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A Study in Adults With Type 2 Diabetes (ELEMENT 2)

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01421459
First received: August 19, 2011
Last updated: January 11, 2013
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: LY2963016
Drug: Lantus
Drug: Oral Antihyperglycemic Medications (OAMs)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-Blind Comparison of a Long-Acting Basal Insulin Analog LY2963016 to Lantus in Adult Patients With Type 2 Diabetes Mellitus: The ELEMENT 2 Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from baseline up to 24 weeks in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, up to 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in insulin antibody levels [ Time Frame: Baseline, 4 weeks, 12 weeks, up to 24 weeks ] [ Designated as safety issue: Yes ]
  • Change in Hemoglobin A1c [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks and 20 weeks ] [ Designated as safety issue: No ]
  • 7-point self-monitored blood glucose (SMBG) profiles [ Time Frame: Baseline and up to 24 weeks ] [ Designated as safety issue: No ]
  • Glycemic variability of fasting blood glucose [ Time Frame: Baseline and up to 24 weeks ] [ Designated as safety issue: No ]
  • Change in body weight [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, up to 24 weeks ] [ Designated as safety issue: No ]
  • Adult Low Blood Sugar Survey (ALBSS) [ Time Frame: 4 weeks, 12 weeks and up to 24 weeks ] [ Designated as safety issue: No ]
  • Insulin Treatment Satisfaction Questionnaire (ITSQ) [ Time Frame: 4 weeks, 12 weeks and up to 24 weeks ] [ Designated as safety issue: No ]
  • Insulin Dose per Body Weight (U/kg) [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
  • Percentage of participants with HbA1c <7 % and HbA1c ≤6.5% [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and up to 24 weeks ] [ Designated as safety issue: No ]
  • Insulin Dose (Units) [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
  • Incidence of Hypoglycemic events [ Time Frame: Baseline and up to 24 weeks ] [ Designated as safety issue: Yes ]
  • Rate per 30 days of hypoglycemic episodes [ Time Frame: Baseline and up to 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 606
Study Start Date: September 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2963016 + OAMs
LY2963016 titrated based on blood glucose readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
 Drug: LY2963016
Administered subcutaneously
Drug: Oral Antihyperglycemic Medications (OAMs)
Administered orally
Active Comparator: Lantus + OAMs
LY2963016 titrated based on blood glucose readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
 Drug: Lantus
Administered subcutaneously
Drug: Oral Antihyperglycemic Medications (OAMs)
Administered orally

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01421459

  Show 62 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Director: 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) Eli Lilly and Company
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01421459     History of Changes
Other Study ID Numbers: 13713, I4L-MC-ABEC, 2011-000828-15
Study First Received: August 19, 2011
Last Updated: January 11, 2013
Health Authority: United States: Food and Drug Administration
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes
France: Conseil National de l'Ordre des Médecins
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Korea: Food and Drug Administration
Mexico: Federal Commission for Protection Against Health Risks
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines and Medical Devices Agency
Russia: Ministry of Health of the Russian Federation
Slovak Republic: Ethics Committee
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Taiwan : Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Diabetes
Type 2 Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Glargine
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013