Diabetes Mellitus, Type 2Phase 1NCT01253278
A Multiple-Ascending Dose Study in Type 2 Diabetes Mellitus Patients
A Phase 1 study testing LY2393910 in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 1 site in Germany.
Trial summary
The study drug LY2393910 is being evaluated as a possible treatment for diabetes. The primary purpose of a patient's participation in this study is to help answer the following research question(s), and not to provide treatment for diabetes: The safety of LY2393910 and any side effects that might be associated with it… 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?
- LY2393910
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2010to May 2011
- 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
- Diagnosis of type 2 diabetes mellitus
- Must be on a stable treatment regimen (maintained on diet/exercise therapy with or without metformin) for at least 4 weeks prior to study entry
- Have a glycated haemoglobin (HbA1c) value greater than or equal to 6.5% and less than or equal to 10.0% on a stable treatment regimen
- Weigh 45.0 kg or more
- Have a Body Mass Index (BMI) greater than or equal to 18.5 and less than or equal to 40.0 kg/m2
- Are willing and able to conduct self-blood glucose monitoring tests
Who cannot join
- Are currently enrolled in, or discontinued within the last 30 days from a clinical trial involving use of an investigational 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 compatible with this study
- Use of insulin for diabetic control for more than 6 consecutive days within 1 year prior to study entry
- Use of thiazolidinediones within 3 months, or other oral anti-diabetics (OADs), apart from metformin, within 1 month prior to study entry. Metformin is acceptable for this study
- Previous myocardial infarction, stroke or transient ischaemic event ('TIA'), or clinically significant coronary events or symptoms within 6 months prior to study entry
- Subjects who have any evidence of heart insufficiency, hypokalaemia, family history of long-QT-syndrome or are receiving other drugs which extend the QT interval
- Clinically significant peripheral vascular disease
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- Clinical evidence of active diabetic proliferative retinopathy
- Known significant autonomic neuropathy
- Any patient having experienced a keto-acidotic episode requiring hospitalisation in the last 6 months
- Symptomatic hyperglycemia exhibited by significant osmotic symptoms (polyuria or polydipsia), unanticipated weight loss or dehydration
- Evidence of hepatitis B and/or positive hepatitis B surface antigen, at screening
- Subjects who have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females)
- Subjects who are heavy smokers (> 10 cigarettes, or equivalent, per day) or are unable or unwilling to refrain from nicotine during CRU admissions
- Regular use of known drugs of abuse and/or positive findings on urinary drug screening
- Evidence of human immunodeficiency virus (HIV) and/or positive HIV antibodies
- Evidence of hepatitis C and/or positive hepatitis C antibodies
Trial locations and contacts
1 site in 1 country.
Germany1 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.
Neuss, D-41460
About this study
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Multiple Escalating Oral Doses of LY2393910 in Patients With Type 2 Diabetes Mellitus
The study drug LY2393910 is being evaluated as a possible treatment for diabetes. The primary purpose of a patient's participation in this study is to help answer the following research question(s), and not to provide treatment for diabetes:
- The safety of LY2393910 and any side effects that might be associated with it following 2 weeks of doses
- How long it takes the body to absorb and remove LY2393910 following dosing over 2 weeks
- How daily dosing of LY2393910 affects blood levels of sugar (glucose), insulin and other naturally occurring substances in your body
- How daily dosing of LY2393910 affects the cells that produce insulin
- Any differences in the above between LY2393910 taken as daily doses in the morning or in the evening
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- LY2393910, Placebo
- 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.
