Phase 2
Completed N=263
A Study of LY2409021 in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov NCT01241448 ↗Enrolled (actual)
263
Serious AEs
2.7%
Results posted
Apr 2018
Primary outcomePrimary: Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c) — -0.15; -0.45; -0.78; -0.92 percentage of Hemoglobin A1c (HbA1c) — p=0.094
Summary
LY2409021 is being evaluated for possible treatment in type 2 diabetes. This study is designed to compare LY2409021 given alone or given in combination with metformin against placebo the change in hemoglobin A1c after a 24-week treatment period.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to 24 Week Endpoint in Hemoglobin A1c (HbA1c) |
-0.15; -0.45; -0.78; -0.92 | 0.094 |
| SECONDARY Change From Baseline to 24 Week Endpoint in Fasting Blood Glucose (FBG) |
-0.36; -0.46; -1.07; -1.14 | — |
| SECONDARY Change From Baseline to 24 Week Endpoint in 7-point Self Monitored Glucose (SMBG) Profile |
-14.45; -15.76; -29.65; -32.55; -28.75; -23.01 | — |
| SECONDARY Change From Baseline to 24 Week Endpoint in Plasma Glucose |
-0.36; -0.46; -1.07; -1.14 | — |
| SECONDARY Change From Baseline to 24 Week Endpoint in Fasting Insulin |
10.62; 2.61; 14.95; 9.65 | — |
| SECONDARY Change From Baseline to 24 Week Endpoint in Fasting Glucagon-like Peptide 1 (GLP-1) Active and Total |
-0.30; 0.13; 0.38; 0.31; -0.12; 1.84 | — |
| SECONDARY Change From Baseline to 24 Week Endpoint in Fasting Lipid Profile |
-0.11; 0.07; 0.06; 0.08; 0.20; 0.05 | — |
| SECONDARY Change From Baseline to 24 Week Endpoint in Lipoprotein Subfractions-Particles (Total) |
1.90; 6.48; 0.07; 2.04 | — |
| SECONDARY Change From Baseline to 24 Week Endpoint in Free Fatty Acids |
-0.04; -0.02; -0.15; -0.07 | — |
| SECONDARY Change From Baseline to 24 Week Endpoint Indices in Insulin Sensitivity Using Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) |
0.19; 0.02; 0.26; 0.19 | — |
| SECONDARY Change From Baseline to 24 Week Endpoint Indices in Beta-cell Function Using HOMA-B |
4.88; 7.90; 17.69; 16.39 | — |
| SECONDARY Change From Baseline to 24 Week Endpoint in Weight |
-1.07; -0.33; 0.55; 0.07 | — |
| SECONDARY Population Pharmacokinetics: Apparent Clearance (CL/F) of LY2409021 |
0.486 | — |
| SECONDARY Population Pharmacokinetics: Apparent Volume of Distribution of LY2409021 |
33.4 | — |
| SECONDARY The Percentage of Participants Experiencing a Hypoglycemic Episode |
3.2; 6.3; 9.4; 7.8 | — |
| SECONDARY The 30-Day Adjusted Rate of Hypoglycemic Episodes |
— | — |
Eligibility Criteria
Inclusion Criteria
- Have a diagnosis of Type 2 diabetes mellitus according to the World Health Organization (WHO) diagnostic criteria
- Are women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause.
- Are male patients using a reliable method of birth control during the study and until 3 months after the last dose of study medication.
- Are being treated with either diet and exercise alone, or with diet and exercise in combination with metformin. Metformin therapy must have been stable and unchanged for at least 3 months prior to screening and at a dose of at least 1000 milligram per day (mg/day).
- Have a hemoglobin A1c (HbA1c) value of 7.0% to 10.5%, inclusive.
- Have a body mass index (BMI) between 25 to 45 kilogram per meter squared (kg/m^2), inclusive.
In the opinion of the investigator, are capable and willing to:
- Perform self-monitoring of blood glucose
- Complete a study diary as required for this protocol
- Maintain consistent dietary, physical activity, and sleeping patterns throughout the duration of the study
- Comply with treatment regimens
- Have given written informed consent to participate in this study in accordance with local regulations and the Ethical Review Board (ERB) governing the study site.
Exclusion Criteria
- Have more than 1 episode of severe hypoglycemia (defined as an event during which the patient requires the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions) within 6 months prior to screening, or have a current diagnosis of hypoglycemia unawareness.
- Have had two or more emergency room visits or hospitalizations due to poor glucose control in the 6 months prior to screening.
- Have gastrointestinal disease that may significantly impact gastric emptying or motility or have undergone gastric bypass or gastric banding surgery.
- Have had a previous diagnosis of pancreatitis.
- Have New York Heart Association (NYHA) class II, III, or IV symptoms of heart failure
- Have a history of myocardial infarction, unstable angina, or a coronary revascularization procedure within 6 months of screening.
- Have a history of supraventricular tachycardia, ventricular tachycardia, or other cardiac arrhythmia.
- Have a history of transient ischemic attack (TIA) or stroke within 6 months of screening.
- Have poorly controlled hypertension (systolic blood pressure greater than or equal to 150 mm Hg or diastolic blood pressure greater than or equal to 90 mm Hg) as determined by the mean of three separate measurements.
- Show evidence of labile blood pressure, including symptomatic postural hypotension.
- Have any abnormality of the ECG that would impact patient safety or data interpretation.
- Show clinical signs or symptoms of liver disease, or liver function tests (LFTs; aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) greater than 2.5 times upper limit of normal (ULN) as determined by the central laboratory at screening.
- Have a current or previous diagnosis of Gilbert's disease.
- Have previous or current diagnosis of Hepatitis B or C
- Have a serum creatinine >2 milligrams per deciliter (mg/dL) or, in patients being treated with metformin, a serum creatinine above (or creatinine clearance below) what is approved in the metformin product labeling in the respective country.
- Show evidence of uncorrected hypothyroidism or hyperthyroidism based on clinical evaluation and/or an abnormal thyroid stimulating hormone result as determined by the central laboratory at screening; patients receiving dose-stable thyroid replacement therapy for at least 3 months prior to screening will be allowed to participate in the study.
- Have any other abnormal laboratory value that, in the opinion of the investigator, precludes the patient from participation in the study. Laboratory abnormalities consistent with type 2 diabetes mellitus and all other eligibility criteri
Data sourced from ClinicalTrials.gov (NCT01241448). 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.