Phase 2
Completed N=145
A Study of LY2189265 in Japanese Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT01001104 ↗Enrolled (actual)
145
Serious AEs
1.4%
Results posted
Sep 2015
Primary outcomePrimary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks — -1.35; -1.15; -0.90; -0.18 percentage glycosylated hemoglobin — p=<.001
Summary
The main purpose of this study is to assess dose-response characteristics in Japanese patients with Type 2 Diabetes taking LY2189265 monotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 12 Weeks |
-1.35; -1.15; -0.90; -0.18 | <.001 sig |
| SECONDARY Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<7% up to 12 Weeks |
77.1; 59.5; 47.2; 10.8 | <0.001 sig |
| SECONDARY Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c)<6.5% up to 12 Weeks |
34.3; 24.3; 8.3; 2.7 | <0.001 sig |
| SECONDARY Change From Baseline in Fasting Blood Glucose (FBG) Values to 12 Weeks |
-37.48; -28.55; -29.21; -9.00 | <0.001 sig |
| SECONDARY Change From Baseline in the Mean Daily Blood Glucose (Based on Self-Monitoring Blood Glucose [SMBG]) at 12 Weeks |
-48.99; -53.12; -40.70; -7.49 | <0.001 sig |
| SECONDARY Change From Baseline in Total Body Weight at 12 Weeks |
-0.58; -0.40; 0.41; -0.84 | 0.987 |
| SECONDARY Change From Baseline in Insulin Sensitivity Using the Updated Homeostasis Model Assessment Insulin Sensitivity (HOMA2-S) at 12 Weeks |
-4.66; -6.07; 4.65; 3.74 | 0.202 |
| SECONDARY Change From Baseline in Beta-Cell Function Using the Updated Homeostasis Model Assessment Beta-Cell Function (HOMA2-B) at 12 Weeks |
38.63; 26.67; 20.04; 6.94 | <0.001 sig |
| SECONDARY Steady-State Concentrations of LY2189265 |
15.8; 28.8; 42.7 | — |
| SECONDARY Percentage of Participants With Self-Reported Hypoglycemic Episodes During the 12-week Treatment Period |
5.7; 2.7; 0.0; 0.0 | 0.073 |
Eligibility Criteria
Inclusion Criteria
- Japanese patients with type 2 diabetes with a body mass index (BMI)≥18.5 kilograms per square meter (kg/m^2) but <40.0 kg/m^2.
- Patients who are oral antidiabetic drug (OAD) naïve or are taking OAD monotherapy except for a dipeptidyl peptidase-4 inhibitor (DPP-IV) and are willing to discontinue their OAD.
- Patients who are OAD naïve with screening glycosylated hemoglobin (HbA1c) value of 7.0% to 9.5% and randomization HbA1c value of 7.0% to 9.5%, or who are taking OAD monotherapy with screening HbA1c value of 6.0% to 8.5% and randomization HbA1c value of 7.0% to 9.5%.
- Patients who have, in the opinion of the investigator, a stable weight during the 12 weeks prior to screening.
Exclusion Criteria
- Patients who are currently taking prescription medications to promote weight loss
- Patients who are receiving chronic systemic glucocorticoid therapy, or have received such therapy within 4 weeks immediately prior to screening.
- Patients who have a known clinically significant gastrointestinal disorder, have undergone excision of all or any part of the gastrointestinal tract, have undergone gastric bypass surgery for treatment of obesity, or chronically take drugs that directly influence gastrointestinal motility.
- Patients who have poorly controlled hypertension, renal artery stenosis, or evidence of labile blood pressure including symptomatic postural hypotension.
- Patients who have obvious clinical signs or symptoms of pancreatitis, a history of chronic pancreatitis or acute pancreatitis. Patients who have amylase and/or lipase of 1.5 times or more the upper limit of the reference range.
- Have a family history, obvious clinical signs, or symptoms of medullary carcinoma of thyroid.
Data sourced from ClinicalTrials.gov (NCT01001104). 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.