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Diabetes Mellitus, Type 2Phase 2NCT02111096

A Study of LY2409021 in Participants With Type 2 Diabetes Mellitus

A Phase 2 study testing LY2409021, Sitagliptin and Metformin in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 33 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The intent of this study is to assess the safety of LY2409021 in participants with Type 2 diabetes mellitus taking metformin and sulfonylurea as prescribed by their personal physician. The study treatment is expected to last 12 months (52 weeks). Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
LY2409021, Sitagliptin and Metformin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
174 participants
Where
33 sitesin 4 countries
Study dates
Apr 2014to Sep 2015
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 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have been treated with a stable dose of metformin for at least 3 months and have been treated with an optimally effective and stable dose of an sulfonylurea for at least 6 months prior to screening.
  • HbA1c value between 7.0% and 10.0%, inclusive.
  • Body mass index (BMI) between 20 and 45 kilograms/square meter (kg/m^2), inclusive.

Who cannot join

  • Known type 1 diabetes mellitus.
  • More than 1 episode of severe hypoglycemia within 6 months prior to screening.
  • Two or more emergency room visits or hospitalizations due to poor glucose control in the 6 months prior to screening.
  • Severe gastrointestinal disease that may significantly impact gastric emptying or motility or having undergone gastric bypass or gastric banding surgery.
  • Previous history or active diagnosis of pancreatitis.
  • Positive hepatitis B surface antigen or hepatitis C antibody.
Show all 10Show fewer
  • Clinical signs or symptoms of liver disease, or hepatic aminotransferases (aminotransferase or alanine aminotransferase) greater than 2.0× upper limit of normal (ULN) or elevated alkaline phosphatase (greater than ULN) unrelated to bone metabolic disease.
  • Elevated total bilirubin level (greater than ULN), clinically suspicious signs/symptoms of cirrhosis or history of cirrhosis.
  • Current diagnosis, personal history of neuroendocrine tumors, family history of any type of multiple endocrine neoplasia (MEN), or Von Hippel-Lindau.
  • Contraindications for magnetic resonance imaging.

Trial locations and contacts

33 sites in 4 countries.

33 sites in 4 countries

United States26 sites

  • University Diabetes and Endocrine Consultants

    Chattanooga, Tennessee, 37411

  • Cedar-Crosse Research Center

    Chicago, Illinois, 60607

  • Cosmopolitan International Diabetes Center

    Columbia, Missouri, 65212

  • John Muir Health Network - The Osteoporosis Center

    Concord, California, 94520

  • Midwest CRC

    Crystal Lake, Illinois, 60012

  • Dallas Diabetes Endocrine Center

    Dallas, Texas, 75230

  • Galenos Research

    Dallas, Texas, 75251

  • Iderc, P.L.C.

    Des Moines, Iowa, 50314

  • Office:Alwine,Lk

    Downingtown, Pennsylvania, 19335

  • Valley Endocrine, Fresno

    Fresno, California, 93720

  • San Gabriel Clinical Research

    Georgetown, Texas, 78626

  • University of Hawaii

    Honolulu, Hawaii, 96813

  • East West Medical Institute

    Honolulu, Hawaii, 96814

  • Rocky Mountain Diabetes and Osteoporosis Center

    Idaho Falls, Idaho, 83404

  • Centex Studies, Inc

    Lake Charles, Louisiana, 70601

  • Palm Research Center

    Las Vegas, Nevada, 89148

  • National Research Institute

    Los Angeles, California, 90057

  • Suncoast Research Group, LLC

    Miami, Florida, 33135

  • New Horizon Research Center

    Miami, Florida, 33175

  • Oakwell Clinical Research

    San Antonio, Texas, 78218

  • Victorium Clinical Research

    San Antonio, Texas, 78240

  • Polyclinic

    Seattle, Washington, 98104

  • Mercy Medical Research Institute

    Springfield, Missouri, 65807

  • Clinical Research of West Florida, Inc.

    Tampa, Florida, 33603

  • SHS Clinical Research Group

    Toms River, New Jersey, 08753

  • Cotton O'Neil Clinic

    Topeka, Kansas, 66606

Other trials in United States

Puerto Rico3 sites

  • PRADNET, Inc. Centro Especializado de Nutricion y Bariatria

    Hato Rey, 00917

  • American Telemedicine Center

    San Juan, 00917-3104

  • GCM Medical Group PSC

    San Juan, 909

Other trials in Puerto Rico

Greece2 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.

    Athens, 11527

  • 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.

    Thessaloniki, 54636

Other trials in Greece

Taiwan2 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.

    Changhua, 500

  • 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.

    Yong Kung City, 71004

Other trials in Taiwan

About this study

Official title: A Phase 2, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of LY2409021 Compared to Sitagliptin in Subjects With Type 2 Diabetes Mellitus

The intent of this study is to assess the safety of LY2409021 in participants with Type 2 diabetes mellitus taking metformin and sulfonylurea as prescribed by their personal physician. The study treatment is expected to last 12 months (52 weeks).

