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Trial · Interventional

CompletedPhase 2Results postedRegistry data

A Study of the Effect of LY2189265 on Blood Pressure and Heart Rate in Type 2 Diabetes

NCTNCT01149421 (opens ClinicalTrials.gov in a new tab)Other id13631Other idH9X-MC-GBDNOther idCTRI/2010/091/001444
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
755 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Quadruple masking
Countries
8 countries

United States, Argentina, Brazil, Canada, Czechia, Denmark, India, Puerto Rico

Start
Jun 2010
Primary completion
Sept 2011
Completion
Jan 2012
First posted
23 Jun 2010 (estimated)
Last update posted
2 Feb 2015 (estimated)
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2010201120122013
  1. Ph 2

    A Study of the Effect of LY2189265 on Blood Pressure and Heart Rate in Type 2 Diabetes

    NCT01149421

    Jun 2010 to Jan 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • LY2189265Drug
  • PlaceboDrug

Arms3

  • Experimental

    1.5 milligram (mg) LY2189265

    LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW)

  • Experimental

    0.75 milligram (mg) LY2189265

    LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW)

  • Placebo comparator

    Placebo

    Placebo: subcutaneous (SC), once weekly (QW)

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline to 16 Weeks in Mean 24-hour Systolic Blood Pressure (SBP)

    Time frame · Baseline, 16 weeks

    Registry description

    Mean 24-hour systolic blood pressure (SBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.

Secondary outcomes(20)

  1. Change From Baseline to 26 Weeks in Mean 24-hour Systolic Blood Pressure (SBP)

    Time frame · Baseline, 26 weeks

    Registry description

    Mean 24-hour systolic blood pressure (SBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.

  2. Change From Baseline to 16 and 26 Weeks in Mean 24-hour Diastolic Blood Pressure (DBP)

    Time frame · Baseline, 16 and 26 weeks

    Registry description

    Mean 24-hour diastolic blood pressure (DBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means of change from baseline was analyzed using mixed model repeated measures (MMRM) adjusted by baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.

  3. Change From Baseline to 16 and 26 Weeks in Mean 24-Hour Heart Rate (HR)

    Time frame · Baseline, 16 and 26 weeks

    Registry description

    Mean 24-hour heart rate (HR) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Heart rate measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.

  4. Change From Baseline to 16 and 26 Weeks in Mean 24-hour Pulse Pressure

    Time frame · Baseline, 16 and 26 weeks

    Registry description

    Mean 24-hour pulse pressure (PP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Pulse pressure (PP) measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.

  5. Change From Baseline to 16 and 26 Weeks in Mean 24-hour Mean Arterial Pressure (MAP)

    Time frame · Baseline, 16 and 26 weeks

    Registry description

    Mean 24-hour mean arterial pressure (MAP) was measured by a using 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.

  6. Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Systolic Blood Pressure (SBP)

    Time frame · Baseline, 16 and 26 weeks

    Registry description

    Mean daytime and nighttime systolic blood pressure (SBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. Clinic SBP was measured in the clinic using the Omron HEM 907XL Blood Pressure monitor.

  7. Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Diastolic Blood Pressure (DBP)

    Time frame · Baseline, 16 and 26 weeks

    Registry description

    Mean daytime and nighttime diastolic blood pressure (DBP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means of change from baseline was analyzed using mixed model repeated measures (MMRM) adjusted by baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. Clinic DBP was measured in the clinic using the Omron HEM 907XL Blood Pressure monitor.

  8. Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Heart Rate (HR)

    Time frame · Baseline, 16 and 26 weeks

    Registry description

    Daytime and nighttime heart rate (HR) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Heart rate measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension. Clinic HR was measured in the clinic using the Omron HEM 907XL Blood Pressure monitor.

  9. Change From Baseline to 16 and 26 Weeks in Mean Daytime and Nighttime Pulse Pressure

    Time frame · Baseline, 16 and 26 weeks

    Registry description

    Mean daytime and nighttime pulse pressure (PP) was measured by using a 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Pulse pressure (PP) measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.

  10. Change From Baseline to 16 and 26 Weeks in Mean Daytime and Nighttime Mean Arterial Pressure (MAP)

    Time frame · Baseline, 16 and 26 weeks

    Registry description

    Mean daytime and nighttime mean arterial pressure (MAP) was measured by a using 24-hour ambulatory blood pressure monitoring (ABPM) device attached to the participant's nondominant arm. Ambulatory blood pressure measurements were recorded every 20 minutes during the daytime (0700 to 2200 hours) and every 30 minutes during the nighttime hours (2200 to 0700), as preprogrammed into the device. For statistical analyses, diurnal hours were defined as 0800 to 2100 and nocturnal hours were defined as 0000 to 0600. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.

  11. Change From Baseline to 16 and 26 Weeks in Glycosylated Hemoglobin (HbA1c)

    Time frame · Baseline, 16 and 26 weeks

    Registry description

    Glycosylated hemoglobin (HbA1c) is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.

  12. Change From Baseline to 16 and 26 Weeks in Fasting Blood Glucose (FBG)

    Time frame · Baseline, 16 and 26 weeks

    Registry description

    Fasting blood glucose (FBG) is a test to determine how much glucose (sugar) is in a blood sample after an overnight fast. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.

  13. Percentage of Participants Achieving an Glycosylated Hemoglobin (HbA1c) of <7% or ≤6.5%

    Time frame · Baseline and 16 and 26 weeks

    Registry description

    Percentages of participants who achieved glycosylated hemoglobin (HbA1c) levels of \<7% or ≤6.5% were analyzed with Chi-squared test/Fisher's exact test.

