Diabetes Mellitus, Type 2Phase 2NCT01408095

A Study in Patients With Type 2 Diabetes

A Phase 2 study testing LY2608204 and Glimepiride in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 38 sites in 7 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

Trial summary

The study is designed to see if once daily oral dosing of LY2608204 will help control diabetes as measured by the glycosylated fraction of hemoglobin A (HbA1c) level. It will also help to determine the safety of the medication and the most useful doses of the medication. 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 and Glimepiride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 240 participants
Where: 38 sitesin 7 countries
Study dates: Sep 2011to Sep 2012
Phase: Phase 2
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 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinical diagnosis of type 2 diabetes mellitus prior to entering the trial
May be treated with:
Diet and exercise alone or
Diet and exercise in combination with a stable dose of metformin for at least 3 months before Screening or
Diet and exercise in combination with a stable dose of sulfonylurea or meglitinide (repaglinide, nateglinide) for at least 3 months before Screening or
Diet and exercise in combination with stable doses of metformin and sulfonylurea or metformin and meglitinides for at least 3 months before Screening and have had diabetes for at least 6 years

Show all 11Show fewer

Must have an Hemoglobin A1c value between 7% and 10%
Must have a body mass index (BMI) between 20 and 40 kg/m2
Must have stable weight during the 3 months prior to Screening (weight change not to exceed 5 kg (11 lb))
If female, you must not be able to get pregnant
Must be well motivated, capable, and willing to complete study required glucose monitoring and instruction

Who cannot join

Use of insulin or any antidiabetic agent other than metformin or sulfonylurea or meglitinide during the 3 months prior to Screening
Have a gastrointestinal disease that significantly impacts gastric emptying or motility or have undergone gastric bypass or gastric banding surgery
Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study, or are currently diagnosed as having hypoglycemia unawareness or have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months
Are currently taking or have taken within the last 2 months, prescription or over-the counter medications which affect body weight
Have cardiac disease with functional status that is New York Heart Association [NYHA] Class II, III, or IV or a history of myocardial infarction, unstable angina, or decompensated congestive heart failure in the past 6 months.
Have poorly controlled hypertension, history of malignant hypertension, evidence of renal artery stenosis and/or evidence of labile blood pressure including symptomatic postural hypotension. Doses of antihypertensive medications must be stable for 30 days before randomization

Show all 15Show fewer

Have a QTcB (Bazett's-corrected QT interval) interval greater than 450 msec for men or greater than 470 for women at Screening or any personal history of ventricular tachycardia or unexplained syncope
Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or significantly elevated liver blood tests
Are currently receiving renal dialysis, have a serum creatinine greater than 2.0 mg/dL (177 μmol/L) or a calculated creatinine clearance of less than 60 ml/min or in patients being treated with metformin, have other known contradictions to metformin use including, but not limited to, a serum creatinine above (or creatinine clearance below) what is approved in the metformin product label
Have fasting state hypertriglyceridemia (defined as greater than 5.65 mmol/L, 500 mg/dl) at Screening. If taking lipid-lowering agents, doses of these medications must be stable for 30 days prior to randomization.
Are receiving chronic (for more than 2 weeks) systemic glucocorticoid therapy (excluding topical or inhaled preparations) or have received such therapy within 4 weeks immediately prior to Randomization
Have an active or untreated malignancy or have been 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 history of seizure disorder
Are currently using or intend to use inhibitors of Cytochrome P450 family 3A (CYP3A4)
Currently taking a medication that is a sensitive substrate of the CYP3A4 pathway with a narrow therapeutic index

Trial locations and contacts

38 sites in 7 countries.

Country

City, postcode or hospital

38 sites in 7 countries

United States18 sites

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.
Anaheim, California, 92801
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Beachwood, Ohio, 44122
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Dallas, Texas, 75230
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Des Moines, Iowa, 50314
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Hollywood, Florida, 33021
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Hurst, Texas, 76054
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Jacksonville, Florida, 32216
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Lancaster, California, 93534
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Metairie, Louisiana, 70006
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Perrysburg, Ohio, 43551
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Plano, Texas, 75093
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Royal Oak, Michigan, 48073
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San Antonio, Texas, 78228
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Shreveport, Louisiana, 71101
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Spring Valley, California, 91978
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St Louis, Missouri, 63141
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Topeka, Kansas, 66606
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West Palm Beach, Florida, 33401