Being tested
LY2409021, Sitagliptin, Placebo, Metformin, Sulfonylurea
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

    Administered orally

  • SitagliptinDrug

    Administered orally

  • PlaceboDrug

    Administered orally

  • MetforminDrug

    Administered orally

  • SulfonylureaDrug

    Administered orally

Study groups in NCT02111096
Study groupRoleWhat they receive
LY2409021Experimental20 milligrams (mg) LY2409021 given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
Receives: Drug: LY2409021; Drug: Metformin; Drug: Sulfonylurea
SitagliptinActive comparator100 mg sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
Receives: Drug: Sitagliptin; Drug: Metformin; Drug: Sulfonylurea
PlaceboPlacebo comparatorPlacebo matching LY2409021 and sitagliptin given orally once daily in the morning for 12 months (52 weeks). Participants remain on stable doses of metformin and sulfonylurea, as prescribed by their personal physician.
Receives: Drug: Placebo; Drug: Metformin; Drug: Sulfonylurea

What is being measured

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

  1. Change From Baseline to 6 Months in Hepatic Fat Fraction

    The hepatic fat fraction (HFF) was calculated by a core imaging laboratory from noncontrast magnetic resonance imaging (MRI) of the liver. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.

    Measured: Baseline, 6 months

Secondary outcomes (14)

  1. Change From Baseline to 6 Months in Alanine Aminotransferase Levels

    Alanine aminotransferase (ALT) assessed by a central laboratory. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.

    Measured: Baseline, 6 months

  2. Number of Participants With Hepatobiliary Adverse Events of Special Interest (AESI)

    Number of participants with ALT or AST greater than 3 times the upper limit of normal at a post-baseline visit. A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.

    Measured: Baseline, 6 months

  3. Change From Baseline to 6 Months in Fasting Lipids Levels

    Lipid values (cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides) assessed by a central laboratory. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.

    Measured: Baseline, 6 months

  4. Change From Baseline to 6 Months in Fasting Blood Glucagon

    Glucagon values assessed by a central laboratory. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.

    Measured: Baseline, 6 months

  5. Change From Baseline to 6 Months in Body Weight

    Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.

    Measured: Baseline, 6 months

  6. Change From Baseline to 6 Months in 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) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, visit, baseline score, and treatment-by-visit.

    Measured: Baseline, 6 months

  7. Change From Baseline to 6 Months in Fasting Plasma Glucose

    Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.

    Measured: Baseline, 6 months

  8. Change From Baseline to 6 Months in Blood Pressure

    Seated systolic blood pressure (SBP) and seated diastolic blood pressure (DBP) were measured in triplicate throughout the study. At each visit, all available blood pressure measurements for a subject were averaged to provide the blood pressure for that visit. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.

    Measured: Baseline, 6 months

  9. Change From Baseline to 6 Months in Pulse Rate

    Seated pulse rate was measured in triplicate throughout the study. At each visit, all available pulse measurements for a subject were averaged to provide the pulse for that visit. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, country, baseline HbA1c stratum (<=8.0%, >8.0%), visit, baseline score, and treatment-by-visit.

    Measured: Baseline, 6 months

  10. Change From Baseline to 6 Months in 7-Point Self-Monitoring of Blood Glucose (SMBG)

    7-point profile consists of pre-meal and 2-hour postprandial SMBG measurements for the morning, midday, and evening meals in 1 day and at 3 AM (nocturnal blood glucose measurement). Pre-meal measurements were taken before the subject began eating the meal. Participants recorded their glucose measurements in their study diaries.

    Measured: Baseline, 6 months

  11. Population Pharmacokinetics: Apparent Clearance of LY2409021

    Reported as a Population Estimate with % Standard Errors of Estimation (SEE), 5th-95th confidence interval.

    Measured: Day 1 Month 1, 3, 6, 9, predose, 1 hour postdose,

  12. Population Pharmacokinetics: Apparent Volume of Distribution of LY2409021

    Measured: Day 1 Month 1, 3, 6, 9, predose, 1 hour postdose,

  13. Rate of Hypoglycemic Events Adjusted Per 30 Days

    Documented symptomatic hypoglycemia, an event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration <=70 mg/dL (<=39 mmol/L),is presented. Rate: (30 days) is calculated as: (number of episodes during the time period divided by the number of days during the time period) multiplied by 30.

    Measured: Baseline through 6 months

  14. Number of Participants With Hypoglycemic Events

    Documented symptomatic hypoglycemia, an event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration <=70 mg/dL (<=39 mmol/L), is presented. The number of subjects with an event are subjects who had at least one episode of documented symptomatic hypoglycemia during the time period.

    Measured: Baseline through 6 months

Timeline

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

  1. First posted10 Apr 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionSep 2015
  4. Study completionSep 2015

Why it stopped: The overall benefit-risk profile did not support continued development of LY2409021 for type 2 diabetes.

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 2
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
174 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02111096
Sponsor's protocol ID
15286
Other IDs
I1R-MC-GLDJ, 2013-004275-12
Status last verified
Sep 2019
First submitted
8 Apr 2014
Last updated
9 Oct 2019
Data monitoring committee
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

  • Kazda CM, Frias J, Foga I, Cui X, Guzman CB, Garhyan P, Heilmann C, Yang JA, Hardy TA. Treatment with the glucagon receptor antagonist LY2409021 increases ambulatory blood pressure in patients with type 2 diabetes. Diabetes Obes Metab. 2017 Aug;19(8):1071-1077. doi: 10.1111/dom.12904. Epub 2017 Mar 27.

    PubMed 28191913

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY2409021, Sitagliptin and Metformin in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 33 sites in 4 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 3 inclusion and 10 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: stopped early, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States, Puerto Rico, Greece, Taiwan. 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?

Change From Baseline to 6 Months in Hepatic Fat Fraction (time frame: Baseline, 6 months). 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 NCT02111096, 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 9 Oct 2019.

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