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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: September 29, 2014
Last verified: September 2014

February 11, 2013
September 29, 2014
March 2013
May 2014   (final data collection date for primary outcome measure)
Change from Baseline to 26 Weeks in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01790438 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study to Compare a New Long-Acting Insulin (LY2605541) and Human Insulin NPH in Participants With Type 2 Diabetes
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

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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: LY2605541
    Administered SQ
  • Drug: Human Insulin NPH
    Administered SQ
  • 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.
    Intervention: Drug: LY2605541
  • 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.
    Intervention: Drug: Human Insulin NPH
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
630
May 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Canada,   Czech Republic,   Germany,   Hungary,   Korea, Republic of,   Mexico,   Poland,   Puerto Rico,   Spain
 
NCT01790438
12143, I2R-MC-BIAK, 2012-003941-13
Yes
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP