Diabetes Mellitus, Type 2Phase 2NCT00871572

A Study for Participants With Type 2 Diabetes Mellitus

A Phase 2 study testing LY2409021 in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 19 sites in 3 countries.

Completed

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

Official record

Search all trials

Trial summary

This drug is being evaluated for possible treatment of type 2 diabetes mellitus. Participation in this study is expected to last up to 18 weeks. A goal of this study is to determine the safety and effectiveness of LY2409021. 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?: LY2409021
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 87 participants
Where: 19 sitesin 3 countries
Study dates: Mar 2009to Feb 2010
Phase: Phase 2
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

Participants must either be male or a female who cannot become pregnant, who has type 2 diabetes and is either controlling your diabetes through diet and exercise alone, or with diet and exercise taking metformin.
If participants are male, participants are willing to talk to the study doctor about birth control options during the study and for 3 months after the last dose of study medication.
Participants must have an Hemoglobin A1c (HbA1c) test of 6.5% to 10%
Participants must have a body mass index (BMI) between 25 to 40 kilograms/square meter (kg/m²).
Participants must be willing and able to test your blood sugar levels at home with a blood sugar meter.
Participants must complete a study diary as instructed by your study doctor and staff and return the study diary as instructed by the study doctor.
Participants must maintain consistent dietary, physical activity, and sleeping patterns throughout the study.

Who cannot join

Insulin, exenatide, or any diabetic medication other than metformin 3 months prior to screening to control you diabetes,
Medications to increase movement in your digestive tract or that slow movement in your digestive tract
Over-the-counter drugs or drugs prescribed by your doctor that cause weight loss or high or low blood sugar,
Chronically use oral glucocorticoids therapy or have received this type of medication within 8 weeks prior to beginning this study,
Class II and III antiarrhythmic agents (commonly used to prevent or relieve an irregular heartbeat),
Drugs that damage the liver

Show all 23Show fewer

Fibrates and niacin (both commonly used to treat high cholesterol) more than 1 gram/day (gm/day),
Central nervous stimulants, alcohol intake for males that is more than 2 units per day and for females that is more than 1 unit per day [1 unit=12 ounces (oz) or 360 milliliter (mL) of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits].
You have had one (1) or more cases of uncontrolled diabetes (very high blood sugars) which required hospitalization in the 6 months prior to the screening visit or have a diagnosis of hypoglycemia (low blood sugar) unawareness.
You had two (2) or more emergency room visits or were hospitalized for poor control of your diabetes (for example, keto-acidotic episode) in the last 6 months.
Participants have a problem with your stomach such that it empties slowly (diabetic gastroparesis) or you have had gastric bypass (bariatric) surgery.
Participants have a personal or family history of pancreatic neoplasia.
Participants have abnormal lipids (for example triglycerides).
Participants have had problems with your heart in the past 6 months, such as a heart attack, chest pain (angina), heart failure, heart bypass operation, angioplasty (a medical procedure to open a narrow or clogged blood vessel of the heart) or stent insertion (a procedure to insert a wire mesh tube to prop open a blood vessel after angioplasty), a heart rhythm problem, or a stroke.
Participants have an elevated or uncontrolled blood pressure.
Participant's electrocardiogram (ECG, a test that measures the electrical activity of your heart) is outside the normal limits, as determined by the study doctor.
Participants have a problem with your kidneys or are on dialysis.
Participants have a problem with your pancreas.
Participants must not have nor had liver disease (for example, Hepatitis B or C).
Participants have cancer, except for skin cancer or have been in remission (the absence of disease activity) from cancer for less than 5 years.
Participants have a serious or uncontrolled health problems (other than type 2 diabetes), blood disorders or laboratory tests that in the opinion of the doctor, could interfere with understanding the results of this study. The doctor will let you know if this applies to you.
Participants previously completed or withdrew from this study or any other study investigating LY2409021.
Participants are allergic to the study drug or other related drugs. You cannot be in this study if you are a woman and you possibly could become pregnant during this study.

Trial locations and contacts

19 sites in 3 countries.

