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Diabetes Mellitus, Type 2Phase 1NCT01247363

A Study of LY2608204 in Patients With Type 2 Diabetes

A Phase 1 study testing LY2608204 in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
LY2608204
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesin 2 countries
Study dates
Nov 2010to Mar 2011
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.
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  • 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
  • Have known allergies to LY2608204 or related compounds
  • Evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies/antigen
  • Evidence of hepatitis B and/or positive hepatitis B surface antigen (HBsAg)
  • Donation or loss of blood equal to or exceeding 450 milliliter (mL) during the 3 months before the first administration of study drug
  • Patients who have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females) (1 unit equal to 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits) or patients unwilling to stop alcohol consumption 24 hours prior to admission until the completion of each in-patient study period
  • Patients who smoke more than 10 cigarettes or other tobacco products per day before study entry. Patients will not be allowed to smoke while in the study Unit
  • Have a history of drug or alcohol abuse
  • Intended use of over-the counter or prescription medications 7 and 14 days, respectively, prior to dosing. If this situation arises, inclusion of an otherwise suitable volunteer may be at the discretion of the investigator. Use of anti-diabetic medication [metformin, sulphonylureas, glinides, thiazolidinediones, acarbose, DPPIV inhibitors, Byetta (but not liraglutide)] by patients with type 2 diabetes mellitus is acceptable for this study
  • Have repeated alanine transaminase levels greater than 2.5 times the upper limit of the reference range at screening, as determined by the central laboratory
  • Have previously been enrolled in this clinical study or any other study of LY2608204.
  • Evidence of hepatitis C and/or positive hepatitis C antibodies, at screening
  • Use of known drugs of abuse and/or positive findings on urinary drug screening, other than findings consistent with medication prescribed by the patient's physician or over-the-counter medications

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • 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

Other trials in United States

Singapore1 site

  • 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

Other trials in Singapore

About this study

Official title: Safety and Tolerability of Multiple Ascending Doses of LY2608204 in Patients With Type 2 Diabetes Mellitus

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.

Being tested
LY2608204
Keywords
Diabetes glucokinase safety
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY2608204Drug

    Also called Glucokinase Activator

    Administered orally.

Study groups in NCT01247363
Study groupRoleWhat they receive
LY2608204ExperimentalOral 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.
Receives: Drug: LY2608204

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 1 through Day 49

Secondary outcomes (4)

  1. Area Under the Concentration Time Curve (AUC)

    AUC for Day 1 is AUC from 0 to 24 hours. AUC for all other days is AUC at a dosing interval.

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

  2. Maximum Drug Concentration (Cmax)

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

  3. Time to Maximum Drug Concentration (Tmax)

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

  4. Number of Hypoglycemic Events

    Number of hypoglycemia events with blood glucose concentration <70 milligram/deciliter (mg/dL).

    Measured: Day 1 through Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Nov 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionMar 2011
  4. Study completionMar 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01247363
Sponsor's protocol ID
14130
Other IDs
I3P-FW-GKBE
Status last verified
Oct 2018
First submitted
22 Nov 2010
Last updated
16 Nov 2018
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY2608204 in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Clinically Significant Adverse Effects (time frame: Day 1 through Day 49). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01247363.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2018.

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