Phase 2
Completed N=270
A Study of LY2409021 on Blood Pressure and Pulse Rate in Participants With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT02091362 ↗Enrolled (actual)
270
Serious AEs
1.2%
Results posted
Jul 2018
Primary outcomePrimary: Change From Baseline to 6 Weeks in Mean 24-Hour Systolic Blood Pressure — 2.79; 0.53 mmHg — p=<.001
Summary
The main purpose of the trial is to determine the effect of a study drug known as LY2409021 on blood pressure and pulse rate in participants with type 2 diabetes mellitus (T2DM) when compared to placebo. The study has two periods. Each participant will receive LY2409021 or placebo in each period. At least 4 weeks will pass between periods. The study will last about 23 weeks for each participant. Participants may remain on stable dose metformin, as prescribed by their personal physician.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to 6 Weeks in Mean 24-Hour Systolic Blood Pressure |
2.79; 0.53 | <.001 sig |
| SECONDARY Change From Baseline to 6 Weeks in Mean 24-Hour Diastolic Blood Pressure |
1.37; 0.00 | <0.01 sig |
| SECONDARY Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Peripheral Pulse Rate |
0.46; 0.43; 0.74; 0.56; -0.39; -0.04 | — |
| SECONDARY Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Pulse Pressures |
1.51; 0.62; 1.49; 0.54; 1.51; 0.80 | — |
| SECONDARY Change From Baseline to 6 Weeks in Mean 24-Hour, Daytime, and Nighttime Mean Arterial Pressures (MAP) |
1.83; 0.17; 2.04; 0.08; 1.31; 0.33 | — |
| SECONDARY Change From Baseline in Hemoglobin A1c (HbA1c) |
-0.65; -0.16 | — |
| SECONDARY Population Pharmacokinetics: Apparent Clearance of LY2409021 |
0.406 | — |
| SECONDARY Population Pharmacokinetics: Apparent Volume of Distribution of LY2409021 |
36.7 | — |
Eligibility Criteria
Inclusion Criteria
- Have type 2 diabetes mellitus (according to the World Health Organization diagnostic criteria) and use diet and exercise alone or in combination with a stable dose of metformin ( >/=1000 mg/day [or /=6.5% and 90/60 millimeters of mercury (mm Hg) and /=3 months before screening.
- Body mass indexes >/=20 kilograms/meters squared (kg/m²) and 40 milli-international units per milliliter (mIU/mL), are not taking hormones or oral contraceptives within 1 year, and are otherwise healthy.
- Males who are sexually active and/or have partners of child-bearing age must use reliable methods of birth control during the study and until 3 months after the last doses of study medication. These requirements do not apply if a participant or his partner has been surgically sterilized or is not between menarche and 1 year postmenopausal.
Exclusion Criteria
- Have severe gastrointestinal disease that may significantly affect gastric emptying or motility.
- Previous histories or active diagnoses of pancreatitis.
- Acute or chronic hepatitis, signs or symptoms of any other liver disease, or alanine aminotransferase (ALT) level greater than 2.5 times the upper limit of normal (ULN).
- Elevated total bilirubin (greater than 2 times ULN), clinically suspicious signs or symptoms of cirrhosis or history of cirrhosis.
- Mean resting pulse rate (PR) less than 60 beats per minute (bpm) or greater than 100 bpm.
- Current diagnosis or personal history of neuroendocrine tumors, family history of any type of multiple endocrine neoplasia, or Von Hippel-Lindau disease.
Data sourced from ClinicalTrials.gov (NCT02091362). 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.