Country

City, postcode or hospital

19 sites in 3 countries

United States13 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.
Buena Park, California, 90620
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.
Fort Lauderdale, Florida, 33306
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.
Huntington Park, California, 90255
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.
Idaho Falls, Idaho, 83404
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.
Jupiter, Florida, 33458
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.
Las Vegas, Nevada, 89101
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.
Madisonville, Kentucky, 42431
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.
New Port Richey, Florida, 34652
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.
Norfolk, Virginia, 23502
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.
Rapid City, South Dakota, 57702
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.
San Antonio, Texas, 78229
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.
Topeka, Kansas, 66606
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.
Westlake Village, California, 91361

Other trials in United States

Germany4 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.
Aschaffenburg, 63739
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.
Mainz, 55116
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.
München, 80336
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.
Saarlouis, 66740

Other trials in Germany

Lithuania2 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.
Kaunas, LT-51270
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.
Vilnius, LT-08661

Other trials in Lithuania

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of LY2409021 in Patients With Type 2 Diabetes Mellitus

Conditions: Diabetes Mellitus, Type 2
Being tested: LY2409021, Placebo
Keywords: Diabetes Mellitus, Type 2
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.

LY2409021Drug
4 capsules by mouth taken once daily for 12 weeks
PlaceboDrug
4 capsules by mouth once daily for 12 weeks

Study groups in NCT00871572
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
LY2409021 10 milligrams (mg)	Experimental	Not described Receives: Drug: LY2409021
LY2409021 30 mg	Experimental	Not described Receives: Drug: LY2409021
LY2409021 60 mg	Experimental	Not described Receives: Drug: LY2409021

What is being measured

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

Mean Change in Glycosylated Hemoglobin A1c (HbA1c)
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was calculated using a mixed-model repeated measures analysis (MMRM) that included terms for treatment group, baseline HbA1c, metformin use, visit, and visit-by-treatment interaction.
Measured: Baseline, Week 12

Secondary outcomes (15)

Change From Baseline Values for Fasting Blood Glucose (FBG)
LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.
Measured: Baseline, Week 12
Change From Baseline for Glucose Area Under the Curve (AUC) From Oral Glucose Tolerance Test (OGTT)
LS mean was calculated using analysis of covariance (ANCOVA) model that included terms for treatment group, baseline value and metformin use.
Measured: Baseline, Week 12
Change From Baseline to Endpoint for Fasting Triglycerides
LS mean was calculated using ANCOVA model that included terms for treatment group, baseline value and metformin use.
Measured: Baseline, Week 12
Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R)
The DSC-R was a participant completed questionnaire that was designed to assess the presence and perceived burden of diabetes-related symptoms. Participants were asked to recall the last 4 weeks and consider each symptom/item in terms of whether they experienced it and if so, how troublesomeness it was. Participants were to consider troublesomeness of the symptom on a 1 (not at all) to 5 (extremely) point scale. There were a total of 34 items, grouped into 8 subscales: cardiovascular (4 items), psychological-cognitive distress (4 items), psychological-fatigue (4 items), hyperglycemic (4 items), hypoglycemic (3 items), neurological-pain (4 items), neurological-sensory (6 items) and visual (5 items). Sub-domain score calculated as: (sum of item scores) divided by (number of items), scores ranged from 1 to 5. Total score was the sum of all sub-domains and ranged from 8 to 40. Higher scores of total and subscales indicated worsened symptoms.
Measured: Baseline, Week 12
Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021)
The Diabetes Medicines Survey was a participant reported questionnaire consisting of 25 items: perceived effectiveness of diabetes medicines (items 1-10) and physical side-effects (items 11-25). Both domains had a scores range from 1 (all of the time) to 4 (none of the time) and a possible total scores range from 25 to 100. Lower scores for perceived effectiveness items indicated a better perceived effectiveness. Lower scores for physical side-effects items indicated a greater frequency of physical side-effects.
Measured: Baseline, Week 12
Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles
Participants obtained 7-point SMBG values immediately before and 2 hours after each meal and at bedtime. LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.
Measured: Baseline, Week 12
Change From Baseline Values for Fasting Insulin
LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.
Measured: Baseline, Week 12
Change From Baseline Values for Fasting Glucagon
LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.
Measured: Baseline, Week 12
Change From Baseline Values for Fasting Glucagon-Like Peptide 1 (GLP-1)
LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.
Measured: Baseline, Week 12
Change From Baseline for Insulin AUC From OGTT
LS mean was calculated using an ANCOVA that included terms for treatment group, baseline value and metformin use.
Measured: Baseline, Week 12
Change From Baseline for C-Peptide AUC From OGTT
LS mean was calculated using an ANCOVA model that included terms for treatment group, baseline value and metformin use.
Measured: Baseline, Week 12
Change From Baseline to Endpoint for Low Density Lipoprotein (LDL)
Fasting LDL LS mean was calculated using ANCOVA that included terms for baseline and treatment.
Measured: Baseline, Week 12
Change From Baseline to Endpoint for High Density Lipoprotein (HDL)
Fasting HDL LS mean was calculated using ANCOVA that included terms for baseline and treatment.
Measured: Baseline, Week 12
Change From Baseline to Endpoint for Non-HDL Cholesterol
Fasting non-HDL cholesterol LS mean was calculated using ANCOVA that included terms for baseline and treatment.
Measured: Baseline, Week 12
Change From Baseline to Endpoint for Total Cholesterol
Fasting total cholesterol LS mean was calculated using ANCOVA that included terms for baseline and treatment.
Measured: Baseline, Week 12

