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Diabetes Mellitus, Type 2Phase 3NCT02106364

A Study of Insulin Peglispro (LY2605541) in Participants With Type 2 Diabetes Mellitus

A Phase 3 study testing Insulin Peglispro and Insulin Glargine in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 10 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The main purpose of this study is to compare the efficacy and safety of a new basal insulin, insulin peglispro, to insulin glargine in participants with type 2 diabetes mellitus (T2DM). Both drugs will be given by an injection under the skin. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Insulin Peglispro and Insulin Glargine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
10 sitesUnited States
Study dates
Feb 2015to Jun 2016
Phase
Phase 3
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have T2DM (per World Health Organization [WHO] Classification of Diabetes) not treated with insulin.
  • Have had diabetes for at least 1 year.
  • Have been receiving at least 2 oral antihyperglycemic medications (OAMs) for at least 3 months prior to the study.
  • Have hemoglobin A1c (HbA1c) of 7.0% to 11.0%, inclusive, according to central lab at screening.
  • Have body mass index (BMI) ≤40 kilogram/square meter (kg/m^2).
  • This inclusion criterion applies to females of child-bearing potential (not surgically sterilized and between menarche and 1-year postmenopausal) only: are not breastfeeding, test negative for a serum pregnancy test, intend not to become pregnant during study or willing to have a reliable method of birth control.

Who cannot join

  • Insulin therapy: have used insulin therapy (outside of pregnancy) anytime in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 continuous weeks. Insulin use of any duration during pregnancy is not considered an exclusion criterion.
  • Concomitant medications: rosiglitazone, pramlintide, glucagon-like peptide-1 (GLP-1) receptor agonist (for example, exenatide, exenatide once weekly, or liraglutide) used concurrently or within 3 months prior to screening.
  • Local OAM restrictions: for participants on OAMs, restrictions for cardiac, renal, hepatic diseases and maximum dose, local product regulations must apply.
  • Weight loss medications: are currently taking, or have taken within the 3 months preceding screening, prescription or over-the-counter medications to promote weight loss.
  • Severe hypoglycemia history: have had any episodes of severe hypoglycemia within 6 months prior to screening.
  • Diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar nonketotic coma (HHNKC): have had 1 or more episodes of DKA or hyperosmolar state/coma in the past 6 months.
Show all 12Show fewer
  • Cardiovascular: have cardiac disease with functional status that is New York Heart Association Class III or IV (per New York Heart Association [NYHA] Cardiac Disease Classification).
  • Renal: have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine ≥2 milligram/deciliter (mg/dL) (177 micromole/liter [mol/L]).
  • Hepatic: have obvious clinical signs or symptoms of liver disease (excluding non-alcoholic fatty liver disease [NAFLD]), acute or chronic hepatitis, non-alcoholic steatohepatitis (NASH), or elevated liver enzyme measurements.
  • Lipid-lowering medications:
  • Are using niacin preparations as a lipid-lowering medication or bile acid sequestrants within 90 days prior to screening; or,
  • Are using lipid-lowering medication at a dose that has not been stable for ≥90 days prior to screening.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Albuquerque Rehabilitation & Rheumatology, PC

    Albuquerque, New Mexico, 87102

  • Rheumatology Associates PC

    Birmingham, Alabama, 35205

  • STAT Research

    Dayton, Ohio, 45417

  • PMG Research of Hickory, LLC

    Hickory, North Carolina, 28602

  • Diagnostic Rheumatology and Research

    Indianapolis, Indiana, 46227

  • Apex Clinical Research

    Kennewick, Washington, 99336

  • Washington University Medical Center

    St Louis, Missouri, 63110

  • Heartland Research Associates

    Wichita, Kansas, 67207

  • Carolina Arthritis Associates

    Wilmington, North Carolina, 28401

  • Florida Medical Clinic PA

    Zephyrhills, Florida, 33542-7505

Other trials in United States

About this study

Official title: A Comparison of LY2605541 Versus Insulin Glargine as Basal Insulin Treatment in Combination With Oral Anti-Hyperglycemia Medications in Insulin-Naïve Patients With Type 2 Diabetes Mellitus: An Open-Label, Randomized, 52-week Study

The main purpose of this study is to compare the efficacy and safety of a new basal insulin, insulin peglispro, to insulin glargine in participants with type 2 diabetes mellitus (T2DM). Both drugs will be given by an injection under the skin. Participants may continue to take oral antihyperglycemic medication (OAM) during the study, as prescribed by their personal physician. The study is expected to last about 12 months for each participant.