LY2393910Drug
as capsules, administered orally once daily for two weeks
PlaceboDrug
as capsules, administered orally once daily for two weeks
| Study group | Role | What they receive |
|---|---|---|
| 20 mg LY2393910 | Experimental | Not described Receives: Drug: LY2393910 |
| 60 mg LY2393910 | Experimental | Not described Receives: Drug: LY2393910 |
| 150 mg LY2393910 | Experimental | Not described Receives: Drug: LY2393910 |
| 450 mg LY2393910 | Experimental | Not described Receives: Drug: LY2393910 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Clinically Significant Effects
Measured: Over four weeks
Secondary outcomes (8)
Pharmacokinetics of LY2393910, Area Under the Curve (AUC)
Measured: From predose Day 1 up until Day 19
Change from baseline to day 28 in glucagon
Measured: Baseline, day 28
Pharmacokinetics of LY2393910, maximum concentration (Cmax)
Measured: From predose Day 1 up until Day 19
Change from baseline to day 28 in glucose-like peptide 1 (GLP-1)
Measured: Baseline, day 28
Change from baseline to day 14 in insulin
Measured: baseline, day 14
Change from baseline to day 14 in proinsulin
Measured: baseline, day 14
Change from baseline to day 28 in glucose
Measured: baseline, day 28
Change from baseline to day 14 in C-peptide
Measured: baseline, day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startMar 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01253278
- Sponsor's protocol ID
- 13183
- Other IDs
- I4B-FW-GPCB
- Status last verified
- Jun 2011
- First submitted
- 1 Dec 2010
- Last updated
- 10 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Multiple Escalating Oral Doses of LY2393910 in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01253278
- Acronym / sponsor ID
- 13183
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 3 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study drug LY2393910 is being evaluated as a possible treatment for diabetes. The primary purpose of a patient's participation in this study is to help answer the following research question(s), and not to provide treatment for diabetes:
- The safety of LY2393910 and any side effects that might be associated with it following 2 weeks of doses
- How long it takes the body to absorb and remove LY2393910 following dosing over 2 weeks
- How daily dosing of LY2393910 affects blood levels of sugar (glucose), insulin and other naturally occurring substances in your body
- How daily dosing of LY2393910 affects the cells that produce insulin
- Any differences in the above between LY2393910 taken as daily doses in the morning or in the evening
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 20 mg LY2393910 | Experimental | Drug: LY2393910 |
| 60 mg LY2393910 | Experimental | Drug: LY2393910 |
| 150 mg LY2393910 | Experimental | Drug: LY2393910 |
| 450 mg LY2393910 | Experimental | Drug: LY2393910 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of type 2 diabetes mellitus
- Must be on a stable treatment regimen (maintained on diet/exercise therapy with or without metformin) for at least 4 weeks prior to study entry
- Have a glycated haemoglobin (HbA1c) value greater than or equal to 6.5% and less than or equal to 10.0% on a stable treatment regimen
- Weigh 45.0 kg or more
- Have a Body Mass Index (BMI) greater than or equal to 18.5 and less than or equal to 40.0 kg/m2
Key exclusion criteria (16 listed)
- Are currently enrolled in, or discontinued within the last 30 days from a clinical trial involving use of an investigational 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 compatible with this study
- Use of insulin for diabetic control for more than 6 consecutive days within 1 year prior to study entry
- Use of thiazolidinediones within 3 months, or other oral anti-diabetics (OADs), apart from metformin, within 1 month prior to study entry. Metformin is acceptable for this study
- Previous myocardial infarction, stroke or transient ischaemic event ('TIA'), or clinically significant coronary events or symptoms within 6 months prior to study entry
- Subjects who have any evidence of heart insufficiency, hypokalaemia, family history of long-QT-syndrome or are receiving other drugs which extend the QT interval
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY2393910as capsules, administered orally once daily for two weeks | Drug | 150 mg LY2393910, 20 mg LY2393910, 450 mg LY2393910, 60 mg LY2393910 |
| Placeboas capsules, administered orally once daily for two weeks | Drug | Placebo |
Primary outcome
Number of Participants with Clinically Significant Effects
Time frame: Over four weeks
8 secondary outcomes
Pharmacokinetics of LY2393910, Area Under the Curve (AUC)
Time frame: From predose Day 1 up until Day 19
Change from baseline to day 28 in glucagon
Time frame: Baseline, day 28
Pharmacokinetics of LY2393910, maximum concentration (Cmax)
Time frame: From predose Day 1 up until Day 19
Change from baseline to day 28 in glucose-like peptide 1 (GLP-1)
Time frame: Baseline, day 28
Change from baseline to day 14 in insulin
Time frame: baseline, day 14
Change from baseline to day 14 in proinsulin
Time frame: baseline, day 14
Change from baseline to day 28 in glucose
Time frame: baseline, day 28
Change from baseline to day 14 in C-peptide
Time frame: baseline, day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY2393910 in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 1 site in Germany.
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 6 inclusion and 16 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 10 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 Clinically Significant Effects (time frame: Over four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2011.