Other trials in United States

Germany6 sites

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Bad Mergentheim, 97980
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Bad Oeynhausen, 32545
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Berlin, 10787
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Giengen an der Brenz, 89537
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Mainz, 55116
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Münster, 48145

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Spain5 sites

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Alicante, 03114
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Alzira, 46600
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Barcelona, 08022
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Petrel, 03610
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Seville, 41014

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Austria3 sites

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Graz, 8036
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Vienna, 1090
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Vorarlberg, 6800

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Russia3 sites

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.
Chelyabinsk, 454047
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Moscow, 129110
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Saint Petersburg, 190000

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Poland2 sites

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Gdynia, 81-557
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Lodz, 90-242

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Czechia1 site

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Prague, 140 59

Other trials in Czechia

About this study

Official title: A 12-Week, Phase 2, Randomized, Double-Blind, Active-Controlled Study of LY2608204 Given as Monotherapy or in Combination With Metformin in Patients With Type 2 Diabetes Mellitus

Conditions: Diabetes Mellitus, Type 2
Being tested: LY2608204, Glimepiride
Keywords: diabetes, glimepiride, diabetes type II, diabetes type 2, Type 2 diabetes, diabetes mellitus
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

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

LY2608204Drug
Administered orally
GlimepirideDrug
Administered orally

Study groups in NCT01408095
Study group	Role	What they receive
LY2608204	Experimental	80 to 400 mg, Doses will be titrated to reach glycemic targets during the first 4 weeks. The starting dose level depends on the participant's HbA1c level measured at Screening. Administered orally, daily for 12 weeks Receives: Drug: LY2608204
Glimepiride	Active comparator	1 to 6 mg, Doses will be titrated to reach glycemic targets during the first 4 weeks. Administered orally, daily for 12 weeks Receives: Drug: Glimepiride

What is being measured

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

Change from baseline to 12 week endpoint in glycosylated fraction of hemoglobin A (HbA1c)
Measured: Baseline, 12 Weeks

Secondary outcomes (15)

Change from baseline to 12 week endpoint in fasting blood glucose
Measured: Baseline, 12 Weeks
Change from baseline to 12 week endpoint in average Seven Point Self Monitored Blood Glucose
Measured: Baseline, 12 Weeks
Change from baseline to 12 week endpoint for Oral Glucose Tolerance Test (OGTT)
Measured: Baseline, 12 Weeks
Change from baseline to 12 week endpoint in Homa-B: Insulin
Measured: Baseline, 12 Weeks
Change from baseline to 12 week endpoint in Homa-IR: Insulin
Measured: Baseline, 12 Weeks
Change from baseline to 12 week endpoint in Homa-S: Insulin
Measured: Baseline, 12 weeks
Change from baseline to 12 week endpoint in fasting lipids
Measured: Baseline, 12 Weeks
Change from baseline to 12 week endpoint in free fatty acids
Measured: Baseline, 12 Weeks
Change from baseline to 12 week endpoint in body weight
Measured: Baseline, 12 Weeks
Incidence of Hypoglycemic Episodes
Measured: Baseline through 12 weeks
Percentage of participants at each dose level up to 12 weeks
Measured: Baseline up to 12 weeks
Pharmacokinetics: Maximum plasma concentration (Cmax) of LY2608204
Measured: pre-dose, up to 12 hours post-dose
Number of participants with severe hypoglycemic episodes
Measured: Baseline through 12 weeks
Rate of hypoglycemic episodes
Measured: Baseline through 12 weeks
Pharmacokinetics: Area under the curve of concentration-time curve for one dosing interval at steady state (AUC0-tau, ss) of LY2608204
Measured: pre-dose, up to 12 hours post-dose

Timeline

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

Sep 2011Sep 2012

First posted3 Aug 2011 (estimated)
Study startSep 2011
Primary completionSep 2012 (estimated)
Study completionSep 2012 (estimated)

Why it stopped: Trial terminated no patients were screened or enrolled

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 240 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01408095
Sponsor's protocol ID: 14090
Other IDs: I3P-MC-GKBC
Status last verified: Aug 2011
First submitted: 1 Aug 2011
Last updated: 25 Aug 2011
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 12-Week, Phase 2, Randomized, Double-Blind, Active-Controlled Study of LY2608204 Given as Monotherapy or in Combination With Metformin in Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01408095
Acronym / sponsor ID: 14090
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes, glimepiride, diabetes type II, diabetes type 2, Type 2 diabetes, diabetes mellitus
Phase: Phase 2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Trial terminated no patients were screened or enrolled
Enrolment: 240 participants (estimated)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Sep 2011
Primary completion: Sep 2012 (estimated)
Study completion: Sep 2012 (estimated)
First posted: 3 Aug 2011 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
LY2608204	Experimental	Drug: LY260820480 to 400 mg, Doses will be titrated to reach glycemic targets during the first 4 weeks. The starting dose level depends on the participant's HbA1c level measured at Screening. Administered orally, daily for 12 weeks
Glimepiride	Active comparator	Drug: Glimepiride1 to 6 mg, Doses will be titrated to reach glycemic targets during the first 4 weeks. Administered orally, daily for 12 weeks