Being tested
Insulin Peglispro, Insulin Glargine
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.

  • Insulin PeglisproDrug

    Also called LY2605541

    Administered SQ

  • Insulin GlargineDrug

    Administered SQ

Study groups in NCT02106364
Study groupRoleWhat they receive
LY2605541ExperimentalLY2605541 administered by subcutaneous (SQ) injection once daily for 52 weeks. Initial dose is 10 units (10 U) and is titrated by investigator. Participants may continue oral antihyperglycemic medication (OAM) as prescribed by their personal physician.
Receives: Drug: Insulin Peglispro
Insulin GlargineActive comparatorInsulin glargine administered by SQ injection once daily for 52 weeks. Initial dose is 10 U and is titrated by investigator. Participants may continue OAM as prescribed by their personal physician.
Receives: Drug: Insulin Glargine

What is being measured

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

  1. Change from Baseline in Hemoglobin A1c (HbA1c) at 26 Week Endpoint

    Measured: Baseline, 26 Weeks

Secondary outcomes (15)

  1. Proportion of Participants with HbA1c ≤6.5% and <7.0%

    Measured: Week 26 and Week 52

  2. Proportion of Participants with HbA1c <7.0% Without Nocturnal Hypoglycemia Event

    Measured: Baseline through 26 Weeks and Baseline through 52 Weeks

  3. Rate of Total and Nocturnal Hypoglycemia Events

    Measured: Baseline to 26 Weeks

  4. Fasting Serum Glucose (FSG) by Laboratory Measurements

    Measured: 26 Weeks

  5. 9 Point Self Monitored Blood Glucose

    Measured: 26 Weeks

  6. Change from Baseline in Body Weight at Week 26 Endpoint

    Measured: Baseline, 26 Weeks

  7. Change from Baseline in HbA1c at 52 Week Endpoint

    Measured: Baseline, Week 52

  8. Insulin Dose by Unit

    Measured: 26 Weeks

  9. Time to Reach Steady-State

    Measured: Baseline through 52 Weeks

  10. Fasting Blood Glucose by Self Monitoring

    Measured: Baseline through 52 Weeks

  11. Intra-Participant Variability in Fasting Blood Glucose

    Measured: Baseline through 52 Weeks

  12. Change from Baseline in EuroQol-5 Dimension Questionnaire (EQ-5D) Score

    Measured: Baseline, Week 26, Week 52

  13. Change from Baseline in the Low Blood Sugar Survey (LBSS)

    Measured: Baseline, Week 26, Week 52

  14. Number of Participants Developing Anti-Insulin Peglispro Antibodies

    Measured: Week 26 and Week 52

  15. Change from Baseline in Lipid Profile

    Measured: Baseline, Week 26

Timeline

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

  1. First posted8 Apr 2014 (estimated)
  2. Study startFeb 2015
  3. Primary completionNov 2015 (estimated)
  4. Study completionJun 2016 (estimated)

Why it stopped: Lilly's decision to cancel this trial is due to regulatory uncertainty in China.

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02106364
Sponsor's protocol ID
13564
Other IDs
I2R-MC-BIDB
Status last verified
Mar 2016
First submitted
3 Apr 2014
Last updated
28 Mar 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Insulin Peglispro and Insulin Glargine in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 10 sites in United States.

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 12 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 28 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 in Hemoglobin A1c (HbA1c) at 26 Week Endpoint (time frame: Baseline, 26 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 NCT02106364.

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 28 Mar 2016.

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