Phase 2 · Dulaglutide

NCT01149421 trial results

The Effect of LY2189265 on Blood Pressure and Heart Rate, as Assessed by Ambulatory Blood Pressure Monitoring, in Patients With Type 2 Diabetes Mellitus

Change From Baseline to 16 Weeks in Mean 24-hour Systolic Blood Pressure (SBP) (millimeters of mercury (mmHg)), Baseline, 16 weeks. 1.5 Milligram (mg) LY2189265: -3.41; 0.75 Milligram (mg) LY2189265: -1.70; Placebo: -0.63.

Participants
755
Status
completed
Completed
2012-01
Sponsor
Eli Lilly and Company

As posted on ClinicalTrials.gov (NCT01149421), updated at source Feb 2, 2015. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT01149421 measured first

Change From Baseline to 16 Weeks in Mean 24-hour Systolic Blood Pressure (SBP)millimeters of mercury (mmHg) · Baseline, 16 weeks · least squares mean
1.5 Milligram (mg) LY2189265n=2470.75 Milligram (mg) LY2189265n=251Placebon=249
-3.41(0.61)-1.70(0.58)-0.63(0.59)

From the results posted on ClinicalTrials.gov (NCT01149421), updated at source Feb 2, 2015.

Side effects by arm

Side effects in NCT01149421

Percent of participants affected. The most common events the registry lists.

Event1.5 Milligram (mg) LY21892650.75 Milligram (mg) LY2189265Placebo
Any serious event4.8%3.1%3.2%
Nausea13.9%7.1%6.4%
Diarrhoea12.4%9.4%8%
Headache10%8.3%10%
Nasopharyngitis9.2%7.5%9.6%
Vomiting7.6%4.3%4.4%
Decreased appetite6.8%3.5%1.2%
Dyspepsia4.4%5.9%2.4%
Back pain3.6%4.7%5.2%
Dizziness5.2%3.9%2.8%
Upper respiratory tract infection2.8%3.1%4.8%
Constipation3.2%4.7%0.8%
Abdominal pain upper4.4%2.4%0.8%
Hyperglycaemia0%0.8%4.4%
Arthralgia2.8%2.4%4%
Cough2.4%2.8%4%

From the results posted on ClinicalTrials.gov (NCT01149421), updated at source Feb 2, 2015.

Secondary outcomes

What else it measured

Change From Baseline to 26 Weeks in Mean 24-hour Systolic Blood Pressure (SBP)millimeters of mercury (mmHg) · Baseline, 26 weeks · least squares mean
1.5 Milligram (mg) LY2189265n=2470.75 Milligram (mg) LY2189265n=251Placebon=249
-2.51(0.63)-1.56(0.60)0.15(0.62)

From the results posted on ClinicalTrials.gov (NCT01149421), updated at source Feb 2, 2015.

Change From Baseline to 16 and 26 Weeks in Mean 24-hour Diastolic Blood Pressure (DBP)millimeters of mercury (mmHg)] · Baseline, 16 and 26 weeks · least squares mean
Measure1.5 Milligram (mg) LY2189265n=2470.75 Milligram (mg) LY2189265n=251Placebon=249
Mean 24-Hour, Week 16-0.23(0.38)-0.13(0.37)-0.55(0.37)
Mean 24-Hour, Week 260.26(0.40)-0.09(0.38)-0.24(0.39)

From the results posted on ClinicalTrials.gov (NCT01149421), updated at source Feb 2, 2015.

Change From Baseline to 16 and 26 Weeks in Mean 24-Hour Heart Rate (HR)beats per minute (bpm) · Baseline, 16 and 26 weeks · least squares mean
Measure1.5 Milligram (mg) LY2189265n=2470.75 Milligram (mg) LY2189265n=251Placebon=249
Mean 24-Hour HR, Week 163.70(0.45)2.48(0.43)0.86(0.44)
Mean 24-Hour HR, Week 264.18(0.47)1.94(0.46)0.68(0.47)

From the results posted on ClinicalTrials.gov (NCT01149421), updated at source Feb 2, 2015.

