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A Study in Adults With Type 2 Diabetes

NCT ID: NCT01421459

Last Updated: 2014-12-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

759 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-09-30

Brief Summary

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The main purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus in controlling blood sugar levels in combination with two or more oral diabetes medications.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Keywords

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Diabetes Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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LY2963016 + OAMs

LY2963016 titrated based on blood glucose readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) \[alpha glucosidase inhibitors (AGI), dipeptidyl peptidases intravenous (DPP-IV), meglitinide (MEG), metformin (MET), sulfonylurea (SU), and thiazolidinedione (TZD)\] administered per standard of care for 24 weeks

Group Type EXPERIMENTAL

LY2963016

Intervention Type DRUG

Administered subcutaneously

OAMs

Intervention Type DRUG

Administered orally

Lantus + OAMs

Lantus titrated based on blood glucose readings, administered subcutaneously, once daily in combination with at least 2 OAMs (AGI, DPP-IV, MEG, MET, SU, and TZD) administered per standard of care for 24 weeks

Group Type ACTIVE_COMPARATOR

Lantus

Intervention Type DRUG

Administered subcutaneously

OAMs

Intervention Type DRUG

Administered orally

Interventions

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LY2963016

Administered subcutaneously

Intervention Type DRUG

Lantus

Administered subcutaneously

Intervention Type DRUG

OAMs

Administered orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have Type 2 Diabetes Mellitus based on the disease diagnostic criteria World Health Organization (WHO) classification
* Have been taking at least 2 types of oral diabetes medications for at least 12 weeks prior to entering the study
* Have a Hemoglobin A1c value greater than or equal to 7.0 percent and less than or equal to 11.0 percent if insulin naive If previously on Lantus, then Hemoglobin A1c must be less than or equal to 11.0 percent
* Have a body mass index of less than or equal to 45 kilogram per meter squared (kg/m\^2)

Exclusion Criteria

* Have significant liver, cardiac or gastrointestinal disease
* Have active cancer or have had cancer within the past 5 years (with the exception of basal cell carcinoma or carcinoma in situ)
* Have an excessive resistance to insulin or hypersensitivity to Lantus
* Have had more than one episode of severe low blood sugar (defined as needing someone else to help because you had very low blood sugar) within the 6 months before entering the study
* Have taken any other insulin other than Lantus within the past 30 days
* Taking any other diabetes medicines that are not allowed in the study or not approved to be taken with insulin
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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.

Montgomery, Alabama, United States

Site Status

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Brooksville, Florida, United States

Site Status

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Fort Lauderdale, Florida, United States

Site Status

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New Port Richey, Florida, United States

Site Status

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Oviedo, Florida, United States

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Pembroke Pines, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

Site Status

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Roswell, Georgia, United States

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Des Moines, Iowa, United States

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Topeka, Kansas, United States

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Port Gibson, Mississippi, United States

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Springfield, Missouri, United States

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Omaha, Nebraska, United States

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Nashua, New Hampshire, United States

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Mineola, New York, United States

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New Hyde Park, New York, United States

Site Status

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Syracuse, New York, United States

Site Status

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Asheville, North Carolina, United States

Site Status

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Salisbury, North Carolina, United States

Site Status

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Fargo, North Dakota, United States

Site Status

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Philadelphia, Pennsylvania, United States

Site Status

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Dallas, Texas, United States

Site Status

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Houston, Texas, United States

Site Status

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Hurst, Texas, United States

Site Status

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Longview, Texas, United States

Site Status

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Plano, Texas, United States

Site Status

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San Antonio, Texas, United States

Site Status

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Brandýs nad Labem, , Czechia

Site Status

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Prague, , Czechia

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Nantes, , France

Site Status

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Vieux-Condé, , France

Site Status

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Aschaffenburg, , Germany

Site Status

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Dresden, , Germany

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Giengen an der Brenz, , Germany

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Hamburg, , Germany

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Heidelberg, , Germany

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Lüneburg, , Germany

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Saint Ingbert-Oberwürzbach, , Germany

Site Status

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Thessaloniki, , Greece

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Budapest, , Hungary

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Pápa, , Hungary

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Guadalajara Jalisco, , Mexico

Site Status

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Mexico City, , Mexico

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Monterrey, , Mexico

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Tampico, , Mexico

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Bialystok, , Poland

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Gdansk, , Poland

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Ruda Śląska, , Poland

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Wroclaw, , Poland

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Carolina, , Puerto Rico

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Manatí, , Puerto Rico

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San Juan, , Puerto Rico

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Santurce, , Puerto Rico

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Seoul, , South Korea

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Ulsan, , South Korea

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Málaga, , Spain

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Palma de Mallorca, , Spain

Site Status

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Teruel, , Spain

Site Status

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Taichung, , Taiwan

Site Status

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Taipei, , Taiwan

Site Status

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Yong Kung City, , Taiwan

Site Status

Countries

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Italy Romania Russia Slovakia United States Czechia France Germany Greece Hungary Mexico Poland Puerto Rico South Korea Spain Taiwan

References

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Nishiyama H, Shingaki T, Suzuki Y, Ilag LL. Similar Intrapatient Blood Glucose Variability with LY2963016 and Lantus(R) Insulin Glargine in Patients with Type 1 (T1D) or Type 2 Diabetes, Including a Japanese T1D Subpopulation. Diabetes Ther. 2018 Aug;9(4):1469-1476. doi: 10.1007/s13300-018-0450-0. Epub 2018 May 31.

Reference Type DERIVED
PMID: 29855972 (View on PubMed)

Pollom RK, Costigan T, Lacaya LB, Ilag LL, Hollander PA. Similar Efficacy and Safety of Basaglar(R) and Lantus(R) in Patients with Type 2 Diabetes in Age Groups (< 65 Years, >/= 65 Years): A Post Hoc Analysis from the ELEMENT-2 Study. Diabetes Ther. 2018 Apr;9(2):827-837. doi: 10.1007/s13300-018-0405-5. Epub 2018 Mar 14.

Reference Type DERIVED
PMID: 29542012 (View on PubMed)

Other Identifiers

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I4L-MC-ABEC

Identifier Type: OTHER

Identifier Source: secondary_id

2011-000828-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

13713

Identifier Type: -

Identifier Source: org_study_id