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Diabetes Mellitus, Type 2Phase 1NCT01606397

A Study of Multiple Increasing Doses of LY2409021 in Participants With Type 2 Diabetes

A Phase 1 study testing LY2409021 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

The study drug LY2409021 is being evaluated as a possible treatment for diabetes. The primary purpose of this study is to help answer the following research questions, and not to provide treatment for diabetes : The safety of LY2409021 and any side effects that might be associated with it following 4 weeks of doses… Read more about this study

Who is it for?
Ages 21 to 70 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
LY2409021
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
2 sitesin 2 countries
Study dates
Mar 2008to Nov 2008
Phase
Phase 1
Are there results?
None posted in the registry

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

Who may be able to join

  • Must be either a male, or a female who cannot become pregnant, who has type 2 diabetes and is either controlling diabetes through diet and exercise, or taking metformin
  • Have an hemoglobin A1c (HbA1c) value at screening of greater than or equal to 6.5% and less than or equal to 10.0% on a stable treatment regimen at the time of measurement
  • Have a screening body mass index (BMI) of 20 to 40 kg/m^2 inclusive
  • Have a blood pressure reading at screening of between 90 to 160 millimeters of mercury (mmHg) (systolic) and 40 to 95 mmHg (diastolic)

Who cannot join

  • Have used insulin for diabetic control within 1 year of study entry
  • Have used thiazolidinediones within 3 months, or any other drugs for treatment of hyperglycemia (except metformin) within 1 month, prior to first planned dosing. Metformin is acceptable for this study.
  • Have clinically significant coronary artery disease
  • Have clinically significant peripheral vascular disease
  • Have clinical evidence of active diabetic proliferative retinopathy
  • Have known significant autonomic neuropathy as evidenced by urinary retention, orthostatic hypotension, diabetic diarrhea or gastroparesis
Show all 14Show fewer
  • Impaired renal function (serum creatinine greater than 115 micromoles/liter [μmol/L] [1.3 mg/dL] in women, greater than 130 μmol/L [1.5 mg/dL] in men)
  • Have triglycerides greater than 4.5 millimoles per liter (mmol/L) [approximately 400 mg/dL] at screening
  • Were hospitalized for poor control of diabetes (keto-acidotic episode) in the last 6 months
  • Are allergic to LY2409021 or similar drugs
  • Have history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (other than diabetes), hematological, or neurological disorders capable of significantly altering the absorption, or metabolism or elimination of drugs or of constituting a risk when taking the study medication or interfering with the interpretation of data
  • Have used systemic glucocorticoids within 1 month prior to first dosing
  • Have donated 450 mL or more of blood in the last 3 months or have donated any blood within the last month
  • Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female), or are unwilling to stop alcohol as required by the study restrictions (1 unit = 360 mL of beer, or 150 mL of wine, or 45 mL of spirits)

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

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

Other trials in Singapore

United Kingdom1 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.

    Plymouth

Other trials in United Kingdom

About this study

Official title: The Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Multiple Escalating Doses of LY2409021 in Patients With Type 2 Diabetes Mellitus

The study drug LY2409021 is being evaluated as a possible treatment for diabetes. The primary purpose of this study is to help answer the following research questions, and not to provide treatment for diabetes :

  • The safety of LY2409021 and any side effects that might be associated with it following 4 weeks of doses
  • How long it takes the body to absorb and remove LY2409021 following dosing over 4 weeks
  • How daily dosing of LY2409021 affects blood levels of sugar (glucose), insulin and other naturally occurring substances before and after a meal
  • How LY2409021 works when given with metformin
  • How daily dosing of LY2409021 affects the cells that produce insulin
Being tested
Placebo, LY2409021
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.

  • PlaceboDrug

    Administered orally (capsule)

  • LY2409021Drug

    Administered orally (capsule)

Study groups in NCT01606397
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo administered orally once daily for 4 weeks
Receives: Drug: Placebo
5 mg LY2409021Experimental5 mg LY2409021 administered orally once daily for 4 weeks
Receives: Drug: LY2409021
30 mg LY2409021Experimental30 mg LY2409021 administered orally once daily for 4 weeks
Receives: Drug: LY2409021
60 mg LY2409021Experimental60 mg LY2409021 administered orally once daily for 4 weeks
Receives: Drug: LY2409021
90 mg LY2409021Experimental90 mg LY2409021 administered orally once daily for 4 weeks
Receives: Drug: LY2409021

What is being measured

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

  1. Number of participants with one or more drug related adverse events (AEs) or any serious AEs

    Measured: From first dose of study drug up to discharge (at least 28 days after last dose)

Secondary outcomes (9)

  1. Pharmacokinetics: Area under the concentration curve (AUC) of LY2409021

    Measured: From first study drug dose to Day 28 post last dose

  2. Pharmacokinetics: Maximum concentration (Cmax) of LY2409021

    Measured: From first study drug dose to Day 28 post last dose

  3. Change in fasting blood glucose level

    Measured: From Day -1 to Day 28 of dosing

  4. Change in incremental area under the curve (AUC) for glucose

    Measured: From Day -1 to Day 28 of dosing

  5. Change in homeostasis model assessment of beta cell function (HOMA-B)

    Measured: From baseline to Day 28

  6. Change in fasting glucagon level

    Measured: From Day -1 to Day 28 of dosing

  7. Change in fasting insulin level

    Measured: From Day -1 to Day 28 of dosing

  8. Change in fasting C-peptide level

    Measured: From Day -1 to Day 28 of dosing

  9. Change in fasting glucagon-like peptide-1 (GLP-1) level

    Measured: From Day -1 to Day 28 of dosing

Timeline

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

  1. First posted25 May 2012 (estimated)
  2. Study startMar 2008
  3. Primary completionNov 2008
  4. Study completionNov 2008

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01606397
Sponsor's protocol ID
11071
Other IDs
I1R-FW-GLBB
Status last verified
May 2012
First submitted
23 May 2012
Last updated
25 May 2012
Results posted
No
Data monitoring committee
No

Publications

  • Tan AYF, Schneck K, Garhyan P, Chan ECY, Tham LS. Evaluation of Four Semi-Mechanistic Models for Predicting Glycemic Control With a Glucagon Receptor Antagonist in People With Type 2 Diabetes. CPT Pharmacometrics Syst Pharmacol. 2025 Aug;14(8):1381-1390. doi: 10.1002/psp4.70058. Epub 2025 Jun 17.

    PubMed 40526184

  • Kelly RP, Garhyan P, Raddad E, Fu H, Lim CN, Prince MJ, Pinaire JA, Loh MT, Deeg MA. Short-term administration of the glucagon receptor antagonist LY2409021 lowers blood glucose in healthy people and in those with type 2 diabetes. Diabetes Obes Metab. 2015 Apr;17(4):414-22. doi: 10.1111/dom.12446. Epub 2015 Mar 2.

    PubMed 25656305

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY2409021 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 4 inclusion and 14 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 25 May 2012. 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 Singapore, United Kingdom. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 one or more drug related adverse events (AEs) or any serious AEs (time frame: From first dose of study drug up to discharge (at least 28 days after last dose)). 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 NCT01606397, which also lists 2 linked publications.

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 25 May 2012.

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