Change From Baseline to 16 and 26 Weeks in Mean 24-hour Pulse Pressuremillimeters of mercury (mmHg) · Baseline, 16 and 26 weeks · least squares mean
Measure1.5 Milligram (mg) LY2189265n=2470.75 Milligram (mg) LY2189265n=251Placebon=249
Mean 24-Hour PP, Week 16-3.07(0.36)-1.60(0.35)-0.02(0.36)
Mean 24-Hour PP, Week 26-2.64(0.38)-1.53(0.37)0.46(0.37)

From the results posted on ClinicalTrials.gov (NCT01149421), updated at source Feb 2, 2015.

Change From Baseline to 16 and 26 Weeks in Mean 24-hour Mean Arterial Pressure (MAP)millimeters of mercury (mmHg) · Baseline, 16 and 26 weeks · least squares mean
Measure1.5 Milligram (mg) LY2189265n=2470.75 Milligram (mg) LY2189265n=251Placebon=249
Week 16-1.31(0.43)-0.65(0.42)-0.60(0.42)
Week 26-0.74(0.44)-0.57(0.42)-0.15(0.43)

From the results posted on ClinicalTrials.gov (NCT01149421), updated at source Feb 2, 2015.

Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Systolic Blood Pressure (SBP)millimeters of mercury (mmHg) · Baseline, 16 and 26 weeks · least squares mean
Measure1.5 Milligram (mg) LY2189265n=2510.75 Milligram (mg) LY2189265n=254Placebon=250
Mean Daytime SBP, Week 16 (n=247, n=251, n=249)-3.67(0.66)-1.57(0.63)-0.34(0.64)
Mean Daytime SBP, Week 26 (n=247, n=251, n=249)-2.52(0.68)-1.47(0.65)0.35(0.67)
Mean Nighttime SBP, Week 16 (n=247, n=251, n=249)-2.32(0.76)-1.23(0.73)-1.08(0.74)
Mean Nighttime SBP, Week 26 (n=247, n=251, n=249)-2.40(0.75)-1.43(0.72)-0.05(0.73)
Mean Clinic SBP, Week 16 (n=251, n=254, n=250)-2.33(0.75)-1.26(0.72)-0.73(0.73)
Mean Clinic SBP, Week 26 (n=251, n=254, n=250)-2.29(0.77)-0.74(0.74)0.40(0.75)

From the results posted on ClinicalTrials.gov (NCT01149421), updated at source Feb 2, 2015.

Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Diastolic Blood Pressure (DBP)millimeters of mercury (mmHg) · Baseline, 16 and 26 weeks · least squares mean
Measure1.5 Milligram (mg) LY2189265n=2510.75 Milligram (mg) LY2189265n=254Placebon=250
Mean Daytime DBP, Week 16 (n=247, n=251, n=249)-0.09(0.43)0.14(0.41)-0.30(0.42)
Mean Daytime DBP, Week 26 (n=247, n=251, n=249)0.52(0.43)0.08(0.41)-0.07(0.42)
Mean Nighttime DBP, Week 16 (n=247, n=251, n=249)-0.01(0.49)-0.28(0.48)-1.10(0.48)
Mean Nighttime DBP, Week 26 (n=247, n=251, n=249)-0.22(0.51)-0.42(0.50)-0.69(0.51)
Mean Clinic DBP, Week 16 (n=251, n=254, n=250)-0.21(0.52)0.76(0.50)-0.21(0.51)
Mean Clinic DBP, Week 26 (n=251, n=254, n=250)0.59(0.50)0.69(0.48)0.61(0.49)

From the results posted on ClinicalTrials.gov (NCT01149421), updated at source Feb 2, 2015.