Timeline

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

Mar 2009Feb 2010

First posted30 Mar 2009 (estimated)
Study startMar 2009
Primary completionFeb 2010
Study completionFeb 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 87 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00871572
Sponsor's protocol ID: 11095
Other IDs: I1R-MC-GLBE
Status last verified: Mar 2018
First submitted: 26 Mar 2009
Last updated: 24 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kazda CM, Ding Y, Kelly RP, Garhyan P, Shi C, Lim CN, Fu H, Watson DE, Lewin AJ, Landschulz WH, Deeg MA, Moller DE, Hardy TA. Evaluation of Efficacy and Safety of the Glucagon Receptor Antagonist LY2409021 in Patients With Type 2 Diabetes: 12- and 24-Week Phase 2 Studies. Diabetes Care. 2016 Jul;39(7):1241-9. doi: 10.2337/dc15-1643. Epub 2015 Dec 17.
PubMed 26681715

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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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of LY2409021 in Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT00871572
Acronym / sponsor ID: 11095
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 87 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: Feb 2010 (actual)
Study completion: Feb 2010 (actual)
First posted: 30 Mar 2009 (estimated)
Results: Posted 24 Apr 2018

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: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo
LY2409021 10 milligrams (mg)	Experimental	Drug: LY2409021
LY2409021 30 mg	Experimental	Drug: LY2409021
LY2409021 60 mg	Experimental	Drug: LY2409021

Who may qualify

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

Key inclusion criteria (7 listed)

Participants must either be male or a female who cannot become pregnant, who has type 2 diabetes and is either controlling your diabetes through diet and exercise alone, or with diet and exercise taking metformin.
If participants are male, participants are willing to talk to the study doctor about birth control options during the study and for 3 months after the last dose of study medication.
Participants must have an Hemoglobin A1c (HbA1c) test of 6.5% to 10%
Participants must have a body mass index (BMI) between 25 to 40 kilograms/square meter (kg/m²).
Participants must be willing and able to test your blood sugar levels at home with a blood sugar meter.

Key exclusion criteria (23 listed)

Insulin, exenatide, or any diabetic medication other than metformin 3 months prior to screening to control you diabetes,
Medications to increase movement in your digestive tract or that slow movement in your digestive tract
Over-the-counter drugs or drugs prescribed by your doctor that cause weight loss or high or low blood sugar,
Chronically use oral glucocorticoids therapy or have received this type of medication within 8 weeks prior to beginning this study,
Class II and III antiarrhythmic agents (commonly used to prevent or relieve an irregular heartbeat),

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
LY24090214 capsules by mouth taken once daily for 12 weeks	Drug	LY2409021 10 milligrams (mg), LY2409021 30 mg, LY2409021 60 mg
Placebo4 capsules by mouth once daily for 12 weeks	Drug	Placebo

Primary outcome

Mean Change in Glycosylated Hemoglobin A1c (HbA1c)
Time frame: Baseline, Week 12
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was calculated using a mixed-model repeated measures analysis (MMRM) that included terms for treatment group, baseline HbA1c, metformin use, visit, and visit-by-treatment interaction.

