Phase 3
Completed N=492
A Study of LY2189265 in Japanese Participants With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01558271 ↗Enrolled (actual)
492
Serious AEs
4.3%
Results posted
Oct 2014
Primary outcomePrimary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks — -1.43; 0.14; -1.33 percentage of HbA1c — p=<0.001
Summary
The purpose of this trial is to examine the efficacy and safety of once-weekly LY2189265 in participants with type 2 diabetes mellitus who are not taking oral antidiabetic medication.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks |
-1.43; 0.14; -1.33 | <0.001 sig |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 52 Weeks |
-1.39; -1.55; -1.19 | 0.040 sig |
| SECONDARY Percentage of Participants Who Achieved HbA1c <=6.5% or <7% |
71.4; 5.9; 69.1; 50.0; 1.5; 49.3 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Blood Glucose (FBG) at 26 Weeks and 52 Weeks |
-39.18; 1.03; -39.75; -38.93; -40.93; -37.15 | <0.001 sig |
| SECONDARY Change From Baseline in 7-Point Self-Monitored Blood Glucose (SMBG) at 26 Weeks and 52 Weeks |
-39.65; -0.15; -34.93; -69.64; -9.29; -61.67 | — |
| SECONDARY Change From Baseline in Body Weight at 26 Weeks and 52 Weeks |
-0.02; -0.63; -0.36; -0.17; -1.03; -0.13 | 0.057 |
| SECONDARY Change From Baseline in Insulin Sensitivity Using Updated Homeostasis Model Assessment (HOMA 2) at 26 Weeks and 52 Weeks |
-4.83; -2.97; -4.82; -5.48; -6.32; -2.46 | 0.723 |
| SECONDARY Change From Baseline in Beta-cell Function Using Updated Homeostasis Model Assessment (HOMA 2) at 26 Weeks and 52 Weeks |
28.42; 0.08; 25.35; 27.77; 2.94; 25.86 | <0.001 sig |
| SECONDARY Percentage of Participants With Hypoglycemic Episodes |
2.1; 1.4; 1.5; 2.9; 2.9; 2.9 | >0.999 |
| SECONDARY 30-Day Rate of Hypoglycemic Episodes |
0.01; 0.00; 0.00; 0.00; 0.01; 0.01 | — |
| SECONDARY Number of Participants With Adjudicated Cardiovascular Events at 26 Weeks and 52 Weeks |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Pulse Rate at 26 Weeks and 52 Weeks |
3.35; 1.49; 4.77; 3.11; 4.42; 5.13 | — |
| SECONDARY Change From Baseline in Blood Pressure at 26 Weeks and 52 Weeks |
0.62; 0.53; -2.10; 1.09; 0.29; 0.43 | — |
| SECONDARY Number of Participants With Adjudicated Pancreatitis at 26 Weeks and 52 Weeks |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Pancreatic Enzymes at 26 Weeks and 52 Weeks |
7.0; 1.0; 11.0; 7.0; 0.0; 7.0 | — |
| SECONDARY Change From Baseline in Serum Calcitonin at 26 Weeks and 52 Weeks |
0.0; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Number of Participants With Treatment-Emergent LY2189265 Anti-Drug Antibodies (ADAs) at 26 Weeks and 52 Weeks |
3; 0; 0; 3; 0; 0 | — |
| SECONDARY Number of Participants Requiring Additional Intervention Due to Hyperglycemia at 26 Weeks and 52 Weeks |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline in Electrocardiogram Parameters at 26 Weeks and 52 Weeks |
-2.02; -0.96; -1.89; -2.76; -0.80; -4.35 | — |
Eligibility Criteria
Inclusion Criteria
- Participants who have had a diagnosis of type 2 diabetes mellitus before screening.
- Participants who have been Oral Antihyperglycemic Medication (OAM)-naïve (diet and exercise only) or been taking OAM monotherapy except for thiazolidinedione (TZD) and are willing to discontinue this medication. Participants taking OAM monotherapy must complete 8-week washout period prior to randomization.
- Participants who are OAM naïve with a screening glycosylated hemoglobin (HbA1c) value of 7.0% to 10.0% and randomization HbA1c value of 7.0% to 10.0%, or who are taking OAM monotherapy with screening HbA1c value of 6.5% to 9.0% and randomization HbA1c value of 7.0% to 10.0%.
- Participants who have a body mass index (BMI) of 18.5 kilograms per meter squared (kg/m^2) to 35.0 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 been receiving more than half of the maximum dose of sulfonylureas at screening.
- Participants who have been currently taking insulin or TZD, or have had previous insulin or TZD 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 (NCT01558271). 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.