Change From Baseline to 16 and 26 Weeks in Mean Daytime, Nighttime, and Clinic Heart Rate (HR)beats per minute (bpm) · Baseline, 16 and 26 weeks · least squares mean
Measure1.5 Milligram (mg) LY2189265n=2510.75 Milligram (mg) LY2189265n=254Placebon=250
Mean Daytime HR, Week 16 (n=247, n=251, n=249)3.56(0.50)2.22(0.49)1.07(0.49)
Mean Daytime HR, Week 26 (n=247, n=251, n=249)4.24(0.51)1.59(0.49)0.67(0.50)
Mean Nighttime HR, Week 16 (n=247, n=251, n=249)4.60(0.51)3.43(0.49)0.65(0.50)
Mean Nighttime HR, Week 26 (n=247, n=251, n=249)4.76(0.57)3.01(0.54)0.77(0.55)
Mean Clinic HR, Week 16 (n=251, n=254, n=250)3.97(0.49)2.11(0.48)0.46(0.48)
Mean Clinic HR, Week 26 (n=251, n=254, n=250)4.89(0.54)1.93(0.52)-0.11(0.53)

From the results posted on ClinicalTrials.gov (NCT01149421), updated at source Feb 2, 2015.

Change From Baseline to 16 and 26 Weeks in Mean Daytime and Nighttime Pulse Pressuremillimeters of mercury (mmHg) · Baseline, 16 and 26 weeks · least squares mean
Measure1.5 Milligram (mg) LY2189265n=2470.75 Milligram (mg) LY2189265n=251Placebon=249
Mean Daytime PP, Week 16-3.46(0.40)-1.76(0.38)0.01(0.39)
Mean Daytime PP, Week 26-2.90(0.42)-1.62(0.41)0.51(0.42)
Mean Nighttime PP, Week 16-2.23(0.45)-0.92(0.43)0.02(0.44)
Mean Nighttime PP, Week 26-2.09(0.43)-0.96(0.41)0.65(0.42)

From the results posted on ClinicalTrials.gov (NCT01149421), updated at source Feb 2, 2015.

Change From Baseline to 16 and 26 Weeks in Mean Daytime and Nighttime Mean Arterial Pressure (MAP)millimeters of mercury (mmHg) · Baseline, 16 and 26 weeks · least squares mean
Measure1.5 Milligram (mg) LY2189265n=2470.75 Milligram (mg) LY2189265n=251Placebon=249
Mean Daytime MAP, Week 16-1.30(0.48)-0.42(0.46)-0.33(0.47)
Mean Daytime MAP, Week 26-0.51(0.49)-0.42(0.47)0.05(0.48)
Mean Nighttime MAP, Week 16-0.80(0.56)-0.59(0.53)-1.11(0.54)
Mean Nighttime MAP, Week 26-0.96(0.57)-0.76(0.54)-0.50(0.56)

From the results posted on ClinicalTrials.gov (NCT01149421), updated at source Feb 2, 2015.

Change From Baseline to 16 and 26 Weeks in Glycosylated Hemoglobin (HbA1c)percentage of HbA1c · Baseline, 16 and 26 weeks · least squares mean
Measure1.5 Milligram (mg) LY2189265n=2510.75 Milligram (mg) LY2189265n=254Placebon=250
Week 16-1.18(0.06)-1.04(0.05)-0.06(0.05)
Week 26-1.01(0.07)-0.89(0.06)-0.02(0.06)

From the results posted on ClinicalTrials.gov (NCT01149421), updated at source Feb 2, 2015.

Change From Baseline to 16 and 26 Weeks in Fasting Blood Glucose (FBG)millimoles per liter (mmol/L) · Baseline, 16 and 26 weeks · least squares mean
Measure1.5 Milligram (mg) LY2189265n=2490.75 Milligram (mg) LY2189265n=247Placebon=249
Week 16-2.05(0.13)-1.94(0.13)-0.30(0.13)
Week 26-1.67(0.15)-1.66(0.15)0.00(0.15)

From the results posted on ClinicalTrials.gov (NCT01149421), updated at source Feb 2, 2015.

The trial

How NCT01149421 was run

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).

  • 1.5 milligram (mg) LY2189265: LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW)
  • 0.75 milligram (mg) LY2189265: LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW)
  • Placebo: Placebo: subcutaneous (SC), once weekly (QW)
Who could join the trial

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

Published papers

Papers from NCT01149421

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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