulin or have had previous insulin treatment within the 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 (NCT01468181). 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.