A Study to Compare a New Long-Acting Insulin (LY2605541) and Human Insulin NPH in Participants With Type 2 Diabetes (IMAGINE 6)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01790438
First received: February 11, 2013
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to compare LY2605541 and human insulin NPH using the following measures for participants treated for up to 26 weeks:

  • Change in participants' overall blood sugar control
  • The number of night time low blood sugar episodes
  • The number of participants that reach blood sugar targets without low night time blood sugar episodes
  • The total number of low blood sugar episodes reported

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: LY2605541
Drug: Human Insulin NPH
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison of LY2605541 Versus Human Insulin NPH as Basal Insulin Treatment in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With 2 or More Oral Antihyperglycemic Medications: An Open-Label, Randomized Study

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from Baseline to 26 Weeks in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 30-Day Adjusted Rate of Total and Nocturnal Hypoglycemic Events [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants with HbA1c ≤6.5% and <7.0% [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
  • Fasting Serum Glucose (FSG) (by Laboratory) and Fasting Blood Glucose (FBG) (by Self Monitoring) [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
  • 6-Point Self-Monitored Blood Glucose (SMBG) [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline to 26 Weeks in Body Weight [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
  • HbA1c [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
  • Insulin Dose per Kilogram (kg) of Body Weight [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
  • Time to Steady-State (Stable Maximum Dose) [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline to 26 Weeks in European Quality of Life - 5 Dimension 3 Levels (EuroQol-5D-3L) Index [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
  • Insulin Treatment Satisfaction Questionnaire (ITSQ) Score [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline to 26 Weeks in Adult Low Blood Sugar Survey (LBSS) Scores [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline to 26 Weeks in Lipid Profile [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: Yes ]
  • Change in Insulin Antibodies [ Time Frame: Baseline to 26 Weeks ] [ Designated as safety issue: Yes ]
  • Intra-Participant Variability in FBG [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants with Total and Nocturnal Hypoglycemic Events [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants with HbA1c <7.0% and without Nocturnal Hypoglycemia [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
  • Number of Participants with Injection Site Reactions [ Time Frame: 26 Weeks ] [ Designated as safety issue: Yes ]
  • 30-Day Adjusted Rate of Severe Hypoglycemic Events [ Time Frame: 26 Weeks ] [ Designated as safety issue: Yes ]
  • Percentage of Participants with Severe Hypoglycemic Events [ Time Frame: 26 Weeks ] [ Designated as safety issue: Yes ]
  • Change from Baseline to 26 Weeks in European Quality of Life - Visual Analog Scales (VAS) Scores [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 630
Study Start Date: March 2013
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2605541
Administered by subcutaneous (SQ) injection once daily in the morning or at bedtime. Initial dose is 10 units and is adjusted weekly based on Fasting Blood Glucose (FBG). LY2605541 will be given alone or in combination with up to 3 pre-study oral antihyperglycemic medications [OAM(s)] whose use is not excluded in combination with insulin. Treatment may last up to 26 weeks.
Drug: LY2605541
Administered SQ
Active Comparator: Human Insulin NPH
Administered by SQ injection once daily at bedtime. Initial dose is 10 units and is adjusted weekly based on FBG. Human insulin NPH will be used alone or in combination with up to 3 pre-study OAM(s) whose use is not excluded in combination with insulin. Treatment may last up to 26 weeks. Some participants who are unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may be asked to add a second injection prior to the morning meal.
Drug: Human Insulin NPH
Administered SQ

  Eligibility

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

Inclusion Criteria:

  • Have had type 2 diabetes mellitus for at least 1 year, not treated with insulin
  • Have been receiving 2 or more OAMS for at least 3 months prior to the study
  • Have a hemoglobin A1c (HbA1c) of 7.0% to 11.0%, inclusive, at screening
  • Have a body mass index (BMI) less than or equal to 45.0 kilograms per square meter (kg/m^2)
  • Women of childbearing potential are not breastfeeding, have a negative pregnancy test at screening and randomization, do not plan to become pregnant during the study, have practiced reliable birth control for at least 6 weeks prior to screening and will continue to do so during the study and until 2 weeks after the last dose of study drug

Exclusion Criteria:

  • Have used insulin therapy in the past 2 years (except for use during pregnancy or for short term use for acute conditions)
  • Have been treated with glucagon-like peptide-1 (GLP-1) receptor agonist, rosiglitazone, pramlintide, or weight-loss medication within 3 months before screening
  • For participants on OAMs: have any restrictions for cardiac, renal, and hepatic diseases in the local product regulations
  • Are taking, or have taken within the 90 days before screening, prescription or over-the-counter medications to promote weight loss
  • Have had any episodes of severe hypoglycemia, diabetic ketoacidosis, or hyperosmolar state/coma within 6 months prior to screening
  • Have cardiac disease with functional status that is New York Heart Association Class III or IV
  • Have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine greater than or equal to 2 milligrams per deciliter (mg/dL) [177 millimoles per liter (mmol/L)]
  • 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
  • Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c
  • Have active or untreated cancer, have been in remission from clinically significant cancer(other than basal cell or squamous cell skin cancer) for less than 5 years, or are at increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator
  • Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intranasal, intraocular, and inhaled preparations) or have received such therapy within the 8 weeks immediately preceding screening
  • Have fasting triglycerides greater than 400 mg/dL (4.5 mmol/L) at screening
  • Have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night) in the investigator's opinion
  • Are using or have used any of the following lipid-lowering medications: niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01790438

  Show 63 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM 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: NCT01790438     History of Changes
Other Study ID Numbers: 12143, I2R-MC-BIAK, 2012-003941-13
Study First Received: February 11, 2013
Last Updated: June 3, 2014
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Canada: Health Canada
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Hungary: Institutional Ethics Committee
Hungary: National Institute of Pharmacy
Poland: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Korea: Food and Drug Administration
Korea: Institutional Review Board
Mexico: Federal Commission for Protection Against Health Risks
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Spain: Comité Ético de Investigación Clínica

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

ClinicalTrials.gov processed this record on July 08, 2014