Phase 2
Completed N=755
A Study of the Effect of LY2189265 on Blood Pressure and Heart Rate in Type 2 Diabetes
Source: ClinicalTrials.gov NCT01149421 ↗Enrolled (actual)
755
Serious AEs
3.7%
Results posted
Feb 2015
Primary outcomePrimary: Change From Baseline to 16 Weeks in Mean 24-hour Systolic Blood Pressure (SBP) — -3.41; -1.70; -0.63 millimeters of mercury (mmHg) — p=<0.001
Summary
The purpose of this study is to assess the effects of 2 doses of LY2189265 on blood pressure and heart rate using 24-hour ambulatory blood pressure monitoring (ABPM), in participants with type 2 diabetes mellitus treated with oral antihyperglycemic medications (OAMs).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to 16 Weeks in Mean 24-hour Systolic Blood Pressure (SBP) |
-3.41; -1.70; -0.63 | <0.001 sig |
| SECONDARY Change From Baseline to 26 Weeks in Mean 24-hour Systolic Blood Pressure (SBP) |
-2.51; -1.56; 0.15 | <0.001 sig |
| SECONDARY Change From Baseline to 16 and 26 Weeks in Mean 24-hour Diastolic Blood Pressure (DBP) |
-0.23; -0.13; -0.55; 0.26; -0.09; -0.24 | <0.001 sig |
| SECONDARY Change From Baseline to 16 and 26 Weeks in Mean 24-Hour Heart Rate (HR) |
3.70; 2.48; 0.86; 4.18; 1.94; 0.68 | 0.556 |
| SECONDARY Change From Baseline to 16 and 26 Weeks in Mean 24-hour Pulse Pressure |
-3.07; -1.60; -0.02; -2.64; -1.53; 0.46 | <0.001 sig |
| SECONDARY Change From Baseline to 16 and 26 Weeks in Mean 24-hour Mean Arterial Pressure (MAP) |
-1.31; -0.65; -0.60; -0.74; -0.57; -0.15 | 0.218 |
| SECONDARY Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Systolic Blood Pressure (SBP) |
-3.67; -1.57; -0.34; -2.52; -1.47; 0.35 | <0.001 sig |
| SECONDARY Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Diastolic Blood Pressure (DBP) |
-0.09; 0.14; -0.30; 0.52; 0.08; -0.07 | 0.717 |
| SECONDARY Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Heart Rate (HR) |
3.56; 2.22; 1.07; 4.24; 1.59; 0.67 | <0.001 sig |
| SECONDARY Change From Baseline to 16 and 26 Weeks in Mean Daytime and Nighttime Pulse Pressure |
-3.46; -1.76; 0.01; -2.90; -1.62; 0.51 | <0.001 sig |
| SECONDARY Change From Baseline to 16 and 26 Weeks in Mean Daytime and Nighttime Mean Arterial Pressure (MAP) |
-1.30; -0.42; -0.33; -0.51; -0.42; 0.05 | 0.128 |
| SECONDARY Change From Baseline to 16 and 26 Weeks in Glycosylated Hemoglobin (HbA1c) |
-1.18; -1.04; -0.06; -1.01; -0.89; -0.02 | — |
| SECONDARY Change From Baseline to 16 and 26 Weeks in Fasting Blood Glucose (FBG) |
-2.05; -1.94; -0.30; -1.67; -1.66; 0.00 | — |
| SECONDARY Percentage of Participants Achieving an Glycosylated Hemoglobin (HbA1c) of <7% or ≤6.5% |
6.8; 6.7; 8.0; 0.0; 0.4; 0.4 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events at 26 Weeks |
160; 156; 162 | — |
| SECONDARY Change From Baseline to 16 and 26 Weeks on Pancreatic Enzymes |
6.00; 5.00; 0.00; 7.00; 4.00; 0.00 | — |
| SECONDARY Change From Baseline to 16 and 26 Weeks on Serum Calcitonin |
-0.30; -0.03; -0.39; -0.19; 0.02; -0.05 | — |
| SECONDARY Change From Baseline to 16 Weeks in High-Sensitivity C-Reactive Protein (Hs-CRP) |
-0.79; -0.20; 0.29 | — |
| SECONDARY Change From Baseline to 16 and 26 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval |
-2.31; -0.96; 1.06; -1.73; -0.93; 1.26 | — |
| SECONDARY Number of Events of Adjudicated Pancreatitis up to 26 Weeks |
0; 0; 0 | — |
| SECONDARY Number of Participants With Adjudicated Cardiovascular Events up to 26 Weeks |
1; 1; 4; 0; 0; 0 | — |
| SECONDARY Anti-LY2189265 Antibodies |
2; 0; 0; 1; 3; 0 | — |
| SECONDARY Rate of Hypoglycemic Episodes |
0; 0; 0; 0.14; 0.16; 0.08 | — |
| SECONDARY Change From Baseline to 16 and 26 Weeks in Body Weight |
-1.84; -0.83; -0.13; -1.85; -0.86; -0.08 | <0.001 sig |
| SECONDARY Measurement of LY2189265 Drug Concentration for Pharmacokinetics - Area Under the Concentration Time Curve (AUC) |
11208; 5998 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes taking 1 or more oral diabetes medications and have taken these medications for at least 1 month prior to screening
- Glycosylated hemoglobin (HbA1c) value ≥7% and ≤9.5% at screening
- Mean blood pressure >90/60 millimeters of mercury (mmHg) and 100 bpm at screening
- Work rotating shifts or work during the hours of 2200 to 0700
- Chronic insulin therapy
- Use of a glucagon-like peptide 1 (GLP-1) receptor agonist within 3 months prior to screening, or a dipeptidylpeptidase-IV (DPP-IV) inhibitor within 2 weeks prior to screening
- Nondominant arm circumference >42 centimeter (cm)
- Use of drugs to promote weight loss
- Chronic use of systemic steroids
- Gastric emptying abnormality or bariatric surgery
- Hepatitis, other liver disease, or alanine transaminase (ALT) >3 times the upper limit of normal
- Acute or chronic pancreatitis
- Severe renal impairment
- Active autoimmune disease or uncontrolled endocrine abnormality
- Self or family history of thyroid cancer, medullary C-cell hyperplasia, or type 2A or 2B multiple endocrine neoplasia
- Calcitonin value greater than or equal to 20 picograms per milliliter (pg/ml) at screening
- Transplanted organ except corneal transplants
- Active or untreated cancer or in remission <5 years, except skin, in situ cervical, or prostate cancer
- Sickle-cell disease, hemolytic anemia, or another hematological condition that may interfere with HbA1c testing
Data sourced from ClinicalTrials.gov (NCT01149421). 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.