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Clinical diagnosis of type 2 diabetes mellitus prior to entering the trial
May be treated with:
Must have an Hemoglobin A1c value between 7% and 10%
Must have a body mass index (BMI) between 20 and 40 kg/m2
Must have stable weight during the 3 months prior to Screening (weight change not to exceed 5 kg (11 lb))

Key exclusion criteria (15 listed)

Use of insulin or any antidiabetic agent other than metformin or sulfonylurea or meglitinide during the 3 months prior to Screening
Have a gastrointestinal disease that significantly impacts gastric emptying or motility or have undergone gastric bypass or gastric banding surgery
Have had more than one episode of severe hypoglycemia within 6 months prior to entry into the study, or are currently diagnosed as having hypoglycemia unawareness or have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months
Are currently taking or have taken within the last 2 months, prescription or over-the counter medications which affect body weight
Have cardiac disease with functional status that is New York Heart Association [NYHA] Class II, III, or IV or a history of myocardial infarction, unstable angina, or decompensated congestive heart failure in the past 6 months.

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
LY2608204Administered orally	Drug	LY2608204
GlimepirideAdministered orally	Drug	Glimepiride

Primary outcome

Change from baseline to 12 week endpoint in glycosylated fraction of hemoglobin A (HbA1c)
Time frame: Baseline, 12 Weeks

15 secondary outcomes

Change from baseline to 12 week endpoint in fasting blood glucose
Time frame: Baseline, 12 Weeks
Change from baseline to 12 week endpoint in average Seven Point Self Monitored Blood Glucose
Time frame: Baseline, 12 Weeks
Change from baseline to 12 week endpoint for Oral Glucose Tolerance Test (OGTT)
Time frame: Baseline, 12 Weeks
Change from baseline to 12 week endpoint in Homa-B: Insulin
Time frame: Baseline, 12 Weeks
Change from baseline to 12 week endpoint in Homa-IR: Insulin
Time frame: Baseline, 12 Weeks
Change from baseline to 12 week endpoint in Homa-S: Insulin
Time frame: Baseline, 12 weeks
Change from baseline to 12 week endpoint in fasting lipids
Time frame: Baseline, 12 Weeks
Change from baseline to 12 week endpoint in free fatty acids
Time frame: Baseline, 12 Weeks
Change from baseline to 12 week endpoint in body weight
Time frame: Baseline, 12 Weeks
Incidence of Hypoglycemic Episodes
Time frame: Baseline through 12 weeks
Percentage of participants at each dose level up to 12 weeks
Time frame: Baseline up to 12 weeks
Pharmacokinetics: Maximum plasma concentration (Cmax) of LY2608204
Time frame: pre-dose, up to 12 hours post-dose
Number of participants with severe hypoglycemic episodes
Time frame: Baseline through 12 weeks
Rate of hypoglycemic episodes
Time frame: Baseline through 12 weeks
Pharmacokinetics: Area under the curve of concentration-time curve for one dosing interval at steady state (AUC0-tau, ss) of LY2608204
Time frame: pre-dose, up to 12 hours post-dose

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2011.

Related trials for Diabetes Mellitus, Type 2

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A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
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Recruiting
Culturally Tailored Program for Food-Insecure Adults: SPICE-D
Type 2 Diabetes Mellitus (T2D)
Not yet recruiting
Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality
Diabetes Mellitus (Type 2), Prediabetes
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction

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

38 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY2608204 and Glimepiride in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 38 sites in 7 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 11 inclusion and 15 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: withdrawn, as of the sponsor's last update on 25 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Germany, Spain, Austria, Russia and 2 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was withdrawn before enrolling participants, so there are no results.

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?

Change from baseline to 12 week endpoint in glycosylated fraction of hemoglobin A (HbA1c) (time frame: Baseline, 12 Weeks). 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 NCT01408095.

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 Aug 2011.