A Study of LY2608204 in Patients With Type 2 Diabetes

NCT01247363 | Completed Phase 1 Results

• 2 other identifiers: 14130I3P-FW-GKBE
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 2

Brief Summary

Safety study with multiple oral doses of LY2608204 given to patients with type 2 diabetes. Study subjects will receive once daily doses of LY2608204 for a total treatment duration of up to 28 days. In this study, each patient will receive increasing doses of LY2608204 until reaching the highest dose that they can tolerate. Continuous glucose monitoring devices will be employed for each patient to monitor for hypoglycemia during study treatment. Dose titration and dose reduction is determined for each individual patient based on their safety and glycemic data.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes glucokinase safety

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Clinically Significant Adverse Effects

  Clinically significant adverse effects refer to any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the investigational product, whether or not related to the medicinal investigational product.

  Day 1 through Day 49

Secondary Outcomes (4)

• Area Under the Concentration Time Curve (AUC)

  Predose, 1, 2, 4, 6, 7, 10, 12 and 24 hours Postdose

• Maximum Drug Concentration (Cmax)

  Predose, 1, 2, 4, 6, 7, 10, 12, 24, 48, 120 and 168 hours Postdose

• Time to Maximum Drug Concentration (Tmax)

  Predose, 1, 2, 4, 6, 7, 10, 12, 24, 48, 120 and 168 hours Postdose

• Number of Hypoglycemic Events

  Day 1 through Day 29

Study Arms (1)

LY2608204

EXPERIMENTAL

Oral capsules of LY2608204 given once daily at a starting dose of 160 milligram (mg), which may be titrated in 3 dose escalations to 240 mg, 320 mg and 400 mg, with a 7-day treatment duration at each dose level for up to 28 days total treatment.

Drug: LY2608204

Interventions

LY2608204 DRUG

Administered orally.

Also known as: Glucokinase Activator

LY2608204

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with Type 2 diabetes mellitus (T2DM) who are currently treated with diet/lifestyle measures alone or in combination with anti-diabetic agents, including insulins
• Have fasting blood glucose (FBG) greater than or equal to 160 milligram/deciliter (mg/dL), with a subset of patients with FBG greater than or equal to 190 mg/dL in at least 2 measurements on separate days
• Have a glycated haemoglobin (HbA1c) level of greater than or equal to 8% and less than or equal to 11% at screening
• If female, are not of child-bearing potential due to surgical sterilisation (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause
• Are males or females who are at least 18 years old (for sites outside of Singapore) or at least 21 years old (for sites within Singapore) but no more than 70 years old (for all sites)
• Body mass index (BMI) greater than 18.5 kilogram/square meter (kg/m²) and less than 40.0 kg/m²
• Have clinical laboratory test results within the normal range for the population or investigator site, or with abnormalities deemed clinically insignificant by the investigator
• Have supine systolic blood pressure (SBP) greater than 160 millimeters of mercury (mmHg) and supine diastolic blood pressure (DBP) less than 100 mmHg
• Have venous access sufficient to allow blood sampling as per the protocol
• Are willing and able to comply with requirements for continuous glucose monitoring (CGM)
• Are reliable and willing to make themselves available for the duration of the study and who will abide by the Clinical Research Unit (CRU) policy and procedure and study restrictions. This includes staying in-patient at the CRU for a total duration of up to 31 days
• Have given written informed consent approved by Lilly and the ethical review board governing the site

You may not qualify if:

• Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or use of a drug or device other than the study drug used in this study, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
• Have significant history of past or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (other than diabetes), hematological, or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs or of constituting a risk when taking the study drug formulations or interfering with the interpretation of data
• Have a history of a seizure disorder
• A corrected QT interval greater than 450 milliseconds (msec) at screening or any personal history of ventricular tachycardia or unexplained syncope, or other abnormality in the 12-lead Electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
• Have family history of long QT syndrome or family history of sudden unexplained death
• Use medications known to prolong the QT interval.
• Have type 1 diabetes mellitus or a history of ketoacidosis or any other type of diabetes mellitus other than type 2
• Use of any known inducers or inhibitors of CYP3A within 14 days prior to the first dosing with study drug or intended use during the study
• History of a hypoglycemic event with acute mental status alteration that was not preceded by prodromal symptoms recognizable to the patient
• Fasting serum triglycerides greater than 500mg/dl
• Serum creatinine greater than 1.3 mg/dL in women, greater than 1.5 mg/dL in men
• Clinical evidence of active diabetic proliferative retinopathy
• Known clinically significant autonomic neuropathy as evidenced by urinary retention, orthostatic hypotension, diabetic diarrhea or gastroparesis
• Clinically significant coronary events or symptoms within 6 months prior to study entry
• Clinically significant peripheral vascular disease

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Miramar, Florida, 33025, United States

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Singapore, 117597, Singapore

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

globalagliatin; glucokinase activator compound 50

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: November 24, 2010
• Study Start: November 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: November 16, 2018
• Results First Posted: October 3, 2018

Record last verified: 2018-10

Locations

US (1); SG (1)