A Study of LY2409021 in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01241448
First received: November 12, 2010
Last updated: May 24, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: LY2409021
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Phase 2b Study of LY2409021 in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from baseline to 24 week endpoint in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline to 24 week endpoint in fasting blood glucose (FBG) [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 24 week endpoint in 7-point self monitored glucose (SMBG) profile [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 24 week endpoint in plasma glucose [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 24 week endpoint in fasting insulin [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 24 week endpoint in fasting GLP-1 active and total [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 24 week endpoint in fasting lipid profile [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 24 week endpoint in lipoprotein subfractions [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 24 week endpoint in free fatty acids [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 24 week endpoint indices in insulin sensitivity using HOMA-IR [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 24 week endpoint indices in beta-cell function using HOMA-B [ Time Frame: Baseline, 24 week ] [ Designated as safety issue: No ]
  • Change from baseline to 24 week endpoint in weight [ Time Frame: Baseline, 24 weeks ] [ Designated as safety issue: No ]
  • Population pharmacokinetics [ Time Frame: Baseline up to 26 weeks ] [ Designated as safety issue: No ]
  • The incidence of hypoglycemic episodes [ Time Frame: Over 24 weeks ] [ Designated as safety issue: Yes ]
  • The rate of hypoglycemic episodes [ Time Frame: Over 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 260
Study Start Date: January 2011
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Once daily for 24 weeks
Drug: Placebo
Administered Orally
Experimental: 2.5 mg LY2409021
Once daily for 24 weeks
Drug: LY2409021
Administered Orally
Experimental: 10 mg LY2409021
Once daily for 24 weeks
Drug: LY2409021
Administered Orally
Experimental: 20 mg LY2409021
Once daily for 24 weeks
Drug: LY2409021
Administered Orally

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 mg/day.
  • Have an HbA1c value of 7.0% to 10.5% , inclusive.
  • Have a body mass index (BMI) between 25 to 45 kg/m2, 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 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 criteria are acceptable: for example, abnormalities of blood glucose, hemoglobin A1C (HbA1c), urinary glucose, and urinary protein (with a range of trace to 1+ on dipstick).
  • Have a currently suspected or treated malignancy, or are in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
  • Have a personal or family history of pancreatic neoplasia.
  • Have non-fasting triglycerides >600 mg/dL.
  • Use or have used insulin or GLP-1 agonists (for more than 1 week within the 3-month period prior to screening), or any oral antihyperglycemic medication (OAM) other than metformin within the 3-month period prior to screening.
  • Currently use or intend to use prescription or over-the-counter medications, including herbal supplements, to promote weight loss or to regulate blood glucose.
  • Have current chronic (>2 weeks) systemic glucocorticoid therapy (excluding ocular topical, other topical, inhaled preparations)or have received such therapy within 8 weeks prior to screening.
  • Currently use hyperglycemia-causing agents, hypoglycemia-causing agents (other than metformin), class II and III antiarrythmic agents, agents that reduce gastrointestinal motility,central nervous system stimulants (with the exception of caffeinated beverages), fibrates, and niacin greater than or equal to 1 gm/day.
  • Have an average weekly alcohol intake that exceeds 2 units per day for males and 1 unit per day for females (1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits).
  • Currently use drugs with a narrow therapeutic index (for example, digoxin,lithium, phenytoin, theophylline, and warfarin).
  • Currently use drugs that are known to prolong the QT interval.
  • Currently use or intend to use potent inhibitors of CYP3A, which include but are not limited to atazanavir, indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, and telithromycin.
  • Have previously completed or withdrawn from this study or any other study investigating LY2409021.
  • Have known allergies to LY2409021 or related compounds.
  • Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or unapproved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
  • Have any other condition such as alcohol abuse, drug abuse, or psychiatric disorder that may affect the ability to participate in the trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01241448

  Show 40 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-4559) or 1-317-615-4559 Mon - Fri 9 Am - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01241448     History of Changes
Other Study ID Numbers: 13031, I1R-MC-GLBG
Study First Received: November 12, 2010
Last Updated: May 24, 2012
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Italy: Ethics Committee
Slovakia: State Institute for Drug Control
Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Eli Lilly and Company:
Type 2 Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 01, 2014