15 secondary outcomes

Change From Baseline Values for Fasting Blood Glucose (FBG)
Time frame: Baseline, Week 12
Change From Baseline for Glucose Area Under the Curve (AUC) From Oral Glucose Tolerance Test (OGTT)
Time frame: Baseline, Week 12
Change From Baseline to Endpoint for Fasting Triglycerides
Time frame: Baseline, Week 12
Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R)
Time frame: Baseline, Week 12
Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021)
Time frame: Baseline, Week 12
Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles
Time frame: Baseline, Week 12
Change From Baseline Values for Fasting Insulin
Time frame: Baseline, Week 12
Change From Baseline Values for Fasting Glucagon
Time frame: Baseline, Week 12
Change From Baseline Values for Fasting Glucagon-Like Peptide 1 (GLP-1)
Time frame: Baseline, Week 12
Change From Baseline for Insulin AUC From OGTT
Time frame: Baseline, Week 12
Change From Baseline for C-Peptide AUC From OGTT
Time frame: Baseline, Week 12
Change From Baseline to Endpoint for Low Density Lipoprotein (LDL)
Time frame: Baseline, Week 12
Change From Baseline to Endpoint for High Density Lipoprotein (HDL)
Time frame: Baseline, Week 12
Change From Baseline to Endpoint for Non-HDL Cholesterol
Time frame: Baseline, Week 12
Change From Baseline to Endpoint for Total Cholesterol
Time frame: Baseline, Week 12

Results and safety

Results posted to the registry on 24 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	10	8
10 mg LY2409021	17	11
30 mg LY2409021	34	30
60 mg LY2409021	26	19

Primary outcome: Mean Change in Glycosylated Hemoglobin A1c (HbA1c)

Time frame: Baseline, Week 12. Least squares mean (90% Confidence Interval). Unit: percentage of HbA1c

Measure	Placebo n = 8	10 mg LY2409021 n = 11	30 mg LY2409021 n = 31	60 mg LY2409021 n = 19
Value	0.11 (-0.44 to 0.65)	-0.83 (-1.28 to -0.38)	-0.65 (-0.93 to -0.37)	-0.66 (-1.00 to -0.31)

Placebo vs 10 mg LY2409021: Mean Difference (Final Values): -0.94 (90% CI -1.64 to -0.23), p = 0.0296, Mixed Models Analysis
Placebo vs 30 mg LY2409021: Mean Difference (Final Values): -0.76 (90% CI -1.37 to -0.15), p = 0.0418, Mixed Models Analysis
Placebo vs 60 mg LY2409021: Mean Difference (Final Values): -0.76 (90% CI -1.41 to -0.12), p = 0.0514, Mixed Models Analysis

Population analysed: Modified Intent-to-Treat (mITT): All randomized participants with at least 1 post baseline HbA1c measurement and analyzed according to the assigned treatment.

15 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 9 (0%)	6 of 9 (66.7%)	Not reported
10 mg LY2409021	1 of 17 (5.9%)	14 of 17 (82.4%)	Not reported
30 mg LY2409021	0 of 34 (0%)	25 of 34 (73.5%)	Not reported
60 mg LY2409021	1 of 25 (4%)	18 of 25 (72%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26681715Kazda CM, Ding Y, Kelly RP, Garhyan P, Shi C, Lim CN, Fu H, Watson DE, Lewin AJ, Landschulz WH, Deeg MA, Moller DE, Hardy TA. Evaluation of Efficacy and Safety of the Glucagon Receptor Antagonist LY2409021 in Patients With Type 2 Diabetes: 12- and 24-Week Phase 2 Studies. Diabetes Care. 2016 Jul;39(7):1241-9. doi: 10.2337/dc15-1643. Epub 2015 Dec 17.

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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 9AM-5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

19 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY2409021 in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 19 sites in 3 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 7 inclusion and 23 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 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, Germany, Lithuania. 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 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?

Yes. Results are posted in the registry (first posted 24 Apr 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?

Mean Change in Glycosylated Hemoglobin A1c (HbA1c) (time frame: Baseline, Week 12). 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 NCT00871572, which also lists 1 linked publication.

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 24 Apr 2018.