  14. Number of Participants With Treatment Emergent Adverse Events at 26 Weeks

    Time frame · Baseline through 26 weeks

    Registry description

    A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

  15. Change From Baseline to 16 and 26 Weeks on Pancreatic Enzymes

    Time frame · Baseline, 16 and 26 weeks

    Registry description

    Amylase (total and pancreas-derived) and lipase concentrations were measured.

  16. Change From Baseline to 16 and 26 Weeks on Serum Calcitonin

    Time frame · Baseline, 16 and 26 weeks

  17. Change From Baseline to 16 Weeks in High-Sensitivity C-Reactive Protein (Hs-CRP)

    Time frame · Baseline, 16 weeks

  18. Change From Baseline to 16 and 26 Weeks on Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval

    Time frame · Baseline, 16 and 26 weeks

    Registry description

    The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR\^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for baseline, pooled sites, treatment, visit, treatment-by-visit interaction, and the stratified variable of diagnosis of hypertension.

  19. Number of Events of Adjudicated Pancreatitis up to 26 Weeks

    Time frame · Baseline through 26 weeks

    Registry description

    The number of adjudicated (by an independent Clinical Endpoint Committee \[CEC\]) pancreatic events is summarized at 26 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

  20. Number of Participants With Adjudicated Cardiovascular Events up to 26 Weeks

    Time frame · Baseline through 26 weeks

    Registry description

    Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by a committee of physicians with cardiology expertise external to the Sponsor. The nonfatal cardiovascular AEs to be adjudicated include myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions (such as coronary artery bypass graft or percutaneous coronary intervention), and cerebrovascular events including cerebrovascular accident (stroke) and transient ischemic attack. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline, 16 weeks

Change From Baseline to 16 Weeks in Mean 24-hour Systolic Blood Pressure (SBP)

GroupValue (millimeters of mercury (mmHg))Spread
1.5 Milligram (mg) LY2189265-3.410.61
0.75 Milligram (mg) LY2189265-1.700.58
Placebo-0.630.59
Secondary and other outcome results(7)
Secondary outcomeLeast squares mean· Baseline, 26 weeks

Change From Baseline to 26 Weeks in Mean 24-hour Systolic Blood Pressure (SBP)

GroupValue (millimeters of mercury (mmHg))Spread
1.5 Milligram (mg) LY2189265-2.510.63
0.75 Milligram (mg) LY2189265-1.560.60
Placebo0.150.62
Secondary outcomeLeast squares mean· Baseline, 16 and 26 weeks

Change From Baseline to 16 and 26 Weeks in Mean 24-hour Diastolic Blood Pressure (DBP)

GroupValue (millimeters of mercury (mmHg)])Spread
1.5 Milligram (mg) LY2189265-0.230.38
0.75 Milligram (mg) LY2189265-0.130.37
Placebo-0.550.37
Secondary outcomeLeast squares mean· Baseline, 16 and 26 weeks

Change From Baseline to 16 and 26 Weeks in Mean 24-Hour Heart Rate (HR)

GroupValue (beats per minute (bpm))Spread
1.5 Milligram (mg) LY21892653.700.45
0.75 Milligram (mg) LY21892652.480.43
Placebo0.860.44
Secondary outcomeLeast squares mean· Baseline, 16 and 26 weeks

Change From Baseline to 16 and 26 Weeks in Mean 24-hour Pulse Pressure

GroupValue (millimeters of mercury (mmHg))Spread
1.5 Milligram (mg) LY2189265-3.070.36
0.75 Milligram (mg) LY2189265-1.600.35
Placebo-0.020.36
Secondary outcomeLeast squares mean· Baseline, 16 and 26 weeks

Change From Baseline to 16 and 26 Weeks in Mean 24-hour Mean Arterial Pressure (MAP)

GroupValue (millimeters of mercury (mmHg))Spread
1.5 Milligram (mg) LY2189265-1.310.43
0.75 Milligram (mg) LY2189265-0.650.42
Placebo-0.600.42
Secondary outcomeLeast squares mean· Baseline, 16 and 26 weeks

Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Systolic Blood Pressure (SBP)

GroupValue (millimeters of mercury (mmHg))Spread
1.5 Milligram (mg) LY2189265-3.670.66
0.75 Milligram (mg) LY2189265-1.570.63
Placebo-0.340.64
Secondary outcomeLeast squares mean· Baseline, 16 and 26 weeks

Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Diastolic Blood Pressure (DBP)

GroupValue (millimeters of mercury (mmHg))Spread
1.5 Milligram (mg) LY2189265-0.090.43
0.75 Milligram (mg) LY21892650.140.41
Placebo-0.300.42

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
1.5 Milligram (mg) LY2189265LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks–12 / 251164 / 251
0.75 Milligram (mg) LY2189265LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks–8 / 254161 / 254
PlaceboPlacebo: subcutaneous (SC), once weekly (QW) for 26 weeks–8 / 250163 / 250

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

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Studies that cite this trial.

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Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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 \<140/90 mmHg at screening * If treated for hypertension, are taking 3 or less antihypertensive medications and have been taking these medications for at least 1 month prior to screening * Stable weight for 3 months prior to screening * Body mass index (BMI) greater than or equal to 23 kilogram-meter squared (kg/m\^2) * Willing to wear an ambulatory blood pressure monitoring device for at least 24 hours on multiple occasions * Women of childbearing potential must test negative for pregnancy and be willing to use a reliable method of birth control * Male participants must use a reliable method of birth control Exclusion Criteria: * Myocardial infarction, stroke, or hospitalization for heart failure within 3 months prior to screening, or heart failure Class III or IV at screening * Ongoing or history of frequent intermittent tachyarrhythmia * Resting heart rate \<60 beats per minute (bpm) or \>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

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